Fymskina

Package leaflet: Information for the user

Fymskina 130 mg concentrate for solution for infusion

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who take this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effect, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Fymskina is and what it is used for
2. What you need to know before using Fymskina
3. How Fymskina will be used
4. Possible side effects
5. How to store Fymskina
6. Contents of the pack and other information

1. What Fymskina is and what it is used for

What Fymskina is
Fymskina contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
Fymskina belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system to some extent.

What Fymskina is used for
Fymskina is used to treat the following inflammatory disease:

• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond adequately or are intolerant to these medicines, Fymskina may be given to you to reduce the signs and symptoms of your disease.

2. What you need to know before using Fymskina

Do not use Fymskina

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below)
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Fymskina.
Warnings and precautions
Talk to your doctor or pharmacist before using Fymskina. Your doctor will check your health status before starting treatment. Make sure to inform your doctor about any medical conditions you have before treatment. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Fymskina. If your doctor believes you are at risk for tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Fymskina can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Fymskina. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Fymskina, contact your doctor

• If you have ever had an allergic reaction to ustekinumab – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants like Fymskina partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – The risk of cancer may be higher.
• If you currently have or have recently had an infection or have abnormal openings on the skin (fistulas).
• If you have ever had any new or changed lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Fymskina has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used allergy injections (immunotherapy) – It is not known whether Fymskina may affect them.
• If you are aged 65 years or older – You may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Fymskina.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Fymskina is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease.
Other medicines, vaccines and Fymskina
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using Fymskina.
• if you received Fymskina during pregnancy, inform your child’s paediatrician about the Fymskina treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Fymskina during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, unless otherwise advised by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Fymskina during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant. You should use an effective method of contraception during treatment with Fymskina and for at least 15 weeks after stopping treatment with Fymskina.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Fymskina during pregnancy, your baby may have an increased risk of developing infections.
• If you received Fymskina during pregnancy, it is important to inform your baby’s paediatrician and other healthcare providers before your baby receives any vaccine. If you received Fymskina during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Fymskina. You cannot do both.

Driving and using machines
Fymskina has no or negligible influence on the ability to drive and use machines.
Fymskina contains sodium
Fymskina contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free". However, before administration, Fymskina is mixed with a solution that contains sodium. Talk to your doctor if you are on a low-salt diet.
Fymskina contains polysorbates
This medicine contains 10.4 mg of polysorbate 80 per 26 mL vial, equivalent to 0.4 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Fymskina will be used

Fymskina is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.
Fymskina 130 mg concentrate for solution for infusion will be administered by your doctor through an intravenous drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your doctor when you should receive your injections and follow-up appointments.

How much Fymskina is administered
Your doctor will decide how much Fymskina you need and for how long.

Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose based on your body weight.

Body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Fymskina via an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

Children with Crohn's disease weighing at least 40 kg

• Your doctor will calculate the recommended intravenous infusion dose based on body weight. Body weight Dose ≥ 40 to ≤ 55 kg 260 mg > 55 kg to ≤ 85 kg 390 mg > 85 kg 520 mg
• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Fymskina via an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

How Fymskina is administered
The first dose of Fymskina for the treatment of Crohn's disease is administered by your doctor via an intravenous drip into a vein in the arm (intravenous infusion).
Inform your doctor if you have any questions about the use of Fymskina.

If you forget to use Fymskina
If you forget or miss your scheduled dose appointment, contact your doctor to arrange a new appointment.

If you stop using Fymskina
Stopping treatment with Fymskina is not dangerous. However, if you discontinue treatment, your symptoms may return. If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab-containing medicines (affecting up to 1 in 1,000 patients). Signs include:
  o Difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness
  o Swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn’s disease, your first dose of
Fymskina is given by intravenous infusion (through a drip). Some patients have experienced severe allergic reactions during infusion of ustekinumab-containing medicines.
Allergic lung reactions and lung inflammation have been reported in rare cases in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Fymskina again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Fymskina may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while taking Fymskina. These include:

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or short of breath, persistent cough
• Warm, red, and painful skin, or a painful blistering rash
• Burning sensation when urinating
• Diarrhea
• Visual disturbance or loss of vision
• Headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Fymskina until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects ( may affect up to 1 in 10 patients)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects ( may affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects ( may affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects ( may affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Fymskina

• Fymskina 130 mg concentrate for solution for infusion is administered in a hospital or clinic setting, and patients do not need to handle or store it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C–8 °C). Do not freeze.
• Keep the vial in its outer packaging to protect the medicine from light.
• Do not shake the Fymskina vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Fymskina and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken.
• If the seal is broken.

Fymskina is for single use only. Any unused diluted solution for infusion remaining in the vial and syringe must be disposed of according to local regulations.

6. Pack contents and other information

What Fymskina contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium EDTA dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Fymskina and pack contents
Fymskina is a concentrate for solution for infusion, clear, colourless to slightly brownish-yellow. It is supplied in a cardboard pack containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of ustekinumab in 26 mL of concentrate for solution for infusion.
Marketing Authorisation Holder and Manufacturer
Formycon AG
Fraunhoferstraße 15
82152 Martinsried/Planegg
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BE / BG / CZ / DK / EE / IE / IS / EL / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL /
NO / AT / PL / PT / RO / SI / SK / FI / SE
Formycon AG
Tel/Tél/Teл./Tlf/Τηλ/Sími/Puh: + 49 89 864 667 100
Germany
ratiopharm GmbH
Tel: +49 731 402 02
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

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The following information is intended exclusively for healthcare professionals.

Traceability:
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product must be clearly documented.

Instructions for dilution:
Fymskina concentrate for solution for infusion must be diluted, prepared and administered by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of Fymskina vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL Fymskina vial contains 130 mg of ustekinumab.
2. Remove and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of Fymskina to be added (discard 26 mL of sodium chloride for each required Fymskina vial: for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL).
3. Withdraw 26 mL of Fymskina from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 24 hours of dilution in the infusion bag.
6. Use a single infusion set with a sterile, non-pyrogenic, low-protein-binding in-line filter (pore size 0.2 micrometres).
7. Each vial is for single use only. Any unused medicinal product must be disposed of in accordance with current local regulations.

Storage:
If necessary, the diluted infusion solution should be stored at room temperature.
The infusion must be completed within 24 hours after dilution in the infusion bag. Do not freeze.

Package leaflet: Information for the user

Fymskina 45 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.
This leaflet is intended for people taking this medicine. If you are a parent or caregiver administering Fymskina to a child, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Fymskina is and what it is used for
2. What you need to know before using Fymskina
3. How to use Fymskina
4. Possible side effects
5. How to store Fymskina
6. Contents of the pack and other information

1. What Fymskina is and what it is used for

What Fymskina is
Fymskina contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific target proteins in the body.
Fymskina belongs to a group of medicines called “immunosuppressants”. These medicines reduce the activity of the immune system to some extent.

What Fymskina is used for
Fymskina is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Fymskina will reduce inflammation and other signs of the disease.
Fymskina is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments have not worked.
Fymskina is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Fymskina to:

• reduce the signs and symptoms of the disease.
• improve physical function.
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Fymskina may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Fymskina

Do not use Fymskina

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before using Fymskina.
Warnings and precautions
Talk to your doctor or pharmacist before using Fymskina. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Additionally, inform your doctor if you have recently been in contact with
people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Fymskina. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.
Be aware of serious side effects
Fymskina can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Fymskina. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Fymskina, contact your doctor

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Fymskina partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to the injection of Fymskina – See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.
• If you are receiving any other type of treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce

immune system activity.

• If you are using or have ever used injections for the treatment of allergies – it is not known whether Fymskina may affect them.
• If you are aged 65 years or older – you may have a higher chance of getting infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Fymskina.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Fymskina is not recommended for the treatment of children under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines, and Fymskina
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Fymskina.
• if you received Fymskina during pregnancy, inform your child’s paediatrician about the Fymskina treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Fymskina during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.

• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Fymskina during pregnancy.

• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Fymskina and for at least 15 weeks after stopping treatment with Fymskina.

• Ustekinumab can cross the placenta and reach the unborn child. If you received Fymskina during pregnancy, your child may have an increased risk of developing an infection.

• If you received Fymskina during pregnancy, it is important that you inform the paediatrician and other healthcare providers before your child receives any vaccine. If you received Fymskina during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.

• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Fymskina. You cannot do both.

Driving and using machines
Fymskina does not affect or has a negligible effect on the ability to drive and use machines.
Fymskina contains polysorbates
This medicine contains 0.02 mg of polysorbate 80 per pre-filled syringe, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Fymskina

Fymskina is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Fymskina is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive your injections and follow-up
appointments.
How much Fymskina is administered
Your doctor will decide how much Fymskina you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Fymskina. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Fymskina is administered by your doctor via intravenous infusion into a vein in the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Fymskina, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Fymskina may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Fymskina to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time of each dose.
• If body weight is below 60 kg, there is no Fymskina formulation available for children weighing less than 60 kg; therefore, other ustekinumab-containing medicines must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Fymskina.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Fymskina.
• Four weeks after the initial dose, the next dose should be administered, followed by subsequent doses every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Fymskina is administered by your doctor via intravenous infusion into a vein in the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Fymskina, followed by subsequent doses every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Fymskina may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Fymskina is administered
Fymskina is administered via subcutaneous injection (“subcutaneously”). At the beginning of
treatment, medical or nursing staff may administer Fymskina to you.

• However, you and your doctor may decide whether you can self-inject Fymskina. In this case, you will be taught how to self-inject Fymskina. In children from 6 years of age, it is recommended that Fymskina be administered by a healthcare professional or caregiver, after appropriate training.
• For instructions on how to inject Fymskina, see “Instructions for administration” at the end of this package leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Fymskina than you should
If you have used or received too much Fymskina, inform your doctor or pharmacist immediately. Always
bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Fymskina
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a
missed dose.
If you stop using Fymskina
Stopping treatment with Fymskina is not dangerous. However, if you stop treatment, symptoms may
return.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency
medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab-containing medicines (affect up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affect up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving
ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of
breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should no longer use Fymskina.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any
of the following signs.

• Nasal, throat infections, and common cold are common (affect up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Fymskina may reduce your ability to fight infections. Some infections may become severe and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of the signs of infection while using Fymskina. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Fymskina until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be
symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If
you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects ( may affect up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects ( may affect up to 1 in 100 people)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects ( may affect up to 1 in 1,000 people)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects ( may affect up to 1 in 10,000 people)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fymskina

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C–8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Fymskina may also be stored at room temperature up to 30 °C for a single period of up to 30 days, remaining in the outer packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it should be discarded in the spaces provided on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Fymskina. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or "Scad". The expiry date refers to the last day of the month.
• If the solution has changed colour, is cloudy, or if foreign particles floating in the solution are visible (see section 6 “Description of the appearance of Fymskina and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously. Fymskina is for single use only. Any unused product remaining in the syringe must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Fymskina contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, polysorbate 80 (E433), sucrose, water for injections, and hydrochloric acid (for pH adjustment).

Description of the appearance of Fymskina and contents of the pack
Fymskina is a clear solution for injection, colourless to slightly brownish-yellow. It is supplied
in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe
contains a dose of 45 mg ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder and Manufacturer
Formycon AG
Fraunhoferstraße 15
82152 Martinsried/Planegg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BE / BG / CZ / DK / EE / IE / IS / EL / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL /
NO / AT / PL / PT / RO / SI / SK / FI / SE
Formycon AG
Tel/Tél/Teл./Tlf/Τηλ/Sími/Puh: + 49 89 864 667 100

Germany
ratiopharm GmbH
Tel: +49 731 402 02

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Fymskina. In this case, you will be taught how to self-administer Fymskina. Inform your doctor if you have any questions regarding self-injection. In children from 6 years of age, it is recommended that Fymskina be administered by a healthcare professional or by the person caring for the child, following appropriate training.

• Do not mix Fymskina with other injectable solutions.
• Do not shake the pre-filled syringes of Fymskina, as vigorous shaking may damage the medicinal product. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe

Plunger Activation clip for needle Syringe body Viewing window Needle protective cap
protection
Plunger tip Needle guard wings Label Needle

Figure 1

1. Check the number of pre-filled syringes and prepare materials

Prepare for using the pre-filled syringes.

• Remove the pre-filled syringe or multiple pre-filled syringes from the refrigerator. Leave the pre-filled syringe outside the carton for about half an hour. This will allow the liquid to reach a comfortable injection temperature (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by its barrel with the covered needle pointing upwards.
• Do not hold the syringe by the plunger head, the plunger, the needle shield, or the needle protective cap.
• Never pull back the plunger.
• Do not remove the needle cap from the pre-filled syringe until ready for use.
• Do not touch the safety activation clip (as indicated by the asterisk * in Figure 1) to prevent premature covering of the needle by the needle safety shield.
• Do not use the pre-filled syringe if it has fallen on a hard surface.

Inspect the pre-filled syringe to ensure:

• the number of pre-filled syringes and the dose are correct; if your dose is 45 mg, you will use one 45 mg pre-filled syringe of Fymskina; if your dose is 90 mg, you will use two 45 mg pre-filled syringes of Fymskina and will need to administer two injections. Choose two different body sites for these injections (e.g., one injection in the right thigh and the other in the left thigh), and administer the injections one after the other
• the medicine is the correct one
• the medicine has not expired
• the pre-filled syringe is not damaged
• the solution in the pre-filled syringe is clear, colorless to slightly brownish-yellow
• the liquid in the pre-filled syringe does not have a changed or cloudy appearance and contains no foreign particles
• the solution in the pre-filled syringe has not been frozen

Gather all necessary supplies and place them on a clean surface. You will need antiseptic swabs, a cotton ball or gauze, and a sharps disposal container.

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• Fymskina is administered by injection under the skin (subcutaneous injection).
• A suitable place for the injection is the upper part of the thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
• If possible, avoid areas of skin showing signs of psoriasis.
• If someone is assisting you with the injection, the upper part of the arms may also be used as an injection site.

Figure 2: The grey areas indicate recommended injection sites
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin using an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Remove the needle protective cap (see Figure 3)

• The needle protective cap must not be removed until you are ready to inject the dose.
• Take the prefilled syringe and hold it by the barrel with one hand.
• Remove and discard the needle protective cap. Do not touch the plunger during this step.

Figure 3

• If you notice an air bubble in the prefilled syringe or a drop of liquid at the tip of the needle, this is normal. Do not remove them.
• Do not touch the needle and avoid letting the needle touch any surface.
• Do not use the prefilled syringe if it is removed without the needle protective cap in place. If this happens, consult your doctor or pharmacist.
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, placing the thumb on top of the plunger. Use the other hand to gently pinch a cleaned area of skin, holding it between the thumb and index finger. Do not pinch too tightly.
• Under no circumstances should you pull back on the plunger.
• With one quick, smooth motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely inside the needle guard (see Figure 5).

Needle guard
Figure 5

• Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while removing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to rise upward, so that the needle is fully covered by the needle guard, as shown in Figure 7.

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if needed.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and the safety of others, never reuse the syringe. Dispose of the sharps container according to local regulations.
• Antiseptic swabs and other devices may be disposed of in regular waste.

Figure 8

Package leaflet: Information for the user

Fymskina 90 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who is to be given Fymskina, please read this information carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Fymskina is and what it is used for
2. What you need to know before using Fymskina
3. How to use Fymskina
4. Possible side effects
5. How to store Fymskina
6. Contents of the pack and other information

1. What Fymskina is and what it is used for

What Fymskina is
Fymskina contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins in the body.
Fymskina belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Fymskina is used for
Fymskina is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Fymskina will reduce inflammation and other signs of the disease.
Fymskina is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate or phototherapy, or in whom these treatments are ineffective.
Fymskina is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Fymskina to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Fymskina may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Fymskina

Do not use Fymskina

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Fymskina.
Warnings and precautions
Talk to your doctor or pharmacist before using Fymskina. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Fymskina. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.

Be aware of serious side effects
Fymskina can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Fymskina. See “Serious side effects” in section 4 for a complete list of these side effects.

Before using Fymskina, contact your doctor

• If you have ever had an allergic reaction to ustekinumab – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants like Fymskina partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – The risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changing skin lesions within the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to the injection of Fymskina – See “Be aware of serious side effects” in section 4 for signs of an allergic reaction.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with Fymskina has not been studied. However, it could increase the possibility of conditions related to a weakened immune system.
• If you are using or have ever used injections for allergy treatment – It is not known whether Fymskina may affect these treatments.
• If you are aged 65 years or older – You may have an increased risk of infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Fymskina.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.

Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
Fymskina is not recommended for the treatment of children under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

Other medicines, vaccines, and Fymskina
Inform your doctor or pharmacist:

• if you are currently taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Fymskina.
• if you received Fymskina during pregnancy, inform your child’s pediatrician about the Fymskina treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Fymskina during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s pediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Fymskina during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant. You should use an effective method of contraception during treatment with Fymskina and for at least 15 weeks after stopping treatment with Fymskina.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Fymskina during pregnancy, your child may have an increased risk of developing infections.
• If you received Fymskina during pregnancy, it is important that you inform your child’s pediatrician and other healthcare providers before your child receives any vaccine. If you received Fymskina during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the pediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Fymskina. You cannot do both.

Driving and operating machinery
Fymskina has no or negligible effect on the ability to drive vehicles and use machinery.

Fymskina contains polysorbates
This medicine contains 0.04 mg of polysorbate 80 per pre-filled syringe, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Fymskina

Fymskina is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Fymskina is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor. Discuss with your doctor when you should receive injections and follow-up visits.
How much Fymskina is administered
Your doctor will decide how much Fymskina you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Fymskina. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of Fymskina is administered by your doctor through an intravenous infusion (IV infusion) into a vein in your arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Fymskina, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Fymskina may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Fymskina to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time of each dose.
• If body weight is below 60 kg, there is no Fymskina formulation available for children weighing less than 60 kg; therefore, other ustekinumab-containing medicines must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Fymskina.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Fymskina.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of Fymskina is administered by your doctor through an intravenous infusion (IV infusion) into a vein in your arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Fymskina, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Fymskina may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Fymskina is administered
Fymskina is administered by subcutaneous injection ("subcutaneously"). At the beginning of
treatment, medical or nursing staff may administer Fymskina to you.

• However, you and your doctor may decide whether you can self-inject Fymskina. In this case, you will be trained on how to self-inject Fymskina. In children from 6 years of age, it is recommended that Fymskina be administered by a healthcare professional or caregiver after appropriate training.
• For instructions on how to inject Fymskina, see “Instructions for administration” at the end of this patient information leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Fymskina than you should
If you have used or received too much Fymskina, inform your doctor or pharmacist immediately. Always
bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Fymskina
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a
missed dose.
If you stop using Fymskina
Stopping treatment with Fymskina is not dangerous. However, if you stop treatment, symptoms
may return.
If you have further questions about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency
medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab-containing medicines (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving
ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness
of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should no longer use Fymskina.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice
any of the following signs.

• Nasal, throat infections and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Fymskina may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while using Fymskina. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Fymskina until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be
symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If
you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects ( affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects ( affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Blocked or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects ( affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects ( affect up to 1 in 10,000 patients)

• Blistering skin rash with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fymskina

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C–8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Fymskina may also be stored at room temperature up to 30 °C for a single period of up to 30 days, remaining in the outer packaging to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date by which it must be discarded in the designated spaces on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Fymskina. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Fymskina and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously. Fymskina is for single use only. Any unused product remaining in the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fymskina contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, polysorbate 80 (E433), sucrose, water for injections, and hydrochloric acid (for pH adjustment).

Description of the appearance of Fymskina and contents of the pack
Fymskina is a clear, colourless to slightly brownish-yellow injection solution. It is supplied in a
cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe
contains a single dose of ustekinumab 90 mg in 1 mL of injection solution.

Marketing Authorisation Holder and Manufacturer
Formycon AG
Fraunhoferstraße 15
82152 Martinsried/Planegg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BE / BG / CZ / DK / EE / IE / IS / EL / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL /
NO / AT / PL / PT / RO / SI / SK / FI / SE
Formycon AG
Tel/Tél/Teл./Tlf/Τηλ/Sími/Puh: + 49 89 864 667 100

Germany
ratiopharm GmbH
Tel: +49 731 402 02

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/.

Instructions for administration
At the beginning of treatment, your doctor will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Fymskina. In this case, you will be trained on how to self-administer Fymskina. Inform your doctor if you have any questions about self-injection. In children from 6 years of age, it is recommended that Fymskina be administered by a healthcare professional or by the person caring for the child, following appropriate training.

• Do not mix Fymskina with other injectable liquids.
• Do not shake the pre-filled syringes of Fymskina, as vigorous shaking may damage the medicinal product. Do not use the medicinal product if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe.

Plunger Activation clip of Body Viewing window Protective needle cap
needle protection
Needle hub Winged needle protector Label Needle
Plunger
Figure 1

1. Check the number of pre-filled syringes and prepare the materials

Prepare for the use of pre-filled syringes.

• Remove the pre-filled syringe or multiple pre-filled syringes from the refrigerator. Leave the pre-filled syringe outside the carton for about 30 minutes. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by its barrel with the covered needle pointing upwards.
• Do not hold it by the plunger rod, plunger, needle guard wings, or needle protective cap.
• Never pull back the plunger under any circumstances.
• Do not remove the needle cap from the pre-filled syringe until ready to use.
• Do not touch the activation clip for needle protection (as indicated by the asterisk * in Figure 1) to prevent premature covering of the needle by the needle guard.
• Do not use the pre-filled syringe if it has fallen on a hard surface.

Inspect the pre-filled syringe to ensure the following:

• The number of pre-filled syringes and the dose are correct; if your dose is 90 mg, you will use one 90 mg pre-filled syringe of Fymskina
• The medicine is the correct one
• The medicine has not expired
• The pre-filled syringe is not damaged
• The solution in the pre-filled syringe is clear, colorless to slightly brownish-yellow
• The liquid in the pre-filled syringe shows no discoloration or cloudiness and contains no foreign particles
• The solution in the pre-filled syringe has not been frozen.

Gather all necessary supplies and place them on a clean surface. The supplies should include antiseptic wipes, a cotton ball or gauze, and a sharps container.

2. Choose and prepare the injection site

Choose an injection site (see Figure 2).

• Fymskina is administered by injection under the skin (subcutaneous injection).
• A suitable place for the injection is the upper thigh or around the abdomen (abdominal area), at least 5 cm away from the navel.
• If possible, avoid areas of skin with signs of psoriasis.
• If someone is assisting you during the injection, the upper arm may also be used as an injection site.

Figure 2: The shaded areas indicate the recommended injection sites.
Prepare the injection site.

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Remove the needle protective cap (see Figure 3)

• The needle protective cap must not be removed until you are ready to inject the dose.
• Take the pre-filled syringe and hold it by the barrel with one hand.
• Remove and discard the needle protective cap. Do not touch the plunger during this step.

Figure 3

• If you notice an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle, this is normal. Do not remove them.
• Do not touch the needle and avoid letting the needle come into contact with any surface.
• Do not use the pre-filled syringe if the needle protective cap has been removed prior to use. If this happens, consult your doctor or pharmacist.
• Inject the contents immediately after removing the needle protective cap.

4. Inject the dose

• Hold the pre-filled syringe in one hand between the middle finger and index finger, placing the thumb on top of the plunger head. Use the other hand to gently pinch the cleaned area of skin between the thumb and index finger. Do not pinch too tightly.
• Do not pull back the plunger in any way.
• With one quick, swift motion, insert the needle into the skin as far as possible (see Figure 4).

Figure 4

• Inject all the liquid by pushing the plunger until the plunger head is completely between the needle guard wings (see Figure 5).

Needle guard
wings
Figure 5

• Push the plunger until it reaches the end of its travel, and continue to keep pressure on the plunger head while withdrawing the needle and gently releasing the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to move upward, completely covering the needle with the needle guard wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or liquid at the injection site. This is normal.
• You may press a cotton ball or gauze pad on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you may cover the injection site with a small adhesive bandage, if needed.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and the safety of others, never reuse the syringe. Dispose of the sharps container in accordance with local regulations.

• Antiseptic swabs and other devices may be disposed of in regular waste.

Figure 8