Otulfi 45 mg solution for injection

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Otulfi 45mg injectable solution

ustekinumab

This medicine is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering Otulfi to a child, please read this information carefully.

• Keep this leaflet, as you may need to refer to 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 they have the same symptoms as you, as it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Otulfi is and what it is used for

What Otulfi is

Otulfi contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain proteins in the body.

Otulfi belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What Otulfi is used for

Otulfi is used to treat the following inflammatory conditions:

• Plaque psoriasis – in adults and children aged 6 years and older
• 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 disease that causes inflammation affecting the skin and nails. Otulfi reduces inflammation and other signs of the disease.

Otulfi is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or when these treatments are ineffective.

Otulfi is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies, or when these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If you do not respond well to these medicines, you may be treated with Otulfi to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce joint damage.

Crohn’s disease

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

2. What you need to know before using Otulfi

Do not use Otulfi

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

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using Otulfi.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Otulfi. Your doctor will assess your health status before 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 close contact with someone who might have tuberculosis. Your doctor will examine you and perform a test to detect tuberculosis before you start using Otulfi. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious side effects

Otulfi may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using Otulfi. See the full list of these side effects in the section “Serious side effects” in section 4.

Before using Otulfi, tell your doctor:

• If you have ever had an allergic reaction to ustekinumab. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Otulfi weaken part of the immune system. This may increase the risk of developing cancer.
• If you have previously been treated for psoriasis with other biologics (a medicine produced from a biological source, usually administered by injection) – the risk of developing cancer may be higher.
• If you currently have or have recently had an infection, or if you have any skin breaks (fistula).
• If you have any new skin lesions or changes in existing lesions within the psoriasis area or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressants or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Otulfi has not been studied. However, it may increase the likelihood of developing illnesses related to a weaker immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Otulfi may affect these treatments.
• If you are 65 years of age or older – you are more likely to develop infections.

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before using Otulfi.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or 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 accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of patients with psoriasis treated with ustekinumab. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention if you experience chest pain, weakness or numbness on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

The use of Otulfi is not recommended in children under 6 years of age with psoriasis, in children with Crohn’s disease weighing less than 40 kg, or in children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

Use of Otulfi with other medicines and vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or might use any other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while you are using Otulfi.
• If you received Otulfi during pregnancy, inform your infant’s doctor about your treatment with Otulfi before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant during the first twelve months after birth if you received Otulfi during pregnancy, unless otherwise advised by your infant’s doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to ustekinumab in the womb. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Otulfi during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use effective contraception while using Otulfi and for at least 15 weeks after the last dose.
• Ustekinumab can cross the placenta to the fetus. If you received Otulfi during pregnancy, your infant may have an increased risk of developing an infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received Otulfi during pregnancy before your infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant during the first twelve months after birth if you received Otulfi during pregnancy, unless otherwise recommended by your infant’s doctor.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether to breastfeed or use Otulfi. Do not do both at the same time.

Driving and using machines

The effect of Otulfi on the ability to drive and use machines is negligible or none.

Otulfi contains polysorbate 80 (E 433)

This medicine contains 0.02 mg of polysorbate 80 in each 0.5 ml vial, equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Otulfi

Otulfi should be used under the guidance and supervision of a physician experienced in the treatment of conditions for which Otulfi is indicated.

Always follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor. Ask your doctor when your injections should be administered and about follow-up appointments.

How much Otulfi should be administered

Your doctor will determine the dose of Otulfi you should receive and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Otulfi. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, the next dose will be given 4 weeks later, and subsequently every 12 weeks. The following doses are usually the same as the starting dose.

Crohn’s disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Otulfi as an intravenous infusion (a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Otulfi 8 weeks later, and then every 12 weeks thereafter, administered as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of Otulfi may be administered every 8 weeks. Your doctor will decide when your next dose should be given.

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of Otulfi to inject to deliver the correct dose. The appropriate dose depends on your body weight at the time each dose is given.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Otulfi per kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Otulfi.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Otulfi.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Otulfi as an intravenous infusion (a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Otulfi 8 weeks later, and then every 12 weeks thereafter, administered as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of Otulfi may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How Otulfi is administered

• Otulfi is administered by subcutaneous injection (“subcutaneously”). At the beginning of your treatment, medical or nursing staff may administer Otulfi to you.
• However, you and your doctor may decide that you can self-inject Otulfi. In this case, you will be trained in how to inject Otulfi yourself.
• For instructions on how to inject Otulfi, see “Administration instructions” at the end of this leaflet.

Consult your doctor if you have any questions about self-injecting.

If you use more Otulfi than you should

If you have used or been given too much Otulfi, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.

If you forget to use Otulfi

If you miss a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

If you stop using Otulfi

Stopping Otulfi is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Some patients may experience serious adverse effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in the population using ustekinumab (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing

• low blood pressure, which may cause dizziness or mild headaches

• swelling of the face, lips, mouth, or throat

• Common signs of an allergic reaction include rash and hives (may affect up to 1 in 100 people).

In rare cases, lung allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, difficulty breathing, or fever.

If you have a severe allergic reaction, your doctor may decide that you should no longer use Otulfi.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

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

Otulfi may affect your ability to fight infections. Some of these infections could become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. They include 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 receiving ustekinumab treatment.

You should monitor for signs of infection while using Otulfi. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; persistent cough
• skin feeling hot, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or loss of vision
• headache, neck stiffness, photosensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Otulfi until the infection resolves. Also contact your doctor if you have any open cuts or ulcers 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 disorders. If you notice any of these symptoms, you must inform your doctor immediately.

Other adverse effects

Common adverse effects (may affect up to 1 in 10 people):

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

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

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and sinking of the muscles 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 (skin exfoliation)
• Acne

Rare adverse 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 cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

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

• Blisters on the skin, which may be red and cause itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Otulfi

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2 °C and 8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Do not shake Otulfi vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and container after “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains floating foreign particles (see section 6, “What Otulfi looks like and contents of the pack”).
• If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).
• If the product has been shaken vigorously.
• If the seal is broken.

Otulfi is for single use only. Any unused product remaining in the vial or syringe must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Otulfi

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 ml.
• The other components are L-histidine, polysorbate 80 (E 433), sucrose, water for injections, and hydrochloric acid (for pH adjustment).

Appearance of Otulfi and contents of the pack

Otulfi is a clear injectable solution, colourless to slightly brownish-yellow.

It is supplied in a pack containing one single-use 3 ml glass vial. Each vial contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorisation Holder

Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria

Date of the most recent revision of this leaflet

Detailed information about this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu/

Administration instructions

At the beginning of treatment, your healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-inject Otulfi. In this case, you will be trained on how to administer Otulfi injections. Speak with your doctor if you have any doubts about administering the injections.

• Do not mix Otulfi with other injectable liquids.
• Do not shake Otulfi vials. The medicine may become damaged if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials:

Remove the vial(s) from the refrigerator. Allow the vial to sit for approximately 30 minutes so the liquid reaches a comfortable temperature for administration (room temperature).

Inspect the vial(s) to ensure that:

• The number of vials and concentration are correct
  • If the dose is 45 mg or less, you will be given one 45 mg vial of Otulfi.
  • If the dose is 90 mg, you will be given two 45 mg vials of Otulfi, and you will need to administer two injections. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other in the left thigh), and administer the injections one immediately after the other. Use a new needle and syringe for each injection.
• It is the correct medicine.
• The expiry date has not passed.
• The vial is not damaged and the seal is intact.
• The solution in the vial is clear, colourless to slightly brownish-yellow.
• The solution has not changed colour, is not cloudy, and contains no foreign particles.
• The solution is not frozen.

Children with paediatric psoriasis weighing less than 60 kg require a dose lower than 45 mg. Make sure you know the correct amount (volume) to withdraw from the vial and the type of syringe needed for dosing. If you are unsure about the amount or type of syringe required, contact your healthcare professional for further instructions.

Gather all necessary supplies and place them on a clean surface. Include the syringe, needle, antiseptic wipes, cotton wool or gauze, and a sharps disposal container (see Figure 1).

1. Choose and prepare the injection site:

Select the injection site (see Figure 2).

• Otulfi is administered by subcutaneous injection (under the skin).
• Suitable injection sites include the upper thigh or the abdominal area (at least 5 cm away from the navel).
• Whenever possible, avoid areas of skin showing signs of psoriasis.
• If someone else is administering the injection, the upper arm may also be used as an injection site.

Prepare the injection site:

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

1. Prepare the dose:
   • Remove the cap covering the top of the vial (see Figure 3).

• Do not remove the stopper.
• Clean the stopper with an alcohol swab.
• Place the vial on a flat surface.
• Take the syringe and remove the needle cap.
• Do not touch the needle or allow it to touch anything.
• Insert the needle through the rubber stopper.
• Turn the vial and syringe upside down.
• Pull back the plunger of the syringe to draw up the amount of liquid prescribed by your doctor.
• It is important that the needle remains fully immersed in the liquid at all times to prevent air bubbles from forming in the syringe (see Figure 4).

• Remove the needle from the vial.
• Hold the syringe with the needle pointing upwards to check for air bubbles inside.
• If air bubbles are present, gently tap the side of the syringe until the bubbles rise to the top (see Figure 5).

• Then, push the plunger gently to expel all air (but not the liquid).
• Do not place the syringe down and ensure the needle does not touch anything.

1. Administer the dose:

   • Gently pinch the disinfected skin between your thumb and index finger without squeezing tightly.
   • Insert the needle into the skin fold.
   • Push the plunger with your thumb slowly and steadily until it reaches the end, injecting all the liquid while maintaining the skin fold.
   • Once the plunger has been fully depressed, withdraw the needle and release the skin fold.

2. After the injection:

   • Press the injection site gently with an antiseptic wipe for a few seconds after the injection.
   • A small amount of blood or fluid may appear at the injection site. This is normal.
   • You may press the injection site with cotton wool or gauze for 10 seconds.
   • Do not rub the skin at the injection site. You may cover the injection site with a plaster if needed.

3. Disposal:

   • Used syringes and needles must be placed in a puncture-resistant container, such as a sharps disposal container. For your safety, your health, and the safety of others, never reuse needles or syringes. Dispose of your sharps container according to local regulations.
   • Empty vials, antiseptic wipes, gauze, and other materials may be discarded in the regular trash.