Steqeyma 90 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Steqeyma 90 mg solution for injection in a pre-filled syringe

ustekinumab

?This medicine is subject to additional monitoring, which will allow quicker 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 all of this 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 Steqeyma to a child, please read this information carefully.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Steqeyma is and what it is used for

What Steqeyma is

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

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

What Steqeyma is used for

Steqeyma is used to treat the following inflammatory diseases:

• 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. Steqeyma reduces inflammation and other signs of the disease.

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

Steqeyma 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 usually occurs alongside psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well to these medicines, you may be treated with Steqeyma 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 medications. If you do not respond adequately or cannot tolerate these medications, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Steqeyma. Your doctor will assess your condition before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Your doctor will also ask whether you have recently been in contact with someone who might have tuberculosis. Your doctor will examine you and perform a test for tuberculosis before you start using Steqeyma. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious adverse effects

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

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

If you are unsure whether you have any of these conditions, speak with your doctor or pharmacist before using Steqeyma.

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, in sun-exposed areas of skin, or if it is accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of psoriasis patients 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 unusual sensations on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

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

Other medicines, vaccines, and Steqeyma

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 using Steqeyma.
• If you received Steqeyma during pregnancy, inform your infant’s doctor about your Steqeyma treatment 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 Steqeyma during pregnancy, unless your infant’s doctor advises otherwise.

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 Steqeyma during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraception while using Steqeyma and for at least 15 weeks after the last dose.
• Ustekinumab can cross the placenta to the fetus. If you received Steqeyma during pregnancy, your infant may have an increased risk of infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received Steqeyma 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 Steqeyma during pregnancy, unless your infant’s doctor recommends otherwise.
• 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 Steqeyma. Do not do both simultaneously.

Driving and using machines

The influence of Steqeyma on the ability to drive and operate machinery is negligible or none.

Steqeyma contains polysorbate 80

Steqeyma contains 0.04 mg of polysorbate 80 (E433) per dosage unit, equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

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

Always follow exactly the dosing instructions for this medicine 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 Steqeyma should be administered

Your doctor will determine the amount of Steqeyma you need and the duration of treatment.

Adults aged 18 years and older Psoriasis or psoriatic arthritis

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

Crohn's disease

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

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of Steqeyma to inject to achieve the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.
• A 45 mg vial is available for children who require less than the full 45 mg dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Steqeyma per kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Steqeyma.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Steqeyma.
• 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 Steqeyma via intravenous infusion (a drip into a vein in your arm). After the initial dose, you will receive the next dose of 90 mg of Steqeyma 8 weeks later, and then every 12 weeks, via subcutaneous injection ("subcutaneous route").
• In some patients, after the first subcutaneous injection, 90 mg of Steqeyma will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How Steqeyma is administered

• Steqeyma is administered by subcutaneous injection ("subcutaneous route"). At the beginning of your treatment, medical or nursing staff may administer Steqeyma to you.
• However, you and your doctor may decide that you will self-inject Steqeyma. In that case, you will be trained on how to self-administer Steqeyma.
• For instructions on how to inject Steqeyma, see "Instructions for administration" at the end of this leaflet.

Consult your doctor if you have any questions about how to self-inject.

If you use more Steqeyma than you should

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

If you forget to use Steqeyma

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

If you stop using Steqeyma

Stopping the use of Steqeyma 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 may cause adverse effects, although not everybody gets 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, allergic reactions affecting the lungs and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience symptoms such as cough, difficulty breathing, and fever.

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

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 the 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).

Steqeyma may affect your ability to fight infections. Some of these infections may become serious and may be caused by viruses, fungi, bacteria (including tuberculosis) or parasites. They include infections that occur mainly 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 Steqeyma. These include:

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

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to serious 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 Steqeyma 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, itchy, and painful (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, possibly accompanied by joint pains).

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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a maximum single period of up to 31 days in their original carton to protect them from light. Write the date when the pre-filled syringe is first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this 31-day period at room temperature, the product may be returned to the refrigerator once and stored there until the original expiration date. Discard the syringe if it is not used within the 31-day room temperature storage period or by the original expiration date, whichever occurs first.
• Do not shake the pre-filled syringes of Steqeyma. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging following “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains foreign particles floating in it (see section 6 “What Steqeyma 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 vigorously shaken.

Steqeyma is for single use only. Any unused portion remaining in the syringe must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Steqeyma

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections.

Appearance of Steqeyma and contents of the pack

Steqeyma is a clear or slightly opalescent (with a pearly sheen), colourless to pale yellow, injectable solution. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing 1 ml pre-filled glass syringe as a single dose. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorisation Holder

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Manufacturer

Nuvisan France SARL

2400, Route des Colles

06410, Biot

France

MIDAS Pharma GmbH

Rheinstrasse 49

55218 West Ingelheim Am Rhein

Rhineland-Palatinate

Germany

Kymos S.L.

Ronda de Can Fatjó 7B

Parc Tecnològic del Vallès

08290 Cerdanyola Del Valles

Barcelona

Spain

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

Belgium/Belgium/Belgium Celltrion Healthcare Belgium BVBA Tel/Tel: + 32 1528 7418 [email protected]	Lithuania Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493
	Luxembourg/Luxembourg Celltrion Healthcare Belgium BVBA Tel/Tel: + 32 1528 7418 [email protected]
Czech Republic Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493	Hungary Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493
Denmark Celltrion Healthcare Denmark ApS Tlf.: +45 3535 2989 [email protected]	Malta Mint Health Ltd Tel: + 356 2093 9800
Germany Celltrion Healthcare Deutschland GmbH Tel: + 49 (0)30 346494150 i [email protected]	Netherlands Celltrion Healthcare Netherlands B.V. Tel: + 31 20 888 7300 [email protected]
Estonia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 [email protected]	Norway Celltrion Healthcare Norway AS [email protected]
Spain Kern Pharma, S.L. Tel: +34 93 700 2525	Austria Astro-Pharma GmbH Tel: + 43 1 97 99 860
Greece BIANEX S.A. Tel: + 30 210 8009111	Poland Celltrion Healthcare Hungary Kft. Tel.: + 36 1 231 0493
France Celltrion Healthcare France SAS Tél: + 33 (0)1 71 25 27 00	Portugal CELLTRION PORTUGAL, UNIPESSOAL LDA Tel: + 351 21 936 8542 [email protected]
Croatia Oktal Pharma d.o.o. Tel: + 385 1 6595 777	Romania Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493
Ireland Celltrion Healthcare Ireland Limited Tel: + 353 1 223 4026 [email protected]	Slovenia OPH Oktal Pharma d.o.o. Tel: + 386 1 519 29 22
Iceland Celltrion Healthcare Hungary Kft. Sími/Tel: + 36 1 231 0493 [email protected]	Slovakia Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493
Italy Celltrion Healthcare Italy S.R.L. Tel: + 39 0247927040 [email protected]	Finland Celltrion Healthcare Finland Oy. Puh/Tel: + 358 29 170 7755 [email protected]
Cyprus C.A. Papaellinas Ltd Tel: + 357 22741741	Sweden Celltrion Sweden AB Tel: +46 8 80 11 77 [email protected]
Latvia Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493

Date of last review of this leaflet <{MM/YYYY}>.

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

Administration instructions

At the beginning of treatment, your healthcare professional will assist you with the first injection. However, you and your doctor may decide that you can self-inject Steqeyma. If so, you will receive training on how to inject Steqeyma. Speak with your doctor if you have any doubts about how to self-inject.

Important information

• Do not open the sealed cardboard packaging until you are ready to use the pre-filled syringe.

• Do not remove the cap until just before administering the injection.

• Do not mix Steqeyma with other injectable liquids.

• The pre-filled syringe is not reusable. Immediately dispose of the used pre-filled syringe in a sharps container (see step 14. Disposal of Steqeyma).

• The syringe cap design may vary depending on the supplied materials and may be flexible or rigid.

Storage of Steqeyma

• Keep the pre-filled syringe out of the sight and reach of children. It contains small parts.
• Store the pre-filled syringe in the refrigerator between 2 °C and 8 °C. Do not freeze.
• Keep this medicine in its closed packaging to protect it from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a maximum single period of up to 31 days in their original carton to protect them from light.
• Record the date when the pre-filled syringes were first removed from the refrigerator in the spaces provided for this purpose on the outer box. ? At any time before the end of the room temperature storage period, the product may be returned to the refrigerator once and stored there until the original expiration date.
• Do not shake the Steqeyma pre-filled syringes. Vigorous shaking may damage the medicine.
• Do not use the medicine if it has been shaken vigorously.
• Do not use the pre-filled syringe if it has been dropped.

Parts of the pre-filled syringe (see Figure A)

Preparation for injection

Figure B	Gather injection supplies. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area. Remove from the refrigerator the boxes containing the prefilled syringes needed to administer the prescribed dose. Ensure you have the following supplies (see Figure B): Box with prefilled syringe Not included in the box: Cotton ball or gauze Bandage Sharps disposal container Alcohol swab
	Figure C	Check the expiration date on the box (see Figure C). Do not use if the expiration date has passed. If the expiration date has passed, return the entire package to the pharmacy.
	Figure D	Wait 30 minutes. Open the box. Holding the barrel of the syringe, remove the prefilled syringe from the box. Let the prefilled syringe sit outside the box for about 30 minutes at room temperature (20 °C to 25 °C) to warm to room temperature (see Figure D). This will allow the liquid to reach an appropriate temperature for injection (room temperature). Do not heat the prefilled syringe using heat sources such as hot water or a microwave. Do not touch the plunger rod or the cap. Do not pull back on the plunger rod at any time.
	Figure E	Inspect the prefilled syringe. Examine the prefilled syringe and confirm it contains the correct medication (Steqeyma) and dose. Check the prefilled syringes to ensure the number of syringes and concentration are correct: If your dose is 90 mg, you will receive one 90 mg prefilled syringe of Steqeyma. Inspect the prefilled syringe to ensure it is not cracked or damaged. Check the expiration date on the label of the prefilled syringe (see Figure E). Do not use if the expiration date has passed. Do not shake the prefilled syringe.

Figure F	Inspect the medication. Examine the medication and confirm that the liquid is clear or slightly opalescent and colorless to pale yellow (see Figure F). Do not use the prefilled syringe if the liquid has changed color or appears cloudy. It is normal to see air bubbles in the liquid.
Figure G	Choose an appropriate injection site (see Figure G). The injection can be given in: The upper thighs. The lower abdomen, except for the 5 cm around the navel. The outer area of the upper arm if you are a caregiver. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or has skin lesions. If possible, avoid areas of skin showing signs of psoriasis. Do not inject through clothing. Choose a different injection site for each new injection, at least 2.5 cm away from the site used for the last injection.
	Figure H	Wash your hands. Wash your hands with soap and water and dry them thoroughly (see Figure H).
		Clean the injection site. Clean the injection site with an alcohol swab using a circular motion (see Figure I). Allow the skin to dry before injecting. Do not blow on or touch the injection site again before administering the injection.
Figure I

Administration of the injection

Figure J	Remove the needle cap. Remove the needle cap when you are ready to inject Steqeyma by holding the body of the pre-filled syringe with one hand between your thumb and index finger (see Figure J). Do not hold the plunger rod while removing the cap. You may notice an air bubble in the pre-filled syringe or a few drops of liquid at the needle tip. This is normal. Immediately dispose of the cap in a sharps container (see Step 14 and Figure J). ? Do not use the pre-filled syringe if it falls without the needle cap in place. If this happens, contact your doctor or pharmacist. Inject the dose immediately after removing the needle cap. Do not recap the pre-filled syringe. Do not touch the needle. Otherwise, you could accidentally prick yourself.
Figure K	Insert the pre-filled syringe at the injection site. Hold the body of the pre-filled syringe with one hand between your thumb and index finger. Use your other hand to gently pinch clean skin between your thumb and index finger. Do not squeeze tightly. Note: Pinching the skin is important to ensure the medication is injected under the skin (into the fatty layer) and not deeper (into the muscle). With a quick, dart-like motion, insert the needle completely into the skin fold at a 45-degree angle (see Figure K). Do not pull back on the plunger rod at any time.
Figure L	Administer the injection. After inserting the needle, release the skin pinch. Slowly push the plunger rod completely down until the full dose of medication is injected and the syringe is empty (see Figure L). Do not change the position of the pre-filled syringe once the injection has started. If the plunger rod is not fully depressed, the needle shield will not extend to cover the needle upon removal.

Remove the prefilled syringe from the injection site. Once the prefilled syringe is empty, as you withdraw the needle, slowly remove the needle by lifting your thumb off the plunger rod until the needle is fully covered by the needle guard (see Figure M). If the needle is not covered, carefully proceed to dispose of the syringe (see Step 14. Disposal of Steqeyma). Do not reuse the prefilled syringe. Do not rub the injection site. Figure M

After the injection

Care of the injection site. If bleeding occurs, treat the injection site by gently pressing, not rubbing, with cotton wool or a gauze pad at the site, and apply a plaster if necessary

Figure N

Disposal of Steqeyma. Place the used pre-filled syringe into a sharps disposal container immediately after use (see Figure N). Do not throw away (dispose of) the pre-filled syringe in household waste. If a sharps disposal container is not available, you may use a household container that can be closed and is puncture-resistant. For your safety and health and that of others, needles and used syringes must never be reused. Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. Medicines must not be disposed of via wastewater drains or with household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.