Benepali 50 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Benepali 50 mg solution for injection in a pre-filled pen

etanercept

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

• Keep this leaflet, as you may need to read it again.
• Your doctor will also provide you with a Patient Information Card containing important safety information you need to know before and during treatment with Benepali.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you or for the child in your care. Do not give it to other people, even if they have the same symptoms as you or the child in your care, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Benepali is and what it is used for

Benepali contains the active substance etanercept.

Benepali is a medicine made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Benepali works by reducing the inflammation associated with certain diseases.

Benepali can be used in adults aged 18 years and older for:

• the treatment of moderate to severe rheumatoid arthritis;
• psoriatic arthritis;
• severe axial spondyloarthritis, including ankylosing spondylitis;
• moderate to severe plaque psoriasis.

Usually, depending on the individual case, Benepali is used when other treatments have not been sufficiently effective or are not suitable for you.

In the treatment of rheumatoid arthritis, Benepali is typically used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is not appropriate for you. Benepali can slow down joint damage caused by rheumatoid arthritis and improve your ability to carry out daily activities, whether used alone or in combination with methotrexate.

In patients with psoriatic arthritis involving multiple joints, Benepali may improve your ability to perform normal daily activities.

In patients with multiple symmetric swollen or painful joints (for example, in the hands, wrists, and feet), Benepali may delay the progression of structural damage to these joints caused by the disease.

Benepali is also indicated for treatment in children and adolescents with the following conditions:

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked adequately or is not suitable:

• Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients from 2 years of age and with a body weight of 62.5 kg or more.

• Psoriatic arthritis in patients from 12 years of age and with a body weight of 62.5 kg or more.

• For enthesitis-related arthritis in patients from 12 years of age and with a body weight of 62.5 kg or more, when other commonly used treatments have not worked adequately or are not suitable.

• Severe plaque psoriasis in patients from 6 years of age and with a body weight of 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

2. What you need to know before using Benepali

Do not use Benepali

• if you or the child in your care are allergic to etanercept or to any of the other components of this medicine (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Benepali and contact your doctor immediately.
• if you or the child are at risk of developing a serious blood infection called sepsis. If you are unsure, consult your doctor.
• if you or the child currently have any type of infection. If you are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to use Benepali.

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Benepali and contact your doctor immediately.
• Infections/surgery: If you or the child develop a new infection or are about to undergo major surgery, your doctor may need to monitor or adjust treatment with Benepali.
• Infections/diabetes: Inform your doctor if you or the child have a history of recurrent infections or if you have diabetes or other disorders that increase the risk of infection.
• Infections/monitoring: Inform your doctor about any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills, or cough, notify your doctor immediately. Your doctor should decide whether continued monitoring for infections is needed even after stopping treatment with Benepali.
• Tuberculosis: Cases of tuberculosis have been reported in patients treated with Benepali. Your doctor will check for signs and symptoms of tuberculosis before starting Benepali. This may include a detailed medical history, chest X-ray, and a tuberculosis test. Completion of these assessments must be recorded on the Patient Information Card. It is very important to tell your doctor if you or the child have had tuberculosis or have been in close contact with someone who had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after treatment, inform your doctor immediately.
• Hepatitis B: Inform your doctor if you or the child have or have had hepatitis B. Your doctor should test you for hepatitis B before starting treatment with Benepali. Treatment with Benepali may reactivate hepatitis B in patients previously infected with the hepatitis B virus. If this occurs, you must stop using Benepali.
• Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may wish to monitor treatment with Benepali in case the infection worsens.
• Blood disorders: Inform your doctor immediately if you or the child have signs or symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate a serious blood disorder that requires discontinuation of Benepali treatment.
• Nervous system and vision disorders: Inform your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves), or transverse myelitis (inflammation of the spinal cord). Your doctor will decide whether Benepali is an appropriate treatment.
• Congestive heart failure: Inform your doctor if you or the child have a history of congestive heart failure, as Benepali must be used with caution in such cases.
• Cancer: Inform your doctor if you have or have had lymphoma (a type of blood cancer) or any other cancer before starting Benepali. Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing lymphoma. Children and adults taking Benepali may have an increased risk of developing lymphoma or other cancers. Some adolescent and pediatric patients who have received etanercept or other medicines that work similarly to etanercept have developed cancers, including unusual types, some of which have been fatal. Some patients receiving Benepali have developed skin cancers. Inform your doctor if you or the child develop any changes in the appearance of the skin or skin growths.
• Chickenpox (varicella): Inform your doctor if you or the child are exposed to chickenpox while using Benepali. Your doctor will determine whether preventive treatment for chickenpox is appropriate.
• Alcoholism: Benepali must not be used for the treatment of hepatitis related to alcoholism. Please inform your doctor if you or the child in your care have a history of alcoholism.
• Wegener’s granulomatosis: Benepali is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener’s granulomatosis, discuss this with your doctor.
• Antidiabetic medicines: Inform your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide that you or the child may need a lower dose of antidiabetic medicine while taking Benepali.
• Vaccines: Some vaccines, such as oral polio vaccine, must not be given while using Benepali. Consult your doctor before you or the child receive any vaccine.

Children and adolescents

The use of Benepali is not indicated in children and adolescents weighing less than 62.5 kg.

• Vaccinations: If possible, children should have all vaccinations up to date before starting Benepali. Some vaccines, such as oral polio vaccine, must not be given while using Benepali. Consult your doctor before you or the child receive any vaccine.

Benepali is generally not to be used in children under 2 years of age or weighing less than 62.5 kg with polyarticular or extended oligoarticular juvenile idiopathic arthritis, in children under 12 years of age or weighing less than 62.5 kg with enthesitis-related arthritis or psoriatic arthritis, or in children under 6 years of age or weighing less than 62.5 kg with psoriasis.

Using Benepali with other medicines

Tell your doctor or pharmacist if you or the child are taking, have recently taken, or might need to take any other medicines (including anakinra, abatacept, or sulfasalazine).

Do not use Benepali or allow the child to use it with medicines containing the active substance anakinra or abatacept.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Women of childbearing age should be advised to use adequate contraception to prevent pregnancy during treatment with Benepali and for at least 3 weeks after stopping treatment.

Benepali should only be used during pregnancy if clearly necessary.

If you have received Benepali during pregnancy, your baby may have an increased risk of developing an infection. In addition, one study reported a higher number of birth defects when the mother received etanercept during pregnancy compared to mothers who did not receive etanercept or similar medicines (TNF antagonists), but there was no consistent pattern in the types of birth defects reported. Another study found no increased risk of congenital malformations when the mother received etanercept during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby. Consult your doctor if you wish to breastfeed while on Benepali treatment. It is important to inform the pediatrician and other healthcare professionals about the use of Benepali during pregnancy and breastfeeding before your baby receives any vaccine.

Driving and using machines

There is no information indicating that the use of Benepali affects the ability to drive or operate machinery.

Benepali contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 25 mg dose; essentially, it is “sodium-free”.

3. How to use Benepali

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

If you think that the effect of Benepali is too strong or too weak, tell your doctor or pharmacist.

Use in adult patients (aged 18 years and older)

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis

The usual dose is 25 mg administered twice weekly or 50 mg once weekly, as a subcutaneous injection.

However, your doctor may determine an alternative frequency for administering Benepali.

Plaque psoriasis

The usual dose is 25 mg twice weekly or 50 mg once weekly.

Alternatively, 50 mg twice weekly may be administered for up to 12 weeks, followed by 25 mg twice weekly or 50 mg once weekly.

Your doctor will decide how long you should use Benepali and whether treatment should be repeated based on your response. If Benepali has no effect on your disease after 12 weeks, your doctor may instruct you to stop using this medicine.

Use in children and adolescents

The dose and dosing frequency will depend on the child's or adolescent's body weight and condition. Your doctor will determine the appropriate dose for the child and will prescribe the most suitable etanercept formulation.

The dose for pediatric patients with a body weight of 62.5 kg or more is 25 mg administered twice weekly or 50 mg administered once weekly using a pre-filled syringe or a pre-filled pen.

Other etanercept medicines with doses appropriate for children are available.

For polyarthritis or extended oligoarthritis in patients aged 2 years and older with a body weight of 62.5 kg or more, or for enthesitis-related arthritis or psoriatic arthritis in patients aged 12 years and older with a body weight of 62.5 kg or more, the usual dose is 25 mg administered twice weekly or 50 mg administered once weekly.

For psoriasis in patients aged 6 years and older with a body weight of 62.5 kg or more, the usual dose is 50 mg administered once weekly. If Benepali has no effect on the child's disease after 12 weeks, your doctor may instruct you to stop using this medicine.

Your doctor will give you precise instructions for preparing and calculating the correct dose.

Method and route of administration

Benepali is administered by subcutaneous injection (subcutaneous use).

Detailed instructions for injecting Benepali are provided in section 7, “Instructions for use”.

The Benepali solution must not be mixed with any other medicine.

To help you remember, it may be useful to record in a diary the day(s) of the week on which you should use Benepali.

If you use more Benepali than you should

If you use more Benepali than you should (either by injecting a higher amount at one time or by using it too frequently), you should speak to a doctor or pharmacist immediately. Always carry the medicine carton with you, even if it is empty.

If you forget to use Benepali

If you miss a dose, you should inject it as soon as you remember, unless the next dose is scheduled for the following day, in which case you should skip the missed dose. Then continue injecting the medicine on your usual day(s). If you do not remember until the day the next dose is due, do not inject a double dose (two doses on the same day) to make up for the missed dose.

If you stop using Benepali

Your symptoms may return after stopping treatment.

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 will experience them.

Allergic reactions

If you notice any of the following reactions, do not inject any more Benepali. Contact your doctor immediately or go to the nearest hospital Emergency Department.

• Difficulty swallowing or breathing
• Swelling of the face, throat, hands, and feet
• Feeling nervous or anxious, palpitations, sudden skin redness, and/or sensation of warmth
• Severe rash, itching, or hives (prominent red or pale welts on the skin, often accompanied by itching)

Severe allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Benepali, so you must seek immediate medical attention.

Serious adverse effects

If you notice any of the following effects, you or the child may require urgent medical care.

• Signs of serious infections (including pneumonia, non-superficial skin infections, joint infections, and blood infection), such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a painful, tender, red, and warm area on the skin or joints;
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• Signs of nervous system disorders, such as numbness or tingling, vision disturbances, eye pain, or sudden weakness in an arm or leg;
• Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of fullness in the neck or abdomen, shortness of breath at night, cough, or bluish discoloration of the nails or around the lips;
• Signs of cancer: cancer can affect any part of the body, including the skin and blood, and possible signs depend on the type and location of the cancer. These may include weight loss, fever, swelling (with or without pain), persistent cough, or lumps or thickening under the skin;
• Signs of autoimmune reactions (in which antibodies develop that may damage normal body tissues), such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, muscle or joint pain, or fatigue;
• Signs of inflammation of blood vessels, such as pain, fever, redness or warmth of the skin, or itching.

These adverse effects are rare or uncommon, but are serious conditions (some of which may, in rare cases, be fatal). If any of these occur, contact your doctor immediately or go to the nearest hospital Emergency Department.

Other adverse effects

The following is a list of known adverse effects of Benepali, grouped in decreasing order of frequency:

• Very common (may affect more than 1 in 10 people)

Infections (including cold, sinusitis, bronchitis, urinary tract infections, and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these occur less frequently after the first month of treatment; some patients have developed injection site reactions at recently used sites); and headache.

• Common (may affect up to 1 in 10 people)

Allergic reactions; fever; rash; itching; antibodies directed against normal tissues (formation of autoantibodies).

• Uncommon (may affect up to 1 in 100 people)

Serious infections (including pneumonia, non-superficial skin infections, joint infections, blood infection, and generalized infections); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); low platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (prominent red or pale welts on the skin, often accompanied by itching); eye inflammation; psoriasis (new onset or worsening); inflammation of blood vessels affecting multiple organs; increased liver enzymes in blood tests (in patients also receiving methotrexate, increased liver enzymes are common); abdominal cramps and pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems).

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

Severe allergic reactions (including severe localized swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukemia (cancer affecting blood and bone marrow); melanoma (a type of skin cancer); combined low counts of red blood cells, white blood cells, and platelets; nervous system disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; new-onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and fatigue); skin rash, which may lead to severe blistering and peeling of the skin; liver inflammation caused by the immune system (autoimmune hepatitis; in patients also receiving methotrexate, frequency is uncommon); an immune disorder that may affect the lungs, skin, and lymph nodes (sarcoidosis); lung inflammation or scarring (in patients also receiving methotrexate, frequency of lung inflammation or scarring is uncommon); lichenoid reactions (itchy, reddish-purple skin rash and/or thick whitish-gray lines on mucous membranes); opportunistic infections (such as tuberculosis and other infections that occur when disease resistance is reduced); erythema multiforme (inflammatory rash); cutaneous vasculitis (inflammation of blood vessels in the skin); nerve damage, including Guillain-Barré syndrome (a serious condition that may affect breathing and damage organs); damage to the small filters in the kidneys, leading to impaired kidney function (glomerulonephritis).

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

Failure of the bone marrow to produce essential blood cells; toxic epidermal necrolysis (a potentially life-threatening skin condition).

• Frequency not known (cannot be estimated from available data):

Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma (a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more commonly as purplish skin lesions); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (inflammation and weakness of muscles accompanied by skin rash); listeriosis (a bacterial infection).

Adverse effects in children and adolescents

The adverse effects observed in children and adolescents, as well as their frequencies, are similar to those described above.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Benepali

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the label of the pre-filled syringe, following “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pre-filled syringes in their outer packaging to protect them from light.

After removing the syringe from the refrigerator, wait approximately 30 minutes for the Benepali solution in the syringe to reach room temperature. Do not heat it in any other way. Immediate use is then recommended.

Benepali may be stored outside the refrigerator at a maximum temperature of 30°C for a single period of up to 31 days; after this period, the medicine must not be refrigerated again. Benepali must be discarded if not used within 31 days of removal from the refrigerator. It is advisable to record the date when Benepali was removed from the refrigerator and the date after which Benepali must be discarded (no later than 31 days after removal from the refrigerator).

Inspect the solution in the syringe. It should be between transparent and slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent protein particles. This is the normal appearance of Benepali. Do not use this medicine if the solution appears more yellowish or cloudy, or if it contains particles different from those described above. If you are concerned about the appearance of the solution, contact your pharmacist for any assistance you may need.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Benepali

• The active substance is etanercept. Each pre-filled pen contains 50 mg of etanercept.
• The other components are sucrose, sodium chloride, monohydrate sodium dihydrogen phosphate, and heptahydrate disodium hydrogen phosphate, and water for injections (see section 2, "Benepali contains sodium").

Nature of the product and contents of the pack

Benepali is presented as an injectable solution in a pre-filled pen (injectable solution). The pen contains an injectable solution that is transparent to slightly opalescent, colourless or pale yellow (injectable).

Benepali is available in packs containing 4 pre-filled pens and multiple packs containing 3 packs of 4 pre-filled pens each. Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Manufacturer

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

The Netherlands

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

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

Belgium/Belgium/Belgium Biogen Belgium NV/SA Tel/Tel: + 32 2 219 121	Lithuania Biogen Lithuania UAB Tel: + 370 5 259 617
	Luxembourg/Luxembourg Biogen Belgium NV/SA Tél/Tel: + 32 2 219 121
Czech Republic Biogen (Czech Republic) s.r.o. Tel: + 420 255 706 200	Hungary Biogen Hungary Kft. Tel.: + 36 1 899 9880
Denmark Biogen (Denmark) A/S Tlf: + 45 77 41 57 57	Malta Pharma.MT Ltd Tel: + 356 2133 7008
Germany Biogen GmbH Tel: + 49 (0) 89 99 6170	Netherlands Biogen Netherlands B.V. Tel: + 31 20 542 2000
Estonia Biogen Estonia OÜ Tel: + 372 618 9551	Norway Biogen Norway AS Tlf: + 47 23 40 01 00
Greece Genesis Pharma S.A. Tel: + 30 210 877 1500	Austria Biogen Austria GmbH Tel: + 43 1 484 46 13
Spain Biogen Spain, S.L. Tel: + 34 91 310 7110	Poland Biogen Poland Sp. z o.o. Tel.: + 48 22 351 51 00
France Biogen France SAS Tél: + 33 (0)1 776 968 14	Portugal Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda Tel: + 351 21 318 8450
Croatia Ewopharma d.o.o Tel: + 385 (0)1 6646 563	Romania Ewopharma România SRL Tel: + 40 212 601 34
Ireland Biogen Idec (Ireland) Ltd. Tel: + 353 (0)1 463 779	Slovenia Biogen Pharma d.o.o. Tel: + 386 1 511 02 90
Iceland Icepharma hf. Tel: + 354 540 8000	Slovakia Biogen Slovakia s.r.o. Tel: + 421 2 323 340 08
Italy Biogen Italia s.r.l. Tel: + 39 02 584 99 010	Finland Biogen Finland Oy Puh/Tel: + 358 207 401 200
Cyprus Genesis Pharma (Cyprus) Ltd Tel: + 357 22 76 57 15	Sweden Biogen Sweden AB Tel: + 46 8 594 113 60
Latvia Biogen Latvia SIA Tel: + 371 68 688 158

Date of the most recent review of this leaflet:

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

7. Instructions for use

Read the instructions for use before starting to use Benepali and each time it is prescribed to you again. They may contain new information.

• Do not attempt to administer an injection until your doctor or nurse has trained you on how to do so.

One pre-filled pen contains a single dose of 50 mg of Benepali.

Find a clean, well-lit surface and gather the components you will need:

• One new pre-filled pen of Benepali

• Do not shake the pre-filled pen.

The pack does not include:

• 1 alcohol wipe, gauze, and dressing

• Sharps disposal container

1. Before starting

2. Inspect the pre-filled pen:

Check the expiry date on the label of the pre-filled pen.

• Do not use the pre-filled pen after the expiry date.
• Do not use the pre-filled pen if it has been dropped on a hard surface. Internal components may have been damaged.
• Do not use the pre-filled pen if the needle cap is missing or not firmly attached.

1. Check the solution:

Look at the medicine through the inspection window.

The medicine should be from clear to slightly opalescent, colourless or pale yellow, and may contain small particles of white or almost transparent protein.

• Do not use the solution if it appears more yellowish, cloudy, or contains particles different from those described above.

1. Allow the medicine to reach room temperature:

Remove one pre-filled pen from the carton stored in the refrigerator and allow it to sit at room temperature for at least 30 minutes before injecting. This makes the injection more comfortable and easier for you.

• Do not remove the needle cap until you are ready to inject.
• Do not use heat sources such as a microwave or hot water to warm Benepali.

1. Choose an injection site:

The Benepali pre-filled pen is intended for subcutaneous injection. It should be injected into the thigh, abdomen, or the back of the upper arm (see image on the left).

A different site must be used for each new injection.

If injecting into the abdomen, select a site at least 5 cm away from the navel.

• Do not administer the injection into areas of red, hardened, bruised, or tender skin.
• Avoid areas with scars or stretch marks.
• If you have psoriasis, do not inject the medicine into any raised, thickened, red, or scaly skin plaques or lesions.

1. Injection steps

1. Care at the injection site

If bleeding occurs at the injection site, press the area with gauze.

• Do not rub the injection site.

If needed, you may cover the injection site with a dressing.