Pegasys 135 micrograms solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a heart attack or have been hospitalised for serious chest pains in the last six months.
• if you have, so called autoimmune hepatitis.
• if you have advanced liver disease and your liver does not work properly (e.g. your skin has become yellow).
• if the patient is a child less than 3 years old.
• if the patient is a child who has ever had serious psychiatric conditions such as severe depression or thoughts of committing suicide.
• if you are infected with both the hepatitis C virus and the human immunodeficiency virus, and your liver does not work properly (e.g. your skin has become yellow).
• if you are being treated with telbivudine, a medicine for hepatitis B infection (see “Other medicines and Pegasys”).

Talk to your doctor, pharmacist or nurse before using Pegasys

• if you have had a severe nervous or mental disorder.
• if you have ever had depression or symptoms associated with depression (e.g. feelings of sadness, dejection, etc.).
• if you are an adult who has or had a history of substance abuse (e.g. alcohol or drugs).
• if you have psoriasis, it may get worse during treatment with Pegasys.
• if you have a problem with your liver other than hepatitis B or C.
• if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination.
• if you have been told you have VKH syndrome.
• if you have thyroid disease that is not well controlled with medicines.
• if you have ever had anaemia.
• if you have had an organ transplant (liver or kidney) or have one planned in the near future.
• if you are coinfected with HIV and treated with anti HIV medicinal products.
• if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count.

Once you have started Pegasys treatment, talk to your doctor, nurse or pharmacist:

• if you develop symptoms associated with depression (e.g. feelings of sadness, dejection, etc.) (see section 4).
• if you notice a change in your vision.
• if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
• if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection.
• if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
• if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while on this medication, seek medical help immediately.
• if you develop symptoms of Vogt-Koyanagi-Harada syndrome; combination of complaints of neck stiffness, headache, loss of colour in skin or hair, eye disorders (such as blurred vision), and/or hearing abnormality (such as ringing in the ears).

During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function, glucose (blood sugar levels) or changes in other laboratory values.

Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy. In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Pegasys with ribavirin. You should brush your teeth thoroughly twice daily and have regular dental examinations. In addition some patients may experience vomiting. If you have this reaction, be sure to rinse your mouth thoroughly afterwards.

Pegasys use is restricted to children and adolescents with chronic hepatitis C aged 5 years and above or children and adolescents with chronic hepatitis B aged 3 years and above. Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.

• If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4).
• When receiving Pegasys, your child may have slower growth and development (see section 4).

Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medicines increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs). Therefore, the combination of Pegasys with telbivudine is contraindicated. Tell your doctor or pharmacist if you are being treated with telbivudine.

Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.

Patients who also have HIV infection: Tell your doctor if you are taking anti-HIV therapy. Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment. If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure. Your doctor will monitor you for signs and symptoms of these conditions. Patients receiving zidovudine in combination with ribavirin and alfa interferons are at increased risk of developing anaemia. Patients receiving azathioprin in combination with ribavirin and peginterferon are at increased risk of developing severe blood disorders. Please be sure to read the ribavirin package leaflet also.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur, as ribavirin can be very damaging to an unborn baby:

• if you are a woman of childbearing potential who is taking Pegasys in combination with ribavirin, you must have a negative pregnancy test before treatment, each month during therapy and for the 4 months after treatment is stopped. You must use an effective contraceptive during the time you are taking the treatment and for 4 months after stopping treatment. This can be discussed with your doctor.
• if you are a man who is taking Pegasys in combination with ribavirin, do not have sex with a pregnant woman unless you use a condom. This will lessen the chance for ribavirin to be left in the woman’s body. If your female partner is not pregnant now, but is of childbearing potential, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. You or your partner must use an effective contraceptive during the time you are taking the treatment and for 7 months after stopping treatment. This can be discussed with your doctor.

Ask your doctor or pharmacist for advice before taking any medicine. It is not known whether this product is present in human milk. Therefore, do not breast-feed an infant if you are taking Pegasys. In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.

Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.

Do not drive or use machinery if you feel drowsy, tired, or confused while taking Pegasys.

Pegasys contains 5 mg benzyl alcohol in each pre-filled syringe which is equivalent to 10 mg/ml.

Benzyl alcohol may cause toxic reactions and allergic reactions.

Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Pegasys must not be given to premature babies, neonates or children up to 3 years old.

Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding, or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Pegasys contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it. If necessary, the dose may be changed during treatment. Do not exceed the recommended dose.

Pegasys is used alone only if you cannot take ribavirin for any reason

Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.

The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before. Please check with your doctor and follow the recommended duration of treatment.

Pegasys injection is normally taken at bedtime.

Use in children and adolescents

Your doctor has determined the exact dose of Pegasys for your child and will tell you how often to use it. The usual dose of Pegasys is based on your child’s height and weight. If necessary, the dose may be changed during treatment. It is recommended that Pegasys pre-filled syringes be used for children and adolescents, as they allow for dose adjustments. Do not exceed the recommended dose.

The duration of combination treatment in children with chronic hepatitis C varies from 6 to 12 months depending on the type of virus your child is infected with and their response to therapy. In chronic hepatitis B the duration of Pegasys treatment is 48 weeks. Please check with your doctor and follow the recommended duration of treatment. Pegasys injection is normally taken at bedtime.

Pegasys is intended for subcutaneous use (under the skin). This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh. If you are injecting this medicine yourself, you will be instructed how to give the injection. Detailed instructions are provided at the end of this leaflet (see “How to inject Pegasys”).

Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor.

If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.

Combination therapy with ribavirin in chronic hepatitis C

In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.

Combination therapy with other medicines in chronic hepatitis C

In the case of combination therapy with Pegasys, please follow the dosing regimen recommended by your doctor and refer also to the package leaflets of any other medicines that are used in combination with Pegasys.

Contact your doctor or pharmacist as soon as possible.

If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible. Take your next injection on the regularly scheduled day.

If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible. Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week.

As an example: Your regular weekly Pegasys injection is on Monday. You remember on Friday that you forgot to take your injection on Monday (4 days late). You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday (5 days after your Friday dose). Your next injection will be on the Monday, 5 days later after the Wednesday injection. You are now back on your regularly scheduled day and should continue your injections every Monday.

If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.

Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.

Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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• The active substance is peginterferon alfa-2a. Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
• The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.

Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle.

Pegasys 90 micrograms solution for injection in pre-filled syringe

The syringe contains graduation marks corresponding to 90 micrograms (mcg), 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg. It is available in packs containing 1 pre-filled syringe.

Pegasys 135 micrograms solution for injection in pre-filled syringe

The syringe contains graduation marks corresponding to 135 micrograms (mcg), 90 mcg and 45 mcg. It is available in packs containing containing 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes. Not all pack-sizes may be marketed.

Pegasys 180 micrograms solution for injection in pre-filled syringe

The syringe contains graduation marks corresponding to 180 micrograms (mcg), 135 mcg and 90 mcg. It is available in packs containing containing 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes. Not all pack-sizes may be marketed.

Wash your hands carefully before handling any of the items.

Collect the necessary items before beginning:

Included in the pack:

• a pre-filled syringe of Pegasys
• an injection needle

Not included in the pack:

• a cleansing swab
• small bandage or sterile gauze
• an adhesive bandage
• a container for the waste material

• Remove the protective cap that covers the back of the needle (1-2).

• Remove the rubber cap from the syringe (3). Do not touch the tip of the syringe.

• Place the needle firmly on the tip of the syringe (4).

• Remove the needle guard from the syringe needle (5).

• To remove air bubbles from the syringe, hold the syringe with the needle pointing up. Tap the syringe gently to bring the bubbles to the top. Push the plunger up slowly to the correct dose, where the edge of the plunger touches the syringe. Replace the needle guard and place the syringe in a horizontal position until ready for use.
• Allow the solution to reach room temperature before injection or warm the syringe between your palms.
• Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.

You are now ready to inject the dose.

• Select the injection site in the abdomen or thigh (except your navel or waistline). Change your injection site each time.
• Clean and disinfect the skin where the injection is to be made with a cleansing swab.
• Wait for the area to dry.
• Remove the needle guard.
• With one hand, pinch a fold of loose skin. With your other hand hold the syringe as you would a pencil.
• Insert the needle all the way into the pinched skin at an angle of 45° to 90° (6).

• Inject the solution by gently pushing the plunger all the way down from the appropriate graduation.
• Pull the needle straight out of the skin.
• Press the injection site with a small bandage or sterile gauze if necessary for several seconds.

Do not massage the injection site. If there is bleeding, cover with an adhesive bandage.

The syringe, needle and all injection materials are intended for single use and must be discarded after the injection. Dispose of the syringe and needle safely in a closed container. Ask your doctor, hospital or pharmacist for an appropriate container.