Peginterferon Alfa-2a, Injection

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What are other names for this medicine?

Type of medicine: antiviral

Generic and brand names: peginterferon alfa-2a, oral; Pegasys

What is this medicine used for?

This medicine is given by injection (shot) to treat continuing (chronic) hepatitis C virus infections in adults who have never taken interferon alfa. It may be given alone or along with ribavirin (Copegus).

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a mental illness such as depression or anxiety
• an autoimmune disease such as psoriasis, lupus, or rheumatoid arthritis
• a blood disorder or bone marrow problems
• an organ transplant
• cancer
• colitis (inflammation of the bowels)
• diabetes
• heart disease or a heart attack
• hepatitis B infection
• high blood pressure
• HIV infection
• kidney problems
• liver problems other than hepatitis C
• lung disease or breathing problems
• problems with drug or alcohol addiction or abuse
• problems with the thyroid gland

Females of childbearing age (if taking this medicine alone): Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

Females of childbearing age (if taking this medicine with ribavirin): Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

The shots are given just under the skin. If your healthcare provider is giving you the shots, keep all your appointments.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. Use sterile, disposable syringes and needles. Use each syringe and needle only once and dispose of them safely, following your healthcare provider's instructions.

Carefully read and follow the directions that come in the package of medicine for preparing the shots. Wash your hands before using this medicine. Do not shake the medicine. Follow these steps to give yourself the shots:

1. Your healthcare provider will tell you where you can give yourself the shots (usually the abdomen or thigh). If you are giving the shot in your abdomen, choose a site around the belly button but not in the belly button. Each day, choose a different spot for the shot to lessen irritation.
2. Use an alcohol swab to clean the skin where you will give yourself the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45° angle. After you insert the needle completely, release your grasp of the skin.
4. Gently pull back on the plunger of the syringe. If no blood appears, inject all of the solution by gently and steadily pushing down the plunger. If blood appears when you pull back on the plunger, withdraw the needle and syringe and gently press the alcohol swab on the injection site. Start over with a fresh needle.
5. After you have given yourself the shot, withdraw the needle and syringe and press an alcohol swab on the spot where the shot was given.
6. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.
7. For each shot, use a new vial of medicine.

If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

If you are giving yourself the shots, be sure to visit your healthcare provider regularly so that your condition can be monitored.

Give yourself your once-a-week shot on the same day each week so that you will remember.

What if I miss a dose?

If you miss a dose on your regular day, give yourself the shot the next day. Do not give double doses.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

The combination of this medicine and ribavirin must not be used by women who are pregnant or by the male partners of women who are pregnant. This medicine can cause severe birth defects. Use 2 forms of birth control to avoid pregnancy while you are using this medicine with ribavirin and for at least 6 months after your treatment ends. This is very important whether you are a man or a woman.

If you feel depressed or have thoughts of suicide, contact your healthcare provider right away.

Fever may be a very serious problem while using this medicine. If the fever continues or gets high, contact your healthcare provider right away.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

Diabetics: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (report these to your healthcare provider right away): Irritability, depression, anxiety, trouble breathing, vision changes, severe chest pain, unusual bleeding or bruising, high fever, bloody diarrhea, severe stomach pain or low back pain, irregular heartbeat.

Other: Mild fever, chills, muscle aches, joint pain, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, trouble sleeping, redness and swelling at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik), and moexipril (Univasc)
• alcohol
• medicines to treat HIV such as zidovudine (AZT, Retrovir), lamivudine (Epivir), didanosine (Videx), zalcitabine (Hivid), emtricitabine (Emtriva), tenofovir (Viread), abacavir (Ziagen), and stavudine (Zerit)
• methadone
• prednisone
• theophylline
• warfarin

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light. Do not use the medicine if:

• It is cloudy or has particles floating in it.
• The medicine is any color other than colorless to light yellow.
• The expiration date has passed.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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