Generic Name: peginterferon alfa-2a (peg in ter FEAR on AL fa 2 a)Brand Names: Pegasys
Peginterferon alfa-2a is made from human proteins that help the body fight viral infections.
Peginterferon alfa-2a is used to treat chronic hepatitis B or C. Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab).
Peginterferon alfa-2a may also be used for other purposes not listed in this medication guide.What is the most important information I should know about peginterferon alfa-2a?Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab). Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before starting this combination treatment. If a man fathers a child while using ribavirin, the baby may have birth defects. You should not use this medication if you are allergic to peginterferon alfa-2a, or if you have autoimmune hepatitis, liver failure, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia, if you are pregnant, or if you are a man and your female sexual partner is pregnant.
Before using this medication, tell your doctor if you have lung disease, kidney disease, heart disease, a thyroid disorder, colitis, HIV or AIDS, an autoimmune disorder (such as psoriasis, lupus, rheumatoid arthritis), a history of organ transplant, or any liver problems other than hepatitis. Also tell your doctor if you have ever had a heart attack, cancer, drug or alcohol addiction, or depression, mental illness, or suicidal thoughts.
Treatment with peginterferon alfa-2a does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.What should I discuss with my healthcare provider before using peginterferon alfa-2a?You should not use this medication if you are allergic to peginterferon alfa-2a, or if you have:
a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
if you are pregnant; or
if you are a man and your female sexual partner is pregnant.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:
history of liver or other organ transplant;
a thyroid disorder;
HIV or AIDS;
an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis;
heart disease or prior heart attack;
a history of cancer;
a history of drug or alcohol addiction; or
a history of depression, mental illness, or suicidal thoughts or behaviors.
If you are a woman, do not use peginterferon alfa-2a and ribavirin if you are pregnant.
If you are a man, do not use peginterferon alfa-2a and ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
Use at least 2 effective forms of birth control while either sexual partner is using peginterferon alfa-2a with ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using peginterferon alfa-2a together with ribavirin.
Peginterferon alfa-2a is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Peginterferon alfa-2a is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from this medication.Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your peginterferon alfa-2a dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Peginterferon alfa-2a can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.
If you have hepatitis B you may develop liver symptoms while you are using peginterferon alfa-2a, and even after you stop using this medication. Your doctor may want to check your liver function more often if this happens.
Hepatitis is sometimes treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with hepatitis should remain under the care of a doctor.Store this medication in the refrigerator, protected from light. Do not allow the medicine to freeze.
Use the medicine as soon as you remember the missed dose, then go back to your regular schedule on the day your next dose is due. If you are more than 2 days late in using your injection, call your doctor for instructions. Do not use extra medicine to make up a missed dose.
Symptoms of a peginterferon alfa-2a overdose are not known.
Treatment with this medication does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.Avoid drinking alcohol while taking peginterferon alfa-2a. Alcohol can increase the risk of damage to your liver. Peginterferon alfa-2a can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
confusion, severe depression, thoughts of hurting yourself or others;
unusual anxiety, aggression, or unusual thoughts or behaviors;
sudden numbness, weakness, or loss of balance or coordination;
fever, chills, body aches, flu symptoms;
easy bruising or bleeding;
worsening of psoriasis;
chest pain, uneven heartbeats, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
cough, stabbing chest pain, feeling short of breath;
severe pain in your upper stomach spreading to your back, fast heart rate;
blurred vision, headache or pain behind your eyes; or
fever with severe stomach pain and bloody diarrhea.
Less serious side effects may include:
increased hunger, thirst, or urination;
feeling mildly anxious or irritable;
headache, muscle or joint pain;
nausea, vomiting, dry mouth, loss of appetite;
hair loss, weight loss;
sleep problems (insomnia);
skin itching; or
pain, redness, swelling, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Chronic Hepatitis C:
Monotherapy: 180 mcg subcutaneously once a week for 48 weeksCombination therapy:Genotypes 1, 4:74 kg or less: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 1000 mg/day orally in 2 divided doses for 48 weeks75 kg or more: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 1200 mg/day orally in 2 divided doses for 48 weeksGenotypes 2, 3: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 800 mg/day orally in 2 divided doses for 24 weeksGenotype 5, 6: Insufficient data to make a recommendationPatients coinfected with HIV:Monotherapy: 180 mcg subcutaneously once a week for 48 weeksCombination therapy: Peginterferon alfa-2a 180 mcg subcutaneously once a week plus ribavirin 800 mg/day orally in 2 divided doses for 48 weeks, regardless of genotype
Usual Adult Dose for Chronic Hepatitis B:
180 mcg subcutaneously once a week for 48 weeks
The following drugs can interact with peginterferon alfa-2a. Tell your doctor if you are using any of these:
theophylline (Slo-Bid, Theobid, Theo-Dur, and others);
methadone (Diskets, Dolophine, Methadose); or
HIV or AIDS medication such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir, Combivir), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).
This list is not complete and there are many other drugs that can interact with peginterferon alfa-2a. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.