Generic Name: peginterferon alfa-2a (peg in ter FEER on AL fa 2 a)
Brand Name: Pegasys, Pegasys ProClick Autoinjector
What is peginterferon alfa-2a?
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 in adults, and to treat chronic hepatitis C in children who are at least 5 years old. Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, RibaPak, Ribasphere, RibaTab).
Peginterferon alfa-2a may also be used for purposes not listed in this medication guide.
What is the most important information I should know about peginterferon alfa-2a?
You should not use this medication if you have liver failure or autoimmune hepatitis. You should not use peginterferon alfa-2a with ribavirin if you have a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia, if you also take didanosine, if you are pregnant, or if you are a man and your sexual partner is pregnant.
Peginterferon alfa-2a is often used together with another medication called ribavirin, which is known to cause birth defects or death in an unborn baby. Do not use peginterferon alfa-2a and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.
Peginterferon alfa-2a can cause infections, serious mood or behavior problems, or new or worsened symptoms of an autoimmune disorder (such as psoriasis, lupus, rheumatoid arthritis).
Call your doctor if you have any new or worsening symptoms, such as: unusual thoughts or behavior, thoughts about suicide or hurting yourself, new or worsening symptoms affecting your skin or joints, or signs of infection (fever, chills, cough, burning when you urinate).
Peginterferon alfa-2a may also cause heart problems or a stroke. Call your doctor or get emergency medical help if you have chest pain spreading to the jaw or shoulder, sudden numbness or weakness, sudden severe headache, slurred speech, or problems with vision or balance.
What should I discuss with my healthcare provider before using peginterferon alfa-2a?
You should not use this medicine if you are allergic to it, or if you have liver failure or autoimmune hepatitis. You also should not use peginterferon alfa-2a with ribavirin if you have:
a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
if you also take didanosine;
if you are pregnant; or
if you are a man and your sexual partner is pregnant.
Peginterferon alfa-2a can cause infections, serious mood or behavior problems, or new or worsened symptoms of an autoimmune disorder. Tell your doctor about all your medical conditions, especially:
diabetes, or a thyroid disorder;
weak immune system (caused by disease such as HIV or AIDS);
an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis; or
history of depression, anxiety, mental illness, suicidal thoughts, or drug or alcohol addiction.
To make sure this medicine is safe for you, tell your doctor about all your other medical conditions, especially:
any type of infection;
heart disease, high blood pressure, or a history of heart attack, blood clot, or stroke;
a blood cell disorder such as anemia (lack of red blood cells), low levels of platelets, or low white blood cell counts;
kidney disease, or liver problems other than hepatitis;
colitis, pancreas problems;
eye or vision problems;
history of liver or other organ transplant; or
if you have both hepatitis B and hepatitis C or HIV.
Peginterferon alfa-2a is often used with another medication called ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before using these two medications, and every month during your treatment.
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 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 and ribavirin.
It is not known whether peginterferon alfa-2a passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medication.
Peginterferon alfa-2a with ribavirin can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate.
How should I use peginterferon alfa-2a?
This medicine is usually given once per week. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. If your doctor changes your brand, strength, or type of interferon, your dosage needs may change. Do not change your doses or medication schedule without your doctor's advice.
Peginterferon alfa-2a is injected under the skin. You may be shown how to use injections 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.
Do not shake the medication bottle or you may ruin the medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
Use a disposable needle only once. 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 and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your blood pressure, vision, and lung function may also need to be checked.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication. Your doctor may want to check your liver function for several months after you stop using peginterferon alfa-2a.
Store in the refrigerator, protected from light. Do not freeze.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using peginterferon alfa-2a?
Avoid drinking alcohol. It may increase your risk of liver damage.
Using this medication will not prevent you from passing hepatitis. Follow your doctor's instructions about how to prevent passing the disease to another person.
Peginterferon alfa-2a side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; difficulty breathing; swelling of your face, lips, tongue, or throat.
This medicine may cause heart problems or a stroke. Call your doctor or get emergency medical help if you have chest pain spreading to the jaw or shoulder, sudden numbness or weakness, sudden severe headache, slurred speech, or problems with vision or balance.
Stop using peginterferon alfa-2a and call your doctor at once if you have:
chest pain, dry cough, wheezing, feeling short of breath;
severe stomach pain with bloody diarrhea;
serious mood or behavior changes--depression, irritability, aggressive behavior, thoughts about suicide or hurting yourself, or falling back into a previous pattern of drug addiction
new or worsened autoimmune disorder symptoms--raised silvery flaking of the skin, joint stiffness with pain or swelling, skin sores, butterfly-shaped skin rash on your face, cold feeling or pale appearance in your fingers or toes;
signs of infection--fever, chills, cough with yellow or pink mucus, increased urination, or burning and pain when you urinate;
bone marrow suppression--pale or yellowed skin, dark colored urine, easy bruising or bleeding, swollen gums, painful mouth sores;
worsening liver symptoms--upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
thyroid problems--weight changes, skin changes, feeling hot or cold all the time; or
high blood sugar--increased thirst or urination, hunger, fruity breath odor, tiredness, weight loss.
Common side effects may include:
nausea, vomiting, loss of appetite;
headache, muscle pain, feeling weak or tired;
sleep problems (insomnia);
temporary hair loss; or
itching, redness, dryness, or swelling 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.
See also: Side effects (in more detail)
Peginterferon alfa-2a dosing information
Usual Adult Dose for Chronic Hepatitis C:
PATIENTS WITHOUT HIV COINFECTION:
-HCV genotypes 1, 2, 3, 4: 180 mcg subcutaneously once a week
-HCV genotypes 5, 6: Insufficient data for dosing recommendations
Duration of therapy when used with other HCV antiviral drugs:
-HCV genotypes 1, 2, 3, 4: The manufacturer product information of the other HCV antiviral drugs should be consulted.
Duration of therapy when used with ribavirin without other HCV antiviral drugs:
-HCV genotypes 1, 4: 48 weeks
-HCV genotypes 2, 3: 24 weeks
Monotherapy: 180 mcg subcutaneously once a week for 48 weeks
Discontinuation of Therapy for HCV Genotype 1 (when used with ribavirin or alone):
-Therapy should be discontinued if there is not at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy or if HCV RNA remains detectable after 24 weeks of therapy.
-The manufacturer product information for specific coadministered HCV antiviral drugs should be consulted for information on discontinuation based on treatment response.
PATIENTS WITH HIV COINFECTION:
Combination Therapy: 180 mcg subcutaneously once a week
Duration of therapy:
-When used with other HCV antiviral drugs: The manufacturer product information of the other HCV antiviral drugs should be consulted.
-When used with ribavirin without other HCV antiviral drugs: 48 weeks, regardless of HCV genotype
-The manufacturer product information for coadministered HCV antiviral drugs should be consulted.
-This drug should not be used alone or in combination with ribavirin without additional HCV antiviral drugs for treatment of chronic hepatitis C (CHC) patients who failed prior interferon alfa therapy.
-This drug is not recommended for treatment of CHC patients who have had solid organ transplantation.
-Therapy should be discontinued at once if hepatic decompensation occurs.
USE: For the treatment of CHC patients (with or without HIV coinfection) with compensated liver disease
-As part of a combination regimen with other HCV antiviral drugs
-As monotherapy if contraindications or significant intolerance to other HCV antiviral drugs
Usual Adult Dose for Chronic Hepatitis B:
180 mcg subcutaneously once a week for 48 weeks
Use: For the treatment of patients with HBeAG-positive and HBeAG-negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation
Usual Pediatric Dose for Chronic Hepatitis C:
5 years or older: 180 mcg/1.73 m2 x BSA subcutaneously once a week
Maximum dose: 180 mcg
Duration of therapy:
-HCV genotypes 2, 3: 24 weeks
-Other HCV genotypes: 48 weeks
-For use with ribavirin
-The manufacturer product information for ribavirin should be consulted.
-Patients who start therapy before their 18th birthday should remain on the recommended pediatric dose until therapy is finished.
Use: In combination with ribavirin, for the treatment of CHC patients with compensated liver disease
What other drugs will affect peginterferon alfa-2a?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with peginterferon alfa-2a, especially:
any medication to treat HIV or AIDS.
This list is not complete. Other drugs may interact with peginterferon alfa-2a, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
More about peginterferon alfa-2a
- Other brands: Pegasys
Related treatment guides
Where can I get more information?
- Your pharmacist can provide more information about peginterferon alfa-2a.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2013-09-15, 6:29:32 PM.