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peginterferon alfa-2b

Generic Name: peginterferon alfa-2b (peg in ter FEAR on AL fa 2 b)
Brand Name: PegIntron, PegIntron Redipen, Sylatron

What is peginterferon alfa-2b?

Peginterferon alfa-2b is made from human proteins that help the body fight viral infections.

Peginterferon alfa-2b is used to treat chronic hepatitis C in adults. Peginterferon alfa-2b is often used in combination with another medicine called ribavirin (Rebetol, Ribasphere).

Peginterferon alfa-2b may be used in combination with boceprevir (Victrelis) or telaprevir (Incivek) to treat hepatitis C. The Sylatron brand of peginterferon alfa-2b is used to treat melanoma (skin cancer) after surgery.

Peginterferon alfa-2b may also be used for purposes not listed in this medication guide.

What is the most important information I should know about peginterferon alfa-2b?

You should not use this medicine if you have liver failure or autoimmune hepatitis. You should not use peginterferon alfa-2b with ribavirin if you have severe kidney disease, or a hemoglobin blood cell disorder (sickle-cell anemia, thalassemia).

Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Prevent pregnancy while using this medicine, and for at least 6 months after you stop using it.

Peginterferon alfa-2b can cause life-threatening infections, autoimmune disorders, serious mood or behavior problems, or a stroke. Stop using this medicine and call your doctor at once if you have any unusual changes in mood or behavior, such as: depression, irritability, aggression, or thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before using peginterferon alfa-2b?

You should not use this medicine if you are allergic to peginterferon alfa-2b or other alfa interferons, or if you have:

  • liver failure; or

  • autoimmune hepatitis.

You should not use peginterferon alfa-2b with ribavirin if you have:

  • severe kidney disease;

  • a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia; or

  • if you are pregnant, or if you are a man and your sexual partner is pregnant.

To make sure peginterferon alfa-2b is safe for you, tell your doctor if you have:

  • cirrhosis, hepatitis B, or liver problems other than hepatitis C;

  • a history of depression, mental illness, suicidal thoughts, alcoholism, or drug addiction;

  • heart disease, high blood pressure, or a history of heart attack, stroke, or blood clot;

  • lung disease;

  • an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;

  • any blood cell disorder causing bleeding episodes, infections, or fever-related illness;

  • HIV or AIDS;

  • diabetes;

  • high triglycerides (a type of fat in the blood);

  • a thyroid disorder;

  • kidney disease (or if you are on dialysis);

  • a weak immune system caused by cancer or other conditions;

  • ulcerative colitis; or

  • a history of organ transplant.

Peginterferon alfa-2b may be harmful to an unborn baby. Tell your doctor if you are pregnant.

Peginterferon alfa-2b is often used together with ribavirin. Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking these two medications together, and every month during your treatment.

  • If you are a woman, do not use peginterferon alfa-2b and ribavirin if you are pregnant.

  • If you are a man, do not use peginterferon alfa-2b 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-2b 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-2b with ribavirin.

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

Peginterferon alfa-2b can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

PegIntron should not be used in a child younger than 3 years old. Sylatron is not approved for use by anyone younger than 18 years old.

How should I use peginterferon alfa-2b?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Peginterferon alfa-2b is usually given once per week as an injection 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. Also be sure you understand how to properly mix and store the medicine.

Do not shake the injection pen or mixed 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 and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using this medicine, you may need frequent medical tests and eye exams.

Store the PegIntron Redipen in a refrigerator. Do not freeze. Mixed medicine may also be stored in the refrigerator but you must use it within 24 hours after mixing. Do not freeze or save any unused mixture.

Store PegIntron or Sylatron vials (bottles) at room temperature away from moisture and heat. Do not freeze. Do not reuse a vial or injection pen.

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-2b?

Using this medicine will not prevent you from passing hepatitis to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

Avoid coffee, tea, cola, energy drinks, or other products that contain caffeine.

Peginterferon alfa-2b side effects

Get emergency medical help if you have signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; chest pain, anxiety, difficult breathing; swelling of your face, lips, tongue, or throat.

Peginterferon alfa-2b can cause life-threatening infections, autoimmune disorders, serious mood or behavior problems, or a stroke.

Stop using peginterferon alfa-2b and call your doctor at once if you have unusual changes in mood or behavior, such as: depression, irritability, aggression, hallucinations, thoughts about hurting yourself, or falling back into a previous pattern of drug addiction. Once you have had this type of reaction to peginterferon alfa-2b, you may not be able to use it again.

Call your doctor at once if you have other serious side effects, such as:

  • vision loss;

  • severe stomach pain with bloody diarrhea;

  • pale skin, easy bruising, unusual bleeding;

  • sudden chest discomfort, wheezing, cough with mucus, feeling short of breath;

  • numbness, tingling, or burning pain in your arms or legs;

  • signs of infection--fever, chills, body aches, cough with yellow or pink mucus, pain or burning when you urinate;

  • pancreas problems--severe pain in your upper stomach spreading to your back, vomiting, fever;

  • high blood sugar--increased thirst or urination, hunger, fruity breath odor, tiredness, weight loss;

  • signs of a stroke or heart attack--chest pain spreading to your jaw or shoulder, sweating, sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance;

  • new or worsened autoimmune disorders--skin problems, joint pain or swelling, cold feeling or pale appearance in your fingers or toes;

  • thyroid problems--weight changes, skin changes, thinking problems, feeling hot or cold all the time; or

  • worsening liver symptoms--upper stomach pain or swelling, loss of appetite, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • flu-like symptoms, weakness, feeling tired;

  • mild depression or sadness, feeling anxious or irritable;

  • nausea, vomiting, loss of appetite, weight loss;

  • thinning hair; or

  • redness, swelling, or itching 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-2b dosing information

Usual Adult Dose for Chronic Hepatitis C:

Combination Therapy: 1.5 mcg/kg subcutaneously once a week

Duration of therapy:
Treatment with peginterferon alfa-2b/ribavirin of interferon alpha-naive patients:
-Genotype 1: 48 weeks
-Genotype 2 and 3: 24 weeks
Retreatment with peginterferon alfa-2b/ribavirin of prior treatment failures: 48 weeks, regardless of HCV genotype

Monotherapy: 1 mcg/kg subcutaneously once a week
Duration of therapy: 1 year

Comments:
-This drug should be used with ribavirin and, if appropriate, an approved HCV NS3/4A protease inhibitor as part of a combination regimen (preferred); combination therapy provides substantially better response rates than monotherapy.
-Ribavirin (capsules or oral solution) dose is 800 to 1400 mg orally per day in 2 divided doses (with food), depending on weight; the manufacturer product information should be consulted.
-The manufacturer product information for the specific HCV NS3/4A protease inhibitor should be consulted for information regarding dosing regimen and administration of the protease inhibitor in combination with peginterferon alfa-2b/ribavirin.
-Patients with previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and/or genotype 1 infection are less likely to benefit from retreatment after a failing course of therapy.

Use: For the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease
-In combination with ribavirin and an approved HCV NS3/4A protease inhibitor: Indicated in patients with HCV genotype 1 infection
-In combination with ribavirin: Indicated in patients with genotypes other than 1 or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications, or other clinical factors
-Monotherapy: Indicated in previously untreated patients only; should only be used if there are contraindications to or significant intolerance of ribavirin

Usual Adult Dose for Malignant Melanoma:

6 mcg/kg subcutaneously once a week for 8 doses, followed by 3 mcg/kg subcutaneously once a week for up to 5 years

Comments:
-Premedication with 500 to 1000 mg of oral acetaminophen is recommended 30 minutes prior to the first dose and as needed for subsequent doses.

Use: For the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy

Usual Adult Dose for Thrombocythemia:

Study (n=11)
1.5 to 3 mcg/kg subcutaneously once a week

Comments:
-Dose escalation to 4.5 or 6 mcg/kg

Usual Adult Dose for Renal Cell Carcinoma:

Study (n=31)
6 mcg/kg subcutaneously once a week

Usual Adult Dose for Chronic Myelogenous Leukemia:

Study (n=31)
6 mcg/kg subcutaneously once a week

Usual Adult Dose for Melanoma - Metastatic:

Study (n=31)
6 mcg/kg subcutaneously once a week

Usual Adult Dose for Chronic Hepatitis B:

Study (n=266)
100 mcg subcutaneously once a week for 31 weeks, then 50 mcg subcutaneously once a week from week 32 to 52

Comments:
-Administered as monotherapy or combination therapy (with lamivudine 100 mg/day)

Usual Pediatric Dose for Chronic Hepatitis C:

3 years or older: 60 mcg/m2 subcutaneously once a week

Duration of therapy:
-Genotype 1: 48 weeks
-Genotype 2 and 3: 24 weeks

Comments:
-For use with ribavirin
-Ribavirin (capsules or oral solution) dose is 15 mg/kg orally per day in 2 divided doses (with food); the manufacturer product information should be consulted.
-Patients who reach their 18th birthday while receiving peginterferon alfa-2b/ribavirin should remain on the pediatric dosing regimen.

Use: In combination with ribavirin, for the treatment of CHC in patients with compensated liver disease

What other drugs will affect peginterferon alfa-2b?

Other drugs may interact with peginterferon alfa-2b, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about peginterferon alfa-2b.
  • 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: 17.05. Revision Date: 2015-10-15, 10:29:58 AM.

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