Interferon Alfa-2b; Ribavirin

March 21, 2017

Interferon Alfa-2b; Ribavirin kit

What is the interferon alfa; ribavirin kit?

REBETRON™ kit contains RIBAVIRIN (Rebetol®) capsules and INTERFERON ALFA-2b (Intron® A) injection. Ribavirin and interferon-alfa are used together to treat chronic hepatitis C infections. Ribavirin is an antiviral agent. It is not for the treatment of simple viral infections or other types of hepatitis infections. Interferon alfa-2b is a synthetic (man-made) protein produced by genetic engineering. Natural interferons are produced to help the immune system fight viral infections. Interferon alfa, which has similar actions to natural interferons, has protective activity against viruses. Generic ribavirin capsules and interferon alfa injections are not yet available.

What should my health care professional know before I use Rebetron™?

They need to know if you have any of these conditions:

  • anemia

  • autoimmune disease

  • bone marrow suppression (low white blood cell, red blood cells, or platelets)

  • breathing problems

  • depression or other mental illness

  • diabetes

  • heart disease such as angina or history of a heart attack

  • high blood pressure

  • human immunodeficiency virus (HIV) infection

  • kidney disease

  • liver disease (other than hepatitis C)

  • pancreatitis

  • past interferon treatment for hepatitis C that did not work

  • prior organ transplant

  • psoriasis

  • recent radiation therapy (within 4 weeks)

  • sickle-cell disease

  • thalassemia

  • thyroid problems

  • an unusual or allergic reaction to ribavirin, interferons, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Finish the full course prescribed by your prescriber or health care professional even if you think your condition is better. Do not stop taking except on your prescriber's advice.

Ribavirin capsules are taken by mouth in the morning and the evening. Swallow capsules with a drink of water. You can take ribavirin capsules with or without food, but you should take it the same way every day. The exact dose will be determined by your prescriber or health care professional. Follow the directions on your prescription package. Take your doses at regular intervals. Do not take your medicine more often than directed

Interferon alfa is for injection into a muscle or under the skin. Injections of interferon alfa can be given in the hospital or clinic, or by a home health-care nurse. If you are giving yourself the injections, make sure you follow the directions carefully. Give interferon injections in the evening or at bedtime to decrease the degree of side effects.

Do NOT share this medicine with anyone else. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Rebetron™?

  • zidovudine, ZDV (AZT)

  • theophylline

  • oral contraceptives

Tell your prescriber or other health care professional about all other medicines you are taking including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking Rebetron™?

Treatment with Rebetron™ may last for 24—48 weeks. It is important not to stop treatment even if you are feeling better. You may need to have blood tests done during therapy to evaluate your progress.

Ribavirin may cause severe birth defects or death to the unborn child if taken during pregnancy; therefore if you are pregnant, you must not take ribavirin. Women who can still have children must have a negative pregnancy test before starting treatment then monthly pregnancy tests until 6 months after stopping ribavirin. Female patients and female partners of men taking ribavirin must use 2 forms of effective birth control methods during treatment with ribavirin and for 6 months after stopping ribavirin therapy. If you think you may have become pregnant and are taking ribavirin, contact your prescriber or health care professional right away.

There is no information regarding whether treatment with Rebetron™ will prevent the spreading hepatitis C to other people. Also, it is not known if Rebetron™ can cure hepatitis C or prevent other complications of hepatitis C infection such as cirrhosis, liver failure, or liver cancer.

Many patients may experience flu-like symptoms after receiving interferon alfa injections. These symptoms may include headache, fatigue, fever, and muscle aches. You may be able to decrease these effects by giving the interferon injection at bedtime. Some patients may be able to take acetaminophen (Tylenol®) before the interferon injection. Check with your prescriber or health care professional before taking any products containing acetaminophen as these may worsen your liver disease.

Ribavirin and interferon therapy may cause anemia (low red blood counts). You will need to have frequent blood checks during the first month of treatment with ribavirin to follow your counts.

Make sure to drink plenty of fluids while taking ribavirin and interferon-alfa, especially during the first part of treatment.

If you will be administering interferon alfa to yourself at home, your prescriber or health care professional should provide you with a puncture-resistant container for the proper disposal of syringes and needles. Never reuse syringes or needles.

What side effects may I notice from using Rebetron™?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • changes in your heart rate

  • depression

  • dizziness or light-headedness

  • increased fatigue

  • increased weakness, fatigue or tiredness

  • missed menstrual cycle

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • flu-like symptoms

  • hair thinning

  • headache

  • heatburn

  • itching

  • nausea

  • skin rash

  • vomiting

Where can I keep my medicine?

Keep out of the reach of children. NEVER share this medicine with anyone.

Ribavirin capsules may be kept in the refrigerator between 2—8 degrees C (36—46 degrees F) or at room temperature, 25 degrees C (77 degrees F). Interferon vials or multidose pens should be kept in the refrigerator between 2—8 degrees C (36—46 degrees F).


March 21, 2017


U.S. FDA-approved Package Insert