Rebetron

Generic Name: interferon alfa-2b and ribavirin (in ter FEAR on AL fa 2b and RYE ba VYE rin)Brand Names: Rebetron

What is Rebetron (interferon alfa-2b and ribavirin)?

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

Ribavirin is an antiviral medication.

Interferon alfa-2b and ribavirin are packaged together as a capsule and injection kit to treat chronic hepatitis C. These medications must be used together.

Interferon alfa-2b and ribavirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Rebetron (interferon alfa-2b and ribavirin)?You should not use this medication if you are allergic to interferon alfa-2b (Intron A) or ribavirin (Copegus, Rebetol), or if you have autoimmune hepatitis, severe liver or kidney disease, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia. Do not use interferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa-2b and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

Before using interferon alfa-2b and ribavirin, tell your doctor about all of your medical conditions, especially kidney disease, liver problems other than hepatitis, heart disease or high blood pressure, a thyroid disorder, eye problems, HIV or AIDS, a blood cell disorder, an autoimmune disorder such as lupus or psoriasis, or a history of heart attack, stroke, organ transplant, depression, mental illness, drug or alcohol addiction, or suicidal thoughts or behaviors.

Also tell your doctor if you have ever used an interferon to treat hepatitis in the past and it did not work.

What should I discuss with my healthcare provider before using Rebetron (interferon alfa-2b and ribavirin)?You should not use this medication if you are allergic to interferon alfa-2b (Intron A) or ribavirin (Copegus, Rebetol), or if you have:

• autoimmune hepatitis;

• liver failure;
• severe kidney disease;

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

• if you are pregnant or breast-feeding; or

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use interferon alfa-2b and ribavirin:

• lung disease;

• kidney disease (or if you are on dialysis);
• hepatitis B, or liver problems other than hepatitis;

• a thyroid disorder;

• uncontrolled diabetes;

• new or worsening problems with your eyes;

• cancer;

• HIV or AIDS;

• high cholesterol or triglycerides;

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

• history of organ transplant;

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

• an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis;

• a history of drug or alcohol addiction, depression, anxiety, or suicidal thoughts or behaviors; or

• if you have ever used an interferon to treat hepatitis in the past and it did not work.

FDA pregnancy category X. Ribavirin is known to cause birth defects or death in an unborn baby. Do not use interferon alfa-2b and ribavirin if you are pregnant. You may need to have a negative pregnancy test before using this medication and every month during your treatment.

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

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

Interferon alfa-2b and ribavirin may pass into breast milk and could harm a nursing baby. Do not use this medication if you are breast-feeding a baby. Interferon alfa-2b and ribavirin 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.

The powder form of interferon alfa-2b contains albumin, but the solution (liquid) form does not. Albumin comes from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use Rebetron (interferon alfa-2b and ribavirin)?

Interferon alfa-2b 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.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use a different place on your arm, stomach, or thigh each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row.

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.

The interferon alfa-2b injection is usually given 3 times per week. The ribavirin capsule is usually taken twice daily. You may take the capsules with or without food but take them the same way each time. Follow your doctor's instructions. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your ribavirin dose needs may change if you gain weight. Tell your doctor if your weight increases to 165 pounds or above.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. You may also need regular eye exams. Do not miss any scheduled appointments.

Store both the ribavirin capsules and the interferon alfa-2b vials (bottles) or injection pens in the refrigerator. Do not allow the medicine to 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 if you think you have used too much of this medicine. Symptoms of an interferon alfa-2b and ribavirin overdose are not known.

What should I avoid while using Rebetron (interferon alfa-2b and ribavirin)?

Avoid drinking alcohol. Alcohol may increase your risk of liver damage.

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.

Rebetron (interferon alfa-2b and ribavirin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• pale or yellowed skin, dark colored urine;

• fever, chills, body aches, flu symptoms, easy bruising or bleeding, unusual weakness;

• confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;

• vision problems;

• high fever with severe stomach pain and bloody diarrhea.

• cough, stabbing chest pain, feeling short of breath, uneven heartbeats;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• worsening psoriasis or other autoimmune disorder.

Less serious side effects may include:

• dizziness, tired feeling, headache, joint or muscle pain;

• mild nausea, loss of appetite, weight loss;

• sleep problems (insomnia);

• feeling mildly anxious, depressed, or irritable; 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.

What other drugs will affect Rebetron (interferon alfa-2b and ribavirin)?

Tell your doctor about all other medications you use, especially HIV or AIDS medications such as :

• abacavir (Ziagen);

• didanosine (Videx);

• efavirenz (Sustiva, Atripla);

• emtricitabine (Emtriva);

• etravine (Intelence);

• lamivudine (Epivir, Epzicom, Combivir, Trizivir);

• stavudine (Zerit);

• tenofovir (Truvada, Viread); or

• zidovudine (Retrovir).

This list is not complete and there may be other drugs that can interact with interferon alfa-2b and ribavirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about interferon alfa-2b and ribavirin.

• 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.
• 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 1996-2006 Cerner Multum, Inc. Version: 7.02. Revision Date: 09/17/2009 10:43:27 AM.