ribavirin (oral)

What is the most important information I should know about ribavirin?

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

You should not take ribavirin if you are allergic to it, or if you have severe liver disease, autoimmune hepatitis, a hemoglobin disorder (anemia, thalassemia, and others), if you are also taking didanosine (Videx), or if you are pregnant woman, or a man whose female sexual partner is pregnant.

This medication can cause birth defects or death in an unborn baby.

If you are a woman, do not take ribavirin if you are pregnant.

If you are a man, do not take 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 two effective forms of birth control while either sexual partner is taking ribavirin, and 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 taking ribavirin.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. Your blood will need to be tested often. Your vision, liver function, and thyroid function may also need to be tested. Visit your doctor regularly.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, weakness, or trouble breathing.

What is ribavirin?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

Ribavirin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ribavirin?

You should not take ribavirin if you are allergic to it, or if you have:

• severe liver disease (especially cirrhosis);
• autoimmune hepatitis;
• a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia;
• if you are also taking didanosine (Videx); or
• if you are pregnant woman, or a man whose female sexual partner is pregnant.

To make sure you can safely take ribavirin, tell your doctor if you have any of these other conditions:

• kidney or liver disease (other than hepatitis C);
• hepatitis B infection;
• a blood cell disorder such as hemolytic anemia (a lack of red blood cells);
• human immunodeficiency virus (HIV or AIDS);
• diabetes;
• a pancreas disorder;
• sarcoidosis;
• breathing problems;
• a thyroid disorder;
• new or worsening eye problems (such as retinopathy);
• a history of heart disease, high blood pressure, or a heart attack;
• a history of depression or suicide attempt;
• a history of a liver, kidney, or other organ transplant; or
• if you have ever received treatment for hepatitis C that did not work well.

This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.
• If you are a man, do not take 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. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking ribavirin.
• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and 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 taking ribavirin.

Your name may need to be listed on a ribavirin pregnancy registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends. This is to track the outcome of the pregnancy and to evaluate any effects of ribavirin on the baby.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking ribavirin.

Ribavirin may affect growth in children.

How should I take ribavirin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Take this medicine with food.

Measure the liquid form of ribavirin with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. Your blood will need to be tested often. Your vision, liver function, and thyroid function may also need to be tested. Visit your doctor regularly.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

Use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking ribavirin, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

Store ribavirin tablets and capsules at room temperature away from moisture, heat, and light.

Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.

What should I avoid while taking ribavirin?

Treatment with ribavirin does not prevent spread of the hepatitis C virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

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

Ribavirin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of ribavirin?

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 ribavirin and call your doctor at once if you have a serious side effect such as:

• problems with your vision;
• fever, chills, body aches, flu symptoms;
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• stabbing chest pain, wheezing, feeling short of breath;
• severe depression, hallucinations, thoughts of suicide or hurting yourself;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness.

Less serious side effects may include:

• headache;
• muscle pain;
• dry mouth;
• nausea; vomiting, stomach pain, loss of appetite;
• weight loss;
• feeling tired or irritable;
• anxiety, mood changes; or
• pain, swelling, or irritation where the interferon injection was given.

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 ribavirin?

Tell your doctor about all other medicines you use, especially:

• abacavir (Ziagen);
• azathiopriine (Azasan, Imuran);
• lamivudine (Combivir, Epivir, Epzicom, Trizivir);
• stavudine (Zerit);
• tenofovir (Viread);
• zalcitabine (Hivid); or
• zidovudine (Retrovir, AZT).

This list is not complete and other drugs may interact with ribavirin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ribavirin.