Ribavirin

Ribavirin is a prescription medication used to treat hepatitis C infection in adults and children.   Ribavirin is also used to treat respiratory syncitial virus in children.  Ribavirin belongs to a group of antiviral drugs called nucleoside analogues, which stop the spread of hepatitis C virus in the body.

This medication comes in capsule, tablet, inhalation and liquid forms. 

Common side effects of ribavirin include flu-like symptoms, mood changes, difficulty breathing, low blood pressure, and decreased appetite.

Ribavirin is a prescription medicine used with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

The inhalation form of this medication, Virazole, can also be used to treat Respiratory Syncytial Virus (RSV) in children. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ribavirin may be found in some form under the following brand names:

• Copegus

• Rebetol

• Ribasphere

• Ribasphere RibaPak

• RibaTab

• Virazole

Ribavirin tablets, capsules, and solution may cause serious side effects, including:

See "Drug Precautions".

• Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting, or diarrhea.
• Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
• Serious eye problems that may lead to vision loss or blindness.
• Dental problems. Your mouth may be very dry, which can lead to problems with your teeth and gums.
• Severe depression
• Suicidal thoughts and attempts. Adults and children who take ribavirin, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves while taking ribavirin. Call your healthcare provider right away or go to the nearest hospital emergency room if you have new or worse depression or thoughts about suicide or dying.
• Severe blood disorders. An increased risk when used in combination with pegylated alpha interferons and azathioprine
• Weight loss and slowed growth in children

Tell your health care provider right away if you have any side effect that bothers you or that does not go away.

The most common side effects of ribavirin tablets, solution, and capsules include:

• flu-like symptoms - feeling tired, headache, shaking along with high temperature (fever), nausea, and muscle aches.
• mood changes, feeling irritable.

The most common side effects of ribavirin solution, tablets, and capsules in children include:

• a decrease in the blood cells that fight infection (neutropenia).
• a decrease in appetite.
• stomach pain and vomiting.

The most common side effects of ribavirin for inhalation (Virazole) are:

• Difficulty breathing
• Low blood pressure
• Rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ribavirin. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin may affect the way other medicines work.

Especially tell your healthcare provider if you take didanosine (Videx) or azathioprine (Imuran and Azasan).

Clinical studies of interactions of the inhalation form of ribavirin with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. Interference by the inhalation form of ribavirin with laboratory tests has not been evaluated.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

1. Do Not take ribavirin capsules, tablets, or solution alone to treat chronic hepatitis C infection. Ribavirin should be used in combination with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic hepatitis C infection.
2. Ribavirin may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of heart problems, and in rare cases can cause a heart attack and death. Tell your healthcare provider if you have ever had any heart problems. Ribavirin may not be right for you. Seek medical attention right away if you experience chest pain.
3. Ribavirin may cause birth defects or the death of your unborn baby. Do not take ribavirin if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing ribavirin therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.
   • Females must have a pregnancy test before starting ribavirin, every month while taking ribavirin, and every month for the 6 months after the last dose of ribavirin.
   • If you or your female sexual partner becomes pregnant while taking ribavirin or within 6 months after you stop taking ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the ribavirin pregnancy registry by calling 1-800-593-2214. The ribavirin pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.

Additionally, for the tablet form of ribavirin (Copegus):

1. Copegus may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of heart problems, and in rare cases can cause a heart attack and death. Tell your healthcare provider if you have ever had any heart problems. Copegus may not be right for you. Seek medical attention right away if you experience chest pain.
2. Copegus may cause liver failure when taken with interferon. Your doctor should monitor your liver function while you are taking Copegus.
3. Copegus may cause severe skin reactions and should be discontinued if you suspect you are developing a skin reaction while taking Copegus.
4. Children treated with Copegus and interferon showed a delay in growth after 48 weeks

For the inhalation form of ribavirin (Virazole):

1. Difficulty breathing.  This may be more common or severe if you have COPD or asthma.
2. Genetic mutations.  Genetic mutations have been see in animals tested with Virazole. The risk of genetic mutations and possible cancer has not been fully evaluated in humans.
3. Male reproductive damage. Virazole has shown to cause harm to male reproductive organs in animals.  The risk for damage in humans has not been fully evaluated.
4. Low blood pressure.  This may be more common or sever if you have inherited heart disease.
5. Virazole may cause birth defects or the death of your unborn baby. Do not take Virazole if you or your sexual partner is pregnant or plan to be come pregnant. It is not known when it is safe to become pregnant after taking Virazole.

Do not take any form of ribavirin if you have:

• or ever had serious allergic reactions to the ingredients in ribavirin.
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• take didanosine (Videx).

Talk to your healthcare provider before taking ribavirin if you have any of these conditions.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ribavirin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take any form of ribavirin tell your healthcare provider if you have or ever had:

• treatment for hepatitis C that did not work for you.
• breathing problems. Ribavirin may cause or worsen breathing problems you already have.
• vision problems. Ribavirin may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin.
• certain blood disorders such as anemia (low red blood cell count).
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with ribavirin.
• thyroid problems
• liver problems other than hepatitis C infection
• human immunodeficiency virus (HIV) or any immunity problems
• mental health problems, including depression or thoughts of suicide
• kidney problems
• an organ transplant
• diabetes. Ribavirin may make your diabetes worse or harder to treat.
• any other medical condition
• are breastfeeding. It is not known if ribavirin passes into your breast milk. You and your healthcare provider should decide if you will take ribavirin or breast feed.

Additionally, before you take ribavirin inhalation, tell your healthcare provider if you have or ever had:

• breathing problems. Ribavirin inhalation may cause or worsen breathing problems you already have.
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with ribavirin inhalation.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin may affect the way other medicines work.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. Ribavirin falls into category X.

It has been shown that women taking ribavirin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women. Do not take ribavirin if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing ribavirin therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.

Ribavirin may cause birth defects or the death of your unborn baby. Do not take ribavirin if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing ribavirin therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.

• Females must have a pregnancy test before starting ribavirin, every month while taking ribavirin, and every month for the 6 months after the last dose of ribavirin.
• If you or your female sexual partner becomes pregnant while taking ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the ribavirin pregnancy registry by calling 1-800-593-2214. The ribavirin pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
• For those taking ribavirin inhalation, it is not known when it is safe to become pregnant after taking ribavirin inhalation.

Tell your healthcare provider if you are breastfeeding. It is not known if ribavirin passes into your breast milk. You and your healthcare provider should decide if you will take ribavirin or breastfeed.

• Take ribavirin tablets, capsules, solution, and inhalation exactly as your healthcare provider tells you. Your healthcare provider will tell you how much ribavirin to take and when to take it.
• Take ribavirin capsules, tablets, and solution with food.
• Take ribavirin capsules whole. Do not open, break, or crush ribavirin capsules before swallowing. If you cannot swallow ribavirin capsules whole, tell your healthcare provider.
• If you miss a dose of ribavirin tablets, capsules, or solution, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider.
• If you take too much ribavirin, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Ribasphere (ribavirin) capsules are typically taken for HCV as 1000 mg or 1200 mg per day divided into two daily doses.

The recommended Virazole (ribavirin) inhalation dose is 20 mg/mL Virazole in the drug reservoir of the SPAG-2 unit, with continuous administration for 12-18 hours per day for 3 to 7 days. Using the recommended dose of 20 mg/mL, the average aerosol concentration for a 12 hour delivery period would be 190 micrograms/liter of air.

Rebetol (ribavirin) capsules and solution are typically given as 800 mg to 1400 mg per day in two divided doses.

The recommended dose of Copegus (ribavirin) tablets for hepatitis C is 800 mg to 1200 mg divided in two daily doses.

If you take too much ribavirin, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

If ribavirin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store ribavirin capsules between 59°F to 86°F (15°C to 30°C).
• Store ribavirin oral solution between 59°F to 86°F (15°C to 30°C) or in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Store ribavirin tablets between 59°F to 86°F (15°C to 30°C).
• Vials containing the lyophilized ribavirin inhalation powder should be stored in a dry place at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F- 86°F). Reconstituted solutions may be stored, under sterile conditions, at room temperature (20-30°C, 68-86°F) for 24 hours.

Keep ribavirin and all medicines out of the reach of children.

Copegus (ribavirin) tablets have the following black box warning:

• Copegus monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
• The primary toxicity of Copegus is hemolytic anemia. The anemia associated with Copegus therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Copegus.
• Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to Copegus. In addition, Copegus has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, Copegus therapy is contraindicated in women who are pregnant and in the male partners of women who are Copegus. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking Copegus therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period.

Rebetol (ribavirin) solution and capsules have the following black box warning:

• Rebetol monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
• The primary toxicity of Rebetol is hemolytic anemia. The anemia associated with Rebetol therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Rebetol.
• Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to Rebetol. In addition, Rebetol has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, Rebetol therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking Rebetol therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period

Virazole (ribavirin) inhalation has the following black box warning:

USE OF AEROSOLIZED VIRAZOLE IN PATIENTS REQUIRING MECHANICAL VENTILATOR ASSISTANCE SHOULD BE UNDERTAKEN ONLY BY PHYSICIANS AND SUPPORT STAFF FAMILIAR WITH THE SPECIFIC VENTILATOR BEING USED AND THIS MODE OF ADMINISTRATION OF THE DRUG. STRICT ATTENTION MUST BE PAID TO PROCEDURES THAT HAVE BEEN SHOWN TO MINIMIZE THE ACCUMULATION OF DRUG PRECIPITATE, WHICH CAN RESULT IN MECHANICAL VENTILATOR DYSFUNCTION AND ASSOCIATED INCREASED PULMONARY PRESSURES. SUDDEN DETERIORATION OF RESPIRATORY FUNCTION HAS BEEN ASSOCIATED WITH INITIATION OF AEROSOLIZED VIRAZOLE USE IN INFANTS. RESPIRATORY FUNCTION SHOULD BE CAREFULLY MONITORED DURING TREATMENT. IF INITIATION OF AEROSOLIZED VIRAZOLE TREATMENT APPEARS TO PRODUCE SUDDEN DETERIORATION OF RESPIRATORY FUNCTION, TREATMENT SHOULD BE STOPPED AND REINSTITUTED ONLY WITH EXTREME CAUTION, CONTINUOUS MONITORING AND CONSIDERATION OF CONCOMITANT ADMINISTRATION OF BRONCHODILATORS. VIRAZOLE IS NOT INDICATED FOR USE IN ADULTS. PHYSICIANS AND PATIENTS SHOULD BE AWARE THAT RIBAVIRIN HAS BEEN SHOWN TO PRODUCE TESTICULAR LESIONS IN RODENTS AND TO BE TERATOGENIC IN ALL ANIMAL SPECIES IN WHICH ADEQUATE STUDIES HAVE BEEN CONDUCTED.

Ribasphere (ribavirin) capsules have the following black box warning:

Ribasphere monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.

The primary toxicity of Ribasphere is hemolytic anemia. The anemia associated with Ribasphere therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Ribasphere.

Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to Ribasphere. In addition, ribavirin has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, Ribasphere therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking Ribasphere therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post-treatment follow-up period.