Ribavirin (Oral)

Ribavirin is used together with injectable interferon alfa-2b, peginterferon alfa-2a, or peginterferon alfa-2b to treat chronic hepatitis C infection.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor the progress of you or your child during regular visits to ensure this medicine is working correctly. Blood tests may be required to check for unwanted effects.

Using this medicine while pregnant can harm your unborn baby. If you are a woman who can become pregnant, your doctor might give you a pregnancy test before you start using this medicine to confirm you are not pregnant. This medicine may also cause birth defects if the father is using it when his partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 9 months after the last dose. Male patients with female partners should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. If you think you or your partner have become pregnant while using this medicine, inform your doctor immediately.

Do not use Copegus® with didanosine (Videx®, Videx® EC). Taking these medicines together may lead to serious medical issues.

Ribavirin may cause some individuals to feel agitated, irritable, or show other abnormal behaviors. It may also lead some individuals to have suicidal thoughts and tendencies or to feel more depressed. If you, your child, or your caregiver notice any of these side effects, inform your doctor or your child's doctor immediately.

Contact your doctor right away if you or your child experience back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a blood disorder called anemia.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical attention. Call your doctor right away if you or your child experience itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth while using this medicine.

Serious skin reactions can happen with this medicine. Contact your doctor immediately if you or your child have blistering, peeling, or loosening skin, fever or chills, hives, red skin lesions, a severe skin rash or acne, or sores or ulcers on the skin while using this medicine.

Pancreatitis may occur while using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause lung or breathing problems (e.g., pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia). Contact your doctor immediately if you have chest pain or tightness, chills, cough, fever, a general feeling of discomfort or illness, sneezing, thickening of bronchial secretions, trouble breathing, or unusual tiredness or weakness.

You should not drink alcoholic beverages (including beer, wine, or liquor) while taking this medicine.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Make sure you know how you react to this medicine before you or your teenager drive, operate machinery, or do anything else that could be dangerous if you are not alert.

Contact your doctor if you experience blurred vision, decreased vision, or any other change in vision while you or your child are using this medicine. Your doctor may want you to see an ophthalmologist (eye doctor).

Peginterferon injection combined with ribavirin can temporarily reduce the number of white blood cells in your blood, increasing the risk of getting an infection. It can also lower the number of platelets in the blood, which are needed for proper blood clotting. If this happens, there are specific precautions you or your child can take, especially when your blood count is low, to lower the risk of infection or bleeding:

• If possible, avoid contact with people who have infections. Contact your doctor immediately if you think you are developing an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your doctor before any dental work.
• Avoid touching your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects like a safety razor or fingernail or toenail clippers.
• Steer clear of contact sports or other situations where bruising or injury could happen.

This medicine may cause issues with teeth and gums. It may lead to a dry mouth, which can harm your teeth and gums if you take the medicine for a long time. To help prevent this, brush your teeth carefully at least twice a day and visit your dentist regularly. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Some patients who have taken this medicine have experienced vomiting. If you vomit during treatment, rinse your mouth with water. This may also help prevent damage to your teeth and gums.

Ribavirin used with injectable peginterferon alfa-2a or peginterferon alfa-2b may affect your child's growth. Your doctor may need to monitor your child's height and weight during and after treatment with these medicines.

This medicine could lead to infertility in men. Discuss with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will evaluate the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how ribavirin tablets affect children younger than 5 years old, or how ribavirin capsules and oral liquid affect children younger than 3 years old. The safety and effectiveness of ribavirin have not been established for these age groups.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of ribavirin. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require adjusting the dose for those taking ribavirin.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could occur. In these cases, your doctor might need to adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the following medicines when using this medicine. The following interactions are based on their potential significance and are not an exhaustive list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change your other medicines.

• Didanosine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or how often you use one or both medicines.

• Abacavir
• Azathioprine
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• Stavudine
• Warfarin
• Zalcitabine
• Zidovudine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed, your doctor may adjust the dose or how often you use one or both medicines.

• Interferon Alfa-2b

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Autoimmune hepatitis (liver inflammation) or
• Unstable heart disease, or history of or
• Severe kidney disease or
• Severe liver disease (including cirrhosis) or
• Sickle cell anemia (red blood cell disorder) or
• Thalassemia major (genetic blood disorder)—Should not be used in patients with these conditions.

• Blood or bone marrow issues (e.g., anemia, pancytopenia) or
• Breathing issues and lung disease (e.g., pneumonia, pulmonary infiltrates, pulmonary hypertension) or
• Colitis (inflammation of the colon) or
• Depression or
• Diabetes or
• History of drug abuse or
• Eye or vision problems (e.g., loss of vision, retinopathy) or
• History of heart attack or
• Hypertension (high blood pressure) or
• Pancreatitis (inflammation of the pancreas) or
• Sarcoidosis (lung disease) or
• Thyroid disease or
• Weakened immune system—Use with caution. May worsen these conditions.

• Blood issues (e.g., spherocytosis) or
• History of heart or blood vessel disease or
• History of stomach problems (e.g., bleeding)—Use with caution. May increase the risk of severe anemia.

• Infection (e.g., adenovirus, RSV) or
• Influenza or parainfluenza—Should not be used in patients with these conditions. Your doctor may provide inhaled ribavirin.

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Decompensated liver disease or
• Organ transplant (e.g., liver, kidney)—The use of ribavirin in combination with peginterferon alfa-2a has not been established in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety
• black, tarry stools
• body aches or pain
• chest pain or tightness
• congestion
• cough or hoarseness
• crying
• depersonalization
• diarrhea
• difficult or labored breathing
• discouragement
• dry mouth
• dryness of the throat
• dysphoria
• euphoria
• feeling sad or empty
• feeling unusually cold
• fever or chills
• general feeling of discomfort or illness
• headache
• irregular heartbeats
• irritability
• joint pain
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• pale skin
• paranoia
• poor concentration
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• runny nose
• shaking
• shivering
• sleeplessness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• tender, swollen glands in the neck
• trouble breathing
• trouble with concentrating
• trouble with sleeping
• trouble with swallowing
• unable to sleep
• upper abdominal or stomach pain
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting

Less common

• Bleeding gums
• blood in the urine or stools
• constipation
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• husky voice
• muscle cramps and stiffness
• pinpoint red spots on the skin
• right upper abdominal or stomach fullness
• slowed heartbeat
• weight gain

Incidence not known

• Blistering, flaking, or peeling of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• being forgetful
• belching
• blurred vision
• bone pain
• change in taste or bad, unusual, or unpleasant (after) taste
• cracked, scaly skin
• crusting, irritation, itching, or reddening of the skin
• difficulty with moving
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• heartburn
• indigestion
• lack or loss of strength
• menstrual changes
• pain or tenderness around the eyes and cheekbones
• rash
• sensation of spinning
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• swelling
• swollen joints
• weight loss

Less common

• Back pain
• burning, dry, or itching eyes
• discharge, excessive tearing
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash, encrusted, scaly, and oozing

Incidence not known

• Change in hearing
• loss of hearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Copegus
• Rebetol
• RibaPak
• Ribasphere
• Ribasphere Ribapak
• RibaTab

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antiviral

Pharmacologic Class: Viral RNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

To help clear up your infection completely, ribavirin must be given for the full time of treatment, even if you or your child begins to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, ribavirin must be given on a regular schedule.

This medicine should come with a Medication Guide. Read and follow the information carefully. Ask your doctor if you have any questions.

You may take this medicine with food.

Swallow the capsule whole. Do not crush, break, or open it.

Measure the oral liquid with a marked measuring cup or spoon. Wash the cup or spoon after each use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hepatitis C virus infection, in combination with interferon alfa-2b: For oral dosage form (capsules): Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1000 to 1200 milligrams (mg) per day, given in 2 divided doses and taken in the morning and evening. Each capsule contains 200 mg of ribavirin. Weighing more than 75 kilograms (kg)—3 capsules in the morning and 3 capsules in the evening. Weighing at least 75 kg—2 capsules in the morning and 3 capsules in the evening. Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening. Each capsule contains 200 mg of ribavirin. Children younger than 3 years of age—Use and dose must be determined by your doctor. For oral dosage form (solution): Adults—Dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers. Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening. Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For hepatitis C virus infection, in combination with peginterferon alfa-2b: For oral dosage form (capsules): Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 800 to 1400 milligrams (mg) per day, given in 2 divided doses and taken in the morning and evening.. Each capsule contains 200 mg of ribavirin. Weighing more than 105 kilograms (kg)—3 capsules in the morning and 4 capsules in the evening. Weighing 81 to 105 kg—3 capsules in the morning and 3 capsules in the evening. Weighing 66 to 80 kg—2 capsules in the morning and 3 capsules in the evening. Weighing less than 66 kg—2 capsules in the morning and 2 capsules in the evening. Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 divided doses and taken in the morning and evening. Each capsule contains 200 mg of ribavirin. Weighing more than 73 kilograms (kg)—3 capsules in the morning and 3 capsules in the evening. Weighing 60 to 73 kg—2 capsules in the morning and 3 capsules in the evening. Weighing 47 to 59 kg—2 capsules in the morning and 2 capsules in the evening. Weighing less than 47 kg—Use of oral solution is recommended. Children younger than 3 years of age—Use and dose must be determined by your doctor. For oral dosage form (solution): Adults—Dose is based on body weight and must be determined by your doctor. The oral solution form of this medicine is not usually prescribed for adults and teenagers. Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight per day, given in two divided doses and taken in the morning and evening. Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For hepatitis C virus infection, in combination with peginterferon alfa-2a:For oral dosage form (tablets): Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 800 to 1200 milligrams (mg) per day, given in 2 divided doses and taken in the morning and evening. Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 400 to 1200 mg per day, given in 2 divided doses and taken in the morning and evening. Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For hepatitis C with HIV virus coinfection, in combination with peginterferon alfa-2a:For oral dosage form (tablets): Adults—800 milligrams (mg) per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules and tablets in a closed container at room temperature, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator or at room temperature, away from heat and direct light. Do not freeze.

• What medications are known to cause hair loss?