Pronunciation:

rye-ba-VYE-rin

Brand Names:

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

Dosage Forms:

• Tablet
• Capsule

Warnings:

Embryo-fetal Toxicity, Hemolytic Anemia, and Monotherapy Not RecommendedSignificant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days and may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy and use effective contraception during therapy and for 9 months after completion of treatment in female patients and for 6 months in female partners of male patients who are taking ribavirin therapy.Hemolytic anemia has been reported with ribavirin therapy. The anemia associated with ribavirin 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 ribavirin.Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Viral RNA Polymerase Inhibitor

Chemical—

Guanosine Nucleoside Analog

Uses of This Medicine:

Ribavirin is used in combination 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ribavirin tablets in children younger than 5 years of age, ribavirin capsules and oral liquid in children younger than 3 years of age. Safety and efficacy of ribavirin have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ribavirin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving ribavirin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Didanosine

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

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

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Interferon Alfa-2b

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune hepatitis (liver inflammation) or
• Heart disease (unstable), or history of or
• Kidney disease, severe or
• Liver disease (including cirrhosis), severe 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 problems (eg, anemia, pancytopenia) or
• Breathing problems and lung disease (eg, pneumonia, pulmonary infiltrates, pulmonary hypertension) or
• Colitis (inflammation of the colon) or
• Depression or
• Diabetes or
• Drug abuse, history of or
• Eye or vision problems (eg, loss of vision, retinopathy) or
• Heart attack, history of 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 make these conditions worse.

• Blood problems (eg, spherocytosis) or
• Heart or blood vessel disease, history of or
• Stomach problems (eg, bleeding), history of—Use with caution. May increase risk for severe anemia.

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

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, decompensated or
• Organ transplant (eg, liver, kidney)—Use of ribavirin and peginterferon alfa-2a combination have not been established in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual 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 who have 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 have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

Do not use Copegus® in combination with didanosine (Videx®, Videx® EC). Using these medicines together may cause serious medical problems.

Ribavirin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Check with your doctor right away if you or your child have 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 symptoms of a blood disorder called anemia.

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, fever or chills, hives, red skin lesions, a severe skin rash or acne, or sores or ulcers on the skin while you are using this medicine.

Pancreatitis may occur while you are 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 (eg, pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia). Check with your doctor right away if you have chest pain or tightness, chills, cough, fever, general feeling of discomfort or illness, sneezing, thickening of bronchial secretions, trouble breathing, unusual tiredness or weakness.

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

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. 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.

Check with your doctor if blurred vision, decreased vision, or any other change in vision occurs while you or your child are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with 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 careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch 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 you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause teeth and gum problems. This medicine may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take the medicine for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

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

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

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

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

Side Effects of This Medicine:

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.