Pronunciation:

rye-ba-VYE-rin

Brand Names:

• Copegus
• Rebetol
• RibaPak
• Ribasphere
• RibaTab

Dosage Forms:

• Tablet
• Capsule
• Solution

Warnings:

• INHALATION
  • Use of aerosolized ribavirin 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 ribavirin use in infants. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized ribavirin 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.
  • Ribavirin 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 (rodents and rabbits) .

Use caution when administering aerosolized ribavirin to patients requiring mechanical ventilator assistance. Sudden deterioration of respiratory function has been associated with initiation of aerosolized ribavirin use in infants. Monitor respiratory function during treatment. Ribavirin is not indicated for use in adults. 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 (rodents and rabbits) .

• ORAL
  • Ribavirin 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 ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin.
  • Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has multiple-dose half-life of 12 days, and so it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in 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 ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period .

Ribavirin is not effective for monotherapy treatment of chronic hepatitis C virus infection. The primary toxicity is hemolytic anemia which may result in worsening of cardiac disease and fatal and nonfatal myocardial infarctions. Avoid use in patients with significant or unstable cardiac disease. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is contraindicated in women who are pregnant and in male partners of women who are pregnant. Use 2 reliable forms of contraception and 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 ribavirin .

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 the pediatric population. Appropriate studies have also not been performed on the relationship of age to the effects of ribavirin capsules in children below 5 years of age, and oral solution in children below 3 years of age. Safety and efficacy of ribavirin tablets, capsules, and oral solution have not been established in these age groups .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-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 of dosage in patients receiving ribavirin .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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—

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
• Didanosine
• Lamivudine
• Stavudine
• Zalcitabine
• Zidovudine

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:

• Anemia (blood disorder) or
• Autoimmune hepatitis (liver inflammation)—Ribavirin may make these conditions worse and lead to very serious side effects .

• Breathing problems and other lung diseases or
• Diabetes or
• Thyroid disease—Use with caution. This medicine may make these conditions worse .

• Heart disease (severe), or history of—Ribavirin may cause serious side effects .

• Kidney disease, severe or
• Liver disease, severe or
• Sickle cell anemia (red blood cell disorder) or
• Thalassemia major (genetic blood disorder)—Ribavirin should not be used in patients with these conditions .

• Mental depression—Ribavirin should be used carefully in patients with this condition, especially adolescents, as serious side effects can occur .

• Pancreatitis (inflammation of the pancreas)—Ribavirin should be stopped in patients with this condition .

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 or continuous schedule .

You should take the oral tablets with food .

You may take the oral capsules and oral solution with or without food, but after you choose, you should always take these forms the same way every day .

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

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

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information .

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—1000 to 1200 milligrams (mg) per day, two or three capsules in the morning and three capsules at night. The dose is based on body weight and must be determined by your doctor.
    • Children 5 years of age and older—The dose is based on body weight and must be determined by your doctor.
    • Children below 5 years of age—Use and dose must be determined by your doctor .
  • For oral dosage form (solution):
    • Adults—The 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—The dose is based on body weight and must be determined by your doctor.
    • Children below 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—800 milligrams (mg) per day, two capsules in the morning and two capsules at night. Your doctor may adjust your dose if needed. The dose is based on body weight and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor .
  • For oral dosage form (solution):
    • Adults—The 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—Use and dose must be determined by your doctor .
• For hepatitic C virus infection, in combination with peginterferon alfa-2a:
  • For oral dosage form (tablets):
    • Adults—800 to 1200 milligrams (mg) daily, divided into two doses (once in the morning and once at night). The dose is based on body weight and must be determined by your doctor.
    • 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress 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. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away. Do not breastfeed while you are using this medicine .

A negative pregnancy test is needed in women who are of childbearing age before starting treatment with this medicine. Two forms of birth control must be used during treatment and for six months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with this medicine and after your treatment ends .

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 are having back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty breathing; fatigue; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia .

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .

You should not drink alcoholic beverages 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 drive, operate machinery, or do anything else that could be dangerous if you are not alert .

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 .

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

congestion

cough or hoarseness

crying

depersonalization

diarrhea

difficult or labored breathing

discouragement

dry mouth

dryness of throat

dysphoria

euphoria

feeling sad or empty

feeling unusually cold

fever or chills

general feeling of discomfort or illness

headache

hyperventilation

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

right upper abdominal pain

runny nose

shaking

shivering

shortness of breath

sleeplessness

sore throat

sores, ulcers, or white spots on lips or in mouth

sweating

tender, swollen glands in neck

tightness in chest

trouble concentrating

trouble in swallowing

trouble sleeping

troubled breathing with exertion

unable to sleep

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

vomiting

wheezing

Less common

Bleeding gums

blood in urine or stools

constipation

depressed mood

dry skin and hair

feeling cold

hair loss

husky voice

muscle cramps and stiffness

pinpoint red spots on skin

right upper abdominal fullness

slowed heartbeat

weight gain

Incidence not known

Blistering, flaking, or peeling of skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal cramps

confusion

convulsions

drowsiness

irregular heartbeats

mood or mental changes

muscle cramps in hands, arms, feet, legs, or face

muscle spasms (tetany) or twitching

numbness and tingling around the mouth, fingertips, or feet

seizures

tremor

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 skin

difficulty in moving

dizziness or lightheadedness

feeling of constant movement of self or surroundings

hair loss, thinning of hair

heartburn

indigestion

lack or loss of strength

menstrual changes

pain or tenderness around 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 eye, eyelid, or inner lining of 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.