Ribavirin monotherapy is not effective for treatment of chronic hepatitis C virus (HCV) infection and should not be used alone for this indication.
The principal toxicity of oral ribavirin is hemolytic anemia which may result in worsening of cardiac disease and has resulted in fatal and nonfatal MI. Patients with a history of substantial or unstable cardiac disease should not be given ribavirin.
Teratogenic and/or embryocidal effects demonstrated. Ribavirin has a long half-life and may persist in nonplasma compartments for as long as 6 months. Contraindicated in pregnant women and in male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during and for 6 months following ribavirin therapy in female patients and in female partners of male patients receiving ribavirin. At least 2 reliable forms of contraception must be used during and for 6 months following completion of treatment.
Initiation of aerosolized ribavirin (given by nasal or oral inhalation) in infants has resulted in sudden deterioration of respiratory function. Monitor respiratory function carefully. If sudden deterioration of respiratory function occurs, discontinue therapy. Reinstitute with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.
Ribavirin for nasal or oral inhalation is not indicated in adults.
Administer aerosolized ribavirin under the supervision of and by qualified clinicians and support staff experienced with the specific ventilator and mode of administration. Attention must be directed to procedures that minimize accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressure.
REMS:
FDA approved a REMS for ribavirin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
This medicine is for inhalation through the mouth. It is given by specially trained personnel in a hospital setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Do not take this medicine with the following medication:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
Visitors and health care workers are at risk of exposure to this medicine by breathing mist from the air. Talk to the doctor for more information. If you are pregnant or breast-feeding talk with the doctor before visiting a patient who is on this medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
breathing problems
chest pain, soreness
fever
lips or nail beds with bluish color
seizures
unusual blood pressure or heart rate
unusually weak or tired
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
