Classes
DEA Class; Rx
Common Brand Names; Rebetol, Ribasphere, RibaPak, Copegus, Virazole, Moderiba
- Hepatitis B/Hepatitis C Agents;
- RSV Agents
Description
Antiviral; synthetic guanosine analog; active against many DNA and RNA viruses.
Used in oral form with interferon alfa, peginterferon alfa, or a direct acting antiviral (DAA) for chronic hepatitis C treatment in adults and certain pediatric patients; not effective as monotherapy; aerosolized and oral ribavirin used for RSV treatment
Intravenous form is available from the US CDC for Hantaan virus infection and Lassa fever
Indications
Indicated for the treatment of Chronic Hepatitis C (In combination with pegterferon alfa-2a (Pegasys))
Contraindications
Women who are or may become pregnant
Men whose female partners are pregnant
Known hypersensitivity reactions to ribavirin (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
Autoimmune hepatitis
Hemoglobinopathies (eg, thalassemia major, sickle-cell anemia)
CrCl <50 mL/min
Coadministration with didanosine
Adverse Effects
- Fatigue (60-70%)
- Headache (63-66%)
- Hemolysis (61-64%)
- Myalgia (61-64%)
- Nausea (38-47%)
- Rigors (40-43%)
- Fever (32-41%)
- Insomnia (26-39%)
- Decreased Hgb (25-36%)
- Depression (23-36%)
- Hyperbilirubinemia (24-34%)
- Arthralgia (29-33%)
- Alopecia (27-32%)
- Irritability (23-32%)
- Musculoskeletal pain (20-28%)
- Rash (20-28%)
- Anorexia (21-27%)
- Dizziness (17-26%)
- Pruritus (13-21%)
- Flu-like syndrome (13-18%)
- Dyspnea (17-19%)
- Nasal congestion (13-18%)
- Dyspepsia (14-16%)
- Impaired concentration (10-14%)
- Thrombocytopenia (6-14%)
- Sinusitis (9-12%)
- Vomiting (9-12%)
- Emotional lability (7-12%)
- Decreased WBC; ANC <500 /cu.mm (5-11%)
Warnings
Use caution in mechanically ventilated patients
Do NOT use for influenza
Only Copegus studied in HCV/HIV coinfected patients, however, the modified dose is CDC recommended
There are significant adverse reactions caused by ribavirin/ peginterferon therapy, including severe depression and suicidal or homicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes; suicidal ideation may occur more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up
Suspend ribavirin and alfa interferon combination therapy in patients with signs and symptoms of pancreatitis and discontinue in patients with confirmed pancreatitis
Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia, reported during therapy with ribavirin with alpha interferon combination therapy; occasional cases of fatal pneumonia have occurred; sarcoidosis or the exacerbation of sarcoidosis reported; closely monitor patient or if necessary discontinue therapy if pulmonary infiltrate or pulmonary function impairment observed
Dental and periodontal disorders reported in patients receiving ribavirin and interferon alfa combination therapy; dry mouth could have damaging effect on teeth and mucous membranes of mouth during long-term treatment with combination of ribavirin and interferon alfa; patients should brush teeth thoroughly twice daily and have regular dental examinations; if vomiting occurs, they should be advised to rinse out their mouth thoroughly afterwards
Take extreme care to avoid pregnancy
Pregnancy and Lactation
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy or within 6 months following cessation of treatment
There are no data on presence of ribavirin in human milk or effects on breastfed infant or milk production
Maximum Dosage
Dependent on route of administration and indication for therapy.
Dependent on route of administration and indication for therapy.
Dependent on route of administration and indication for therapy.
Dependent on route of administration and indication for therapy.
Dependent on route of administration and indication for therapy.
How supplied
Ribavirin
tablet
- 200mg
- 400mg
- 600mg
inhalation solution
- 6g/vial
oral solution
- 40mg/mL