Dosing & Uses
Dosage Forms & Strengths
tablet
- 200mg
- 400mg
- 600mg
inhalation solution
- 6g/vial
oral solution
- 40mg/mL
Chronic Hepatitis C
In combination with pegterferon alfa-2a (Pegasys)
Dose reductions/interruptions recommended if Hgb falls (see Mfr's PI for specifics)
Tablets (Copegus)
- In combination with peginterferon alfa-2a
- Genotype 1, 4; HIV-free (<75 kg): 1000 mg/day PO divided q12hr x48 weeks
- Genotype 1, 4; HIV-free (≥75 kg): 1200 mg/day PO divided q12hr x48 weeks
- Genotype 2/3; HIV-free: 800 mg/day PO divided q12hr x24 weeks
- Chronic hepatitis C coinfected with HIV: peginterferon alfa-2a 180 mcg SC qWeek plus ribavirin 800 mg PO divided q12hr (regardless of genotype)
Rebetol capsule, oral solution, Ribasphere combo with peginterferon alfa 2b
- <66 kg (145 lb): 800 mg/day (400 mg AM and 400 PM) + peginterferon 1.5 mcg/kg/Wk SC
- 66-80 kg (145-177 lb): 1000 mg/day (400 mg AM and 600 PM) + peginterferon 1.5 mcg/kg/Wk SC
- 81-105 kg (178-231 lb): 1200 mg/day (600 mg AM and 600 PM) + peginterferon 1.5 mcg/kg/Wk SC
- >105 kg (231 lb): 1400 mg/day (600 mg AM and 800 PM) + peginterferon 1.5 mcg/kg/Wk SC
Recommended therapy duration
- Genotype 1: 48 wks
- Genotype 2,3: 24 wks
- Patients who previously failed therapy: 48 wks, regardless of genotype
Ribavirin (Rebetol capsule and solution; Ribasphere) with interferon alfa 2b
- ≤75 kg: 400 mg PO qAM, 600mg PO qPM plus 3 million IU three times weekly SC for 24-48 wks
- >75 kg: 600 mg PO q12hr plus 3 million IU three times weekly SC for 24-48 wks
Recommended therapy duration
- Patients previously untreated with interferon: 24-48 wks
- Patients who relapse following inteferon monotherapy: 24 wks
HIV/HCV coinfection: Copegus
- 800 mg/d PO divided q12h x48 weeks
RibaPak, Copegus, Ribasphere and equivalents used with peginterferon alfa-2a (Pegasys)
- Coadministered dose of peginterferon alfa-2a: 180 mcg qWeek
Renal Impairment
Rebetol capsules/solution, Ribasphere capsules
- CrCl < 50 mL/min: Use contraindicated
- CrC l ≥ 50 mL/min: Dose adjustment not necessary
Ribasphere tablets
- CrCl < 50 mL/min: Use contraindicated
- CrC l ≥ 50 mL/min: Dose adjustment not necessary
Copegus tablets
- CrCl <30 mL/min or hemodialysis: 200 mg PO qDay
- CrCl 30-50 mL/min: Alternating doses, 200 mg and 400 mg PO every other day
- CrCl ≥ 50 mL/min: Dose adjustment not necessary
Thyroid Cancer (Orphan)
Ribavirin elaidate: Treatment of follicular, medullary, and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer
Orphan indication sponsor
- Translational Therapeutics, Inc; 163 Scituate Street; Arlington, MA 02476
Hemorrhagic Fever (Orphan)
Treatment of hemorrhagic fever (Lassa fever) with renal syndrome
Treatment: Load 30 mg/kg IV (up to 2 g), THEN 16 mg/kg IV (up to 1 g) q6hr x4 days, THEN 8 mg/kg IV (up to 500 mg) q8hr x6 days
IV form available from CDC on compassionate basis
Prophylaxis: 500-600 mg PO q6hr x7-10 days
Orphan indication sponsor
- Valeant Pharmaceuticals International; 3300 Hyland Avenue; Costa Mesa, CA 92626
Administration
Take with food
Take 1 dose AM and one at night (may not be equal)
Dosage Forms & Strengths
tablet
- 200mg
- 400mg
- 600mg
inhalation solution
- 6g/vial
oral solution
- 40mg/mL
Respiratory Syncytial Virus
Virazole: Put 20 mg/mL solution (6 g drug reconstituted with 300 mL sterile water for injection) in SPAG-2 unit
Continuous aerosolized administration for 12-18 hr/day x 3-7 days
Delivers 190 mcg/L of air for a 12-hr period
Chronic Hepatic C Virus Infection
Indicated in combination with peginterferon alfa-2a for treatment of chronic hepatitis C in patients with compensated liver disease and no prior history of interferon therapy
Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through completion of therapy
Length of treatment determined by genotype; genotypes 2 or 3 administer for 24 weeks, for genotype 1 is 48 weeks
Rebetol capsule, oral solution
- Ages 3-17 years
- <47 kg (103 lb): 15 mg/kg/day oral solution divided q12hr, plus peginterferon alfa-2b 60 mcg/m² SC qWeek
- 47-59 kg (103-131 lb): 400 mgPO q12hr, plus peginterferon alfa-2b 60 mcg/m² SC qWeek
- 60-73 kg (132-162 lb): 400 mg PO qAM, 600 mg PO qPM plus peginterferon alfa-2b 60 mcg/m² SC qWeek
- >73 kg (162 lb): 600 mg PO q12hr plus peginterferon alfa-2b 60 mcg/m² SC qWeek
Copegus, Moderiba (tablets)
- <5 years: Safety and efficacy not established
- 5-17 years: ~15 mg/kg/day PO divided q12hr with weekly SC peginterferon alfa-2a
- 23-33 kg: 200 mg PO q12hr
- 34-46 kg: 200 mg PO qAM and 400 mg PO qPM
- 47-59 kg: 400 mg PO q12hr
- 60-74 kg: 400 mg PO qAM and 600 mg PO qPM
- ≥75 kg: 600 mg PO q12hr
Lassa Fever Prophylaxis
>9 years: As adult; Load 30 mg/kg IV (up to 2 g), THEN 16 mg/kg IV (up to 1 g) q6hr x4 days, THEN 8 mg/kg IV (up to 500 mg) q8hr x6 days
6-9 years: 400 mg PO q6hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- didanosine
ribavirin increases toxicity of didanosine by unspecified interaction mechanism. Contraindicated. Risk of hepatic failure, peripheral neuropathy, pancreatitis, lactic acidosis.
Serious - Use Alternative (3)
- abacavir
ribavirin increases toxicity of abacavir by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of lactic acidosis and hepatic decompensation.
- stavudine
ribavirin decreases effects of stavudine by Other (see comment). Contraindicated. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
- zidovudine
ribavirin decreases effects of zidovudine by Other (see comment). Avoid or Use Alternate Drug. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
Monitor Closely (3)
- emtricitabine
ribavirin increases toxicity of emtricitabine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.
- lamivudine
ribavirin increases toxicity of lamivudine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.
- tobramycin inhaled
tobramycin inhaled and ribavirin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
Minor (0)
Adverse Effects
>10%
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%)
1-10%
Hemolytic anemia (~10%)
Weakness (9-10%)
Chest pain (5-9%)
Taste perversion (6-8%)
Nervousness (~5%)
Postmarketing Reports
Combined with peginterferon alfa-2a
- Dehydration
- Hearing impairment
- Hearing loss
- Retinal detachment
- Pure red cell aplasia (PRCA)
- Serious skin reactions
- Liver and renal graft rejection
- Homicidal ideation
- Growth inhibition in pediatric patients
Warnings
Black Box Warnings
Oral
- Monotherapy not effective for treatment of chronic hepatitis C virus (HCV) infection and should not be used alone for this indication
- Hemolytic anemia is the primary toxicity, which may result in worsening of cardiac disease and lead to fatal and nonfatal MI; do not use if history of significant or unstable cardiac disease
- Significant teratogenic and/or embryocidal effects demonstrated in all animal species exposed to ribavirin
- Half-life is 12 days, and drug may persist in nonplasma compartments for as long as 6 months
- Contraindicated during pregnancy and in the male partners of pregnant women
- Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and female partners of male patients taking ribavirin
- At least 2 reliable forms of effective contraception must be used during treatment and during the 6-month posttreatment follow-up period
Inhalation
- Aerosolized ribavirin in patients requiring mechanical ventilator assistance should be administered only by health care providers and support staff familiar with this mode of administration and the specific ventilator being used
- Strictly follow procedures that minimize drug precipitate accumulation to avoid mechanical ventilator dysfunction
- Sudden respiratory function deterioration in infants may occur during initiation of aerosolized ribavirin
- Carefully monitor respiratory function during treatment
- If sudden deterioration of respiratory function occurs, stop treatment and reinstitute only with extreme caution, continuous monitoring, and possibly bronchodilator coadministration
- Aerosolized ribavirin not indicated for adults
- Produces testicular lesions in rodents and is teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits)
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
Cautions
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
Ocular disorders reported when ribavirin is used in combination therapy with alpha interferons (eg, decrease or loss of vision, retinopathy including macular edema, retinal artery or vein, thrombosis, retinal hemorrhages; cotton wool spots, optic neuritis, papilledema, serous retinal detachment)
Study in boys showed growth rate inhibited (ie, height percentile decreases) with peginterferon alfa-2b plus ribavirin
Pancytopenia and bone marrow suppression reported when coadministered with pegylated interferon and azathioprine
Assess patient for underlying cardiac disease before initiating therapy
Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment and should be appropriately monitored during therapy; if there is deterioration of cardiovascular status, therapy should be suspended or discontinued
Peginterferon in combination with ribavirin may cause severe decreases in neutrophil and platelet counts, and hematologic, endocrine (eg, TSH), and hepatic abnormalities
Obtain hematology and blood chemistry testing in patients on Peginterferon/ribavirin combination therapy before start of treatment and periodically thereafter
Hepatic decompensation
- Patients with chronic hepatitis C (CHC) and cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS
- Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART
Drug interaction overview
- Pancytopenia (marked decreases in red blood cells, neutrophils, and platelets) and bone marrow suppression reported to occur within 3 to 7 weeks after concomitant administration of pegylated interferon/ribavirin and azathioprine; myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of both HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone; discontinue peginterferon, ribavirin, and azathioprine for pancytopenia, and do not reintroduce pegylated interferon/ribavirin with concomitant azathioprine
- Exposure to didanosine or its active metabolite (deoxyadenosine 5’-triphosphate) is increased when didanosine is coadministered with ribavirin, which could cause or worsen clinical toxicities; therefore, coadministration of ribavirin and didanosine is contraindicated
Pregnancy & Lactation
Pregnancy
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to drug during pregnancy or within 6 months following cessation of treatment; healthcare providers and patients are encouraged to report such cases by calling 1-800-593-2214
Therapy is contraindicated for use in pregnant women and in men whose female partners are pregnant; obtain negative pregnancy test before initiating therapy; patients should have periodic pregnancy tests during treatment and during the 9-month period after treatment has been stopped
Female patients of reproductive potential should use effective contraception during treatment and for 9 months post-therapy
Male patients should use effective contraception during treatment and during 6-month period after treatment has been stopped
Infertility
- Based on animal data, the drug may impair male fertility; in animal studies, these effects were mostly reversible within a few months after drug cessation
Animal data
- Therapy has demonstrated significant teratogenic and embryocidal effects in all animal species tested; these effects occurred at doses as low as one-twentieth of recommended human dose of ribavirin
- Interim data from Pregnancy Registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes
- The drug is known to accumulate in intracellular components from where it is cleared very slowly; in animal studies, drug exposure was shown to have teratogenic and/or embryocidal effects
Lactation
There are no data on presence of ribavirin in human milk or effects on breastfed infant or milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
May inhibit the initiation and elongation of RNA fragments by inhibiting polymerase activity, which in turn results in the inhibition of viral protein synthesis
Absorption
Absorption (inhalation): Systemic maximal absorption occurs with use of aerosol generator via endotracheal tube; highest concentrations may occur in respiratory tract and erythrocytes
Peak plasma time: 3 hr (multiple doses; capsule at end of inhalation period)
Bioavailability: 64% (PO)
Distribution
Significantly prolonged in erythrocyte (16-40 days), which may use as marker for intracellular metabolism
Vd: 2825 L
Protein bound: None (PO)
Metabolism
Hepatically and intracellularly (forms active metabolites); may be necessary for drug action
Elimination
Half-life: 24 hr in healthy adults (capsule); 44 hr (chronic hepatitis C infection; increases to ~298 hr at steady state)
Excretion: Urine (61%); feces (12%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| ribavirin oral - | 200 mg capsule |  | |
| ribavirin oral - | 200 mg tablet |  | |
| ribavirin oral - | 200 mg capsule |  | |
| ribavirin oral - | 200 mg tablet |  | |
| ribavirin oral - | 200 mg capsule |  | |
| ribavirin inhalation - | 6 gram nebulizer soln |  | |
| ribavirin inhalation - | 6 gram nebulizer soln |  | |
| Virazole inhalation - | 6 gram nebulizer soln |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ribavirin inhalation
RIBAVIRIN - INHALATION
(RYE-ba-VYE-rin)
COMMON BRAND NAME(S): Virazole
WARNING: Caution is advised when using this medication in people who are using a certain breathing device (ventilator). Read and follow the manufacturer's directions for use and care of the ventilator. Follow all directions from the manufacturer to prevent particle buildup in the device. Doing so will help the device work properly and may prevent serious side effects (such as air pressure buildup inside the lungs).Rarely, sudden worsening of breathing problems may occur, especially when this medication is first started. If this occurs, treatment should be stopped. If you and the doctor decide to restart ribavirin treatment, the doctor will monitor closely to decrease the risk of side effects.
USES: This medication is an anti-viral drug used to treat infants and young children who have a severe lung infection caused by a certain virus (respiratory syncytial virus-RSV). Nearly all children become infected with this virus before they are 3 years old. Most cases are mild and do not require anti-viral drugs. This medication is used to treat severe RSV infections that need treatment in a hospital.Ribavirin for inhalation is not recommended for use in adults.
HOW TO USE: This medication is given by a health care professional. It is given by continuous inhalation as directed by the doctor, usually for 12 to18 hours a day for 3 to 7 days. A special machine (small-particle aerosol generator) is used to make a mist, which is then inhaled through the mouth or nose.Health care workers providing care to patients receiving this medication should learn all precautions for handling/giving this medication (such as wearing a mask, room ventilation). The manufacturer recommends that health care workers who are pregnant should consider avoiding direct care of patients using this medication. This medication must not be used during pregnancy since it may harm an unborn baby. Consult the manufacturer's package or the hospital/occupational safety guidelines for details.
SIDE EFFECTS: Chest soreness may occur. Redness/irritation of the eye or eyelid may also occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell the doctor right away if your child has any serious side effects, including: pale/bluish skin around the mouth/lips/fingernails, worsening of breathing trouble, slow/fast/irregular heartbeat.Get medical help right away if your child has any very serious side effects, including: fainting, seizure.This medication may rarely cause anemia, usually within 1 to 2 weeks after treatment is started. Tell the doctor right away if you notice any symptoms of anemia such as unusual tiredness or fast/pounding heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before your child receives ribavirin for inhalation, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: breathing disorders (such as asthma).Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).This product is not usually used by adults. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product. (See also health care worker information in How to Use section.)
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: certain HIV drugs (didanosine, stavudine, zidovudine).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as lung function, blood counts) should be done while your child is using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If a dose is interrupted or stopped, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital and will not be stored at home.
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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