Ribavirin (Monograph)

Brand names: Copegus, Rebetol, Ribasphere, Virazole
Drug class: Nucleosides and Nucleotides
VA class: AM800
Chemical name: 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3 carboxamide
CAS number: 36791-04-5

Medically reviewed by Drugs.com on Oct 16, 2023. Written by ASHP.

Warning

Ribavirin not effective alone for treatment of chronic HCV infection; do not use ribavirin monotherapy for this indication.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Principal toxicity of oral ribavirin is hemolytic anemia which may result in worsening of cardiac disease and has resulted in fatal and nonfatal MI.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Do not use ribavirin in patients with a history of clinically important or unstable cardiac disease.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Teratogenic and/or embryocidal effects demonstrated in all animal species exposed to ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Ribavirin has a long half-life (12 days after multiple doses) and may persist in nonplasma compartments for as long as 6 months.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Contraindicated in pregnant women and male partners of pregnant women.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Extreme care must be used to avoid pregnancy during and for 6 months following ribavirin therapy in female patients and female partners of male patients receiving ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Must use at least 2 reliable forms of contraception during and for 6 months following completion of treatment.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Aerosolized ribavirin (ribavirin for nasal and oral inhalation) should be used in patients requiring mechanical ventilator assistance only if clinicians and support staff are familiar with this mode of administration and the specific ventilator being used.¹ Strict attention must be directed to procedures that minimize accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressure.¹
Initiation of aerosolized ribavirin in infants has resulted in sudden deterioration of respiratory function.¹ Monitor respiratory function carefully during treatment.¹ If sudden deterioration of respiratory function occurs, discontinue the drug.¹ Reinstitute only with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.¹
Ribavirin for nasal and oral inhalation is not indicated in adults.¹

Introduction

Antiviral agent; nucleoside derivative.¹ ⁴ ⁶ ⁷ ⁹ ¹¹ ²² ¹⁶⁶

Uses for Ribavirin

Chronic HCV Infection

Treatment of chronic HCV infection in adults and pediatric patients with compensated liver disease.¹¹⁹ ³⁴² ³⁴⁹ ³⁶² ³⁷⁷ ⁴⁰² ⁴⁰³ ⁴¹⁹ ⁴²⁰ ⁴²¹ ⁴²²

Used in conjunction with other drugs in multiple-drug regimens for treatment of chronic HCV infection; do not use alone.¹¹⁹ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Has been used in conjunction with peginterferon alfa (peginterferon alfa-2a, peginterferon alfa-2b).²⁰ ¹¹⁹ ³⁴² ³⁴⁹ ³⁶² ³⁷⁷ ³⁸⁸ ⁴⁰² ⁴⁰³ ⁴¹⁹ ⁴²⁰ ⁴²¹ ⁴²² ⁴²³ Although used in conjunction with nonconjugated interferon alfa-2b in the past,³²³ ³²⁴ ³²⁵ ³²⁶ ³³¹ ³³² ³³³ ³³⁸ ³³⁹ ³⁴⁰ ³⁴⁹ ³⁶² ⁴⁰³ ⁴²⁸ such regimens no longer included in recommendations for treatment of chronic HCV infection.¹¹⁹

Usually used in multiple-drug regimens that include one or more HCV direct-acting antivirals (DAAs) with or without peginterferon alfa.¹¹⁹ ¹⁷⁹ ¹⁸⁰ ¹⁸⁷ ¹⁸⁸ Has been used in regimens that include simeprevir (an HCV protease inhibitor), ribavirin, and peginterferon alfa;¹⁸⁷ regimens that include sofosbuvir (an HCV polymerase inhibitor) and ribavirin with or without peginterferon alfa;¹¹⁹ ¹⁸⁸ regimens that include simeprevir (an HCV protease inhibitor), sofosbuvir (an HCV polymerase inhibitor), and ribavirin;¹¹⁹ regimens that include the fixed combination of ombitasvir (an HCV replication complex inhibitor), paritaprevir (an HCV protease inhibitor), and ritonavir (ombitasvir/paritaprevir/ritonavir) and ribavirin;¹¹⁹ ¹⁷⁹ or regimens that include the fixed combination ombitasvir/paritaprevir/ritonavir with dasabuvir and with ribavirin.¹¹⁹ ¹⁸⁰

Safety and efficacy of oral ribavirin in conjunction with peginterferon alfa not established for treatment of chronic HCV infection in patients with decompensated liver disease,³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ HBV coinfection,³⁴⁹ ⁴⁰³ or liver or other organ transplants.²⁰ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Most appropriate multiple-drug regimen depends on specific HCV genotype and patient population involved.¹¹⁹

Treatment of chronic HCV infection is complex and rapidly evolving; consult a specialist to obtain the most up-to-date information.¹¹⁹ Information from the American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA), and International Antiviral Society–USA (IAS–USA) regarding diagnosis and management of HCV infection, including recommendations for initial treatment, is available at [Web].¹¹⁹

Acute HCV Infection

Treatment of acute HCV infection^{† [off-label]} in an attempt to prevent progression to chronic HCV infection; used in conjunction with peginterferon alfa (alfa-2a, alfa-2b).⁹⁶ ¹²¹ ¹²⁶ ¹²⁸ ¹²⁹ ¹⁹⁰

Approximately 10–50% of patients with acute HCV infection have self-limited disease and spontaneous clearance of the virus without treatment;¹²⁰ optimum regimen (including dosage and duration of therapy) and optimum time to initiate treatment in patients with acute HCV infection not established.¹²⁰ ¹⁹⁰

To allow for spontaneous resolution, some experts suggest delaying initiation of treatment of acute HCV infection (especially in asymptomatic individuals) for 8–12 weeks after acute onset of hepatitis, unless HCV RNA levels are high and not declining.¹²⁰

Consult a specialist to obtain the most up-to-date information regarding treatment of acute HCV infection.¹²⁰ ¹²¹

Hepatitis E Virus (HEV) Infection

Treatment of chronic HEV infection^{† [off-label]};⁴³⁰ ⁴³¹ ⁴³² ⁴³³ has been used alone or in conjunction with peginterferon alfa.⁴³⁰ ⁴³¹ ⁴³² ⁴³³

Chronic HEV infection reported almost exclusively among immunocompromised individuals, including solid organ transplant recipients, patients receiving cancer chemotherapy, and HIV patients.⁴³⁰ ⁴³¹ ⁴³² ⁴³³ Optimal treatment of chronic HEV infection not identified.⁴³¹ ⁴³²

Respiratory Syncytial Virus (RSV) Infection

Ribavirin nasal and oral inhalation used for treatment of severe lower respiratory tract infections (i.e., bronchiolitis, pneumonia) caused by RSV in hospitalized infants and young children.¹ ¹⁶ ⁴¹ ⁴⁵ ⁷⁵ ⁷⁶ ⁸⁹ ⁹⁰ ⁹¹ ¹⁰⁰ ¹⁰¹ ¹⁰⁵ ¹⁹⁶ ¹⁹⁷ ²⁰² ²⁷⁷ ²⁷⁸ ⁴⁰⁵ ⁴¹⁰ ⁴¹¹ ⁴¹² ⁴¹³ ⁴¹⁴ ⁴¹⁵ ⁴¹⁶ ⁴¹⁷ ⁴¹⁸

Manufacturer states consider use only in infants and small children with severe RSV lower respiratory tract infections; use in mechanically ventilated patients only if clinicians and support staff are familiar with the mode of administration and specific ventilator being used.¹

AAP states ribavirin nasal and oral inhalation therapy may be considered for selected patients with documented life-threatening RSV infection, but routine use not recommended.¹⁰⁵

Ribavirin nasal and oral inhalation has been used for treatment of RSV infection in immunocompromised adults^{† [off-label]}, including bone marrow or hematopoietic cell transplant recipients;²¹³ ⁴⁰⁷ ⁴⁰⁹ ⁴²⁹ ⁴³⁴ manufacturer states not indicated for treatment of RSV infection in adults.¹

Viral Hemorrhagic Fevers

Treatment of certain viral hemorrhagic fevers^{† [off-label]}, including Lassa fever, hemorrhagic fever with renal syndrome (HFRS) caused by Hantavirus infection, infections caused by New World arenaviruses, and Crimean-Congo hemorrhagic fever.¹⁰⁵ ³³⁷ ³⁴³ ³⁴⁴ ³⁵¹ ³⁸⁹ ³⁹²

Inactive against and not used for treatment of infections caused by Filoviridae (including Ebola hemorrhagic fever and Marburg hemorrhagic fever).³⁴³ ³⁴⁴ ³⁵¹ Also inactive against and not used for infections by caused most Flaviviridae (including dengue hemorrhagic fever).³⁴³ ³⁴⁴ ³⁵¹

Treatment of Lassa fever^{† [off-label]}; considered the drug of choice.⁵⁹ ¹⁰⁴ ¹⁰⁵ ¹⁴⁶ ¹⁷⁷ ²¹⁹ ²⁵⁷ ²⁵⁸ ³⁴³ ³⁵¹ Previously recommended for postexposure prophylaxis of Lassa fever in high-risk contacts,²¹⁹ but CDC recommends the strategy of placing exposed individuals or contacts under medical surveillance for 21 days and treating presumptively with ribavirin if clinical evidence of viral hemorrhagic fever develops.³⁹⁷

Treatment of hemorrhagic fever with renal syndrome^† (HFRS);¹⁰⁵ ²⁷⁰ ²⁷¹ ²⁷² ²⁷⁶ designated an orphan drug by FDA for this use.²⁷³ When administered IV^† within 4–7 days after onset of fever, has decreased viremia, renal dysfunction, vascular instability, and mortality of HFRS.¹⁰⁵ ²⁷⁰ ²⁷¹ ²⁷² ²⁷⁶

Treatment of Crimean-Congo hemorrhagic fever^† (CCHF).¹⁰⁵ ³⁴⁷ ³⁸⁹ ³⁹² Although experience limited, CDC states use of ribavirin to treat the disease and prevent infection in high-risk contacts is reasonable based on in vitro susceptibility data for this and other Bunyaviridae.²¹⁹

Treatment of clinically evident viral hemorrhagic fever in the context of biologic warfare or bioterrorism^† when the disease is caused by Arenavirus (e.g., Lassa fever, New World hemorrhagic fever) or Bunyavirus (e.g., Rift Valley fever) or is of unknown etiology.³⁴³ ³⁵¹ ³⁵⁷ Preemptive administration of ribavirin or postexposure prophylaxis with ribavirin not recommended following known or presumed exposure to hemorrhagic fever virus in the context of biologic warfare or bioterrorism.³⁵¹ Those with known or presumed exposure, including high-risk contacts (i.e., individuals with mucous membrane contact with infected patient) and close contacts (i.e., individuals who live with, shake hands or hug, process laboratory specimens from, or care for infected patients [prior to initiation of appropriate precautions]) should be placed under medical surveillance for 21 days and treated presumptively with ribavirin if fever ≥38.3°C develops.³⁵¹

Information on diagnosis and management of viral hemorrhagic fevers is available from Special Pathogens Branch of CDC at [Web] or at 404-639-1115.³⁴⁵ Any suspected cases of viral hemorrhagic fever occurring in individuals residing in or requiring evacuation to the US should immediately be reported to local health authorities and the CDC Viral Special Pathogens Branch at 404-639-1115 or CDC Emergency Operations Center at 770-488-7100.³³⁷

Adenovirus Infections

Has been used for treatment of infections caused by adenovirus^† in immunocompromised adults and children, including bone marrow or stem cell transplant recipients, solid organ transplant recipients (e.g., liver, kidney), and patients with leukemia or severe combined immunodeficiency.³⁹³ ³⁹⁴ ³⁹⁵ ³⁹⁶

Safety and efficacy not established;³⁴⁹ ³⁷⁷ only limited experience to date.³⁹³ ³⁹⁴ ³⁹⁵ ³⁹⁶

Generally has been used in critically ill patients with severe adenovirus infections (e.g., hemorrhagic cystitis, nephritis, respiratory tract infections, GI infections, disseminated disease) who received multiple treatment modalities.³⁹³ ³⁹⁵ ³⁹⁶ Not all patients respond;³⁹³ ³⁹⁴ ³⁹⁶ unlikely to be of benefit if initiated late in the course of severe infections.³⁹³

Has been used for preemptive therapy in immunocompromised patients who were asymptomatic but had clinical cultures positive for adenovirus.³⁹⁵ Possible benefits and risks in such patients not determined; asymptomatic adenovirus infections often resolve spontaneously.³⁹⁵

Coronavirus Infections

Has been used alone or in conjunction with systemic corticosteroids for treatment of severe acute respiratory syndrome^† (SARS) caused by the SARS coronavirus (SARS-CoV). ³⁶⁷ ³⁶⁸ ³⁶⁹ ³⁷⁰ ³⁷¹ ³⁷³ ³⁸⁰ ³⁸¹ ³⁸² Clinical benefits of various anti-infective regimens used for empiric treatment of SARS, including oral ribavirin, have been disappointing.³⁶⁸ ³⁶⁹ ³⁷³ SARS first reported in Asia during early 2003 and then spread to many areas of the world, including North America, South America, and Europe.³⁴⁶ ³⁶⁷ ³⁶⁸ ³⁶⁹ ³⁷⁰ ³⁷¹ ³⁷² ³⁷³ ³⁷⁶ ³⁸⁰ ³⁸¹ Person-to-person transmission of SARS-CoV not currently occurring anywhere in the world, but could recur and future outbreaks are possible.³⁸⁶

Has been used in conjunction with an interferon (e.g., peginterferon alfa-2a, interferon alfa-2b) for treatment of Middle East respiratory syndrome^† (MERS) caused by the Middle East respiratory syndrome coronavirus (MERS-CoV).⁴⁴⁰ ⁴⁴¹ ⁴⁴² ⁴⁴³ ⁴⁴⁵ No specific treatment for MERS has been identified;⁴³⁶ ⁴⁴⁴ ⁴⁴⁵ some evidence that regimen of oral ribavirin and peginterferon alfa-2a may improve 14-day survival rate when used in addition to usual supportive care, but 28-day survival rate not significantly improved.⁴⁴³ MERS-CoV infections first reported in September 2012 in Saudi Arabia;⁴³⁵ ⁴³⁶ ⁴³⁹ ⁴⁴¹ ⁴⁴⁴ as of August 28, 2015, 1,474 laboratory-confirmed cases (including 515 deaths) reported worldwide.⁴⁴⁴ Most reported cases to date (including 2 in the US and an outbreak in Republic of Korea) directly or indirectly linked through travel or residence to the Middle East.⁴³⁶ ⁴⁴⁴ ⁴⁴⁶ Information regarding evaluation, diagnosis, and management of MERS-CoV infection and guidance for individuals traveling to areas where MERS reported (e.g., the Middle East) is available at CDC website at [Web].⁴³⁶

Ribavirin Dosage and Administration

Administration

Administer orally³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ or by nasal and oral inhalation.¹ Also has been administered IV^†.¹⁰⁵ ²⁷⁰ ²⁷¹ ²⁷² ²⁷⁶ ³⁸⁹ ³⁹³ ³⁹⁴ ³⁹⁵ ³⁹⁶ ³⁹⁷

Oral Administration

Administer ribavirin capsules,³⁴⁹ ⁴⁰³ tablets,³⁷⁷ ⁴⁰² and oral solution³⁴⁹ with food.

Do not open, crush, or break capsules.³⁴⁹ ⁴⁰³

Oral solution containing 40 mg of ribavirin per mL recommended (instead of capsules) in children ≥3 years of age weighing <47 kg.³⁴⁹ The oral solution may be used in any patient ≥3 years of age, regardless of weight.³⁴⁹

Patients should be well hydrated, especially during initial treatment.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Nasal and Oral Inhalation

Ribavirin sterile powder (Virazole) must be reconstituted and diluted and administered as a solution only via nasal and oral inhalation using the Valeant small-particle aerosol generator (SPAG) Model SPAG-2 available from the manufacturer.¹ ¹⁶² Do not administer using any other aerosol generator and do not administer concomitantly with other drug solutions for nebulization.¹

Consult the SPAG-2 manual for detailed administration instructions.¹ ¹⁶²

In patients not requiring mechanical ventilation, ribavirin solution for nebulization should be administered from the SPAG-2 aerosol generator via an oxygen hood.¹ ¹⁶² If an oxygen hood cannot be used, the solution may be administered from the SPAG-2 aerosol generator via a face mask or oxygen tent;¹ ¹⁶² because the volume and condensation area of the solution for nebulization are larger in an oxygen tent, this may alter delivery dynamics of the drug.¹

When ribavirin inhalation therapy is used in patients who require assisted ventilation, constantly monitor the patient and apparatus (e.g., in an intensive care setting).¹⁸² ¹⁸³ Use either a pressure or volume cycle ventilator in conjunction with the SPAG-2.¹ For pressure or volume cycle ventilators, heated wire connective tubing and bacterial filters in series in the expiratory limb of the system must be used to minimize the risk of ribavirin precipitation in the system and risk of ventilator dysfunction; the filters should be changed frequently (e.g., every 4 hours).¹ Water column pressure release valves should be used in the ventilator circuit for pressure cycle ventilators and may be used in the ventilator circuit for volume cycle ventilators.¹ The endotracheal tube should be suctioned every 1–2 hours; monitor pulmonary pressure frequently (every 2–4 hours).¹

Reconstitution and Dilution

Add a minimum of 75 mL of sterile water for injection or inhalation (additive free) to the vial containing 6 g of ribavirin; shake well.¹ ¹⁶² Transfer reconstituted solution to the sterile 500-mL reservoir of the SPAG-2 aerosol generator; further dilute with sterile water for injection or inhalation (additive free) to a final volume of 300 mL to provide a solution containing 20 mg/mL.¹ ¹⁶²

Solutions that have been placed into the SPAG-2 reservoir should be discarded at least every 24 hours and prior to the addition of freshly reconstituted solution whenever the amount of solution remaining in the reservoir is low.¹ ¹⁶²

Rate of Administration

When 20-mg/mL solution is delivered using the SPAG-2 aerosol generator according to the manufacturer's instructions, the average aerosol concentration for a 12-hour delivery period is 190 mcg/L.¹

Administer the 20-mg/mL solution via the SPAG-2 aerosol generator at a rate of about 15 L/minute when using an oxygen hood or tent or about 12 L/minute when using a face mask.¹⁶²

Parenteral Administration

Although not commercially available, parenteral ribavirin is available for compassionate use protocols for treatment of viral hemorrhagic fevers^† such as Lassa fever^†, Hantavirus infections^†, and Congo-Crimean hemorrhagic fever^†.³³⁷ To obtain IV ribavirin for emergency use, contact FDA at 301-736-3400 for compassionate use authorization and also contact the manufacturer (Valeant Pharmaceuticals) at 800-548-5100.³³⁷

Dosage

Pediatric Patients

Treatment of Chronic HCV Infection

Must be used in conjunction with other drugs as part of a multiple-drug regimen.³⁴⁹ ³⁷⁷ ⁴⁰³ May be used in conjunction with peginterferon alfa;³⁴⁹ ³⁷⁷ ⁴⁰³ although no longer recommended,¹¹⁹ has been used in conjunction with nonconjugated interferon alfa.³⁴⁹ ⁴⁰³

Concomitant Ribavirin Capsules (Rebetol, Ribasphere) or Oral Solution (Rebetol) and Peginterferon Alfa-2b (PegIntron) or Interferon Alfa-2b (Intron A)

Oral

Children 3–17 years of age: 15 mg/kg daily in 2 divided doses in conjunction with sub-Q peginterferon alfa-2b or interferon alfa-2b.³⁴⁹ ⁴⁰³ (See Table 1.) Use oral solution in those weighing <47 kg.³⁴⁹ If patient reaches 18th birthday during treatment, complete treatment using pediatric dosage.³⁴⁹ ⁴⁰³

Recommended treatment duration is 24 weeks for HCV genotype 2 or 3 and 48 weeks for genotype 1.³⁴⁹ ⁴⁰³

With the exception of HCV genotypes 2 and 3, consider discontinuing HCV treatment if HCV RNA levels have not decreased ≥2 log₁₀ from baseline at week 12 or remain detectable after 24 weeks of treatment.³⁴⁹ ⁴⁰³

Table 1. Pediatric Dosage of Ribavirin Capsules (Rebetol, Ribasphere) or Oral Solution (Rebetol) for Concomitant Use with Peginterferon Alfa-2b (PegIntron) or Nonconjugated Interferon Alfa-2b (Intron A)349403
Weight	Ribavirin Dosage (Capsules, Oral Solution)
<47 kg	15 mg/kg daily, given as oral solution in 2 divided doses
47–59 kg	400 mg in morning and 400 mg in evening
60–73 kg	400 mg in morning and 600 mg in evening
>73 kg	600 mg in morning and 600 mg in evening

Concomitant Ribavirin Tablets (Copegus) and Peginterferon Alfa-2a (Pegasys)

Oral

Children ≥5 years of age: Approximately 15 mg/kg daily in 2 divided doses in conjunction with sub-Q peginterferon alfa-2a.³⁷⁷ (See Table 2.) If patient reaches 18th birthday during treatment, complete treatment using pediatric dosage.³⁷⁷

Recommended treatment duration is 24 weeks for HCV genotype 2 or 3 and 48 weeks for other HCV genotypes.³⁷⁷

Table 2. Pediatric Dosage of Ribavirin Tablets (Copegus) for Concomitant Use with Peginterferon Alfa-2a (Pegasys)377
Weight	Copegus Dosage (Tablets)
23–33 kg	200 mg in morning and 200 mg in evening
34–46 kg	200 mg in morning and 400 mg in evening
47–59 kg	400 mg in morning and 400 mg in evening
60–74 kg	400 mg in morning and 600 mg in evening
>75 kg	600 mg in morning and 600 mg in evening

Dosage Modification for Toxicity

Oral

If serious adverse effects or laboratory changes occur when oral ribavirin used in conjunction with peginterferon alfa or nonconjugated interferon alfa, modify dosage of one or both drugs, if appropriate, until adverse effects abate.³⁴⁹ ³⁷⁷ ⁴⁰³ If intolerance persists after dosage adjustment, discontinue both drugs.³⁴⁹ ³⁷⁷ ⁴⁰³

Concomitant ribavirin capsules or oral solution (Rebetol, Ribasphere) and peginterferon alfa-2b or nonconjugated interferon alfa-2b in children 3–17 years of age: If hemoglobin <10 g/dL, decrease ribavirin dosage from 15 mg/kg daily to 12 mg/kg daily and, if needed, to 8 mg/kg daily.³⁴⁹ ⁴⁰³ If hemoglobin <8.5 g/dL, leukocyte count <1000/mm³, neutrophil count <500/mm³, or platelet count <50,000/mm³, permanently discontinue both drugs.³⁴⁹ ⁴⁰³ In pediatric patients with preexisting cardiac conditions, closely monitor with weekly hematology evaluations if hemoglobin decreases by ≥2 g/dL during any 4-week period; discontinue if hemoglobin concentration <8.5 g/dL (or <12 g/dL after 4 weeks of reduced dosage).³⁴⁹

Concomitant ribavirin tablets (Copegus) and peginterferon alfa-2a in children ≥5 years of age without cardiac disease: If hemoglobin <10 g/dL, decrease ribavirin dosage to 200 mg daily (200 mg in morning) in those weighing 23–33 kg, 400 mg daily (200 mg in morning and 200 mg in evening) in those weighing 34–59 kg, or 600 mg daily (200 mg in morning and 400 mg in evening) in those weighing ≥60 kg.³⁷⁷ If hemoglobin <8.5 g/dL, discontinue both drugs.³⁷⁷

Concomitant ribavirin tablets (Copegus) and peginterferon alfa-2a in children ≥5 years of age with history of stable cardiac disease: If hemoglobin decreases by ≥2 g/dL during any 4-week period, decrease ribavirin dosage to 200 mg daily (200 mg in morning) in those weighing 23–33 kg, 400 mg daily (200 mg in morning and 200 mg in evening) in those weighing 34–59 kg, or 600 mg daily (200 mg in morning and 400 mg in evening) in those weighing ≥60 kg.³⁷⁷ If hemoglobin <12 g/dL after 4 weeks of reduced dosage, discontinue both drugs.³⁷⁷

Consult manufacturer's information for more specific recommendations regarding dosage modification for hematologic or other adverse effects.³⁴⁹ ³⁷⁷ ⁴⁰³

Treatment of Respiratory Syncytial Virus (RSV) Infection

Inhalation

Using a solution containing 20 mg/mL and SPAG-2 aerosol generator with an oxygen hood, face mask, or oxygen tent, deliver mist continuously for 12–18 hours daily for 3–7 days.¹ ¹⁶² Manufacturer recommends mist be delivered at a rate of about 15 L/minute when using an oxygen hood or tent or about 12 L/minute when using a face mask.¹⁶² The average aerosol concentration for a 12-hour delivery period is 190 mcg/L.¹

Dose and administration schedule for infants requiring mechanical ventilation is the same as that for infants not requiring assisted ventilation.¹

Viral Hemorrhagic Fevers†

Treatment of Viral Hemorrhagic Fevers in Context of Biologic Warfare or Bioterrorism†

Oral

US Army Medical Research Institute of Infectious Diseases (USAMRIID) and US Working Group on Civilian Biodefense recommend initial loading dose of 30 mg/kg, followed by 15 mg/kg daily given in 2 divided doses.³⁴³ ³⁵¹ Duration of treatment is 10 days.³⁴³ ³⁵¹

IV regimen usually preferred.³⁴³ ³⁵¹ Oral regimen may be used when parenteral preparation cannot be obtained or would be impractical (e.g., when large numbers of individuals require treatment in a mass casualty setting).³⁴³ ³⁵¹

IV^†

USAMRIID and US Working Group on Civilian Biodefense recommend initial loading dose of 30 mg/kg (maximum 2 g), followed by 16 mg/kg (maximum 1 g) every 6 hours for 4 days and then 8 mg/kg (maximum 500 mg) every 8 hours for 6 days.³⁴³ ³⁵¹

IV regimen recommended for contained casualty settings if parenteral preparation can be obtained.³⁵¹

Treatment of Adenovirus Infections†

IV†

Severe infections in immunocompromised children: 25 mg/kg daily in 3 divided doses on day 1 followed by 15 mg/kg daily in 3 divided doses on days 2–10 has been used.³⁹³ Alternatively, 15 mg/kg daily for 10 days has been used.³⁹⁶

Adults

Treatment of Chronic HCV Infection

Must be used in conjunction with other drugs as part of a multiple-drug regimen.¹¹⁹ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ May be used in conjunction with peginterferon alfa;¹¹⁹ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ although no longer recommended,¹¹⁹ has been used in conjunction with nonconjugated interferon alfa.³⁴⁹ ⁴⁰³

Usually used in multiple-drug regimens that include one or more HCV DAAs with or without peginterferon alfa.¹¹⁹ ¹⁷⁹ ¹⁸⁰ ¹⁸⁷ ¹⁸⁸ Most appropriate multiple-drug regimen depends on specific HCV genotype and patient population involved.¹¹⁹

Concomitant Ribavirin Capsules (Rebetol, Ribasphere) and Peginterferon Alfa-2b (PegIntron)

Oral

800–1400 mg daily (based on body weight) in 2 divided doses in conjunction with sub-Q peginterferon alfa-2b.³⁴⁹ ⁴⁰³ (See Table 3.) Duration of treatment depends on history of prior treatment, HCV genotype, and treatment response.³⁴⁹ ⁴⁰³ (See Table 4.)

Table 3. Adult Dosage of Ribavirin Capsules (Rebetol, Ribasphere) for Concomitant Use with Peginterferon Alfa-2b (PegIntron) for Chronic HCV Infection.349403
Weight	Total Daily Dosage of Ribavirin (Capsules)	Recommended Ribavirin Dosage Regimen (Capsules)
≤65 kg	800 mg	400 mg in morning and 400 mg in evening
66–80 kg	1 g	400 mg in morning and 600 mg in evening
81–105 kg	1.2 g	600 mg in morning and 600 mg in evening
>105 kg	1.4 g	600 mg in morning and 800 mg in evening

Table 4. Duration of Treatment with Ribavirin Capsules (Rebetol, Ribasphere) and Peginterferon Alfa-2b (PegIntron) in Adults for Chronic HCV Infection.349403
Patient Type and Response	HCV Genotype	Duration	Considerations
Treatment-naive	1	48 weeks	Consider discontinuing HCV treatment if HCV RNA has not decreased ≥2 log₁₀ by week 12 or remains detectable after 24 weeks of treatment³⁴⁹ ⁴⁰³
Treatment-naive	2,3	24 weeks
Prior failure	Any	48 weeks	Consider discontinuing HCV treatment if HCV RNA still detectable at week 12 or remains detectable after 24 weeks of treatment³⁴⁹ ⁴⁰³

Concomitant Ribavirin Capsules (Rebetol, Ribasphere) and Interferon Alfa-2b (Intron A)

Oral

Adults weighing ≤75 kg: 1 g daily (400 mg in morning and 600 mg in evening) in conjunction with sub-Q interferon alfa-2b.³⁴⁹ ⁴⁰³

Adults weighing >75 kg: 1.2 g daily (600 mg in morning and 600 mg in evening) in conjunction with sub-Q interferon alfa-2b.³⁴⁹ ⁴⁰³

Duration of treatment depends on history of prior treatment, HCV genotype, and treatment response.³⁴⁹ ⁴⁰³ In treatment-naive adults, usual duration is 24–48 weeks; consider discontinuing if HCV RNA levels are not below the limit of detection at 24 weeks.³⁴⁹ ⁴⁰³ If used in adults who relapsed after prior nonconjugated interferon monotherapy, manufacturers recommend treatment duration of 24 weeks.³⁴⁹ ⁴⁰³

Concomitant Ribavirin Tablets (Copegus, generic) and Peginterferon Alfa-2a (Pegasys)

Oral

Adults with HCV monoinfection (without coexisting HIV infection): 800–1200 mg daily in 2 divided doses in conjunction with sub-Q peginterferon alfa-2a.³⁷⁷ ⁴⁰² Treatment duration depends on HCV genotype.³⁷⁷ ⁴⁰² (See Table 5.)

Table 5. Adult Dosage of Ribavirin Tablets (Copegus, generic) for Concomitant Use with Peginterferon Alfa-2a (Pegasys) for Chronic HCV Monoinfection377402
HCV Genotype	Ribavirin Dosage (Tablets)	Duration
1,4	1 g daily (500 mg twice daily) in those weighing <75 kg	48 weeks
	1.2 g daily (600 mg twice daily) in those weighing ≥75 kg
2,3	800 mg daily (400 mg twice daily)	24 weeks
5,6	Data insufficient to make dosage recommendations	–

Adults with HCV and HIV coinfection: 800 mg daily in 2 divided doses in conjunction with sub-Q peginterferon alfa-2a for 48 weeks, regardless of HCV genotype.³⁷⁷ ⁴⁰² Some experts suggest HIV-infected adults with HCV coinfection types 1, 4, 5, or 6 receive weight-based ribavirin dosage: 1 g daily (600 mg in morning and 400 mg in evening) for those weighing <75 kg or 1.2 g daily (600 mg in morning and 600 mg in evening) for those weighing ≥75 kg.¹⁹⁰

Consider discontinuing HCV treatment if HCV RNA levels have not decreased ≥2 log₁₀ from baseline at week 12 or are still detectable after 24 weeks of treatment.³⁷⁷ ⁴⁰²

Manufacturer states safety and efficacy beyond 48 weeks of therapy not established.³⁷⁷ ⁴⁰²

Dosage Modification for Toxicity

Oral

If serious adverse effects or laboratory changes occur when oral ribavirin used in conjunction with peginterferon alfa or nonconjugated interferon alfa, modify dosage of one or both drugs, if appropriate, until adverse effects abate.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ If intolerance persists after dosage adjustment, discontinue both drugs.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Ribavirin capsules (Rebetol, Ribasphere) and peginterferon alfa-2b or interferon alfa-2b in adults: If hemoglobin decreases to <10 g/dL, decrease ribavirin dosage by 200 mg daily (or by 400 mg daily in those originally receiving 1.4 g daily); an additional dosage reduction of 200 mg daily may be used if needed.³⁴⁹ ⁴⁰³ If hemoglobin <8.5 g/dL, leukocyte count <1000/mm³, neutrophil count <500/mm³, or platelet count <25,000/mm³, permanently discontinue both drugs.³⁴⁹ ⁴⁰³ In those with history of stable cardiovascular disease, decrease ribavirin dosage by 200 mg daily if hemoglobin decreases by ≥2 g/dL during any 4-week period; discontinue if hemoglobin <8.5 g/dL (or <12 g/dL after 4 weeks of reduced dosage).³⁴⁹

Ribavirin tablets (Copegus, generic) and peginterferon alfa-2a in adults: In those without cardiac disease, decrease ribavirin dosage to 600 mg daily (200 mg in morning and 400 mg in evening) if hemoglobin decreases to <10 g/dL; discontinue the drug if hemoglobin decreases to <8.5 g/dL.³⁷⁷ ⁴⁰² In those with history of stable cardiac disease, decrease ribavirin dosage to 600 mg daily (200 mg in morning and 400 mg in evening) if hemoglobin decreases by ≥2 g/dL during any 4-week period; discontinue the drug if hemoglobin decreases to <12 g/dL after 4 weeks of reduced dosage.³⁷⁷ ⁴⁰² If ribavirin tablets have been withheld and toxicity resolves or decreases in severity, may attempt reinitiation using ribavirin dosage of 600 mg daily; may then increase ribavirin dosage to 800 mg daily if tolerated.³⁷⁷ ⁴⁰² Do not resume usual maximum recommended adult dosage of 1–1.2 g daily (see Table 5).³⁷⁷ ⁴⁰²

Consult manufacturer's information for more specific recommendations regarding dosage modification for hematologic or other adverse effects.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Viral Hemorrhagic Fevers†

Treatment of Lassa Fever†

IV^†

CDC and USAMRIID recommend initial loading dose of 30 mg/kg (up to 2 g), followed by 16 mg/kg (up to 1 g) every 6 hours for 4 days and then 8 mg/kg (up to 500 mg) every 8 hours for 6 days for total treatment duration of 10 days.²¹⁹ ³⁴³

Treatment of Hantavirus Infections†

IV^†

Hemorrhagic fever with renal syndrome^† (HFRS): Initial loading dose of 33 mg/kg, followed by 16 mg/kg every 6 hours for 4 days and then 8 mg/kg every 8 hours for 3 days for a total treatment duration of 7 days has been used.²⁷⁰ ²⁷¹ ²⁷⁶

Treatment of Crimean-Congo Hemorrhagic Fever†

Oral

Initial loading dose of 30 mg/kg, followed by 15 mg/kg every 6 hours for 4 days and then 7.5 mg/kg every 8 hours for 6 days has been used.³⁹²

IV^†

CDC and USAMRIID recommend initial loading dose of 30 mg/kg (up to 2 g), followed by 16 mg/kg (up to 1 g) every 6 hours for 4 days and then 8 mg/kg (up to 500 mg) every 8 hours for 6 days for a total treatment duration of 10 days.²¹⁹ ³⁴³

Treatment of Viral Hemorrhagic Fevers in Context of Biologic Warfare or Bioterrorism†

Oral

USAMRIID and US Working Group on Civilian Biodefense recommend initial loading dose of 2 g, followed by 1.2 daily given in 2 divided doses for those weighing >75 kg or 1 g daily (400 mg in morning and 600 mg in evening) for those weighing ≤75 kg.³⁴³ ³⁵¹ Duration of treatment is 10 days.³⁴³ ³⁵¹

IV^†

IV regimen recommended for contained casualty settings if parenteral preparation can be obtained.³⁴³ ³⁵¹

Treatment of Adenovirus Infections†

IV†

Severe infections in immunocompromised adults: Initial 33-mg/kg loading dose followed by 16 mg/kg every 6 hours for 4 days and then 8 mg/kg every 8 hours for another 3 days or longer until relevant cultures are negative for adenovirus.³⁹⁴ ³⁹⁶

Special Populations

Hepatic Impairment

Effect of hepatic impairment on pharmacokinetics of oral ribavirin not fully evaluated;³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ peak concentrations are increased depending on severity of hepatic impairment.³⁴⁹ ⁴⁰³ (See Pharmacokinetics.)

Renal Impairment

Ribavirin tablets (Copegus): Reduce dosage in adults with Cl_cr ≤50 mL/minute.³⁷⁷ For treatment of chronic HCV infection, use alternating doses of 200 mg and 400 mg every other day in adults with Cl_cr 30–50 mL/minute and use 200 mg daily in adults with Cl_cr <30 mL/minute or undergoing hemodialysis.³⁷⁷ Do not reduce dosage any further; if severe adverse effects or laboratory abnormalities occur, discontinue drug.³⁷⁷ Data insufficient to make dosage recommendations for pediatric patients with renal impairment.³⁷⁷

Ribavirin capsules (Rebetol, Ribasphere),³⁴⁹ ⁴⁰³ tablets (generic),⁴⁰² oral solution (Rebetol) and peginterferon alfa-2b or interferon alfa-2b therapy:³⁴⁹ Contraindicated in adults with Cl_cr <50 mL/minute.³⁴⁹ ⁴⁰² ⁴⁰³

Pediatric patients with renal impairment: Discontinue ribavirin capsules or oral solution (Rebetol) and peginterferon alfa-2b or interferon alfa-2b if S_cr concentrations >2 mg/dL.³⁴⁹

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal, hepatic, and/or cardiac function.³⁴⁹ ⁴⁰³ Initiate therapy at the lower end of the dosing range.³⁴⁹ ⁴⁰³ (See Geriatric Precautions under Cautions.)

Cautions for Ribavirin

Contraindications

Hypersensitivity to ribavirin or any ingredient in the formulation.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Sensitivity Reactions under Cautions.)
Women who are or may become pregnant.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Male partners of pregnant women.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Patients with hemoglobinopathies (e.g., thalassemia major, sickle cell anemia).³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Concomitant use with didanosine.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Interactions.)
Use of ribavirin capsules (Rebetol, Ribasphere), tablets (generic), and oral solution (Rebetol) in patients with Cl_cr <50 mL/minute.³⁴⁹ ⁴⁰² ⁴⁰³
Use of concomitant oral ribavirin and peginterferon alfa in patients with autoimmune hepatitis.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Use of concomitant oral ribavirin tablets (Copegus, generic) and peginterferon alfa-2a in cirrhotic patients with chronic HCV monoinfection (without coexisting HIV infection) who have hepatic decompensation (Child-Pugh score >6; class B and C) prior to or during treatment.³⁷⁷ ⁴⁰²
Use of concomitant oral ribavirin tablets (Copegus, generic) and peginterferon alfa-2a in cirrhotic patients with chronic HCV infection who are coinfected with HIV and have hepatic decompensation (Child-Pugh score ≥6) prior to or during treatment.³⁷⁷ ⁴⁰²

Hypersensitivity to ribavirin or any ingredient in the formulation.¹ (See Sensitivity Reactions under Cautions.)
Women who are or may become pregnant.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Warnings/Precautions

Warnings

Precautions Related to Combination HCV Treatment Regimens

Do not use oral ribavirin alone for treatment of chronic HCV infection.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

When used in conjunction with peginterferon alfa or interferon alfa, consider cautions, precautions, and contraindications associated with both oral ribavirin and peginterferon alfa or interferon alfa.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Ribavirin in conjunction with peginterferon alfa or interferon alfa is associated with substantial adverse effects including severe depression and suicidal ideation, hemolytic anemia, bone marrow suppression, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Review prescribing information and medication guide prior to initiation of therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

When used in multiple-drug regimen that includes one or more HCV DAAs, such as an HCV protease inhibitor (e.g., paritaprevir, simeprevir), an HCV polymerase inhibitor (e.g., dasabuvir, sofosbuvir), or an HCV replication complex inhibitor (e.g., ombitasvir), consider cautions, precautions, and contraindications associated with the HCV DAAs.¹⁷⁹ ¹⁸⁰ ¹⁸⁷ ¹⁸⁸

Respiratory Effects

Use of aerosolized ribavirin for treatment of RSV in infants has resulted in sudden deterioration of respiratory function.¹ Monitor respiratory function carefully.¹ If sudden deterioration of respiratory function occurs, discontinue therapy.¹ Reinstitute with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.¹

Optimum monitoring and attention to respiratory and fluid status needed in patients with severe lower respiratory tract infection due to RSV.¹

Use of oral ribavirin has been associated with adverse pulmonary effects, including dyspnea, pulmonary infiltrates, pulmonary hypertension, pneumonitis, and pneumonia (sometimes fatal).³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Sarcoidosis or exacerbation of sarcoidosis reported rarely with oral ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Closely monitor patients who experience pulmonary infiltrates or deterioration in pulmonary function; if appropriate, discontinue ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Mechanically Ventilated Patients

Administer aerosolized ribavirin under the supervision of and by qualified clinicians and support staff experienced with the specific ventilator and mode of administration.¹ (See Nasal and Oral Inhalation under Dosage and Administration.)

Fetal/Neonatal Morbidity and Mortality

Teratogenic and/or embryocidal.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Exercise extreme care to avoid pregnancy in female patients and in female partners of male patients.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Women of childbearing potential and men must use 2 forms of effective contraception during therapy and for 6 months following completion of therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Do not initiate therapy until a report of a negative pregnancy test has been obtained; the pregnancy test should be performed immediately prior to initiating therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Perform pregnancy testing monthly during therapy and for 6 months after therapy is completed.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

If pregnancy occurs in a patient or in the partner of a patient during oral ribavirin therapy or during the 6 months following completion of therapy, report such cases to the pregnancy registry at 800-593-2214.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Hematologic Effects

Hemolytic anemia reported in patients receiving oral ribavirin in conjunction with interferon alfa; anemia usually occurs 1–2 weeks after initiation of therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Use with caution in patients with baseline risk of severe anemia (e.g., spherocytosis, history of GI bleeding).³⁷⁷ ⁴⁰²

Monitor hemoglobin or hematocrit before initiating therapy, at week 2 and 4 (or more frequently if needed), and during therapy as appropriate.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Dosage modification may be necessary.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Treatment of Chronic HCV Infection under Dosage and Administration.)

Cardiovascular Effects

Fatal and nonfatal MI reported in patients with anemia due to oral ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Assess patient for cardiac disease before initiating therapy and monitor during therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Obtain an electrocardiogram in patients with known cardiac disease.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Temporarily interrupt or discontinue therapy if cardiovascular status deteriorates.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Dosage modification may be necessary.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Treatment of Chronic HCV Infection under Dosage and Administration.)

Not recommended in those with substantial or unstable cardiac disease.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Hepatic Failure

Patients with chronic HCV infection and cirrhosis may be at risk of hepatic decompensation and death during interferon alfa (including peginterferon alfa) therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Such patients who are coinfected with HIV and receiving highly active antiretroviral therapy (HAART) in conjunction with interferon alfa-2a therapy (with or without ribavirin) appear to be at increased risk for development of hepatic decompensation compared with patients not receiving HAART.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Closely monitor clinical status and hepatic function.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Decrease dosage or immediately discontinue peginterferon alfa if decompensation (Child-Pugh score ≥6) occurs.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Sensitivity Reactions

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme, reported in patients receiving peginterferon with or without oral ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

If acute hypersensitivity reactions (urticaria, angioedema, bronchoconstriction, anaphylaxis) occur, discontinue immediately and initiate appropriate medical intervention.³⁷⁷ ⁴⁰²

General Precautions

Other Viral Infections

Safety and efficacy of oral ribavirin for treatment of HIV infection, adenovirus infection, RSV infection, parainfluenzae virus infection, or influenza virus infection not established; do not use oral ribavirin to treat these viral infections.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Pancreatitis

Temporarily interrupt oral ribavirin in patients with manifestations of pancreatitis; discontinue in patients with confirmed pancreatitis.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Dental and Periodontal Disorders

Dental and periodontal disorders reported in patients receiving oral ribavirin in conjunction with peginterferon alfa or interferon alfa; dry mouth may contribute to damage of teeth and oral mucous membranes during long-term treatment.³⁴⁹ ⁴⁰³

Advise patients to have regular dental examinations during treatment, brush their teeth thoroughly twice daily, and rinse their mouth thoroughly after vomiting.³⁴⁹ ⁴⁰³

Environmental Exposure of Health-care Personnel and Visitors

The potential risks, particularly for long-term and cumulative effects, associated with environmental exposure to aerosolized ribavirin by health-care personnel and visitors while in contact with patients undergoing inhalation therapy with the drug have not been elucidated; acute effects do not appear to be substantial.¹⁷¹ ¹⁷² ¹⁸⁹ ¹⁹² ¹⁹⁵ ²⁰⁶ ²¹⁶ ²¹⁷ ²²⁷ ²²⁸ ²²⁹ ²³⁴ ²³⁵ ²³⁶ ²³⁷ ²³⁸ ²³⁹ ²⁴⁰ ²⁴¹ ²⁴² ²⁴³ ²⁴⁷ ²⁶¹ ²⁶⁶ ²⁶⁷ Exposure of pregnant women¹⁷¹ ¹⁷² ²¹⁶ ²¹⁷ ²¹⁸ ²²⁶ ²²⁷ ²²⁸ ²³⁴ ²³⁸ ²³⁹ ²⁴⁰ ²⁴¹ ²⁴² ²⁴³ ²⁴⁴ ²⁴⁷ ²⁶³ ²⁶⁵ ²⁶⁷ and possibly those who may become pregnant¹⁷¹ ¹⁷² ²¹⁶ ²⁶⁵ may represent a risk to the fetus. Consult specialized sources (e.g., National Institute for Occupational Safety and Health [NIOSH]) for recommended procedures to minimize environmental exposure.

Specific Populations

Pregnancy

Category X.¹ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Pregnancy Registry at 800-593-2214 to monitor pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Lactation

Not known whether ribavirin is distributed into human milk.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Discontinue nursing or delay or discontinue the drug.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Pediatric Use

Nasal and oral inhalation: Safety and efficacy established for treatment of RSV infection in infants and young children.¹

Ribavirin oral capsules (Rebetol, Ribasphere) and oral solution (Rebetol): Safety and efficacy in conjunction with peginterferon alfa-2b or nonconjugated interferon alfa-2b for treatment of chronic HCV infection not established in children <3 years of age.³⁴⁹ ⁴⁰³ When deciding whether to use such regimens in HCV-infected children, consider evidence of disease progression (hepatic inflammation, fibrosis), prognostic factors for response, HCV genotype, and viral load.³⁴⁹ ⁴⁰³ Weigh benefits against adverse effects reported in pediatric patients.³⁴⁹ ⁴⁰³ Do not use concomitant ribavirin capsules or oral solution (Rebetol) and peginterferon alfa-2b or nonconjugated interferon alfa-2b in pediatric patients with S_cr >2 mg/dL.³⁴⁹

Ribavirin tablets (Copegus): Safety and efficacy in conjunction with peginterferon alfa-2b for treatment of chronic HCV infection not established in children <5 years of age.³⁷⁷

Ribavirin tablets (generic): Safety and efficacy not established in patients <18 years of age.⁴⁰²

Adverse effects reported with oral ribavirin in pediatric patients generally similar to those reported in adults.³⁴⁹ ³⁷⁷ Suicidal ideation or attempts reported more frequently during or after oral ribavirin in pediatric patients (primarily adolescents) than in adults receiving the drug.³⁴⁹ Other adverse psychiatric effects (depression, emotional lability, somnolence), anemia, and neutropenia reported as in adults.³⁴⁹

Decreased weight and height for age z-scores as well as percentiles of the normative population reported in pediatric patients receiving peginterferon alfa and oral ribavirin therapy.³⁴⁹ ³⁷⁷ ⁴⁰³ Data from an open-label trial in pediatric patients 3 through 17 years of age receiving peginterferon alfa-2b and oral ribavirin indicate that weight and height gain generally lagged behind that predicted by normative population data for entire length of treatment (48 weeks).³⁴⁹ Although general reversal of these trends noted during the 24-week posttreatment period, long-term follow-up data in pediatric patients indicate that growth inhibition induced by the regimen results in reduced final adult height in some patients.³⁴⁹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Higher incidence of anemia reported in geriatric patients compared with younger adults.³⁴⁹ ⁴⁰³

Caution advised; start at the lower end of the dosing range due to greater frequency of decreased renal, hepatic, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.³⁴⁹ ⁴⁰³

Substantially eliminated by kidneys; risk of adverse effects increased in patients with renal impairment.³⁴⁹ ⁴⁰³ Monitor renal function and consider age-related decreases in renal function when selecting dosage.³⁴⁹ ⁴⁰³ (See Renal Impairment under Dosage.)

Hepatic Impairment

Do not use in patients with autoimmune hepatitis or hepatic decompensation.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Contraindications under Cautions.)

Monitor liver function before and during therapy.³⁴⁹ ³⁷⁷ ⁴⁰²

Renal Impairment

Capsules (Rebetol, Ribasphere),³⁴⁹ ⁴⁰³ tablets (generic),⁴⁰² oral solution (Rebetol)³⁴⁹ : Contraindicated in patients with Cl_cr <50 mL/minute.³⁴⁹ ⁴⁰³

Tablets (Copegus): Use reduced dosage in adults with Cl_cr <50 mL/minute.³⁷⁷ (See Renal Impairment under Dosage.)

Common Adverse Effects

Oral: Fatigue/asthenia, headache, fever, rigors, nausea, myalgia, emotional lability/irritability.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³

Nasal and oral inhalation: Respiratory and cardiovascular effects.¹

Drug Interactions

Does not inhibit and is not a substrate for CYP450 isoenzymes.³⁴⁹ ³⁷⁷ Interactions with drugs affecting or metabolized by CYP enzymes unlikely.³⁴⁹ ³⁷⁷

Specific Drugs

Drug	Interaction	Comments
Antacids containing magnesium, aluminum, and simethicone (Mylanta)	Decreased ribavirin concentrations³⁴⁹	Clinical importance unknown³⁴⁹
Antiretrovirals, HIV nucleoside reverse transcriptase inhibitors (NRTIs)	Possible increased risk of potentially fatal hepatic decompensation in cirrhotic patients with chronic HCV coinfected with HIV who are receiving peginterferon alfa (with or without ribavirin) and antiretroviral regimens that include NRTIs²⁰ ³⁷⁷ Didanosine: Fatal hepatic failure, peripheral neuropathy, pancreatitis, symptomatic hyperlactatemia/lactic acidosis reported³⁴⁹ ³⁷⁷ Zidovudine: Possible increased risk of severe neutropenia (ANC <500/mm³) and severe anemia (hemoglobin <8 g/dL) if used concomitantly with peginterferon alfa and ribavirin²⁰ ³⁷⁷ Ribavirin can reduce phosphorylation of lamivudine, stavudine, and zidovudine; no evidence of pharmacokinetic or pharmacodynamic interaction when ribavirin used concomitantly with these drugs in patients coinfected with HCV and HIV³⁴⁹ ³⁷⁷ Stavudine and zidovudine: In vitro evidence of antagonistic antiretroviral effects; possibility of increased risk of adverse effects¹⁷³ ²²² ²⁷⁹ ³⁴⁹ ³⁵² ³⁵³ ³⁵⁴ ³⁷⁷	If used in patients coinfected with HIV who are receiving NRTIs, closely monitor for toxicities;²⁰ ³⁷⁷ if worsening toxicities are observed, consider discontinuing or reducing dosage of peginterferon and/or ribavirin;²⁰ ³⁷⁷ if decompensation occurs (Child-Pugh score ≥6), discontinue²⁰ Didanosine: Concomitant use contraindicated²⁰⁰ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Stavudine: Use concomitantly with caution²²⁰ ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Zidovudine: Concomitant use not recommended;²⁰⁰ use concomitantly with caution and increased monitoring²⁰⁰ ²²² ³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Azathioprine	Severe pancytopenia and bone marrow suppression reported in patients receiving peginterferon alfa and oral ribavirin;³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ may be due to interaction with ribavirin which may increase accumulation of azathioprine metabolite associated with myelotoxicity³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³	If used concomitantly with oral ribavirin and peginterferon alfa, perform CBCs (including platelet counts) weekly for first month, twice monthly during second and third months, and then monthly or more frequently if necessary³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ If pancytopenia develops, discontinue all 3 drugs (azathioprine, ribavirin, peginterferon alfa) and do not reinitiate peginterferon alfa and ribavirin concomitantly with azathioprine³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Daclatasvir	Clinically important interactions not expected¹⁷⁸
Interferons (interferon alfa, peginterferon alfa)	Hepatic decompensation, including some fatalities, reported in cirrhotic HCV patients coinfected with HIV receiving ribavirin, peginterferon alfa, and NRTIs³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Ribavirin may potentiate hematologic effects of interferons (anemia, neutropenia, lymphocytopenia);²⁰ ³⁸⁸ no evidence of pharmacokinetic interaction³⁷⁷
Ombitasvir, paritaprevir, dasabuvir fixed combination	Ombitasvir/paritaprevir/ritonavir: No in vitro evidence of antagonistic anti-HCV effects¹⁸⁰
Simeprevir	No effect on simeprevir concentrations or AUC when used with ribavirin and peginterferon alfa¹⁸⁷ In vitro evidence of additive effects against HCV;¹¹⁴ no in vitro evidence of antagonistic anti-HCV effects¹¹⁴ ¹⁸⁷
Sofosbuvir	No in vitro evidence of antagonistic anti-HCV effects¹⁸⁸

Ribavirin Pharmacokinetics

Absorption

Bioavailability

Absorbed rapidly from GI tract; peak plasma concentrations achieved within 1–3 hours.³⁴⁹ ³⁷⁷ Bioavailability is 64%.³⁴⁹

Following nasal and oral inhalation, absorbed systemically from the respiratory tract.¹ Concentrations achieved in respiratory tract secretions are likely to be substantially greater than those achieved in plasma.¹ ⁴ ¹⁶

Food

Administration with a high-fat meal increases oral bioavailability.³⁴⁹ ³⁷⁷

Special Populations

Mean peak plasma concentrations increased with severity of hepatic impairment; mean AUCs in individuals with mild, moderate, or severe hepatic impairment similar to AUCs in controls.³⁴⁹

Following a single oral dose of ribavirin, AUC increased twofold or threefold in non-HCV-infected individuals with Cl_cr 30–60 or 10–30 mL/minute, respectively.³⁴⁹

In HCV-infected individuals with end-stage renal disease requiring hemodialysis, ribavirin 200 mg daily (Copegus tablets) produced plasma exposures about 20% lower than exposures achieved with 1–1.2 g daily in individuals with normal renal function.³⁷⁷

Distribution

Extent

Ribavirin and/or its metabolites accumulate in erythrocytes.¹ ⁴ ¹⁶ ²² ⁶¹ ¹³² ¹³³ ¹³⁸ ¹⁴⁹ ¹⁹³

Distributes slowly into CSF.⁷⁸ ¹⁶⁹ CSF concentrations approximately 70% of concurrent plasma concentrations reported in HIV-infected patients.⁷⁸

Not known whether ribavirin crosses the placenta¹⁵⁸ or distributes into milk in humans.¹

Plasma Protein Binding

Not bound.³⁴⁹

Elimination

Metabolism

Undergoes reversible phosphorylation in nucleated cells and deribosylation and amide hydrolysis.³⁴⁹

Elimination Route

Following oral administration, eliminated in urine (61%) and feces (12%) as metabolites and unchanged drug (17%).³⁴⁹

Half-life

Rebetol capsules: 43.6 hours (single dose) and 298 hours (multiple doses).³⁴⁹

Copegus tablets: 120–170 hours (single dose).³⁷⁷

Special Populations

Clearance reduced in patients with renal impairment.³⁴⁹

Stability

Storage

Nasal and Oral Inhalation

For Inhalation Solution

25°C (may be exposed to 15–30°C).¹ Following reconstitution, store solution under sterile conditions at 20–30°C for up to 24 hours.¹

After placement in SPAG-2 reservoir, discard unused solution within 24 hours and prior to adding any newly reconstituted solution (e.g., when remaining amount of solution in reservoir is low).¹

Oral

Capsules

25°C (may be exposed to 15–30°C).³⁴⁹ ⁴⁰³

Oral solution

2–8°C or 25°C (may be exposed to 15–30°C).³⁴⁹

Tablets

25°C (may be exposed to 15–30°C).³⁷⁷

Actions and Spectrum

Exact mechanism of antiviral activity not fully elucidated,¹ ³ ⁴ but appears to interfere with RNA³ ⁷ ²¹ ²⁸ ³⁴ ³⁵ ¹⁴⁰ ¹⁴⁹ ¹⁶⁶ and DNA synthesis³ ⁷ ³⁵ ³⁸ ³⁹ ¹⁴⁰ ¹⁴⁹ ¹⁶⁶ and subsequently inhibit protein synthesis²¹ ²⁸ and viral replication.³ ¹⁵ ¹⁸ ²⁸ ³³ ¹⁴⁸ ¹⁵⁷
Antiviral activity appears to depend principally on intracellular conversion to ribavirin-5′-triphosphate³ ⁴ ⁶ ⁷ ¹⁶ ²² ²⁴ ⁸³ ¹⁴⁰ ¹⁴⁹ ¹⁶¹ and -monophosphate.³ ⁴ ⁷ ¹⁶ ²⁴ ²⁹ ¹⁴⁰ ¹⁴⁹ ¹⁶¹
Active in vitro against many RNA viruses including respiratory syncytial virus (RSV);¹ ⁴⁴ ⁶⁰ ⁶¹ ⁶⁴ many strains of influenza A¹ ⁷ ¹⁶ ²² ³¹ ⁴⁰ ⁴⁴ ⁵⁰ ⁵⁵ ⁵⁶ ⁵⁸ ⁶¹ ⁶⁶ ⁶⁹ ⁷⁰ ¹⁶⁶ and B¹ ⁷ ¹⁶ ²² ³¹ ⁴⁰ ⁴⁴ ⁵⁰ ⁵⁵ ⁵⁶ ⁶¹ ⁶⁶ ⁶⁹ ¹⁶⁶ viruses; measles virus;⁷ ¹⁶ ¹⁸ ²² ³¹ ⁴⁴ ⁴⁶ ⁶⁹ ⁸² ¹⁴¹ ¹⁶⁶ subacute sclerosing panencephalitis virus;¹⁶ ¹⁸ ²² ³¹ ⁶¹ ⁶⁹ ⁸² ¹⁶⁶ parainfluenzae viruses;⁷ ¹⁶ ²² ³¹ ⁴⁴ ⁴⁶ ⁵⁰ ⁶¹ ⁶² ⁶⁹ ⁸² ¹⁶⁶ mumps virus;⁷ ⁴⁰ ⁶¹ ⁶⁵ ⁶⁹ enterovirus 72 (formerly hepatitis A virus);⁴³ ¹⁴⁸ human rhinoviruses;⁷ ¹⁶ ²² ³¹ ⁴⁰ ⁶⁹ ⁸² ¹⁶⁶ human rotavirus;⁷ and Colorado tick fever virus.⁵⁷ ⁶¹
Active in vitro against Crimean-Congo hemorrhagic fever virus;²¹⁹ Junin virus (causes Argentine hemorrhagic fever);⁶⁸ ¹⁸⁶ various hantaviruses (including those causing Korean hemorrhagic fever and hantavirus pulmonary syndrome);¹⁶⁴ ¹⁶⁵ Lassa fever virus;⁸¹ and Machupo virus (causes Bolivian hemorrhagic fever).⁶⁸ Also has antiviral activity in vivo against hantavirus,⁵¹ ⁶⁸ ¹⁶³ Lassa fever virus,¹⁶ ²² ⁴⁰ ⁵¹ ⁶¹ ⁷¹ ⁸¹ and Rift Valley fever virus.⁴⁰ ⁵¹ ⁶⁸ ⁷¹
Ribavirin concentrations that inhibit ribavirin-susceptible viruses do not inhibit replication or cell-to-cell transmission of SARS-CoV.³⁷³ ³⁸⁴ Some in vitro evidence that ribavirin is active against MERS-CoV.⁴³⁷ ⁴³⁸
Some viruses, including arboviruses,⁷ ³¹ ⁴⁰ ⁶⁸ ⁷¹ ¹⁴⁴ rhinoviruses,⁷ and rotaviruses,⁷ ⁴⁰ ¹⁴⁴ that are inhibited in vitro by ribavirin may not be inhibited in vivo.

Advice to Patients

Advise patient of the benefits and risks of therapy for chronic HCV infection.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Importance of reading the medication guide.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Effect of therapy on transmission of HCV unknown; appropriate precautions to prevent transmission should be used.³⁴⁹ ³⁷⁷
Possibility of anemia; necessity of laboratory monitoring.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Importance of adequate hydration, especially during the initial phase of therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Importance of taking ribavirin as instructed; importance of taking with food.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³
Potential for the drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual known.³⁷⁷ ⁴⁰²
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.³⁴⁹ ³⁷⁷
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ Advise men and women of importance of using effective contraception during and for 6 months after ribavirin therapy.³⁴⁹ ³⁷⁷ ⁴⁰² ⁴⁰³ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Importance of advising patients of other important precautionary information.³⁴⁹ ³⁷⁷ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ribavirin
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal and Oral Inhalation	For inhalation solution	6 g	Virazole	Valeant
Oral	Capsules	200 mg*	Rebetol	Merck
			Ribasphere	Kadmon
			Ribavirin Capsules
	Solution	40 mg/mL	Rebetol	Merck
	Tablets, film-coated	200 mg*	Copegus	Genentech
			Ribavirin Tablets
		400 mg*	Ribavirin Tablets
		500 mg*	Ribavirin Tablets
		600 mg*	Ribavirin Tablets

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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372. Drazen JM. Case clusters of severe acute respiratory syndrome. N Engl J Med. 2003 Mar 31 http://www.nejm.org

373. Centers for Disease Control and Prevention. Severe acute respiratory syndrome (SARS) and coronavirus testing—United States, 2003. MMWR Morb Mortal Wkly Rep. 2003; 52:297-302. http://www.ncbi.nlm.nih.gov/pubmed/12731699?dopt=AbstractPlus

374. Centers for Disease Control and Prevention. CDC lab sequences genome of new coronavirus. 2003 Apr 14. Press release http://www.cdc.gov/od/oc/media/pressrel/r030414.htm

376. World Health Organization. Cumulative number of reported probable cases of severe acute respiratory syndrome (SARS); from: 1 Nov 2002 to: 13 May 2003, 17:00 GMT + 2. 2002 May 13 http://www.who.int

377. Genentech. Copegus (ribavirin) tablets prescribing information. South San Francisco, CA; 2013 Feb.

378. Anon. Peginterferon alfa-2a (Pegasys) for chronic hepatitis C. Med Letter Drug Ther. 2003; 45:19-20.

379. Roche Pharmaceuticals, Nutley, NJ: Personal Communication.

380. Booth CM, Matukas LM, Tomlinson GA et al. Clinical features and short-term outcomes of 144 patients with SARS in the greater Toronto area. JAMA. 2003; 289:2801-9. http://www.ncbi.nlm.nih.gov/pubmed/12734147?dopt=AbstractPlus

381. Loletta KYS, Lau ACW, Yam LYC et al. Development of a standard treatment protocol for severe acute respiratory syndrome. Lancet. 2003; 361:1615-7. http://www.ncbi.nlm.nih.gov/pubmed/12747883?dopt=AbstractPlus

382. Hon KLE, Leung CW, Cheng WTF et al. Clinical presentation and outcome of severe acute respiratory syndrome in children. Lancet>. 2003; 361:1701-3.

383. Baker RO, Bray M, Huggins JW. Potential antiviral therapeutics for smallpox, monkeypox and other orthopoxvirus infections. Antiviral Res. 2003; 57:13-23. http://www.ncbi.nlm.nih.gov/pubmed/12615299?dopt=AbstractPlus

384. Cinati J, Morgenstern B, Bauer G et al. Glycyrrhizin, an active component of liquorice roots, and replication of SARS-associated coronavirus. Lancet. 2003; 261:2045-6.

385. Rota PA, Oberste MS, Monroe SS et al. Characterization of a novel coronavirus associated with severe acute respiratory syndrome. Science. 2003; 300:1394-9. http://www.ncbi.nlm.nih.gov/pubmed/12730500?dopt=AbstractPlus

386. Centers for Disease Control and Prevention. In the absence of SARS-CoV transmission worldwide: Guidance for surveillance, clinical and laboroatory evaluation, and reporting version 2. From CDC website. Accessed Aug 5, 2014. http://www.cdc.gov/sars/Surveillance/absence.html

388. Schering Corporation. PegIntron (peginterferon alfa-2b) injection, powder for solution for subcutaneous use prescribing information. Whitehouse Station, NJ; 2013 May.

389. Ozkurt Z, Kiki I, Erol S et al. Crimean-Congo hemorrhagic fever in Eastern Turkey: clinical features, risk factors and efficacy of ribavirin therapy. J Infect. 2005; epub.

390. Cheng FW, Ng EK, Li AM et al. Clinical, virologic and immunologic profiles of a young infant with severe acute respirtory syndrome. Pediatr Infect Dis. 2005; 24:567-8.

391. Day CW, Smee DF, Julander JG et al. Error-prone replication of West Nile virus caused by ribavirin. Antiviral Res. 2005; 67:38-45. http://www.ncbi.nlm.nih.gov/pubmed/15919121?dopt=AbstractPlus

392. Mardani M, Jahromi MK, Naieni KH et al. The efficacy of oral ribavirin in the treatment of crimean-congo hemorrhagic fever in Iran. Clin Infect Dis. 2003; 36:1613-8.

393. Gavin PJ, Katz BZ. Intravenous ribavirin tretment for severe adenovirus disease in immunocompromised children. Pediatrics. 2002; 110:e9. http://www.ncbi.nlm.nih.gov/pubmed/12093990?dopt=AbstractPlus

394. Schleuning M, Buxbaum-Contradi H, Jager G et al. Intravenous ribavirin for eradication of respiratory syncytial virus (RSV) and adenovirus isolates from the respiratory and/or gastrointestinal tract in recipients of allogeneic hematopoietic stem cell transplants. Hematol J. 2004; 5:135-44. http://www.ncbi.nlm.nih.gov/pubmed/15048064?dopt=AbstractPlus

395. Ljungman P. Treatment of adenovirus infections in the immunocompromised host. Eur J Clin Microbiol Infect Dis. 2004; 23:583-8. http://www.ncbi.nlm.nih.gov/pubmed/15248091?dopt=AbstractPlus

396. Miyamura K, Hamaguchi M, Taji H et al. Successful ribavirin therapy for severe adenovirus hemorrhagic cystitis after allogeneic marrow transplant from close HLA donors rather than distant donors. Bone Marr Transplant. 2000; 25:545-8.

397. Centers for Disease Control and Prevention. Imported Lassa fever–New Jersey, 2004. MMWR Morb Mortal Wkly Rep. 2004; 53:894-7. http://www.ncbi.nlm.nih.gov/pubmed/15457145?dopt=AbstractPlus

400. Dashefsky B, Wald ER, Green M. Ribavirin use questioned. Pediatrics. 1988; 82:283. http://www.ncbi.nlm.nih.gov/pubmed/3399307?dopt=AbstractPlus

402. Zydus Pharmaceuticals. Ribavirin tablets prescribing information. Pennington, NJ; 2013 Jul.

403. Kadmon Pharmaceuticals. Ribasphere (ribavirin) capsules prescribing information. Warrendale, PA; 2012 Dec.

405. American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006; 118:1774-93. http://www.ncbi.nlm.nih.gov/pubmed/17015575?dopt=AbstractPlus

406. Glanville AR, Scott AI, Morton JM et al. Intravenous ribavirin is a safe and cost-effective treatment for respiratory syncytial virus infection after lung transplantation. J Heart Lung Transplant. 2005; 24:2114-9. http://www.ncbi.nlm.nih.gov/pubmed/16364859?dopt=AbstractPlus

407. Ghosh S, Champlin RE, Englund J et al. Respiratory syncytial virus upper respiratory tract illnesses in adult blood and marrow transplant recipients: combination therapy with aerosolized ribavirin and intravenous immunoglobulin. Bone Marrow Transplant. 2000; 25:751-5. http://www.ncbi.nlm.nih.gov/pubmed/10745261?dopt=AbstractPlus

408. Lewinsohn DM, Bowden RA, Mattson D et al. Phase I study of intravenous ribavirin treatment of respiratory syncytial virus pneumonia after marrow transplantation. Antimicrob Agents Chemother. 1996; 40:2555-7. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=163574&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/8913463?dopt=AbstractPlus

409. Whimbey E, Champlin RE, Englund JA et al. Combination therapy with aerosolized ribavirin and intravenous immunoglobulin for respiratory syncytial virus disease in adult bone marrow transplant recipients. Bone Marrow Transplant. 1995; 16:393-9. http://www.ncbi.nlm.nih.gov/pubmed/8535312?dopt=AbstractPlus

410. Edell D, Khoshoo V, Ross G et al. Early ribavarin treatment of bronchiolitis: effect on long-term respiratory morbidity. Chest. 2002; 122:935-9. http://www.ncbi.nlm.nih.gov/pubmed/12226035?dopt=AbstractPlus

411. Everard ML, Swarbrick A, Rigby AS et al. The effect of ribavirin to treat previously healthy infants admitted with acute bronchiolitis on acute and chronic respiratory morbidity. Respir Med. 2001; 95:275-80. http://www.ncbi.nlm.nih.gov/pubmed/11316109?dopt=AbstractPlus

412. Guerguerian AM, Gauthier M, Lebel MH et al. Ribavirin in ventilated respiratory syncytial virus bronchiolitis. A randomized, placebo-controlled trial. Am J Respir Crit Care Med. 1999; 160:829-34. http://www.ncbi.nlm.nih.gov/pubmed/10471604?dopt=AbstractPlus

413. Janai HK, Stutman HR, Zaleska M et al. Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis. Pediatr Infect Dis J. 1993; 12:214-8. http://www.ncbi.nlm.nih.gov/pubmed/8451098?dopt=AbstractPlus

414. Meert KL, Sarnaik AP, Gelmini MJ et al. Aerosolized ribavirin in mechanically ventilated children with respiratory syncytial virus lower respiratory tract disease: a prospective, double-blind, randomized trial. Crit Care Med. 1994; 22:566-72. http://www.ncbi.nlm.nih.gov/pubmed/8143465?dopt=AbstractPlus

415. Rodriguez WJ, Arrobio J, Fink R et al. Prospective follow-up and pulmonary functions from a placebo-controlled randomized trial of ribavirin therapy in respiratory syncytial virus bronchiolitis. Ribavirin Study Group. Arch Pediatr Adolesc Med. 1999; 153:469-74. http://www.ncbi.nlm.nih.gov/pubmed/10323626?dopt=AbstractPlus

416. King VJ, Viswanathan M, Bordley WC et al. Pharmacologic treatment of bronchiolitis in infants and children: a systematic review. Arch Pediatr Adolesc Med. 2004; 158:127-37. http://www.ncbi.nlm.nih.gov/pubmed/14757604?dopt=AbstractPlus

417. Long CE, Voter KZ, Barker WH et al. Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo. Pediatr Infect Dis J. 1997; 16:1023-8. http://www.ncbi.nlm.nih.gov/pubmed/9384333?dopt=AbstractPlus

418. Groothuis JR, Woodin KA, Katz R et al. Early ribavirin treatment of respiratory syncytial viral infection in high-risk children. J Pediatr. 1990; 117:792-8. http://www.ncbi.nlm.nih.gov/pubmed/2231215?dopt=AbstractPlus

419. Jacobson IM, Brown RS, Freilich B et al. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. Hepatology. 2007; 46:971-81. http://www.ncbi.nlm.nih.gov/pubmed/17894303?dopt=AbstractPlus

420. McHutchison JG, Lawitz EJ, Shiffman ML et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009; 361:580-93. http://www.ncbi.nlm.nih.gov/pubmed/19625712?dopt=AbstractPlus

421. Hadziyannis SJ, Sette H, Morgan TR et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004; 140:346-55. http://www.ncbi.nlm.nih.gov/pubmed/14996676?dopt=AbstractPlus

422. Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002; 347:975-82. http://www.ncbi.nlm.nih.gov/pubmed/12324553?dopt=AbstractPlus

423. Torriani FJ, Rodriguez-Torres M, Rockstroh JK et al. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med. 2004; 351:438-50. http://www.ncbi.nlm.nih.gov/pubmed/15282351?dopt=AbstractPlus

424. Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010; 59(RR-12):1-110.

426. Wirth S, Ribes-Koninckx C, Calzado MA et al. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J Hepatol. 2010; 52:501-7. http://www.ncbi.nlm.nih.gov/pubmed/20189674?dopt=AbstractPlus

427. Schwarz KB, Gonzalez-Peralta RP, Murray KF et al. The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology. 2011; 140:450-458.e1. http://www.ncbi.nlm.nih.gov/pubmed/21036173?dopt=AbstractPlus

428. González-Peralta RP, Kelly DA, Haber B et al. Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics. Hepatology. 2005; 42:1010-8. http://www.ncbi.nlm.nih.gov/pubmed/16250032?dopt=AbstractPlus

429. Boeckh M, Englund J, Li Y et al. Randomized controlled multicenter trial of aerosolized ribavirin for respiratory syncytial virus upper respiratory tract infection in hematopoietic cell transplant recipients. Clin Infect Dis. 2007; 44:245-9. http://www.ncbi.nlm.nih.gov/pubmed/17173225?dopt=AbstractPlus

430. Hoofnagle JH, Nelson KE, Purcell RH. Hepatitis E. N Engl J Med. 2012; 367:1237-44. http://www.ncbi.nlm.nih.gov/pubmed/23013075?dopt=AbstractPlus

431. Kamar N, Izopet J, Tripon S et al. Ribavirin for chronic hepatitis E virus infection in transplant recipients. N Engl J Med. 2014; 370:1111-20. http://www.ncbi.nlm.nih.gov/pubmed/24645943?dopt=AbstractPlus

432. Kamar N, Rostaing L, Abravanel F et al. Ribavirin therapy inhibits viral replication on patients with chronic hepatitis e virus infection. Gastroenterology. 2010; 139:1612-8. http://www.ncbi.nlm.nih.gov/pubmed/20708006?dopt=AbstractPlus

433. Mallet V, Nicand E, Sultanik P et al. Brief communication: case reports of ribavirin treatment for chronic hepatitis E. Ann Intern Med. 2010; 153:85-9. http://www.ncbi.nlm.nih.gov/pubmed/20547886?dopt=AbstractPlus

434. Shah DP, Ghantoji SS, Shah JN et al. Impact of aerosolized ribavirin on mortality in 280 allogeneic haematopoietic stem cell transplant recipients with respiratory syncytial virus infections. J Antimicrob Chemother. 2013; 68:1872-80. http://www.ncbi.nlm.nih.gov/pubmed/23572228?dopt=AbstractPlus

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