Drug reference

Ribavirin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 684, 685, 686

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Bronchiolitis ▶BY INHALATION OF AEROSOL, OR BY INHALATION OF NEBULISED SOLUTION ▶Child 1–23 months: Inhale a solution containing 20 mg/mL for 12–18 hours for at least 3 days, maximum of 7 days, to be administered via small particle aerosol generator Life-threatening RSV, parainfluenza virus, and adenovirus infection in immunocompromised children (administered on expert advice) ▶BY INTRAVENOUS INFUSION ▶Child: 33 mg/kg for 1 dose, to be administered over 15 minutes, then 16 mg/kg every 6 hours for 4 days, then 8 mg/kg every 8 hours for 3 days COPEGUS ® TABLETS Chronic hepatitis C (in combination with direct acting antivirals, or interferon alfa 2a, or peginterferon alfa 2a with or without direct acting antivirals) ▶BY MOUTH ▶Adult (body-weight up to 75 kg): 400 mg, dose to be taken in the morning and 600 mg, dose to be taken in the evening ▶Adult (body-weight 75 kg and above): 600 mg twice daily Chronic hepatitis C (in combination with peginterferon alfa 2b with or without direct acting antivirals) ▶BY MOUTH ▶Adult (body-weight up to 65 kg): 400 mg twice daily ▶Adult (body-weight 65–80 kg): 400 mg, to be taken in the morning and 600 mg, to be taken in the evening ▶Adult (body-weight 81–105 kg): 600 mg twice daily ▶Adult (body-weight 106 kg and above): 600 mg, to be taken in the morning and 800 mg, to be taken in the evening Chronic hepatitis C genotype 2 or 3 (not previously treated), or patients infected with HIV and hepatitis C (in combination with peginterferon alfa) ▶BY MOUTH ▶Adult: Usual dose 400 mg twice daily REBETOL ® CAPSULES Chronic hepatitis C (in combination with interferon alfa 2b, or peginterferon alfa 2b with or without boceprevir) ▶BY MOUTH ▶Adult (body-weight up to 65 kg): 400 mg twice daily ▶Adult (body-weight 65–80 kg): 400 mg, dose to be taken in the morning and 600 mg, dose to be taken in the evening ▶Adult (body-weight 81–104 kg): 600 mg twice daily ▶Adult (body-weight 105 kg and above): 600 mg, dose to be taken in the morning and 800 mg, dose to be taken in the evening REBETOL ® ORAL SOLUTION Chronic hepatitis C (in combination with interferon alfa 2b, or peginterferon alfa 2b with or without boceprevir) ▶BY MOUTH ▶Adult (body-weight up to 65 kg): 400 mg twice daily ▶Adult (body-weight 65–80 kg): 400 mg, dose to be taken in the morning and 600 mg, dose to be taken in the evening ▶Adult (body-weight 81–104 kg): 600 mg twice daily ▶Adult (body-weight 105 kg and above): 600 mg, dose to be taken in the morning and 800 mg, dose to be taken in the evening l UNLICENSED USE ▶When used by inhalation in children Inhalation licensed for use in children (age range not speciﬁed by manufacturer). ▶With intravenous use in children Intravenous preparation not licensed.

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Contra Indications

▶With systemic use consult product literature for speciﬁc contra-indications when ribavirin used in combination with other medicinal products. haemoglobinopathies. severe cardiac disease (in adults). severe, uncontrolled cardiac disease in children with chronic hepatitis C. unstable or uncontrolled cardiac disease in previous 6 months (in adults)

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Cautions

▶When used by inhalation maintain standard supportive respiratory and ﬂuid management therapy ▶With systemic use anaemia (haemoglobin concentration should be monitored during the treatment and corrective action taken) (in adults). cardiac disease (assessment including ECG recommended before and during treatment—discontinue if deterioration). consult product Infection literature for speciﬁc cautions when ribavirin used in combination with other medicinal products. gout (in adults). haemolysis (haemoglobin concentration should be monitored during the treatment and corrective action taken) (in adults). patients with a transplant—risk of rejection. risk of growth retardation in children, the reversibility of which is uncertain—if possible, consider starting treatment after pubertal growth spurt. severe dental disorders (in adults). severe ocular disorders (in adults). severe periodontal disorders (in adults). severe psychiatric effects (in adults)

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Prescribing And Dispensing Information

Flavours of oral liquid formulations may include bubble-gum.

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National Funding Access Decisions

NICE decisions ▶Peginterferon alfa and ribavirin for mild chronic hepatitis C (August 2006 and September 2010) NICE TA200 ▶In adults The combination of peginterferon alfa and ribavirin can be used for treating mild chronic hepatitis C in patients over 18 years. Alternatively, treatment can be delayed until the disease has reached a moderate stage (‘watchful waiting’). www.nice.org.uk/guidance/ta200 ▶Peginterferon alfa, interferon alfa, and ribavirin for moderate to severe chronic hepatitis C (January 2004 and September 2010) NICE TA200 ▶In adults The combination of peginterferon alfa and ribavirin should be used for treating moderate to severe chronic hepatitis C in patients aged over 18 years:. . not previously treated with interferon alfa or peginterferon alfa; . treated previously with interferon alfa alone or in combination with ribavirin; . whose condition did not respond to peginterferon alfa alone or to a combination of peginterferon alfa and ribavirin, or responded but subsequently relapsed; . co-infected with HIV. Peginterferon alfa alone should be used if ribavirin is contra-indicated or not tolerated. Interferon alfa for either monotherapy or combined therapy should be used only if neutropenia and thrombocytopenia are a particular risk. Patients receiving interferon alfa may be switched to peginterferon alfa. www.nice.org.uk/guidance/ta200 ▶Peginterferon alfa and ribavirin for chronic hepatitis C (November 2013) NICE TA300 ▶In children Peginterferon alfa in combination with ribavirin is recommended (within the marketing authorisation) as an option for treating chronic hepatitis C in children. www.nice.org.uk/guidance/ta300 l LESS SUITABLE FOR PRESCRIBING Ribavirin inhalation is less suitable for prescribing.

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Safety

Interactions

→Appendix 1: ribavirin

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Side Effects

▶Common or very common Alopecia. anaemia. anxiety. appetite decreased. arrhythmias. arthralgia. arthritis. asthenia. behaviour abnormal. chest pain. chills. concentration impaired. constipation. cough. depression . diarrhoea. dizziness. drowsiness. dry mouth. dysphagia. dyspnoea. ear pain. eye disorders. eye inﬂammation. eye pain. fever. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headaches. hyperthyroidism. hypotension. hypothyroidism. increased risk of infection. inﬂuenza like illness. lymphadenopathy. malaise. memory loss. mood altered. muscle complaints. muscle weakness. nasal congestion. nausea. neutropenia. oral disorders. pain. palpitations. peripheral oedema. photosensitivity reaction. respiratory disorders. sensation abnormal. sexual dysfunction. skin reactions. sleep disorders. sweat changes. syncope. taste altered. thirst. throat pain. thrombocytopenia. tinnitus. tremor. vasodilation. vertigo. vision disorders. vomiting. weight decreased ▶Uncommon Dehydration. diabetes mellitus. hallucination . hearing loss. hepatic disorders. hypertension. nerve disorders. sarcoidosis. suicidal tendencies. thyroiditis ▶Rare or very rare Angina pectoris. angioedema. bone marrow disorders. cardiac inﬂammation. cerebral ischaemia. cholangitis. coma. congestive heart failure. facial paralysis. hepatic failure (discontinue). hypersensitivity. intracranial haemorrhage. myocardial infarction. myopathy. pancreatitis. psychotic disorder. pulmonary embolism. retinopathy. seizure. severe cutaneous adverse reactions (SCARs). systemic lupus erythematosus (SLE). vasculitis ▶Frequency not known Haemolytic anaemia. homicidal ideation. nephrotic syndrome. pure red cell aplasia. renal failure. solid organ transplant rejection. tongue discolouration. ulcerative colitis SIDE-EFFECTS, FURTHER INFORMATION Side effects listed are reported when oral ribavirin is used in combination with peginterferon alfa or interferon alfa, consult product literature for details.

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Conception And Contraception

▶With systemic use Exclude pregnancy before treatment in females of childbearing age. Effective contraception essential during treatment and for 4 months after treatment in females and for 7 months after treatment in males of childbearing age. Routine monthly pregnancy tests recommended. Condoms must be used if partner of male patient is pregnant (ribavirin excreted in semen). ▶When used by inhalation Women planning pregnancy should avoid exposure to aerosol.

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Pregnancy

Avoid; teratogenicity in animal studies. ▶When used by inhalation Pregnant women should avoid exposure to aerosol.

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Breast Feeding

Avoid—no information available.

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Renal Impairment

Plasma-ribavirin concentration increased. Infection ▶In adults Manufacturer advises avoid oral ribavirin unless essential if eGFR less than 50 mL/minute/1.73 m2— monitor haemoglobin concentration closely. ▶In children Manufacturer advises avoid oral ribavirin if estimated glomerular ﬁltration rate less than 50 mL/minute/1.73 m2—monitor haemoglobin concentration closely. Manufacturer advises use intravenous preparation with caution if estimated glomerular ﬁltration rate less than 30 mL/minute/1.73 m2.

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Monitoring Requirements

▶When used by inhalation Monitor electrolytes closely. Monitor equipment for precipitation. ▶With systemic use in children Determine full blood count, platelets, electrolytes, serum creatinine, liver function tests and uric acid before starting treatment and then on weeks 2 and 4 of treatment, then as indicated clinically— adjust dose if adverse reactions or laboratory abnormalities develop (consult product literature). Test thyroid function before treatment and then every 3 months. ▶With oral use in children Eye examination recommended before treatment. Eye examination also recommended during treatment if pre-existing ophthalmological disorder or if decrease in vision reported—discontinue treatment if ophthalmological disorder deteriorates or if new ophthalmological disorder develops. ▶With systemic use in adults Determine full blood count, platelets, electrolytes, glucose, serum creatinine, liver function tests and uric acid before starting treatment and then on weeks 2 and 4 of treatment, then as indicated clinically—adjust dose if adverse reactions or laboratory abnormalities develop (consult product literature).

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Virazole (Mylan) Ribavirin 100 mg per 1 ml Virazole 1.2g/12ml solution for injection vials | 5 vial P £3,600.00 Oral solution CAUTIONARY AND ADVISORY LABELS 21 ▶Rebetol (Merck Sharp & Dohme Ltd) Ribavirin 40 mg per 1 ml Rebetol 40mg/ml oral solution | 100 ml P £67.08 Capsule CAUTIONARY AND ADVISORY LABELS 21 ▶Rebetol (Merck Sharp & Dohme Ltd) Ribavirin 200 mg Rebetol 200mg capsules | 168 capsule P £321.38 ANTIVIRALS › NUCLEOTIDE ANALOGUES

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Dose text by age group

Child 1–23 months

Inhale a solution containing

First-line fragment. Read the complete Indications and Dose section above.

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Child

33 mg/kg for 1 dose, to be administered over

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight up to 75 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 75 kg and above)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 65–80 kg)

400 mg, to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 81–105 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 106 kg and above)

600 mg, to be

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Usual dose 400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 65–80 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight 81–104 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 105 kg and above)

600 mg, dose to be

First-line fragment. Read the complete Indications and Dose section above.

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Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 65–80 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 81–104 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 105 kg and above)

600 mg, dose to be

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Ribavirin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 684, 685, 686

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF pages 684, 685

Contra Indications

PDF page 685

Cautions

PDF page 685

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include bubble-gum.

PDF page 686

National Funding Access Decisions

PDF page 686

Safety

Interactions

→Appendix 1: ribavirin

PDF page 685

Side Effects

PDF page 685

Conception And Contraception

PDF pages 685, 686

Pregnancy

Avoid; teratogenicity in animal studies. ▶When used by inhalation Pregnant women should avoid exposure to aerosol.

PDF page 686

Breast Feeding

Avoid—no information available.

PDF page 686

Renal Impairment

PDF page 686

Monitoring Requirements

PDF page 686

Dose and formulations

Medicinal Forms

PDF page 686

Dose text by age group

Child 1–23 months

Inhale a solution containing

First-line fragment. Read the complete Indications and Dose section above.

PDF page 684

Child

33 mg/kg for 1 dose, to be administered over

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight up to 75 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 75 kg and above)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 65–80 kg)

400 mg, to be taken in the

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 81–105 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 106 kg and above)

600 mg, to be

First-line fragment. Read the complete Indications and Dose section above.

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Adult

Usual dose 400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 65–80 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 81–104 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 105 kg and above)

600 mg, dose to be

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight up to 65 kg)

400 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 65–80 kg)

400 mg, dose to be taken

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 81–104 kg)

600 mg twice daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Adult (body-weight 105 kg and above)

600 mg, dose to be

First-line fragment. Read the complete Indications and Dose section above.

PDF page 685

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.