Generic Name: Ribavirin Brand Name(s): Generics only. No brands available.

Uses

What is Ribavirin used for?

Ribavirin is used in combination with other antiviral medications (such as interferon, sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. Ribavirin works by reducing the amount of hepatitis C virus in your body, which may help your liver recover.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice “safer sex” (including the use of latex condoms) to lower the risk of passing the virus to others.

How should I take Ribavirin?

Take this medication by mouth as directed by your doctor, usually twice daily with food.

The dosage and length of treatment is based on your age, weight, medical condition, and response to treatment.

If this medication comes in a dosing package, carefully follow the directions on the dosing package unless your doctor directs you otherwise.

This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Continue to take ribavirin and your other antiviral medication(s) for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping any of the drugs too early may result in a return of the infection.

Drink plenty of water while being treated with this medication. Doing so will decrease the risk of serious side effects.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

How do I store Ribavirin?

-Inhalation solution: Lyophilized drug powder should be stored in a dry area at room temperature; reconstituted solutions may be stored (under sterile conditions) at room temperature for 24 hours; solutions in SPAG-2 unit should be discarded at least every 24 hours.

-Oral solution: May be stored at room temperature or in the refrigerator

-Tablets and capsules: Should be stored at room temperature

There may be different brands of Ribavirin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ribavirin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ribavirin?

Before taking ribavirin, tell your doctor or pharmacist if you are allergic to it; or if you have 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 your doctor or pharmacist your medical history, especially of: blood disorders (e.g., sickle cell anemia, low hemoglobin, thalassemia), kidney disease, other liver problems (e.g., autoimmune hepatitis), heart disease, high blood pressure, breathing problems, pancreas problems (e.g., pancreatitis), diabetes.

This drug may make you dizzy or unusually tired or blur your vision. Alcohol or marijuana can make you more dizzy or tired. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for anemia while using this drug.

Ribavirin must not be used during pregnancy. It is recommended that female patients or female partners of male patients take a pregnancy test before this medication is started, during treatment, and for 6 months after this drug is stopped. If you become pregnant or think you may be pregnant, inform your doctor right away.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this medication is not recommended.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ribavirin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ribavirin. Ribavirin is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ribavirin?

Nausea, diarrhea, stomach upset, headache, dizziness, blurred vision, trouble sleeping, cough, low appetite, weight loss or gain, dry skin, or changes in taste/hearing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness/weakness, fast/pounding/irregular heartbeat, muscle/joint pain, vision changes, easy bruising/bleeding, dark urine, yellowing of eyes/skin.

Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, stomach/lower back pain, black/bloody stools.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ribavirin?

Some products that may interact with this drug include: antacids, didanosine, zidovudine.

Ribavirin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ribavirin?

Ribavirin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ribavirin?

Ribavirin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ribavirin.

What is the dose of Ribavirin for an adult?

Usual Adult Dose for Chronic Hepatitis C

CAPSULES, ORAL SOLUTION:

In combination with peginterferon alfa-2b:

Less than 66 kg: 400 mg orally twice a day

66 to 80 kg: 400 mg orally in the morning and 600 mg in the evening

81 to 105 kg: 600 mg orally twice a day

Greater than 105 kg: 600 mg orally in the morning and 800 mg in the evening

Duration of therapy:

-Interferon alpha-naive patients with genotype 1: 48 weeks

-Interferon alpha-naive patients with genotype 2 and 3: 24 weeks

-Retreatment with peginterferon alfa-2b/ribavirin of prior treatment failures: 48 weeks, regardless of HCV genotype

In combination with interferon alfa-2b:

75 kg or less: 400 mg orally in the morning and 600 mg in the evening

Greater than 75 kg: 600 mg orally twice a day

Duration of therapy:

-Interferon alpha-naive patients: 24 to 48 weeks

-Retreatment with interferon alfa-2b/ribavirin in patients who relapse after nonpegylated interferon monotherapy: 24 weeks

Comments:

-The manufacturer’s product information for peginterferon alfa-2b or interferon alfa-2b should be consulted.

-Combination therapy with peginterferon alfa-2b is preferred; provides substantially better response rates than combination therapy with interferon alfa-2b.

-Patients with previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and/or genotype 1 infection are less likely to benefit from retreatment after a failing course of therapy.

Approved indication: In combination with peginterferon alfa-2b or interferon alfa-2b, for treatment of chronic hepatitis C in patients with compensated liver disease

TABLETS:

In combination with peginterferon alfa-2a:

-Genotypes 1 and 4 in patients less than 75 kg: 1000 mg/day orally in 2 divided doses for 48 weeks

-Genotypes 1 and 4 in patients 75 kg or more: 1200 mg/day orally in 2 divided doses for 48 weeks

-Genotypes 2 and 3: 800 mg/day orally in 2 divided doses for 24 weeks

-Genotypes 5 and 6: Insufficient data to make a recommendation

-In patients coinfected with HIV: 800 mg/day orally in 2 divided doses for 48 weeks, regardless of HCV genotype

Comments:

-The manufacturer’s product information for peginterferon alfa-2a should be consulted.

Approved indication: In combination with peginterferon alfa-2a, for treatment of patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa

Usual Adult Dose for Respiratory Syncytial Virus

(Not approved by FDA)

Case Review: One vial (6 g) dissolved and delivered through a Small Particle Aerosol Generator (SPAG-2) over a continuous 22-hour period, daily for 5 consecutive days

Renal Dose Adjustments

CAPSULES, ORAL SOLUTION:

CrCl less than 50 mL/min: Contraindicated

TABLETS:

Adults:

In combination with peginterferon alfa-2a:

CrCl 30 to 50 mL/min: Alternating doses, 200 mg and 400 mg orally every other day

CrCl less than 30 mL/min: 200 mg orally once a day

Comments:

-The dose of ribavirin tablets should not be further modified in patients with renal dysfunction. If severe side effects or laboratory abnormalities develop, ribavirin should be discontinued, if appropriate, until side effects abate or decrease in severity. If intolerance persists after restarting ribavirin, peginterferon alfa-2a/ribavirin should be discontinued.

Dose Adjustments

Dosage must be individualized to patient’s specific disease characteristics (e.g., genotype), preexisting cardiac disease, and development of side effects or laboratory abnormalities.

If severe side effects or laboratory abnormalities develop during combination therapy, the dose should be modified or discontinued, if appropriate, until the side effects abate or decrease in severity. Combination therapy should be discontinued if intolerance persists after dose adjustment.

ADULTS (with normal renal function):

CAPSULES, ORAL SOLUTION:

Hemoglobin (Hgb) 8.5 to less than 10 g/dL in patients without history of cardiac disease:

First dose reduction: Dose should be reduced by 200 mg/day (except in patients receiving 1400 mg/day, dose should be reduced by 400 mg/day).

Second dose reduction (if needed): Dose should be reduced by an additional 200 mg/day.

2 g/dL or greater decrease in Hgb during any 4 week period during therapy in patients with history of stable cardiac disease: Dose should be permanently reduced by 200 mg/day.

Interferon alfa-2b (pegylated or nonpegylated) plus ribavirin should be discontinued if:

-Hgb less than 8.5 g/dL

-Hgb less than 12 g/dL after 4 weeks of dose reduction (in patients with history of stable cardiac disease)

-WBC less than 1 x 10(9)/L

-Neutrophils less than 0.5 x 10(9)/L

-Platelets less than 25 x 10(9)/L

Discontinuation of therapy:

-In HCV genotype 1, interferon alpha-naive patients receiving peginterferon alfa-2b/ribavirin should discontinue therapy if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable after 24 weeks of therapy.

-Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24, are highly unlikely to achieve sustained virologic response and discontinuation of therapy should be considered.

-Treatment discontinuation should be considered in any interferon alpha-naive patient receiving interferon alfa-2b/ribavirin whose HCV-RNA levels remain detectable after 24 weeks of therapy.

TABLETS:

Patients with no cardiac disease:

Hgb less than 10 g/dL: 200 mg orally in the morning and 400 mg in the evening

Hgb less than 8.5 g/dL: Discontinue.

Patients with history of stable cardiac disease:

2 g/dL or greater decrease in Hgb during any 4 week period: 200 mg orally in the morning and 400 mg in the evening

Hgb less than 12 g/dL despite 4 weeks at reduced dose: Discontinue.

Comments:

-These guidelines also apply to laboratory abnormalities or side effects other than decreases in Hgb values.

-Once ribavirin has been withheld due to a laboratory abnormality or clinical side effect, restarting at 600 mg/day and further increase to 800 mg/day may be attempted; increasing ribavirin to the original dose is not recommended.

Discontinuation of therapy:

-Discontinuation of peginterferon alfa-2a/ribavirin should be considered if patient has not shown at least a 2 log10 reduction from baseline in HCV-RNA by 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy.

-Peginterferon alfa-2a/ribavirin should be discontinued if hepatic decompensation occurs during therapy.

PEDIATRICS (with normal renal function):

CAPSULES, ORAL SOLUTION:

Hgb 8.5 to less than 10 g/dL in patients without history of cardiac disease:

First dose reduction: Dose should be reduced to 12 mg/kg/day orally in 2 divided doses.

Second dose reduction (if needed): Dose should be reduced to 8 mg/kg/day orally in 2 divided doses.

2 g/dL or greater decrease in Hgb during any 4 week period during therapy in pediatric patients with preexisting cardiac conditions: Weekly evaluations and hematology testing are recommended.

Interferon alfa-2b (pegylated or nonpegylated) plus ribavirin should be discontinued if:

-Hgb less than 8.5 g/dL

-Hgb less than 12 g/dL after 4 weeks of dose reduction (in patients with history of stable cardiac disease)

-WBC less than 1 x 10(9)/L

-Neutrophils less than 0.5 x 10(9)/L

-Platelets less than 50 x 10(9)/L

-Creatinine greater than 2 mg/dL

Discontinuation of therapy:

-Pediatric patients receiving peginterferon alfa-2b/ribavirin (excluding those with HCV genotype 2 and 3) should discontinue therapy if their HCV-RNA dropped less than 2 log10 after 12 weeks of therapy compared to pretreatment or if they have detectable HCV-RNA after 24 weeks of therapy.

-Treatment discontinuation should be considered in any patient receiving interferon alfa-2b/ribavirin whose HCV-RNA levels remain detectable after 24 weeks of therapy.

TABLETS:

Hgb less than 10 g/dL in patients with no cardiac disease or decrease in Hgb of 2 g/dL or more during any 4 week period in patients with history of stable cardiac disease:

23 to 33 kg: 200 mg orally in the morning

34 to 59 kg: 200 mg orally twice a day

60 kg or more: 200 mg orally in the morning and 400 mg in the evening

Hgb less than 8.5 g/dL in patients with no cardiac disease or Hgb less than 12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease: Discontinue.

Comments:

-These guidelines also apply to laboratory abnormalities or side effects other than decreases in Hgb values.

-An increase to the original dose may be attempted upon resolution of a laboratory abnormality or clinical side effect, depending on physician’s judgment; if ribavirin was withheld due to a laboratory abnormality or clinical side effect, restarting at one-half the full dose may be attempted.

Discontinuation of therapy:

-Discontinuation of peginterferon alfa-2a/ribavirin should be considered if patient has not shown at least a 2 log10 reduction from baseline in HCV-RNA by 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy.

-Peginterferon alfa-2a/ribavirin should be discontinued if hepatic decompensation occurs during therapy.

Dialysis

Oral ribavirin is not effectively removed by hemodialysis.

CAPSULES, ORAL SOLUTION:

CrCl less than 50 mL/min: Contraindicated

TABLETS:

Adults:

In combination with peginterferon alfa-2a:

Hemodialysis: 200 mg orally once a day

Comments:

-The dose of ribavirin tablets should not be further modified in patients with renal dysfunction. If severe side effects or laboratory abnormalities develop, ribavirin should be discontinued, if appropriate, until side effects abate or decrease in severity. If intolerance persists after restarting ribavirin, peginterferon alfa-2a/ribavirin should be discontinued.

Other Comments

Administration advice:

-Use the Small Particle Aerosol Generator Model-2 (SPAG-2) for administration of inhaled ribavirin; no other aerosol generation device recommended. Consult the manufacturer’s product information for further information regarding administration of the inhalation solution.

-Do not give oral ribavirin as monotherapy.

-Take oral ribavirin with food.

-Do not open, crush, or break ribavirin oral capsules.

Storage requirements:

-Inhalation solution: Lyophilized drug powder should be stored in a dry area at room temperature; reconstituted solutions may be stored (under sterile conditions) at room temperature for 24 hours; solutions in SPAG-2 unit should be discarded at least every 24 hours.

-Oral solution: May be stored at room temperature or in the refrigerator

-Tablets and capsules: Should be stored at room temperature

Reconstitution/preparation techniques:

Inhalation solution: The manufacturer’s product information should be consulted.

General:

-Only physicians and support staff familiar with the specific ventilator used and this method of drug administration should use aerosolized ribavirin in patients requiring mechanical ventilator assistance. Strict attention must be paid to procedures that minimize accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.

-Safety and efficacy of ribavirin capsules/oral solution have not been established for treatment beyond 1 year; when used with interferon alfa-2b in previously untreated patients, safety and efficacy have not been established beyond 48 weeks.

-Safety and efficacy of ribavirin tablets have not been established for treatment beyond 48 weeks.

Monitoring:

-Cardiovascular: ECG (prior to therapy) and cardiovascular status (prior to and during therapy) in patients with preexisting cardiac disease

-Endocrine: Blood chemistries, including TSH (prior to therapy and periodically thereafter)

-General: Pregnancy testing in women of childbearing potential (prior to therapy and monthly thereafter)

-Hematologic: Standard hematologic tests (prior to therapy and periodically thereafter) including Hgb (pretreatment, weeks 2 and 4 of therapy, and as clinically appropriate), complete and differential white blood cell counts, platelet count; signs/symptoms of anemia in patients with renal dysfunction and those older than 50 years

-Hepatic: Blood chemistries, including liver function tests (prior to therapy and periodically thereafter); clinical status and hepatic function (during therapy); signs/symptoms of hepatic decompensation

Patient advice:

-Patients should be well hydrated, especially during initial stages of oral therapy.

What is the dose of Ribavirin for a child?

Usual Pediatric Dose for Respiratory Syncytial Virus

20 mg/mL as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12 to 18 hours per day for 3 to 7 days

Comments:

-The operator’s manual for the SPAG-2 should be consulted.

-Using 20 mg/mL, the aerosol concentration for a 12-hour delivery period averages 190 mcg/L of air.

-Ribavirin should not be administered simultaneously or combined with any other aerosolized medications.

-Sudden deterioration of respiratory function has been associated with initiation of ribavirin inhalation therapy in infants; careful monitoring of respiratory function during therapy recommended. If initiation of inhaled ribavirin produces sudden deterioration of respiratory function, therapy should be discontinued and restarted only with extreme caution, continuous monitoring, and coadministration of bronchodilators should be considered.

Approved indication: For treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus

Usual Pediatric Dose for Chronic Hepatitis C

CAPSULES, ORAL SOLUTION:

3 years or older:

In combination with peginterferon alfa-2b or interferon alfa-2b: 15 mg/kg orally per day in 2 divided doses

Ribavirin dosages according to weight:

Less than 47 kg: 15 mg/kg (oral solution) orally per day in 2 divided doses

47 to 59 kg: 400 mg orally twice a day

60 to 73 kg: 400 mg orally in the morning and 600 mg in the evening

Greater than 73 kg: 600 mg orally twice a day

Duration of therapy:

-Genotype 1: 48 weeks

-Genotypes 2 and 3: 24 weeks

Comments:

-The manufacturer’s product information for peginterferon alfa-2b or interferon alfa-2b should be consulted.

-Combination therapy with peginterferon alfa-2b is preferred; provides substantially better response rates than combination therapy with interferon alfa-2b.

-Patients who reach their 18th birthday while receiving peginterferon alfa-2b plus ribavirin should remain on the pediatric dosing regimen.

-Patients with previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and/or genotype 1 infection are less likely to benefit from retreatment after a failing course of therapy.

Approved indication: In combination with peginterferon alfa-2b or interferon alfa-2b, for treatment of chronic hepatitis C in patients with compensated liver disease

TABLETS:

5 years or older:

In combination with peginterferon alfa-2a:

23 to 33 kg: 200 mg orally twice a day

34 to 46 kg: 200 mg orally in the morning and 400 mg in the evening

47 to 59 kg: 400 mg orally twice a day

60 to 74 kg: 400 mg orally in the morning and 600 mg in the evening

75 kg or more: 600 mg orally twice a day

Duration of therapy:

-Genotype 2 and 3: 24 weeks

-Other genotypes: 48 weeks

Comments:

-The manufacturer’s product information for peginterferon alfa-2a should be consulted.

-Patients who reach their 18th birthday while receiving peginterferon alfa-2a plus ribavirin should remain on the pediatric dosing regimen.

Approved indication: In combination with peginterferon alfa-2a, for treatment of patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa

Precautions

Oral: Safety and efficacy have not been established in patients younger than 3 years.

Inhalation: Safety and efficacy have only been established in hospitalized infants and young children; not for use in adults

How is Ribavirin available?

Ribavirin is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral capsule,
  • Oral solution,
  • Inhalation powder for reconstitution,
  • Compounding powder.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ribavirin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 21, 2018 | Last Modified: April 21, 2018

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