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Drug overview for RIBAVIRIN (ribavirin):
Generic name: RIBAVIRIN (RYE-ba-VYE-rin)
Drug class: Ribavirin
Therapeutic class: Anti-Infective Agents
Ribavirin is a synthetic nucleoside antiviral agent that has a broad spectrum of antiviral activity against both RNA and DNA viruses.
No enhanced Uses information available for this drug.
Generic name: RIBAVIRIN (RYE-ba-VYE-rin)
Drug class: Ribavirin
Therapeutic class: Anti-Infective Agents
Ribavirin is a synthetic nucleoside antiviral agent that has a broad spectrum of antiviral activity against both RNA and DNA viruses.
No enhanced Uses information available for this drug.
DRUG IMAGES
RIBAVIRIN 6 GM INHALATION VIAL
The following indications for RIBAVIRIN (ribavirin) have been approved by the FDA:
Indications:
Respiratory syncytial virus infection
Professional Synonyms:
Respiratory syncytial virus pneumonia
RSV infection
Syncytial virus infection of the respiratory tract
Indications:
Respiratory syncytial virus infection
Professional Synonyms:
Respiratory syncytial virus pneumonia
RSV infection
Syncytial virus infection of the respiratory tract
The following dosing information is available for RIBAVIRIN (ribavirin):
Administer oral ribavirin with caution to patients with pre-existing cardiac disease. Evaluate patients before commencement of therapy and monitor patients appropriately during therapy. If there is any deterioration of cardiovascular status, discontinue therapy.
If severe adverse effects or laboratory changes occur when ribavirin capsules are used in combination with interferon alfa-2b (Intron(R) A) or peginterferon alfa-2b (PegIntron(R)), dosage should be modified or the agent(s) should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dosage adjustment, discontinue combination therapy. Refer to Table 6 for recommendations for dosage modification or treatment discontinuation based on laboratory parameters.
In pediatric patients, dosage reduction is accomplished by modifying the recommended ribavirin capsules dose from the original starting dosage of 15 mg/kg daily in a 2-step process to 12 mg/kg daily, then to 8 mg/kg daily, if needed (see Table 6).
In patients with a history of stable cardiovascular disease, permanently reduce dosage if the hemoglobin decreases by >=2 g/dL during any 4-week period. If hemoglobin remains <12 g/dL after 4 weeks on a reduced dosage, discontinue combination therapy.
Modify or discontinue ribavirin capsules dosing in any patient whose hemoglobin level falls below 10 g/dL.
Table 6. Dosage Modification Recommendations for Ribavirin Capsule Combination Therapy in Adults and Pediatric Patients
Laboratory Parameters Recommendation WBC Discontinue combination therapy if <1000/mm3 Neutrophils Discontinue combination therapy if <500/mm3 Platelets Discontinue combination therapy if <25,000/mm3 (adults) or <50,000/mm3 (pediatrics) Creatinine Discontinue combination therapy if >2 mg/dL (pediatrics) Hemoglobin in patients without Reduce ribavirin capsule daily history of cardiac disease dosage if 8.5 to <10 g/dL; Discontinue combination therapy if <8.5 g/dL Hemoglobin in patients with history Reduce ribavirin capsule daily of stable cardiac disease dosage by 200 mg/day if >=2 g/dL decrease in hemoglobin during any 4-week period during treatment Discontinue combination therapy <8.5
g/dL or <12 g/dL after 4 weeks of dosage reduction
Refer to labeling for interferon alfa-2b (Intron(R) A) or peginterferon alfa-2b (PegIntron(R)) for information on how and when to reduce dosage of these agents for specific laboratory parameters.
In adults, 1st dosage reduction of ribavirin is by 200 mg/day (except in patients receiving 1400 mg, for whom dosage reduction should be by 400 mg/day). If needed, 2nd dosage reduction of ribavirin is by an additional 200 mg/day. Patients whose dosage of ribavirin is reduced to 600 mg daily receive 200 mg in the morning and 400 mg in the evening.
In pediatric patients, 1st dosage reduction of ribavirin is to 12 mg/kg daily, and 2nd dosage reduction of ribavirin is to 8 mg/kg daily.
Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease >=2 g/dL during any 4-week period during therapy should undergo weekly evaluations and hematology testing.
Patients with a history of significant or unstable cardiac disease should not be treated with peginterferon alfa-2b/ribavirin capsules combination therapy.
If serious adverse effects or laboratory changes occur when ribavirin tablets are used in conjunction with peginterferon alfa-2a (Pegasys(R)), dosage should be modified or the agent(s) should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dosage adjustment, discontinue combination therapy. Refer to Table 7 for recommendations for dosage modifications and treatment discontinuation based on the patient's hemoglobin concentration and cardiac status.
In adults, once ribavirin tablets have been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dosage to 800 mg daily. However, do not increase the dosage to the original assigned dosage (1-1.2 g).
In pediatric patients, upon resolution of a laboratory abnormality or clinical adverse reaction, an attempt may be made (based on physician judgment) to increase the ribavirin tablet dosage to the original dosage. If ribavirin tablets have been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin tablets at one-half the full dosage.
Table 7. Ribavirin Tablet Dosage Modification Recommendations in Adults and Pediatric Patients
Recommendations Recommendations Regarding Ribavirin Regarding Ribavirin Therapy Therapy Laboratory Values Hemoglobin <10 g/dL in Hemoglobin <8.5 g/dL in patients with no cardiac patients with no cardiac disease, or Decrease in disease, or Hemoglobin hemoglobin of >=2 g/dL <12 g/dL despite 4 weeks during any 4-week period at reduced dose in in patients with history patients with history of of stable cardiac stable cardiac disease disease Adults (any weight) Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening Pediatric patients 5-18 years of age 23-33 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning 34-46 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 200 mg in the evening 47-59 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 200 mg in the evening 60-74 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening >=75 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening
The recommendations in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.
If severe adverse effects or laboratory changes occur when ribavirin capsules are used in combination with interferon alfa-2b (Intron(R) A) or peginterferon alfa-2b (PegIntron(R)), dosage should be modified or the agent(s) should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dosage adjustment, discontinue combination therapy. Refer to Table 6 for recommendations for dosage modification or treatment discontinuation based on laboratory parameters.
In pediatric patients, dosage reduction is accomplished by modifying the recommended ribavirin capsules dose from the original starting dosage of 15 mg/kg daily in a 2-step process to 12 mg/kg daily, then to 8 mg/kg daily, if needed (see Table 6).
In patients with a history of stable cardiovascular disease, permanently reduce dosage if the hemoglobin decreases by >=2 g/dL during any 4-week period. If hemoglobin remains <12 g/dL after 4 weeks on a reduced dosage, discontinue combination therapy.
Modify or discontinue ribavirin capsules dosing in any patient whose hemoglobin level falls below 10 g/dL.
Table 6. Dosage Modification Recommendations for Ribavirin Capsule Combination Therapy in Adults and Pediatric Patients
Laboratory Parameters Recommendation WBC Discontinue combination therapy if <1000/mm3 Neutrophils Discontinue combination therapy if <500/mm3 Platelets Discontinue combination therapy if <25,000/mm3 (adults) or <50,000/mm3 (pediatrics) Creatinine Discontinue combination therapy if >2 mg/dL (pediatrics) Hemoglobin in patients without Reduce ribavirin capsule daily history of cardiac disease dosage if 8.5 to <10 g/dL; Discontinue combination therapy if <8.5 g/dL Hemoglobin in patients with history Reduce ribavirin capsule daily of stable cardiac disease dosage by 200 mg/day if >=2 g/dL decrease in hemoglobin during any 4-week period during treatment Discontinue combination therapy <8.5
g/dL or <12 g/dL after 4 weeks of dosage reduction
Refer to labeling for interferon alfa-2b (Intron(R) A) or peginterferon alfa-2b (PegIntron(R)) for information on how and when to reduce dosage of these agents for specific laboratory parameters.
In adults, 1st dosage reduction of ribavirin is by 200 mg/day (except in patients receiving 1400 mg, for whom dosage reduction should be by 400 mg/day). If needed, 2nd dosage reduction of ribavirin is by an additional 200 mg/day. Patients whose dosage of ribavirin is reduced to 600 mg daily receive 200 mg in the morning and 400 mg in the evening.
In pediatric patients, 1st dosage reduction of ribavirin is to 12 mg/kg daily, and 2nd dosage reduction of ribavirin is to 8 mg/kg daily.
Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease >=2 g/dL during any 4-week period during therapy should undergo weekly evaluations and hematology testing.
Patients with a history of significant or unstable cardiac disease should not be treated with peginterferon alfa-2b/ribavirin capsules combination therapy.
If serious adverse effects or laboratory changes occur when ribavirin tablets are used in conjunction with peginterferon alfa-2a (Pegasys(R)), dosage should be modified or the agent(s) should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dosage adjustment, discontinue combination therapy. Refer to Table 7 for recommendations for dosage modifications and treatment discontinuation based on the patient's hemoglobin concentration and cardiac status.
In adults, once ribavirin tablets have been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dosage to 800 mg daily. However, do not increase the dosage to the original assigned dosage (1-1.2 g).
In pediatric patients, upon resolution of a laboratory abnormality or clinical adverse reaction, an attempt may be made (based on physician judgment) to increase the ribavirin tablet dosage to the original dosage. If ribavirin tablets have been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin tablets at one-half the full dosage.
Table 7. Ribavirin Tablet Dosage Modification Recommendations in Adults and Pediatric Patients
Recommendations Recommendations Regarding Ribavirin Regarding Ribavirin Therapy Therapy Laboratory Values Hemoglobin <10 g/dL in Hemoglobin <8.5 g/dL in patients with no cardiac patients with no cardiac disease, or Decrease in disease, or Hemoglobin hemoglobin of >=2 g/dL <12 g/dL despite 4 weeks during any 4-week period at reduced dose in in patients with history patients with history of of stable cardiac stable cardiac disease disease Adults (any weight) Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening Pediatric patients 5-18 years of age 23-33 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning 34-46 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 200 mg in the evening 47-59 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 200 mg in the evening 60-74 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening >=75 kg Reduce ribavirin dosage Discontinue ribavirin to 200 mg in the morning and 400 mg in the evening
The recommendations in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.
Ribavirin is administered orally or by inhalation. Ribavirin has been administered IV+. When oral ribavirin is used in conjunction with peginterferon or interferon, the cautions, precautions, and contraindications associated with both oral ribavirin and the interferon should be considered. Refer to the full prescribing information for warnings and precautions of peginterferon alfa-2a (Pegasys(R)), peginterferon alfa-2b (PegIntron(R)), or interferon alfa-2b (Intron(R) A).
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for RIBAVIRIN (ribavirin):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Stavudine; Zidovudine/Ribavirin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ribavirin is believed to inhibit the phosphorylation of zidovudine to its active form, zidovudine triphosphate, by reducing the activity of thymidine kinase.(1) Ribavirin is also believed to inhibit the phosphorylation of stavudine to its active form.(2) CLINICAL EFFECTS: Concurrent use of ribavirin with stavudine may result in decreased efficacy of stavudine(2,3) or hepatic failure.(4) Concurrent use of ribavirin and zidovudine may result in decreased efficacy of zidovudine,(3,5,6) hepatic failure,(4) neutropenia,(4) or anemia.(4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of zidovudine states that concurrent use with ribavirin should be avoided.(3,5) The manufacturer of Rebetol (ribavirin) states that the combination should be used with caution.(6) Patients receiving concurrent therapy with zidovudine and ribavirin should be closely monitored for hepatic failure, neutropenia, and anemia. The manufacturer of stavudine states that concurrent use with ribavirin should be approached with caution.(7) The manufacturer of Rebetrol (ribavirin) states that the combination should be used with caution.(6) Patients receiving concurrent therapy with stavudine and ribavirin should be closely monitored for hepatic failure. DISCUSSION: Zidovudine is converted to its active form by a series of phosphorylations. Ribavirin reduces the activity of thymidine kinase, resulting in higher levels of the natural nucleoside thymidine triphosphate and decreased levels of zidovudine triphosphate. Zidovudine triphosphate competes with thymidine triphosphate for insertion in the viral DNA chain. (3) Several in-vitro studies have shown that the concurrent administration of ribavirin results in decreased phosphorylation of zidovudine(1,8-10), increased sensitivity to zidovudine toxicity,(8) and decreased sensitivity to zidovudine.(9,10) However, no pharmacokinetic or pharmacodynamic changes were seen in a study of 6 subjects receiving concurrent ribavirin and zidovudine.(4) In study NR15961, patients receiving concurrent ribavirin, interferon, and zidovudine developed severe neutropenia (ANC less than 500, 15% versus 9%) and severe anemia (hemoglobin less than 8 g/dL, 5% versus 1%) more frequently than patients not receiving zidovudine.(4) Stavudine is also converted to its active form by a series of phosphorylations.(7) In vitro studies have shown that ribavirin inhibits this process.(2,4,7) However, no pharmacokinetic or pharmacodynamic changes were seen in a study of 10 subjects receiving concurrent ribavirin and stavudine.(4) In study NR15961, 14 (11%) of 129 HIV-positive chronic hepatitis C patients receiving HAART developed hepatic decompensation. All 14 patients were on NRTIs, including stavudine, didanosine, abacavir, zidovudine, and lamivudine.(4) |
LAMIVUDINE-ZIDOVUDINE, RETROVIR, ZIDOVUDINE |
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Azathioprine/Ribavirin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ribavirin inhibits inosine monophosphate dehydrogenase (IMDH), which leads to accumulation of 6-methylthioinosine monophosphate (6-MTITP), a metabolite of azathioprine that is associated with myelotoxicity (neutropenia, thrombocytopenia, and anemia).(1,2) CLINICAL EFFECTS: Concurrent use of ribavirin and azathioprine may increase the risk of severe pancytopenia, bone marrow suppression, and azathioprine-related myelotoxicity. Pancytopenia and/or bone marrow suppression has typically developed within 3 to 7 weeks after initiation of concurrent therapy and has reversed within 4 to 6 weeks of withdrawing concurrent therapy.(1,2) PREDISPOSING FACTORS: Concurrent use of interferon may make the interaction more severe and/or likely.(1) Patients with reduced or absent thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) activity are at higher risk of accumulating thiopurine metabolites and severe myelosuppression. Approximately 0.3 % of patients of European, Latino, or African descent have mutations of the TPMT gene resulting in little to no TPMT activity (homozygous deficiency), and approximately 10 % have intermediate TPMT activity (heterozygous deficiency). NUDT15 deficiency is not seen in patients of African descent and is seen in less than 1 % of patients of European descent. Approximately 1 % of patients of East Asian descent, 0.5 % of patients of central/south Asian descent, and 2 % of patients of Latino descent have homozygous NUDT15 deficiency. About 17 % of patients of East Asian descent, 13 % of patients of central/south Asian descent, and 8 % of patients of Latino descent have heterozygous NUDT15 deficiency.(3) PATIENT MANAGEMENT: Patients receiving concurrent azathioprine and ribavirin should have complete blood counts, including platelet counts, weekly during the first month of therapy, then twice monthly for the second and third months of treatment, then monthly or more frequently if therapy changes are made.(1,2) If pancytopenia develops, discontinue concurrent therapy and do not reintroduce concurrent therapy.(1) The UK manufacturer of mercaptopurine states that concomitant administration of ribavirin and mercaptopurine is not advised.(7) DISCUSSION: Pancytopenia, bone marrow suppression, and azathioprine-related myelotoxicity have been reported with concurrent use of azathioprine and ribavirin.(1,2,4-6) Pancytopenia and/or bone marrow suppression has typically developed within 3 to 7 weeks after initiation of concurrent therapy and has reversed within 4 to 6 weeks of withdrawing concurrent therapy.(1) |
AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, IMURAN, MERCAPTOPURINE, PURIXAN |
The following contraindication information is available for RIBAVIRIN (ribavirin):
Drug contraindication overview.
Oral Ribavirin *Known hypersensitivity (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to ribavirin or any ingredient in the formulation (capsules). *Women who are or may become pregnant. *Male partners of pregnant women.
*Hemoglobinopathies (e.g., thalassemia major, sickle cell anemia). *Creatinine clearance <50 mL/minute (capsules). *Autoimmune hepatitis (ribavirin capsules; ribavirin tablets and peginterferon alfa-2a combination therapy).
*Use of ribavirin tablets and peginterferon alfa-2a combination therapy in cirrhotic patients with chronic hepatitis C virus (HCV) monoinfection (without coexisting human immunodeficiency virus (HIV) infection) who have hepatic decompensation (Child-Pugh score >6; class B and C) prior to treatment. *Use of ribavirin tablets and peginterferon alfa-2a combination therapy in cirrhotic patients with chronic HCV infection who are coinfected with HIV and have hepatic decompensation (Child-Pugh score >=6) prior to treatment. Ribavirin Nasal and Oral Inhalation *Known hypersensitivity to ribavirin or any ingredient in the formulation. *Women who are or may become pregnant.
Oral Ribavirin *Known hypersensitivity (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to ribavirin or any ingredient in the formulation (capsules). *Women who are or may become pregnant. *Male partners of pregnant women.
*Hemoglobinopathies (e.g., thalassemia major, sickle cell anemia). *Creatinine clearance <50 mL/minute (capsules). *Autoimmune hepatitis (ribavirin capsules; ribavirin tablets and peginterferon alfa-2a combination therapy).
*Use of ribavirin tablets and peginterferon alfa-2a combination therapy in cirrhotic patients with chronic hepatitis C virus (HCV) monoinfection (without coexisting human immunodeficiency virus (HIV) infection) who have hepatic decompensation (Child-Pugh score >6; class B and C) prior to treatment. *Use of ribavirin tablets and peginterferon alfa-2a combination therapy in cirrhotic patients with chronic HCV infection who are coinfected with HIV and have hepatic decompensation (Child-Pugh score >=6) prior to treatment. Ribavirin Nasal and Oral Inhalation *Known hypersensitivity to ribavirin or any ingredient in the formulation. *Women who are or may become pregnant.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 0 severe contraindications.
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Anemia |
| Asthma |
| Chronic obstructive pulmonary disease |
The following adverse reaction information is available for RIBAVIRIN (ribavirin):
Adverse reaction overview.
The most common adverse effects in adults (>=40%) receiving ribavirin capsule plus peginterferon alfa-2b (PegIntron(R)) or interferon alfa-2b (Intron(R) A) combination therapy were injection site reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia and anxiety/emotional lability/irritability. Hemolytic anemia occurred in >10% of adults receiving ribavirin capsule plus peginterferon alfa-2b or interferon alfa-2b combination therapy. The most common adverse effects (greater than 25%) in pediatric patients receiving ribavirin capsule plus peginterferon alfa-2b or interferon alfa-2b combination therapy were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, and vomiting.
The most common adverse effects (frequency >40%) in adults receiving ribavirin tablet plus peginterferon alfa-2a (Pegasys(R)) combination therapy were fatigue/asthenia, pyrexia, myalgia, and headache. The most common adverse effects in pediatric patients were similar to those seen in adults. Information on adverse effects of ribavirin inhalation therapy has been obtained principally from clinical studies conducted prior to 1986, from a controlled study conducted in 1989-1990, and from postmarketing surveillance reports. The most common adverse effects associated with inhalation of the drug appear to include respiratory and cardiovascular effects.
The most common adverse effects in adults (>=40%) receiving ribavirin capsule plus peginterferon alfa-2b (PegIntron(R)) or interferon alfa-2b (Intron(R) A) combination therapy were injection site reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia and anxiety/emotional lability/irritability. Hemolytic anemia occurred in >10% of adults receiving ribavirin capsule plus peginterferon alfa-2b or interferon alfa-2b combination therapy. The most common adverse effects (greater than 25%) in pediatric patients receiving ribavirin capsule plus peginterferon alfa-2b or interferon alfa-2b combination therapy were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, and vomiting.
The most common adverse effects (frequency >40%) in adults receiving ribavirin tablet plus peginterferon alfa-2a (Pegasys(R)) combination therapy were fatigue/asthenia, pyrexia, myalgia, and headache. The most common adverse effects in pediatric patients were similar to those seen in adults. Information on adverse effects of ribavirin inhalation therapy has been obtained principally from clinical studies conducted prior to 1986, from a controlled study conducted in 1989-1990, and from postmarketing surveillance reports. The most common adverse effects associated with inhalation of the drug appear to include respiratory and cardiovascular effects.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Dyspnea |
None. |
| Rare/Very Rare |
|---|
|
Apnea Bradycardia Bronchospastic pulmonary disease Cardiac arrest Cyanosis Hypotension Hypoventilation Pneumonia Pneumothorax Pulmonary edema |
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Conjunctivitis Skin rash |
The following precautions are available for RIBAVIRIN (ribavirin):
Safety and efficacy of aerosolized ribavirin (ribavirin nasal and oral inhalation) have been established for treatment of RSV infection in infants and young children. Safety and efficacy of ribavirin tablets have not been established for treatment of chronic HCV infection in children younger than 5 years of age. Pharmacokinetic evaluations in pediatric patients have not been performed.
Safety and efficacy of ribavirin capsules in conjunction with peginterferon alfa-2b (PegIntron(R)) have not been established for treatment of chronic HCV infection in children younger than 3 years of age. When deciding whether to use ribavirin capsules in conjunction with interferon alfa-2b (Intron(R) A) in HCV-infected children, evidence of disease progression (e.g., hepatic inflammation, fibrosis), prognostic factors for response, HCV genotype, and viral load should be considered. The benefits of such treatment should be weighed against adverse effects reported in pediatric patients.
Suicidal ideation or attempts occurred more frequently in pediatric patients (2.4%) than in adults (1%) during or after therapy; most of these children were adolescents. Like adults, other adverse psychiatric effects (e.g., depression, emotional lability, somnolence), anemia, and neutropenia were also reported in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy of ribavirin capsules in conjunction with peginterferon alfa-2b (PegIntron(R)) have not been established for treatment of chronic HCV infection in children younger than 3 years of age. When deciding whether to use ribavirin capsules in conjunction with interferon alfa-2b (Intron(R) A) in HCV-infected children, evidence of disease progression (e.g., hepatic inflammation, fibrosis), prognostic factors for response, HCV genotype, and viral load should be considered. The benefits of such treatment should be weighed against adverse effects reported in pediatric patients.
Suicidal ideation or attempts occurred more frequently in pediatric patients (2.4%) than in adults (1%) during or after therapy; most of these children were adolescents. Like adults, other adverse psychiatric effects (e.g., depression, emotional lability, somnolence), anemia, and neutropenia were also reported in pediatric patients.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Ribavirin may cause fetal toxicity and/or death based on findings from animal studies. The drug has been shown to be teratogenic and/or embryocidal in almost all animal species tested to date at dosages well below the recommended human dosage. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and GI tract have been reported in animal studies.
The incidence and severity of teratogenic effects increase with increasing dosage. Survival of fetuses and offspring was reduced. Data from the ribavirin pregnancy registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes in humans.
Oral ribavirin is contraindicated in women who are or may become pregnant and also is contraindicated in male partners of such women. Extreme care should be exercised to avoid pregnancy in female patients receiving ribavirin and in female partners of male patients receiving ribavirin. Based on a multiple-dose ribavirin half-life of 12 days, the drug may persist in nonplasma compartments for as long as 6 months (e.g., 15 half-lives of clearance for ribavirin).
If ribavirin is inadvertently administered during pregnancy or pregnancy occurs, inform the patient of the potential hazard to the fetus. Oral ribavirin should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiating therapy. Perform periodic pregnancy testing during treatment with ribavirin capsules and during the 9-month period after treatment discontinuation.
Perform pregnancy testing monthly during therapy with ribavirin tablets and for 6 months after treatment discontinuation. Advise female patients of reproductive potential to use effective contraception during treatment with ribavirin capsules and for 9 months after treatment discontinuation. Advise male patients and their female partners of reproductive potential to use effective contraception during treatment with ribavirin capsules and for 6 months after treatment discontinuation.
Advise female patients of reproductive potential and male patients and their female partners of reproductive potential to use >=2 forms of effective contraception during treatment with ribavirin tablets and for 6 months after treatment discontinuation. Ribavirin nasal and oral inhalation is contraindicated in women who are or may become pregnant. Because of animal evidence of the drug's teratogenic potential, hospitals are encouraged to perform training programs to minimize potential occupational exposure to ribavirin.
Health-care personnel who are pregnant should consider avoiding direct care of patients being treated with aerosolized ribavirin. If close patient contact cannot be avoided, precautions to limit exposure should be taken. Refer to the National Institute for Occupational Safety and Health (NIOSH) recommendations for hazardous drugs for additional information to minimize environmental exposures.
The incidence and severity of teratogenic effects increase with increasing dosage. Survival of fetuses and offspring was reduced. Data from the ribavirin pregnancy registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes in humans.
Oral ribavirin is contraindicated in women who are or may become pregnant and also is contraindicated in male partners of such women. Extreme care should be exercised to avoid pregnancy in female patients receiving ribavirin and in female partners of male patients receiving ribavirin. Based on a multiple-dose ribavirin half-life of 12 days, the drug may persist in nonplasma compartments for as long as 6 months (e.g., 15 half-lives of clearance for ribavirin).
If ribavirin is inadvertently administered during pregnancy or pregnancy occurs, inform the patient of the potential hazard to the fetus. Oral ribavirin should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiating therapy. Perform periodic pregnancy testing during treatment with ribavirin capsules and during the 9-month period after treatment discontinuation.
Perform pregnancy testing monthly during therapy with ribavirin tablets and for 6 months after treatment discontinuation. Advise female patients of reproductive potential to use effective contraception during treatment with ribavirin capsules and for 9 months after treatment discontinuation. Advise male patients and their female partners of reproductive potential to use effective contraception during treatment with ribavirin capsules and for 6 months after treatment discontinuation.
Advise female patients of reproductive potential and male patients and their female partners of reproductive potential to use >=2 forms of effective contraception during treatment with ribavirin tablets and for 6 months after treatment discontinuation. Ribavirin nasal and oral inhalation is contraindicated in women who are or may become pregnant. Because of animal evidence of the drug's teratogenic potential, hospitals are encouraged to perform training programs to minimize potential occupational exposure to ribavirin.
Health-care personnel who are pregnant should consider avoiding direct care of patients being treated with aerosolized ribavirin. If close patient contact cannot be avoided, precautions to limit exposure should be taken. Refer to the National Institute for Occupational Safety and Health (NIOSH) recommendations for hazardous drugs for additional information to minimize environmental exposures.
Ribavirin has been shown to be toxic to lactating animals and their offspring. It is not known whether ribavirin is distributed into human milk following nasal/oral inhalation or oral administration. There are no data on the effects of ribavirin on the breast-fed infant or on milk production.
Because of the potential for serious adverse reactions to oral ribavirin in nursing infants, a decision should be made whether to discontinue nursing or discontinue ribavirin therapy, taking into account the importance of the drug to the woman. The benefits of breast-feeding should be considered along with the mother's clinical need for ribavirin and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Because of the potential for serious adverse reactions to oral ribavirin in nursing infants, a decision should be made whether to discontinue nursing or discontinue ribavirin therapy, taking into account the importance of the drug to the woman. The benefits of breast-feeding should be considered along with the mother's clinical need for ribavirin and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Clinical studies of oral ribavirin used in conjunction with interferon therapy did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In clinical trials, geriatric patients had a higher frequency of anemia (67%) than did younger patients (28%). Pharmacokinetic evaluations for ribavirin in geriatric patients have not been performed.
Because ribavirin is known to be substantially excreted by the kidney, patients with renal impairment are at increased risk of ribavirin-induced toxicity; geriatric patients frequently have decreased renal function, and renal function should be monitored closely and dosage adjusted accordingly. Ribavirin capsules should be used with caution in geriatric patients, usually initiating therapy at the lower end of the usual dosage range to reflect the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in this population.
Because ribavirin is known to be substantially excreted by the kidney, patients with renal impairment are at increased risk of ribavirin-induced toxicity; geriatric patients frequently have decreased renal function, and renal function should be monitored closely and dosage adjusted accordingly. Ribavirin capsules should be used with caution in geriatric patients, usually initiating therapy at the lower end of the usual dosage range to reflect the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in this population.
The following prioritized warning is available for RIBAVIRIN (ribavirin):
WARNING: Caution is advised when using this medication in people who are using a certain breathing device (ventilator). Read and follow the manufacturer's directions for use and care of the ventilator. Follow all directions from the manufacturer to prevent particle buildup in the device.
Doing so will help the device work properly and may prevent serious side effects (such as air pressure buildup inside the lungs). Rarely, sudden worsening of breathing problems may occur, especially when this medication is first started. If this occurs, treatment should be stopped. If you and the doctor decide to restart ribavirin treatment, the doctor will monitor closely to decrease the risk of side effects.
WARNING: Caution is advised when using this medication in people who are using a certain breathing device (ventilator). Read and follow the manufacturer's directions for use and care of the ventilator. Follow all directions from the manufacturer to prevent particle buildup in the device.
Doing so will help the device work properly and may prevent serious side effects (such as air pressure buildup inside the lungs). Rarely, sudden worsening of breathing problems may occur, especially when this medication is first started. If this occurs, treatment should be stopped. If you and the doctor decide to restart ribavirin treatment, the doctor will monitor closely to decrease the risk of side effects.
The following icd codes are available for RIBAVIRIN (ribavirin)'s list of indications:
| Respiratory syncytial virus infection | |
| B97.4 | Respiratory syncytial virus as the cause of diseases classified elsewhere |
| J12.1 | Respiratory syncytial virus pneumonia |
| J20.5 | Acute bronchitis due to respiratory syncytial virus |
| J21.0 | Acute bronchiolitis due to respiratory syncytial virus |
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