United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (peginterferon alfa-2b - unii:g8rgg88b68) - peginterferon alfa-2b 40 ug in 0.1 ml - sylatron™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. sylatron is contraindicated in patients with: - a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b - autoimmune hepatitis - hepatic decompensation (child-pugh score >6 [class b and c]) risk summary based on findings from animal studies, sylatron can cause embryo-fetal harm when administered to a pregnant woman. available human data with sylatron use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than the recommended dose of 6 mcg/kg/week (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - peginterferon alfa-2b (unii: g8rgg88b68) (interferon alfa-2b - unii:43k1w2t1m6) - peginterferon alfa-2b 50 ug in 0.5 ml - pegintron® , as part of a combination regimen, is indicated for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease. - pegintron in combination with ribavirin and an approved hepatitis c virus (hcv) ns3/4a protease inhibitor is indicated in adult patients with hcv genotype 1 infection (see labeling of the specific hcv ns3/4a protease inhibitor for further information). - pegintron in combination with ribavirin is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an hcv ns3/4a protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. pegintron monotherapy should only be used in the treatment of chc in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. combination therapy provides substantially better respons

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - ribavirin - capsules - ribavirin 200 mg - ribavirin - ribavirin - tritherapy:rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis c (chc) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.bitherapy:rebetol is indicated for the treatment of chronic hepatitis c virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b .rebetol monotherapy must not be used. there is no safety or efficacy information on the use of rebetol with other forms of interferon (i.e., not alfa-2b).previously untreated (naïve) patientsadult patients (18 years of age or older): rebetol is indicated for:• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis c genotype1 infection with compensated liver disease.• bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, fo

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) are indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10), and use in specific populations (8.4)]. the following points should be considered when initiating ribavirin capsules combination therapy with pegintron® or intron a® : - combination therapy with ribavirin capsules/pegintron is preferred over ribavirin capsules/intron a as this combination provides substantially better response rates [see clinical studies (14)]. - patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see clinical studies (14)]. - no safety and efficacy data are available for treatment duration lasting longer than one year.     ribavirin capsules combination therapy is contraindicated in: - pregnancy. ribavirin capsules may cause fetal harm when administered to a pregnant woman. ribavirin capsules are contraindicated in women who are pregnant or planning to become pregnant. if a patient becomes pregnant while taking ribavirin capsules, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.1) , and use in specific populations (8.1, 8.3)]. - men whose female partners are pregnant [see use in specific populations (8.3)] - patients with known hypersensitivity reactions such as stevens-johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product - patients with autoimmune hepatitis - patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) - patients with creatinine clearance less than 50 ml/min [see clinical pharmacology (12.3)] - when coadministered with didanosine because exposure to the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) is increased. fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis, has been reported in patients receiving didanosine in combination with ribavirin [see drug interactions (7.1)].    risk summary ribavirin is contraindicated for use in pregnant women and in men whose female partners are pregnant [see contraindications (4)] . based on animal data, ribavirin use in pregnancy may be associated with birth defects. data from the ribavirin pregnancy registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. in animal studies, ribavirin exposure was shown to have teratogenic and/or embryocidal effects (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2 to 4% and 15 to 20%, respectively. data human data available data from the ribavirin pregnancy registry on 88 live births from pregnancies in women directly exposed and 98 live births from pregnancies in women indirectly exposed (by a male partner) to ribavirin during pregnancy or during the 6 months prior to pregnancy show a higher rate of birth defects (9.09% and 6.12%, respectively) compared to a background birth defect rate of 2.72% in the metropolitan atlanta congenital defects program (macdp) birth defects surveillance system. no pattern of birth defects can be identified from these reports. the miscarriage rate was approximately 21%. the current sample size is insufficient for reaching definitive conclusions based on statistical analysis. trends suggesting a common etiology or relationship with ribavirin exposure were not observed. methodologic limitations of the ribavirin pregnancy registry include the use of macdp as the external comparator group. limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease and comorbidities. animal data embryotoxicity/teratogenicity studies with ribavirin were conducted in rats (oral doses of 0.3, 1 and 10 mg/kg on gestation days 6 to 15) and rabbits (oral dose of 0.1, 0.3 and 1 mg/kg on gestation days 6 to 18). ribavirin demonstrated significant embryocidal and teratogenic effects at doses well below the recommended human dose in all animal species in which adequate studies have been conducted. malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. the incidence and severity of teratogenic effects increased with escalation of the drug dose. survival of fetuses and offspring was reduced [see contraindications (4) and warnings and precautions (5.1)]. risk summary there are no data on the presence of ribavirin in human milk or the effects on the breastfed infant or milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ribavirin and any potential adverse effects on the breastfed infant from ribavirin or from the underlying maternal condition. ribavirin may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of treatment. patients should have periodic pregnancy tests during treatment and during the 9-month period after treatment has been stopped [see warnings and precautions (5.1)]. contraception female patients of reproductive potential should use effective contraception during treatment and for 9 months post-therapy. male patients and their female partners should use effective contraception during treatment with ribavirin and for the 6-month post-therapy period [see warnings and precautions (5.1)] . infertility based on animal data, ribavirin may impair male fertility. in animal studies, these effects were mostly reversible within a few months after drug cessation [see nonclinical toxicology (13.1)] .     safety and effectiveness of ribavirin in combination with pegintron has not been established in pediatric patients below the age of 3 years. for treatment with ribavirin/intron a, evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load should be considered when deciding to treat a pediatric patient. the benefits of treatment should be weighed against the observed safety findings. long-term follow-up data in pediatric subjects indicates that ribavirin in combination with pegintron or with intron a may induce a growth inhibition that results in reduced height in some patients [see warnings and precautions (5.9) and adverse reactions (6.1)] . suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% vs. 1%) during treatment and off-therapy follow-up [see warnings and precautions (5.10)]. as in adult patients, pediatric patients experienced other psychiatric adverse reactions (e.g., depression, emotional lability, somnolence), anemia, and neutropenia [see warnings and precautions (5.2) ]. juvenile animal toxicity data in a study in which rat pups were dosed postnatally with ribavirin at doses of 10, 25, and 50 mg/kg/day, drug-related deaths occurred at 50 mg/kg (at rat pup plasma concentrations below human plasma concentrations at the human therapeutic dose) between study days 13 and 48. rat pups dosed from postnatal days 7 through 63 demonstrated a minor, dose-related decrease in overall growth at all doses, which was subsequently manifested as slight decreases in body weight, crown-rump length, and bone length. these effects showed evidence of reversibility, and no histopathological effects on bone were observed. no ribavirin effects were observed regarding neurobehavioral or reproductive development. clinical trials of ribavirin combination therapy did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. ribavirin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients often have decreased renal function, care should be taken in dose selection. renal function should be monitored and dosage adjustments made accordingly. ribavirin should not be used in patients with creatinine clearance less than 50 ml/min [see contraindications (4)] . in general, ribavirin capsules should be administered to elderly patients cautiously, starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic and cardiac function, and of concomitant disease or other drug therapy. in clinical trials, elderly subjects had a higher frequency of anemia (67%) than younger patients (28%) [see warnings and precautions (5.2)].   the safety and efficacy of intron a and pegintron alone or in combination with ribavirin for the treatment of hepatitis c in liver or other organ transplant recipients have not been established. in a small (n=16) single-center, uncontrolled case experience, renal failure in renal allograft recipients receiving interferon alpha and ribavirin combination therapy was more frequent than expected from the center’s previous experience with renal allograft recipients not receiving combination therapy. the relationship of the renal failure to renal allograft rejection is not clear. the safety and efficacy of pegintron/ribavirin and intron a/ribavirin for the treatment of patients with hcv co-infected with hiv or hbv have not been established.

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10), and use in specific populations (8.4)]. the following points should be considered when initiating ribavirin capsules combination therapy with pegintron® or intron a® : - combination therapy with ribavirin /pegintron is preferred over ribavirin /intron a as this combination provides substantially better response rates [see clinical studies (14) ]. - patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see clinical studies (14) ]. - no safety and efficacy data are available for treatment duration lasting longer than

United States - English - NLM (National Library of Medicine)

richmond pharmaceuticals, inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10) , and use in specific populations (8.4) ]. the following points should be considered when initiating ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b: ribavirin combination therapy is contraindicated in: pregnancy category x [see contraindications (4), warnings and precautions (5.1), and nonclinical toxicology (13.1) ]. treatment and posttreatment potential risk to the fetus ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. it is not known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova. in a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (estimat

European Union - English - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin teva is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).naïve patients adult patients ribavirin teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for hepatitis c viral ribonucleic acid hcv-rna.paediatric patients (children 3 years of age and older and adolescents) ribavirin teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis.previous treatment failure patientsadult patients ribavirin teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin biopartners is indicated for the treatment of chronic hepatitis-c-virus (hcv) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. ribavirin monotherapy must not be used. there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).naïve patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for hepatitis c viral ribonucleic acid (hcv-rna) (see section 4.4)children three years of age and older and adolescentsribavirin biopartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for hcv-rna.when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).previous-treatment-failure patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).

United States - English - NLM (National Library of Medicine)

genentech, inc. - peginterferon alfa-2a (unii: q46947fe7k) (peginterferon alfa-2a - unii:q46947fe7k) - peginterferon alfa-2a 180 ug in 1 ml - adult patients: pegasys, as part of a combination regimen with other hepatitis c virus (hcv) antiviral drugs, is indicated for the treatment of adults with chc and compensated liver disease. for information about the safe and effective use of other hcv antiviral drugs to be used in combination with pegasys, refer to their prescribing information. pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. pediatric patients: pegasys in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with chc and compensated liver disease. limitations of use : - pegasys alone or in combination with ribavirin without additional hcv antiviral drugs is not recommended for treatment of patients with chc who previously failed therapy with an interferon-alfa. - pegasys is not recommended for treatment of patients with chc who have had solid

European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum hcv rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case-by-case basis (see section 4.4).previously treatment-failure patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.