RIBAVIRIN capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K)

Tersedia dari:

Aurobindo Pharma Limited

INN (Nama Internasional):

RIBAVIRIN

Komposisi:

RIBAVIRIN 200 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Ribavirin Capsules USP, 200 mg are white/white, size ‘1’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on white cap and ‘81’ on white body with black ink.             Bottles of 42                            NDC 65862-290-42             Bottles of 56                            NDC 65862-290-56             Bottles of 70                            NDC 65862-290-70             Bottles of 84                            NDC 65862-290-84             Bottles of 180                          NDC 65862-290-18             Bottles of 500                          NDC 65862-290-05   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Aurobindo Pharma Limited
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MEDICATION GUIDE
Ribavirin (rye” ba vye’ rin) Capsules
What is the most important information I should know about ribavirin
capsules?
1. Ribavirin capsules may cause birth defects, miscarriage or death of
your unborn baby. Do not take
ribavirin capsules if you or your sexual partner is pregnant or plan
to become pregnant.
In females: Do not become pregnant during treatment or within 9 months
after you stop treatment with
ribavirin capsules.
•
Females must have a pregnancy test before starting ribavirin capsules,
during treatment with
ribavirin capsules, and for 9 months after you stop treatment with
ribavirin capsules.
•
You must use effective birth control during treatment and for 9 months
after you stop treatment
with ribavirin capsules.
In males: Your sexual partner should not become pregnant during your
treatment or within 6 months after
you stop treatment with ribavirin capsules. You and your female sexual
partner must use effective birth
control during treatment and for 6 months after you stop treatment
with ribavirin capsules.
Tell your healthcare provider right away if:
•
You become pregnant during treatment or within 9 months after you stop
taking ribavirin
capsules.
•
Your female sexual partner becomes pregnant during your treatment or
within 6 months after you
stop treatment with ribavirin capsules.
2. Ribavirin capsules may cause a significant drop in your red blood
cell count and cause anemia in some
cases. Anemia has been associated with worsening of heart problems,
and in rare cases can cause a heart
attack and death. Tell your healthcare provider if you have ever had
any heart problems. Ribavirin
capsules may not be right for you. Get medical help right away if you
experience chest pain.
3. Do not take ribavirin capsules alone to treat chronic hepatitis C
infection. Ribavirin capsules should be
used in combination with either interferon alfa-2b or peginterferon
alfa-2b to treat chronic hepatitis C
infection.
What are ribavirin capsules?
Ribavirin cap

Karakteristik produk

RIBAVIRIN - RIBAVIRIN CAPSULE
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIBAVIRIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIBAVIRIN
CAPSULES.
RIBAVIRIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: EMBRYO-FETAL TOXICITY, HEMOLYTIC
ANEMIA, AND MONOTHERAPY NOT RECOMMENDED
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SIGNIFICANT TERATOGENIC AND EMBRYOCIDAL EFFECTS HAVE BEEN DEMONSTRATED
IN ALL
ANIMAL SPECIES EXPOSED TO RIBAVIRIN. THEREFORE, RIBAVIRIN THERAPY IS
CONTRAINDICATED
IN WOMEN WHO ARE PREGNANT AND IN THE MALE PARTNERS OF WOMEN WHO ARE
PREGNANT.
AVOID PREGNANCY DURING THERAPY AND FOR 9 MONTHS AFTER COMPLETION OF
TREATMENT IN
FEMALE PATIENTS AND FOR 6 MONTHS IN FEMALE PARTNERS OF MALE PATIENTS
WHO ARE
TAKING RIBAVIRIN THERAPY. (4, 5.1, 8.1, 8.3, 13.1)
THE HEMOLYTIC ANEMIA ASSOCIATED WITH RIBAVIRIN THERAPY MAY RESULT IN
WORSENING OF
CARDIAC DISEASE THAT HAS LED TO FATAL AND NONFATAL MYOCARDIAL
INFARCTIONS. PATIENTS WITH
A HISTORY OF SIGNIFICANT OR UNSTABLE CARDIAC DISEASE SHOULD NOT BE
TREATED WITH RIBAVIRIN.
(2.5, 5.2, 6.1)
RIBAVIRIN MONOTHERAPY IS NOT EFFECTIVE FOR THE TREATMENT OF CHRONIC
HEPATITIS C.
(5.10)
INDICATIONS AND USAGE
Ribavirin capsules are a nucleoside analogue indicated in combination
with interferon alfa-2b (pegylated
and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in
patients 3 years of age or older with
compensated liver disease. (1.1)
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.
DOSAGE AND ADMINISTRATION
Ribavirin capsules are administered according to body weight. (2.1,
2.2, 2.3)
Dose reduction or discontinuation is recommended in patients
experiencing certain adverse reactions or
renal dysfunction. (2.5, 2