Ribavirin Capsule while Breastfeeding
Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Ribavirin Capsule ? Know what is Ribavirin Capsule and how it can affect your breast milk and whether Ribavirin Capsule is safe for your kid or not.
What is Ribavirin Capsule used for?
Ribavirin capsules are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy. The safety and efficacy of ribavirin capsules with non-pegylated interferons other than the INTRON A product have not been established. Description of Clinical Studies Ribavirin/INTRON A Combination Therapy Adult Patients Previously Untreated Patients Adults with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who were previously untreated with alpha interferon therapy were enrolled into two multi-center, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A Injection 3 MIU TIW or INTRON A Injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. The International study did not contain a 24-week INTRON A plus placebo treatment arm. The US study enrolled 912 patients who, at baseline, were 67% male, 89% Caucasian with a mean Knodell HAI score (I+II+III) of 7.5, and 72% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 799 patients (65% male, 95% Caucasian, mean Knodell score 6.8, and 58% genotype 1). Study results are summarized in TABLE 2. TABLE 2. Virologic and Histologic Responses: Previously Untreated PatientsNumber (%) of patients. US Study International Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment 48 weeks of treatment INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin (N=265) INTRON A plus Ribavirin (N=268) INTRON A plus Placebo (N=266) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 65 (29) 13 (6) 85 (37) 27 (12) 86 (32) 113 (42) 46 (17) Nonresponder 147 (64) 194 (84) 110 (48) 168 (75) 158 (60) 120 (45) 196 (74) Missing Data 16 (7) 24 (10) 33 (14) 30 (13) 21 (8) 35 (13) 24 (9) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 102 (45) 77 (33) 96 (42) 65 (29) 103 (39) 102 (38) 69 (26) No improvement 77 (34) 99 (43) 61 (27) 93 (41) 85 (32) 58 (22) 111 (41) Missing Data 49 (21) 55 (24) 71 (31) 67 (30) 77 (29) 108 (40) 86 (32) Of patients who had not achieved HCV RNA below the limit of detection of the research based assay by week 24 of ribavirin/INTRON A treatment, less than 5% responded to an additional 24 weeks of combination treatment. Among patients with HCV Genotype 1 treated with ribavirin/INTRON A therapy who achieved HCV RNA below the detection limit of the research-based assay by 24 weeks, those randomized to 48 weeks of treatment had higher virologic responses compared to those in the 24 week treatment group. There was no observed increase in response rates for patients with HCV nongenotype 1 randomized to ribavirin/INTRON A therapy for 48 weeks compared to 24 weeks. Relapse Patients Patients with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who had relapsed following one or two courses of interferon therapy (defined as abnormal serum ALT levels) were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive ribavirin 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A 3 MIU TIW or INTRON A plus placebo for 24 weeks followed by 24 weeks of off-therapy follow-up. The US study enrolled 153 patients who, at baseline, were 67% male, 92% Caucasian with a mean Knodell HAI score (I+II+III) of 6.8, and 58% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 192 patients (64% male, 95% Caucasian, mean Knodell score 6.6, and 56% genotype 1). Study results are summarized in TABLE 3. TABLE 3. Virologic and Histologic Responses: Relapse PatientsNumber (%) of patients. US Study International Study INTRON A plus Ribavirin (N=77) INTRON A plus Placebo (N=76) INTRON A plus Ribavirin (N=96) INTRON A plus Placebo (N=96) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 33 (43) 3 (4) 46 (48) 5 (5) Nonresponder 36 (47) 66 (87) 45 (47) 91 (95) Missing Data 8 (10) 7 (9) 5 (5) 0 (0) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 38 (49) 27 (36) 49 (51) 30 (31) No improvement 23 (30) 37 (49) 29 (30) 44 (46) Missing Data 16 (21) 12 (16) 18 (19) 22 (23) Virologic and histologic responses were similar among male and female patients in both the previously untreated and relapse studies.
INDICATIONS AND USAGE Ribavirin capsules are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy. The safety and efficacy of ribavirin capsules with non-pegylated interferons other than the INTRON A product have not been established. Description of Clinical Studies Previously Untreated Patients Adults with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who were previously untreated with alpha interferon therapy were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A Injection 3 MIU TIW or INTRON A Injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. The International study did not contain a 24-week INTRON A plus placebo treatment arm. The US study enrolled 912 patients who, at baseline, were 67% male, 89% caucasian with a mean Knodell HAI score (I+II+III) of 7.5, and 72% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 799 patients (65% male, 95% caucasian, mean Knodell score 6.8, and 58% genotype 1). Study results are summarized in TABLE 2. TABLE 2. Virologic and Histologic Responses: Previously Untreated PatientsNumber (%) of patients. US Study International Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment 48 weeks of treatment INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin capsules (N=265) INTRON A plus Ribavirin capsules (N=268) INTRON A plus Placebo (N=266) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 65 (29) 13 (6) 85 (37) 27 (12) 86 (32) 113 (42) 46 (17) Nonresponder 147 (64) 194 (84) 110 (48) 168 (75) 158 (60) 120 (45) 196 (74) Missing Data 16 (7) 24 (10) 33 (14) 30 (13) 21 (8) 35 (13) 24 (9) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 102 (45) 77 (33) 96 (42) 65 (29) 103 (39) 102 (38) 69 (26) No improvement 77 (34) 99 (43) 61 (27) 93 (41) 85 (32) 58 (22) 111 (41) Missing Data 49 (21) 55 (24) 71 (31) 67 (30) 77 (29) 108 (40) 86 (32) Of patients who had not achieved HCV RNA below the limit of detection of the research based assay by week 24 of ribavirin capsules/INTRON A treatment, less than 5% responded to an additional 24 weeks of combination treatment. Among patients with HCV genotype 1 treated with ribavirin capsules/INTRON A therapy who achieved HCV RNA below the detection limit of the research-based assay by 24 weeks, those randomized to 48 weeks of treatment had higher virologic responses compared to those in the 24-week treatment group. There was no observed increase in response rates for patients with HCV nongenotype 1 randomized to ribavirin capsules/INTRON A therapy for 48 weeks compared to 24 weeks. Relapse Patients Patients with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research based RT-PCR assay) who had relapsed following one or two courses of interferon therapy (defined as abnormal serum ALT levels) were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A 3 MIU TIW or INTRON A plus placebo for 24 weeks followed by 24 weeks of off-therapy follow-up. The US study enrolled 153 patients who, at baseline, were 67% male, 92% caucasian with a mean Knodell HAI score (I+II+III) of 6.8, and 58% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 192 patients (64% male, 95% caucasian, mean Knodell score 6.6, and 56% genotype 1). Study results are summarized in TABLE 3. TABLE 3. Virologic and Histologic Responses: Relapse PatientsNumber (%) of patients. US Study International Study INTRON A plus Ribavirin capsules (N=77) INTRON A plus Placebo (N=76) INTRON A plus Ribavirin capsules (N=96) INTRON A plus Placebo (N=96) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 33 (43) 3 (4) 46 (48) 5 (5) Nonresponder 36 (47) 66 (87) 45 (47) 91 (95) Missing Data 8 (10) 7 (9) 5 (5) 0 (0) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 38 (49) 27 (36) 49 (51) 30 (31) No improvement 23 (30) 37 (49) 29 (30) 44 (46) Missing Data 16 (21) 12 (16) 18 (19) 22 (23) Virologic and histologic responses were similar among male and female patients in both the previously untreated and relapse studies.
INDICATIONS AND USAGE Ribavirin capsules are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy. The safety and efficacy of ribavirin capsules with non-pegylated interferons other than the INTRON A product have not been established. Description of Clinical Studies Previously Untreated Patients Adults with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) who were previously untreated with alpha interferon therapy were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A Injection 3 MIU TIW or INTRON A Injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. The International study did not contain a 24-week INTRON A plus placebo treatment arm. The US study enrolled 912 patients who, at baseline, were 67% male, 89% caucasian with a mean Knodell HAI score (I+II+III) of 7.5, and 72% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 799 patients (65% male, 95% caucasian, mean Knodell score 6.8, and 58% genotype 1). Study results are summarized in TABLE 2. TABLE 2. Virologic and Histologic Responses: Previously Untreated PatientsNumber (%) of patients. US Study International Study 24 weeks of treatment 48 weeks of treatment 24 weeks of treatment 48 weeks of treatment INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=231) INTRON A plus Ribavirin capsules (N=228) INTRON A plus Placebo (N=225) INTRON A plus Ribavirin capsules (N=265) INTRON A plus Ribavirin capsules (N=268) INTRON A plus Placebo (N=266) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 65 (29) 13 (6) 85 (37) 27 (12) 86 (32) 113 (42) 46 (17) Nonresponder 147 (64) 194 (84) 110 (48) 168 (75) 158 (60) 120 (45) 196 (74) Missing Data 16 (7) 24 (10) 33 (14) 30 (13) 21 (8) 35 (13) 24 (9) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 102 (45) 77 (33) 96 (42) 65 (29) 103 (39) 102 (38) 69 (26) No improvement 77 (34) 99 (43) 61 (27) 93 (41) 85 (32) 58 (22) 111 (41) Missing Data 49 (21) 55 (24) 71 (31) 67 (30) 77 (29) 108 (40) 86 (32) Of patients who had not achieved HCV RNA below the limit of detection of the research based assay by week 24 of ribavirin capsules/INTRON A treatment, less than 5% responded to an additional 24 weeks of combination treatment. Among patients with HCV genotype 1 treated with ribavirin capsules/INTRON A therapy who achieved HCV RNA below the detection limit of the research-based assay by 24 weeks, those randomized to 48 weeks of treatment had higher virologic responses compared to those in the 24-week treatment group. There was no observed increase in response rates for patients with HCV nongenotype 1 randomized to ribavirin capsules/INTRON A therapy for 48 weeks compared to 24 weeks. Relapse Patients Patients with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research based RT-PCR assay) who had relapsed following one or two courses of interferon therapy (defined as abnormal serum ALT levels) were enrolled into two multicenter, double-blind trials (US and International) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus INTRON A 3 MIU TIW or INTRON A plus placebo for 24 weeks followed by 24 weeks of off-therapy follow-up. The US study enrolled 153 patients who, at baseline, were 67% male, 92% caucasian with a mean Knodell HAI score (I+II+III) of 6.8, and 58% genotype 1. The International study, conducted in Europe, Israel, Canada, and Australia, enrolled 192 patients (64% male, 95% caucasian, mean Knodell score 6.6, and 56% genotype 1). Study results are summarized in TABLE 3. TABLE 3. Virologic and Histologic Responses: Relapse PatientsNumber (%) of patients. US Study International Study INTRON A plus Ribavirin capsules (N=77) INTRON A plus Placebo (N=76) INTRON A plus Ribavirin capsules (N=96) INTRON A plus Placebo (N=96) Virologic Response ResponderDefined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period. 33 (43) 3 (4) 46 (48) 5 (5) Nonresponder 36 (47) 66 (87) 45 (47) 91 (95) Missing Data 8 (10) 7 (9) 5 (5) 0 (0) Histologic Response ImprovementDefined as posttreatment (end of follow-up) minus pretreatment liver biopsy Knodell HAI score (I+II+III) improvement of ≥2 points. 38 (49) 27 (36) 49 (51) 30 (31) No improvement 23 (30) 37 (49) 29 (30) 44 (46) Missing Data 16 (21) 12 (16) 18 (19) 22 (23) Virologic and histologic responses were similar among male and female patients in both the previously untreated and relapse studies.
Is Ribavirin Capsule usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?
Ribavirin Capsule contains only one active ingredient that is Ribavirin. We have analyzed the usage of Ribavirin in breastfeeding and our analysis suggest that Ribavirin poses Low risk for infant while breastfeeding and hence Ribavirin Capsule itself shall be considered Low risk item for breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers It is not known whether the ribavirin product is excreted in human milk. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to delay or discontinue ribavirin capsules.
Nursing Mothers It is not known whether ribavirin capsules and INTRON A are excreted in human milk. However, studies in mice have shown that mouse interferons are excreted into the milk. Because of the potential for serious adverse reactions from the drugs in nursing infants, a decision should be made whether to discontinue nursing or to discontinue combination ribavirin capsules/INTRON A therapy, taking into account the importance of the therapy to the mother.
Nursing Mothers It is not known whether the ribavirin product is excreted in human milk. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to delay or discontinue ribavirin capsules.
Nursing Mothers It is not known whether ribavirin capsules and INTRON A are excreted in human milk. However, studies in mice have shown that mouse interferons are excreted into the milk. Because of the potential for serious adverse reactions from the drugs in nursing infants, a decision should be made whether to discontinue nursing or to discontinue combination ribavirin capsules/INTRON A therapy, taking into account the importance of the therapy to the mother.
Ribavirin Capsule Breastfeeding Analsys
Ribavirin while Breastfeeding
Low RiskCAS Number: 36791-04-5
Synthetic drug and nucleoside analogue which is structurally related to guanine with antiviral activity. It is used in infants and newborns for treatment of respiratory syncytial virus (RSV) and adenovirus. Along with interferon for treatment of hepatitis C (authorized on these cases from the 3 years of life). At latest update no published data on excretion into breast milk were found. Its large volume of distribution makes it unlikely that may occur the passage of significant amounts to the milk. Its low oral bioavailability hinder the passage toward infant’s plasma from ingested milk, except in preterm milk and immediate neonatal period, for which there may be an increased intestinal permeability. Since it is used as treatment on infants and its pharmacokinetic data are favorable, it should be regarded as compatible with breastfeeding for short-term exposures, however, to be cautiously used on long-term treatments.
Ribavirin Capsule Breastfeeding Analsys - 2
Ribavirin while Breastfeeding
CAS Number: 36791-04-5
Ribavirin has not been studied in nursing mothers being treated for hepatitis C infection. However, ribavirin is given directly to infants by inhalation to treat respiratory syncytial virus (RSV) infection. The amount in milk is likely to be lower than the doses received by infants treated with ribavirin for RSV infection. Hepatitis C is not transmitted through breastmilk[1][2] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[3][4] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[1][2]
What if I already have used Ribavirin Capsule?
During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Ribavirin Capsule then you shall inform your doctor, But you should not be worried too much as Ribavirin Capsule comes in category of low risk drug.
I am nursing mother and my doctor has suggested me to use Ribavirin Capsule, is it safe?
Though Ribavirin Capsule dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.
If I am using Ribavirin Capsule, will my baby need extra monitoring?
Not much
Who can I talk to if I have questions about usage of Ribavirin Capsule in breastfeeding?
US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week