Ribasphere
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Questions & Answers
Side Effects & Adverse Reactions
Based on results of clinical trials ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection; therefore, RIBASPHERE® (Ribavirin capsules) must not be used alone. The safety and efficacy of ribavirin capsules have only been established when used together with INTRON A (interferon alfa-2b, recombinant) as a combination therapy or with PEG-INTRON (peginterferon alfa-2b, recombinant) Injection.
There are significant adverse events caused by ribavirin/INTRON A or PEG-INTRON therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up. The INTRON A and PEG-INTRON package inserts should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.
RIBASPHERE® (Ribavirin capsules) may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. RIBASPHERE® (Ribavirin capsules) has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. RIBAVIRIN THERAPY SHOULD NOT BE STARTED UNTIL A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO PLANNED INITIATION OF THERAPY. Patients should be instructed to use at least two forms of effective contraception during treatment and during the six month period after treatment has been stopped based on multiple dose half-life of ribavirin of 12 days. Pregnancy testing should occur monthly during ribavirin therapy and for six months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS:Information for Patients and Pregnancy Category X).
The primary toxicity of ribavirin is hemolytic anemia, which was observed in approximately 10% of ribavirin/INTRON A-treated patients in clinical trials (See ADVERSE REACTIONS laboratory values – Hemoglobin). The anemia associated with RIBASPHERE® (Ribavirin capsules) occurs within 1 to 2 weeks of initiation of therapy. BECAUSE THE INITIAL DROP IN HEMOGLOBIN MAY BE SIGNIFICANT, IT IS ADVISED THAT HEMOGLOBIN OR HEMATOCRIT BE OBTAINED PRETREAMENT AND AT WEEK 2 AND WEEK 4 OF THERAPY, OR MORE FREQUENTLY IF CLINICALLY INDICATED. Patients should then be followed as clinically appropriate.
Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin. Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued. (See DOSAGE AND ADMINISTRATION: Guidelines for Dose Modification.) Because cardiac disease may be worsened by drug induced anemia, patients with a history of significant or unstable cardiac disease should not use ribavirin. (See ADVERSE REACTIONS.)
Ribavirin and INTRON A or PEG-INTRON therapy should be suspended in patients with signs and symptoms of pancreatitis and discontinued in patients with confirmed pancreatitis.
Ribavirin should not be used in patients with creatinine clearance <50 mL/min. (See CLINICAL PHARMACOLOGY, Special Populations.)
Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, have been reported during therapy with ribavirin/INTRON A; occasional cases of fatal pneumonia have occurred. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported. If there is evidence of pulmonary infiltrates or pulmonary function impairment, the patient should be closely monitored, and if appropriate, combination ribavirin/INTRON A treatment should be discontinued.
Dental and periodontal disorders have been reported in patients receiving ribavirin and interferon or peginterferon combination therapy. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of ribavirin and interferon alfa-2b or pegylated interferon alfa-2b. Patients should brush their teeth thoroughly twice daily and have regular dental examinations. In addition, some patients may experience vomiting. If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RIBASPHERE® (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 and in patients 18 years of age and older who have relapsed following alpha interferon therapy.
RIBASPHERE® (Ribavirin capsules) are indicated in combination with PEG-INTRON (peginterferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.
The safety and efficacy of RIBASPHERE® (Ribavirin capsules) with interferons other than INTRON A or PEG-INTRON products have not been established.
History
There is currently no drug history available for this drug.
Other Information
RIBASPHERE® (Ribavirin capsules) is Three Rivers Pharmaceuticals’ brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-ß-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:
Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21.
RIBASPHERE® (Ribavirin capsules) consist of white pellets in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients: Croscarmellose Sodium, NF; Lactose Monohydrate, NF; Microcrystalline Cellulose, NF; and Povidone, USP. The capsule shell consists of gelatin and titanium dioxide. The capsule is printed horizontally with "riba 200" on both the body and the cap of the capsule using edible, green pharmaceutical ink which is made of Butyl Alcohol, NF; Yellow Iron Oxide, NF; Dehydrated Alcohol, USP; FD&C Blue #2 Aluminum Lake; Isopropyl Alcohol, USP; Propylene Glycol, USP; Shellac, NF; Strong Ammonia Solution, NF; and Titanium Dioxide.
The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy with ribavirin and interferon products has not been established.
Sources
Ribasphere Manufacturers
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Three Rivers Pharmaceuticals, Llc
![Ribasphere (Ribavirin) Capsule [Three Rivers Pharmaceuticals, Llc ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ribasphere | Three Rivers Pharmaceuticals, Llc
(see CLINICAL PHARMACOLOGY, SPECIAL POPULATIONS; see WARNINGS)
Ribavirin/INTRON A Combination Therapy AdultsThe recommended dose of RIBASPHERE® (Ribavirin capsules) in patients 18 years of age and older depends on the patient’s body weight. The recommended dose of ribavirin is provided in TABLE 9.
The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen. (See Description of Clinical Studies and ADVERSE REACTIONS.) After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.
In patients who relapse following non-pegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient population.
TABLE 9. Recommended Dosing for Patients 18 years of age and older Body Weight RIBASPHERE® (Ribavirin capsules) <75 kg 2 times 200 mg capsules AM,
3 times 200 mg capsules PM
daily p.o. >75 kg 3 times 200 mg capsules AM,
3 times 200 mg capsules PM
daily p.o.Ribavirin may be administered without regard to food, but should be administered in a consistent manner with respect to food intake. (See CLINICAL PHARMACOLOGY.)
RIBASPHERE® (Ribavirin capsules)/PEG-INTRON Combination TherapyThe recommended dose of RIBASPHERE® (Ribavirin, capsules) is 800 mg/day in 2 divided doses: two capsules (400 mg) in the morning with food and two capsules (400 mg) in the evening with food.
Dose Modifications (TABLE 10)If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/INTRON A therapy the dose should be modified, or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin/INTRON A therapy should be discontinued.
Ribavirin should not be used in patients with creatinine clearance <50 mL/min. Subjects with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to development of anemia. (See WARNINGS and CLINICAL PHARMACOLOGY, Special Populations.)
Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped. (See WARNINGS.)
For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by >2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains <12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination ribavirin/INTRON A therapy.
It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin dose reduced to 600 mg daily (1 times 200 mg capsule AM, 2 times 200 mg capsules PM) for adults. A patient whose hemoglobin level falls below 8.5 g/dL should be permanently discontinued from ribavirin therapy. (See WARNINGS.)
TABLE 10. Guidelines for Dose Modifications and Discontinuation for Anemia Dose Reduction
Ribavirin – 600 mg daily adults Permanent Discontinuation of
Ribavirin Treatment Hemoglobin
No Cardiac History
<10 g/dL
<8.5 g/dL Cardiac History Patients >2 g/dL decrease during any 4-week period during treatment <12 g/dL after 4 weeks of dose reduction -
Remedyrepack Inc.
Ribasphere | Remedyrepack Inc.
CHC Monoinfection
The recommended dose of RIBASPHERE (ribavirin, USP) tablets is provided in Table 4. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.
The daily dose of RIBASPHERE (ribavirin, USP) is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 4).
In the pivotal clinical trials, patients were instructed to take ribavirin with food; therefore, patients are advised to take RIBASPHERE (ribavirin, USP) with food.
Table 4 Peginterferon alfa-2a and RIBASPHERE (ribavirin, USP) Dosing Recommendations
GenotypePeginterferon alfaDoseRIBASPHERE (ribavirin, USP) DoseDurationGenotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.Genotypes 1, 4180<75 kg = 1000 mg48 weekskg = 1200 mg48 weeksGenotypes 2, 3180800 mg24 weeks
Dose Modifications
If severe adverse reactions or laboratory abnormalities develop during combination RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a therapy should be discontinued.
RIBASPHERE (ribavirin, USP) should be administered with caution to patients with pre-existing cardiac disease (see Table 5). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).
Table 5 RIBASPHERE (ribavirin, USP) Dosage Modification Guidelines
* One 200 mg tablet in the morning and either two 200 mg tablets or one 400 mg tablet in the evening.Laboratory ValuesReduce Only RIBASPHERE (ribavirin, USP) Dose to 600 mg/day* if:Discontinue RIBASPHERE (ribavirin, USP) if:Hemoglobin in patients with no cardiac disease<10 g/dL<8.5 g/dLHemoglobin in patients with history of stable cardiac diseaseg/dL decrease in hemoglobin during any 4 week period treatment<12 g/dL despite 4 weeks at reduced doseOnce RIBASPHERE (ribavirin, USP) has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart RIBASPHERE (ribavirin, USP) at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that RIBASPHERE (ribavirin, USP) be increased to its original assigned dose (1000 mg to 1200 mg).
Renal Impairment
RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance <50 mL/min (see WARNINGSand CLINICAL PHARMACOLOGY: Special Populations).
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Remedyrepack Inc.
Ribasphere | Remedyrepack Inc.
CHC Monoinfection
The recommended dose of RIBASPHERE (ribavirin, USP) tablets is provided in Table 4. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.
The daily dose of RIBASPHERE (ribavirin, USP) is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 4).
In the pivotal clinical trials, patients were instructed to take ribavirin with food; therefore, patients are advised to take RIBASPHERE (ribavirin, USP) with food.
Table 4 Peginterferon alfa-2a and RIBASPHERE (ribavirin, USP) Dosing Recommendations
GenotypePeginterferon alfaDoseRIBASPHERE (ribavirin, USP) DoseDurationGenotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.Genotypes 1, 4180<75 kg = 1000 mg48 weekskg = 1200 mg48 weeksGenotypes 2, 3180800 mg24 weeks
Dose Modifications
If severe adverse reactions or laboratory abnormalities develop during combination RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a therapy should be discontinued.
RIBASPHERE (ribavirin, USP) should be administered with caution to patients with pre-existing cardiac disease (see Table 5). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).
Table 5 RIBASPHERE (ribavirin, USP) Dosage Modification Guidelines
* One 200 mg tablet in the morning and either two 200 mg tablets or one 400 mg tablet in the evening.Laboratory ValuesReduce Only RIBASPHERE (ribavirin, USP) Dose to 600 mg/day* if:Discontinue RIBASPHERE (ribavirin, USP) if:Hemoglobin in patients with no cardiac disease<10 g/dL<8.5 g/dLHemoglobin in patients with history of stable cardiac diseaseg/dL decrease in hemoglobin during any 4 week period treatment<12 g/dL despite 4 weeks at reduced doseOnce RIBASPHERE (ribavirin, USP) has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart RIBASPHERE (ribavirin, USP) at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that RIBASPHERE (ribavirin, USP) be increased to its original assigned dose (1000 mg to 1200 mg).
Renal Impairment
RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance <50 mL/min (see WARNINGSand CLINICAL PHARMACOLOGY: Special Populations).
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Kadmon Pharmaceuticals, Llc
Ribasphere | Amneal Pharmaceuticals Of New York, Llc
The recommended dosage for both adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered BID for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg BID. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
Tobramycin inhalation solution, USP is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help the patient breathe through the mouth.
Tobramycin inhalation solution, USP is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop tobramycin inhalation solution, USP therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle.
Tobramycin inhalation solution, USP is supplied as a single-use ampule and is administered by inhalation, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. Tobramycin inhalation solution, USP is not for subcutaneous, intravenous or intrathecal administration.
Usage
Tobramycin inhalation solution, USP is administered by inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. Tobramycin inhalation solution, USP should not be diluted or mixed with dornase alfa (PULMOZYME®, Genentech) or other medications in the nebulizer.
During clinical studies, patients on multiple therapies were instructed to take them first, followed by tobramycin inhalation solution, USP.
![Ribasphere (Ribavirin) Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cf7cf753-b35a-4f04-8dbe-f2cf8e229eec&name=MM2.jpg)
![Ribasphere (Ribavirin) Tablet [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bfab78e9-ca51-4ae7-87fa-924d6ca5608a&name=MM2.jpg)
![Ribasphere (Ribavirin) Capsule [Kadmon Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=15f9c0cd-7dbf-4a91-9961-14f1dd000343&name=tobramycin-inhalation-solution-usp-15.jpg)
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