Ribasphere Ribapak
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Questions & Answers
Side Effects & Adverse Reactions
RIBASPHERE(ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection. The safety and efficacy of ribavirin have only been established when used together with peginterferon alfa-2a, recombinant.
RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.
There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. The PEGASYS package insert and MEDICATION GUIDE should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.
Treatment with RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy.
Ribavirin 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. Ribavirin 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. RIBASPHERE (ribavirin, USP) THERAPY SHOULD NOT BE STARTED UNLESS 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 for 6 months after treatment has been stopped. Pregnancy testing should occur monthly during RIBASPHERE (ribavirin, USP) therapy and for 6 months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS: Information for Patients and Pregnancy: Category X).
The primary toxicity of ribavirin is hemolytic anemia (hemoglobin <10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials (see PRECAUTIONS: Laboratory Tests). The anemia associated with ribavirin 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 PRETREATMENT 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: RIBASPHERE (ribavirin, USP) Dosage Modification Guidelines). Because cardiac disease may be worsened by drug induced anemia, patients with a history of significant or unstable cardiac disease should not use RIBASPHERE (ribavirin, USP) (see ADVERSE REACTIONS).
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alfa-2a. During treatment, patients’ clinical status and hepatic function should be closely monitored, and peginterferon alfa-2a treatment should be immediately discontinued if decompensation (Child-Pugh score ≥6) is observed (see CONTRAINDICATIONS).
Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been rarely observed during alpha interferon and ribavirin therapy.
If such reaction occurs, therapy with peginterferon alfa-2a and ribavirin should be discontinued and appropriate medical therapy immediately instituted. Serious skin reactions including vesilculobullous eruptions, reactions in the spectrum of Stevens Johnson Syndrome (erythema multiforme major) with varying degrees of skin and mucosal involvement and exfoliative dermatitis (erythroderma) have been rarely reported in the patients receiving peginterferon alfa-2a with and without ribavirin. Patients developing signs or symptoms of severe skin reactions must discontinue therapy. (see ADVERSE REACTIONS: Postmarketing Experience).
Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis and occasional cases of fatal pneumonia, have been reported during therapy with ribavirin and interferon. 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 RIBASPHERE (ribavirin, USP)/peginterferon alfa-2a treatment should be discontinued.
RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.
RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance <50 mL/min (see CLINICAL PHARMACOLOGY: Special Populations).
RIBASPHERE (ribavirin, USP) must be discontinued immediately and appropriate medical therapy instituted if an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops. Transient rashes do not necessitate interruption of treatment.
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, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
History
There is currently no drug history available for this drug.
Other Information
RIBASPHERE (ribavirin, USP), is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:
The molecular formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin is a white to off-white powder. It is freely soluble in water and slightly soluble in anhydrous alcohol.
RIBASPHERE (ribavirin, USP) is available as a blue-colored (shade depending on strength), capsule-shaped, film-coated tablet for oral administration. Each tablet contains 400 mg, or 600 mg of ribavirin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K27-33, magnesium stearate, and purified water. The coating contains partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C blue #1 [brilliant blue FCF aluminum lake], and carnauba wax.
Ribavirin is a synthetic nucleoside analogue. The mechanism by which the combination of ribavirin and an interferon product exerts its effects against the hepatitis C virus has not been fully established.
Sources
Ribasphere Ribapak Manufacturers
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Par Pharmaceutical Companies, Inc.
![Ribasphere Ribapak (Ribavirin) Tablet Ribasphere Ribapak (Ribavirin) Kit [Par Pharmaceutical Companies, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ribasphere Ribapak | Par Pharmaceutical Companies, Inc.
CHC MonoinfectionThe 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 Genotype Peginterferon alfa‑2a Dose RIBASPHERE (ribavirin, USP) Dose DurationGenotypes 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, 4 180 µg <75 kg = 1000 mg 48 weeks ≥75 kg = 1200 mg 48 weeks Genotypes 2, 3 180 µg 800 mg 24 weeks Dose ModificationsIf 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 Values Reduce 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/dL Hemoglobin in patients with history of stable cardiac disease ≥2 g/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 ImpairmentRIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and CLINICAL PHARMACOLOGY: Special Populations).
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Kadmon Pharmaceuticals, Llc
Ribasphere Ribapak | Navarro Discount Pharmacies,llc
When using this product, avoid contact with eyes. In case of contact flush eyes with water.
Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours.
![Ribasphere Ribapak (Ribavirin) Kit Ribasphere Ribapak (Ribavirin) Tablet Ribasphere (Ribavirin) Tablet, Film Coated [Kadmon Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6fed3131-1d9e-4ac6-a96f-b6053cc9d31a&name=VMHandSanitizer(Dial)2oz.jpg)
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