Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4300
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RIBASPHERE (Capsule)
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Ribavirin/INTRON A Combination Therapy:<br/>Adults: The 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. 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 limitof 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. Ribavirin may be administered without regard to food, but should be administered in a consistent manner with respect to food intake.<br/>RIBASPHERE' (Ribavirin capsules)/PEG-INTRON Combination Therapy: The 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.<br/>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. 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. 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.
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Ribavirin: RIBASPHERE' (Ribavirin capsules) is Three Rivers Pharmaceuticals' brand name for ribavirin, a nucleoside analog. The chemical name of ribavirin is 1-��-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 CHNOand 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.<br/>Mechanism of Action: The mechanism of inhibition of hepatitis C virus (HCV) RNA by combination therapy with ribavirin and interferon products has not been established.
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Pharmacokinetics:<br/>Ribavirin: Single- and multiple-dose pharmacokinetic properties in adults are summarized in TABLE 1. Ribavirin was rapidly and extensively absorbed following oral administration. However, due to first-pass metabolism, the absolute bioavailability averaged 64% (44%). There was a linear relationship between dose and AUC(AUC from time zero to last measurable concentration) following single doses of 200 to 1200 mg ribavirin. The relationship between dose and Cwas curvilinear, tending to asymptote above single doses of 400 to 600 mg. Upon multiple oral dosing, based on AUC12, a sixfold accumulation of ribavirin was observed in plasma. Following oral dosing with 600 mg BID, steady-state was reached by approximately 4 weeks, with mean steady-state plasma concentrations of 2200 (37%) ng/mL. Upon discontinuation of dosing, the mean half-life was 298 (30%) hours, which probably reflects slow elimination from nonplasma compartments.<br/>Effect of Food on Absorption of Ribavirin: Both AUCand Cincreased by 70% when ribavirin capsules were administered with a high-fat meal (841 kcal, 53.8 g fat, 31.6 g protein, and 57.4 g carbohydrate) in a single-dose pharmacokinetic study. There are insufficient data to address the clinical relevance of these results. Clinical efficacy studies with ribavirin/INTRON'A (interferon alfa-2b, recombinant) were conducted without instructions with respect to food consumption. During clinical studies with ribavirin capsules/PEG-INTRON'(peginterferon alfa-2b, recombinant), all subjects were instructed to take ribavirin capsules with food.<br/>Effect of Antacid on Absorption of Ribavirin: Coadministration of ribavirin capsules with an antacid containing magnesium, aluminum, and simethicone (Mylanta') resulted in a 14% decrease in mean ribavirin AUC. The clinical relevance of results from this single-dose study is unknown. Ribavirin transport into nonplasma compartments has been most extensively studied in red blood cells, and has been identified to be primarily via an e-type equilibrative nucleoside transporter. This type of transporter is present on virtually all cell types and may account for the extensive volume of distribution. Ribavirin does not bind to plasma proteins. Ribavirin has two pathways of metabolism: (i) a reversible phosphorylation pathway in nucleated cells; and (ii) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxylic acid metabolite. Ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are excreted renally. After oral administration of 600 mg ofC-ribavirin, approximately 61% and 12% of the radioactivity was eliminated in the urine and feces, respectively, in 336 hours. Unchanged ribavirin accounted for 17% of the administered dose. Results of in vitro studies using both human and rat liver microsome preparations indicated little or no cytochrome P450 enzyme-mediated metabolism of ribavirin, with minimal potential for P450 enzyme-based drug interactions. No pharmacokinetic interactions were noted between INTRON A Injection and ribavirin capsules in a multiple-dose pharmacokinetic study.<br/>Drug Interactions: Ribavirin has been shown in vitro to inhibit phosphorylation of zidovudine and stavudine which could lead to decreased antiretroviral activity. Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased when didanosine is co-administered with ribavirin, which could cause or worsen clinical toxicities .<br/>Special Populations:<br/>Renal Dysfunction: The pharmacokinetics of ribavirin were assessed after administration of a single oral dose (400 mg) of ribavirin to non HCV-infected subjects with varying degrees of renal dysfunction. The mean AUCvalue was threefold greater in subjects with creatinine clearance values between 10 to 30 mL/min when compared to control subjects (creatinine clearance>90 mL/min). In subjects with creatinine clearance values between 30 to 60 mL/min, AUCwas twofold greater when compared to control subjects. The increased AUCappears to be due to reduction of renal and non-renal clearance in these patients. Phase III efficacy trials included subjects with creatinine clearance values>50 mL/min. The multiple dose pharmacokinetics of ribavirin cannot be accurately predicted in patients with renal dysfunction. Ribavirin is not effectively removed by hemodialysis. Patients with creatinine clearance<50 mL/min should not be treated with RIBASPHERE' (Ribavirin capsules) .<br/>Hepatic Dysfunction: The effect of hepatic dysfunction was assessed after a single oral dose of ribavirin (600 mg). The mean AUCvalues were not significantly different in subjects with mild, moderate, or severe hepatic dysfunction (Child-Pugh Classification A, B, or C) when compared to control subjects. However, the mean Cvalues increased with severity of hepatic dysfunction and was twofold greater in subjects with severe hepatic dysfunction when compared to control subjects.<br/>Elderly Patients: Pharmacokinetic evaluations in elderly subjects have not been performed.<br/>Gender: There were no clinically significant pharmacokinetic differences noted in a single-dose study of eighteen male and eighteen female subjects.
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Pregnancy: RIBASPHERE' (Ribavirin capsules) may cause birth defects and/or death of the exposed fetus. Ribavirin therapy is contraindicated for use in women who are pregnant or in men whose female partners are pregnant. . RIBASPHERE' (Ribavirin capsules) are contraindicated in patients with a history of hypersensitivity to ribavirin or any component of the capsule. Patients with autoimmune hepatitis must not be treated with combination ribavirin/INTRON A therapy because using these medicines can make the hepatitis worse. Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) should not be treated with RIBASPHERE' (Ribavirin capsules).
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RIBASPHERE' (Ribavirin capsules), 200 mg are white, opaque, gelatin capsules printed horizontally with "riba 200" on both the body and the cap of the capsule in edible, green pharmaceutical ink. RIBASPHERE' (Ribavirin capsules), 200 mg are packaged in HDPE bottles with child-resistant closures containing 42 capsules (NDC 66435-101-42), 56 capsules (NDC66435-101-56), 70 capsules (NDC 66435-101-70), 84 capsules (NDC 66435-101-84), 140 capsules (NDC 66435-101-14), 168 capsules (NDC 66435-101-16) and 180 capsules (NDC 66435-101-18).<br/>Storage Conditions: The bottle of RIBASPHERE' (Ribavirin capsules) should be stored at 25��C (77��F); excursions are permitted between 15��C and 30��C (59��F and 86��F). [see USP Controlled Room Temperature] Manufactured byDSM PHARMACEUTICALS, INC.Greenville, NC 27834, USA Manufactured forTHREE RIVERS PHARMACEUTICALS, LLCCranberry Township, PA 16066, USA U.S. Patent 6,720,000Copyright��2007, Three Rivers Pharmaceuticals, LLC. All rights reserved.Rev. 12/07XXXXXX
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The safety and efficacy of ribavirin/INTRON A and PEG-INTRON therapy for the treatment of HIV infection, adenovirus, RSV, parainfluenza, or influenza infections have not been established. RIBASPHERE' (Ribavirin capsules) should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered. The safety and efficacy of ribavirin/INTRON A therapy has not been established in liver or other organ transplant patients, patients with decompensated liver disease due to hepatitis C infection, patients who are nonresponders to interferon therapy, or patients coinfected with HBV or HIV.<br/>Information for Patients: Patients must be informed that RIBASPHERE' (Ribavirin capsules) may cause birth defects and/or death of the exposed fetus. Ribavirin must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking ribavirin. Ribavirin should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months posttherapy. Women of childbearing potential must be counseled about use of effective contraception (two reliable forms) prior to initiating therapy. Patients (male and female) must be advised of the teratogenic/embryocidal risks and must be instructed to practice effective contraception during ribavirin and for 6 months posttherapy. Patients (male and female) should be advised to notify thephysician immediately in the event of a pregnancy. If pregnancy does occur during treatment or during 6 months posttherapy, the patient must be advised of the teratogenic risk of ribavirin therapy to the fetus. Patients, or partners of patients, should immediately report any pregnancy that occurs during treatment or within 6 months after treatment cessation to their physician. Physicians should report such cases by calling 1-800-593-2214. Patients receiving RIBASPHERE' (Ribavirin capsules) should be informed of the benefits and risks associated with treatment, directed in its appropriate use, and referred to the patient MEDICATION GUIDE for RIBASPHERE' (Ribavirin capsules). Patients should be informed that the effect of treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of the hepatitis C virus should be taken. The most common adverse experience occurring with RIBASPHERE' (Ribavirin capsules) is anemia, which may be severe. Patients should be advised that laboratory evaluations are required prior to starting therapy and periodically thereafter. (See Laboratory Tests.) It is advised that patients be well hydrated, especially during the initial stages of treatment.<br/>Laboratory Tests: The following laboratory tests are recommended for all patients treated with RIBASPHERE' (Ribavirin capsules), prior to beginning treatment and then periodically thereafter.<br/>Carcinogenesis and Mutagenesis: Ribavirin did not cause an increase in any tumor type when administered for 6 months in the transgenic p53 deficient mouse model at doses up to 300 mg/kg (estimated human equivalent of 25 mg/kg based on body surface area adjustment for a 60 kg adult; approximately 1.9 times the maximum recommended human daily dose). Ribavirin was non-carcinogenic when administered for 2 years to rats at doses up to40 mg/kg (estimated human equivalent of 5.71 mg/kg based on body surface area adjustment for a 60 kg adult). However, this dose was less than the maximum tolerated dose, and therefore the study was not adequate to fully characterize the carcinogenic potential of ribavirin. Ribavirin demonstrated increased incidences of mutation and cell transformation in multiple genotoxicity assays. Ribavirin was active in the Balb/3T3 In Vitro Cell Transformation Assay. Mutagenic activity was observed in the mouse lymphoma assay, and at doses of 20 to 200 mg/kg (estimated human equivalent of 1.67 to 16.7 mg/kg, based on body surface area adjustment for a 60 kg adult; 0.1 to 1 times the maximum recommended human 24-hour dose of ribavirin) in a mouse micronucleus assay. A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.<br/>Impairment of Fertility: Ribavirin demonstrated significant embryocidal and/or teratogenic effects at doses well below the recommended human dose in all animal species in which adequate studies have been conducted. Fertile women and partners of fertile women should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms). Based on a multiple dose half-life (t) of ribavirin of 12 days, effective contraception must be utilized for 6 months posttherapy (e.g., 15 half-lives of clearance for ribavirin). Ribavirin should be used with caution in fertile men. In studies in mice to evaluate the time course and reversibility of ribavirin-induced testicular degeneration at doses of 15 to 150 mg/kg/day (estimated human equivalent of 1.25 to 12.5 mg/kg/day, based on body surface area adjustment for a 60 kg adult; 0.1 to 0.8 times the maximum human 24-hour dose of ribavirin) administered for 3 or 6 months, abnormalities in sperm occurred. Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity was apparent within 1 or 2 spermatogenesis cycles.<br/>Animal Toxicology: Long-term studies in the mouse and rat (18 to 24 months; doses of 20 to 75 and 10 to 40 mg/kg/day, respectively {estimated human equivalent doses of 1.67 to 6.25 and 1.43 to 5.71 mg/kg/day, respectively, based on body surface area adjustment for a 60 kg adult; approximately 0.1 to 0.4 times the maximum human 24-hour dose of ribavirin}) have demonstrated a relationship between chronic ribavirin exposure and increased incidences of vascular lesions (microscopic hemorrhages) in mice. In rats, retinal degeneration occurred in controls, but the incidence was increased in ribavirin-treated rats.<br/>Pregnancy Category X: Ribavirin produced significant embryocidal and/or teratogenic effects 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. In conventional embryotoxicity/teratogenicity studies in rats and rabbits, observed no effect dose levels were well below those for proposed clinical use (0.3 mg/kg/day for both the rat and rabbit; approximately 0.06 times the recommended human 24-hour dose of ribavirin). No maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (estimated human equivalent dose of 0.17 mg/kg basedon body surface area adjustment for a 60 kg adult; approximately 0.01 times the maximum recommended human 24-hour dose of ribavirin).<br/>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 (estimated human equivalent doses of 7.14 to 28.6 mg/kg, based on body surface area adjustment for a 60 kg adult; up to 1.7 times the maximum recommended human dose of ribavirin). However, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners. Women of childbearing potential should not receive ribavirin unless they are using effective contraception (two reliable forms) during the therapy period. In addition, effective contraception should be utilized for 6 months posttherapy based on a multiple-dose half-life (t) of ribavirin of 12 days. Male patients and their female partners must practice effective contraception (two reliable forms) during treatment with ribavirin and for the 6-month posttherapy period (e.g., 15 half-lives for ribavirin clearance from the body).<br/>Ribavirin Pregnancy Registry: A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for six months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.<br/>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 RIBASPHERE' (Ribavirin capsules).<br/>Geriatric Use: Clinical studies of ribavirin/INTRON A or PEG-INTRON 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 should be made accordingly. Ribavirin should not be used in patients with creatinine clearance<50 mL/min. In general, RIBASPHERE' (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/or cardiac function, and of concomitant disease or other drug therapy. In clinical trials, elderly subjects had a higher frequency of anemia (67%) than did younger patients (28%).<br/>Pediatric Use: 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 . As in adult patients, pediatric patients experienced other psychiatric adverse events (e.g., depression, emotional lability, somnolence), anemia, and neutropenia . During a 48-week course of therapy there was a decrease in the rate of linear growth (mean percentile assignment decrease of 9%) and a decrease in the rate of weight gain (mean percentile assignment decrease of 13%). A general reversal of these trends was noted during the 24-week post-treatment period.<br/>Drug Interactions:<br/>Didanosine: Co-administration of RIBASPHERE' (Ribavirin capsules) and didanosine is not recommended. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactactemia/lactic acidosis have been reported in clinical trials .<br/>Stavudine and Zidovudine: Ribavirin may antagonize the in vitro antiviral activity of stavudine and zidovudine against HIV. Therefore, concomitant use of ribavirin with either of these drugs should be used with caution .
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There is limited experience with overdosage. Acute ingestion of up to 20 grams of ribavirin capsules, INTRON A ingestion up to 120 million units, and subcutaneous doses of INTRON A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse events related to the therapeutic use of INTRON A and ribavirin. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of INTRON A that exceed dosing recommendations. There is no specific antidote for INTRON A or ribavirin, and hemodialysis and peritoneal dialysis are not effective treatment of overdose of either agent.
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Ribavirin
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RIBASPHERE (Capsule)
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The primary toxicity of ribavirin is hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1 to 2 weeks of oral therapy. (See WARNINGS.) Cardiac and pulmonary events associated with anemia occurred in approximately 10% of patients.<br/>Ribavirin/INTRON A Combination Therapy: In clinical trials, 19% and 6% of previously untreated and relapse patients, respectively, discontinued therapy due to adverse events in the combination arms compared to 13% and 3% in the interferon arms. Selected treatment-emergent adverse events that occurred in the US studies with>5% incidence are provided in TABLE 5 by treatment group. In general, the selected treatment-emergent adverse events reported with lower incidence in the international studies as compared to the US studies with the exception of asthenia, influenza-like symptoms, nervousness, and pruritus. In addition, the following spontaneous adverse events have been reported during the marketing surveillance of ribavirin/INTRON A therapy: hearing disorder and vertigo.<br/>Ribavirin/PEG-INTRON (peginterferon alfa-2b, recombinant) Combination Therapy: Overall, in clinical trials, 14% of patients receiving ribavirin in combination with PEG-INTRON, discontinued therapy compared with 13% treated with ribavirin in combination with INTRON A (interferon alfa-2b, recombinant). The most common reasons for discontinuation of therapy were related to psychiatric, systemic (e.g., fatigue, headache), or gastrointestinal adverse events. Adverse events that occurred in clinical trial at>5% incidence are provided in TABLE 6 by treatment group. Safety and effectiveness of Ribavirin capsules in combination with PEG-INTRON has not been established in pediatric patients.<br/>Laboratory Values:<br/>Ribavirin/INTRON A Combination Therapy: Changes in selected hematologic values (hemoglobin, white blood cells, neutrophils, and platelets) during therapy are described below. (See TABLE 7.)<br/>Ribavirin/PEG-INTRON Combination Therapy: Changes in selected hematologic values (hemoglobin, white blood cells, neutrophils, and platelets) during therapy are described below. (See TABLE 8.)
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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.<br/>Pregnancy: 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 .<br/>Anemia: 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. (SeeDOSAGE 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. 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.<br/>Pulmonary: 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.<br/>Dental and Periodontal Disorders: 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 theirteeth 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.
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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.
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RIBASPHERE
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