Three Rivers Pharmaceuticals, Llc.
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Three Rivers Pharmaceuticals, Llc. Drugs
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Ribasphere
(see CLINICAL PHARMACOLOGY, SPECIAL POPULATIONS; see WARNINGS)
Ribavirin/INTRON A Combination Therapy
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. (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 PMdaily 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 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.
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 ReductionRibavirin – 600 mg daily adults Permanent Discontinuation ofRibavirin Treatment HemoglobinNo 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 -
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Topotecan Hydrochloride
Prior to administration of the first course of Topotecan Hydrochloride for Injection, patients must have a baseline neutrophil count of >1,500 cells/mm3 and a platelet count of >100,000 cells/mm3.
2.1 Small Cell Lung Cancer
Recommended Dosage:
The recommended dose of Topotecan Hydrochloride for Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day course. In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed. The median time to response in 4 small cell lung cancer trials was 5 to 7 weeks.Dosage Modification Guidelines:
In the event of severe neutropenia (defined as 500 cells/mm3) during any course, reduce the dose by 0.25 mg/m2 to (1.25 mg/m2) for subsequent courses. Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration). In the event the platelet count falls below 25,000 cells/mm3, reduce doses by 0.25 mg/m2 (to 1.25 mg/m2) for subsequent courses.2.2 Cervical Cancer
Recommended Dosage: The recommended dose of Topotecan Hydrochloride for Injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course).
Dosage Modification Guidelines: Dosage adjustments for subsequent courses of Topotecan Hydrochloride for Injection in combination with cisplatin are specific for each drug. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity.
In the event of severe febrile neutropenia (defined as <1000 cells/mm3 with temperature of 38.0˚C or 100.4˚ F), reduce the dose of Topotecan Hydrochloride for Injection to 0.60 mg/m2 for subsequent courses. Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of Topotecan Hydrochloride for Injection). If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of Topotecan Hydrochloride for Injection to 0.45 mg/m2 for subsequent courses. In the event the platelet count falls below 25,000 cells/mm3, reduce doses to 0.60 mg/m2 for subsequent courses.2.3 Dosage Adjustment in Specific Populations
Renal Impairment: No dosage adjustment of Topotecan Hydrochloride for Injection appears to be required for patients with mild renal impairment (CIcr 40 to 60 mL/min.). Dosage adjustment of Topotecan Hydrochloride for Injection to 0.75 mg/m2 is recommended for patients with moderate renal impairment (20 to 39 mL/min.). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for Topotecan Hydrochloride for Injection. [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Topotecan Hydrochloride for Injection in combination with cisplatin for the treatment of cervical cancer should only be initiated in patients with serum creatinine ≤1.5 mg/dL. In the clinical trial, cisplatin was discontinued for a serum creatinine >1.5 mg/dL. Insufficient data are available regarding continuing monotherapy with Topotecan Hydrochloride for Injection after cisplatin discontinuation in patients with cervical cancer.
2.4 Instructions for Handling, Preparation and Intravenous Administration
Handling: Topotecan Hydrochloride for Injection is a cytotoxic anticancer drug. Prepare Topotecan Hydrochloride for Injection under a vertical laminar flow hood while wearing gloves and protective clothing. If Topotecan Hydrochloride for Injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If Topotecan Hydrochloride for Injection contacts mucous membranes, flush thoroughly with water.
Use procedures for proper handling and disposal of anticancer drugs. Several guidelines on this subject have been published. 1-4
Preparation and Administration: Each 4-mg vial of Topotecan Hydrochloride for Injection is reconstituted with 4 mL Sterile Water for Injection. Then the appropriate volume of the reconstituted solution is diluted in either 0.9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration.
Stability: Unopened vials of Topotecan Hydrochloride for Injection are stable until the date indicated on the package when stored between 20˚ and 25˚ C (68˚ and 77˚ F) [see USP] and protected from light in the original package. Because the vials contain no preservative, contents should be used immediately after reconstitution.
Reconstituted vials of Topotecan Hydrochloride for Injection diluted for infusion are stable at approximately 20˚ to 25˚ C (68˚ to 77˚ F) and ambient lighting conditions for 24 hours.
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