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besponsa 0 9 mg

besponsa 0 9 mg

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besponsa 0 9 mg
Besponsa - FDA prescribing information, side effects and uses, BESPONSA 1 mg powder for concentrate for solution for , Welcome to BESPONSA® | BESPONSA®, Besponsa Dosage Guide - Drugs.com, besponsa 0.9 mg/vial powder for solution in Canada, Besponsa for Acute Lymphoblastic Leukemia – Details | CADTH.ca, BILLING AND CODING INFORMATION FOR HOSPITAL OUTPATIENT, Besponsa (inotuzumab ozogamicin) - Moda Health, Drugs@FDA: FDA Approved Drug Products.
In a female fertility and early embryonic development study, female rats were administered daily intravenous doses of inotuzumab ozogamicin up to 0.11 mg/m2 for 2 weeks before mating through Day 7 of pregnancy. An increase in the proportion of resorptions and decrease in the number of viable embryos and gravid uterine weights were observed at the 0.11 mg/m2 dose level (approximately 2 times the exposure in patients at the maximum recommended dose, based on AUC). Additional findings in female reproductive organs occurred in repeat-dose toxicology studies and included decreased ovarian and uterine weights, and ovarian and uterine atrophy. Findings in male reproductive organs occurred in repeat-dose toxicology studies and included decreased testicular weights, testicular degeneration, hypospermia, and prostatic and seminal vesicle atrophy. Testicular degeneration and hypospermia were nonreversible following a 4-week nondosing period. In the chronic studies of 26-weeks duration, adverse effects on reproductive organs occurred at ≥0.07 mg/m2 in male rats and at 0.73 mg/m2 in female monkeys [see ].. Reconstitute each vial with 4 mL of Sterile Water for Injection, USP, to obtain a concentration of 0.25 mg/mL of Besponsa that delivers 3.6 mL (0.9 mg). Gently swirl the vial to aid dissolution. DO NOT SHAKE .. The recommended BESPONSA dose was determined to be 1.8 mg/m 2 /cycle administered at a dose of 0.8 mg/m 2 on Day 1 and 0.5 mg/m 2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi..
The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%).. Recommended Dosage. Pre-medicate before each dose [see Dosage and Administration (2.2)]. For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m 2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m 2), Day 8 (0.5 mg/m 2), and Day 15 (0.5 mg/m 2).. © 2019 Canadian-Pill-Identifier.com © All Rights Reserved. Drug Product Database and Data Extract. Health Canada, 2015. Adapted and reproduced with permission from . ‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback.. BESPONSA is supplied as a 0.9 mg single-dose vial. Each vial is reconstituted with 4 mL of Sterile Water for Injection, USP, to obtain a concentration of Please refer to the full Prescribing Information for complete Dosage and Administration instructions. Administration3,5 (CPT®) The information provided in this document is intended for informational purposes only, and is not a comprehensive . 8 (0.5 mg/m 2), and Day 15 (0.5 mg/m ) Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves CR or CRi, and/or to allow recovery from toxicity.
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