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besponsa drug
Besponsa - Drugs.com, Besponsa: Indications, Side Effects, Warnings - Drugs.com, Besponsa (Inotuzumab ozogamicin) Drug / Medicine Information, Welcome to BESPONSA® | BESPONSA®, Besponsa (inotuzumab ozogamicin) Side Effects , Besponsa New FDA Drug Approval | CenterWatch, NICE to reassess Pfizer’s leukaemia drug Besponsa , Drug Trials Snapshots: BESPONSA - U S Food and Drug , About BESPONSA® | BESPONSA®.
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 ].. Besponsa is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1; Calculate the dose (mg) and number of vials of Besponsa required. 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.. This is not a list of all drugs or health problems that interact with Besponsa (inotuzumab ozogamicin). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems..
Consumer Medicine Information (CMI) about Besponsa (Inotuzumab ozogamicin) intended for persons living in Australia.. 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%).. Inotuzumab ozogamicin is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Inotuzumab ozogamicin is used to treat a certain type of acute lymphocytic leukemia. General Information. Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC). Besponsa is specifically indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Besponsa is supplied as a solution for intravenous injection.. Besponsa is an antibody drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on around 90 percent of B-cell malignancies, linked to a cytotoxic agent. When the drug binds to CD22 on malignant B-cells it is taken into the cell, where the cytotoxic agent calicheamicin is released to destroy it.. The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age .
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