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besponsa fda

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besponsa fda
Besponsa - FDA prescribing information, side effects and uses, FDA approves new treatment for adults with relapsed or , About BESPONSA® | BESPONSA®, Welcome to BESPONSA® | BESPONSA®, Besponsa New FDA Drug Approval | CenterWatch, FDA Approves BESPONSA - ACCP, FDA Approves Besponsa (Inotuzumab Ozogamicin) for Acute , BESPONSA (inotuzumab ozogamicin) Lyophilized Powder, Drug Trials Snapshots: 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 official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.. Release. The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment,.
BESPONSA is a type of medicine called an antibody-drug conjugate. BESPONSA is designed to find and attach to a specific protein, called CD22, found on leukemia cells BESPONSA is designed to find and attach to a specific protein, called CD22, found on leukemia cells. BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age.. 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.. FDA Approves BESPONSA (Inotuzumab Ozogamicin) for Adults with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved BESPONSA (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. FDA Approves Besponsa (Inotuzumab Ozogamicin) for Acute Lymphoblastic Leukemia in Adults Aug 18, 2017 The US Food and Drug Administration has approved the targeted therapy drug Besponsa (inotuzumab ozogamicin) for adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is not getting better with treatment, or came back after treatment.. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA.
 
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