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besponsa fda label

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besponsa fda label
Reference ID: 4140675 - Food and Drug Administration, Welcome to BESPONSA® | BESPONSA®, FDA approves inotuzumab ozogamicin for relapsed or , Besponsa (inotuzumab ozogamicin) FDA Approval History , Besponsa for Acute Lymphoblastic Leukemia Approved by FDA, Besponsa New FDA Drug Approval | CenterWatch, Pfizer Receives U.S. FDA Approval for BESPONSA , About BESPONSA® | BESPONSA®, Drugs@FDA: FDA Approved Drug Products.
`C;٤1.Y_USK87JĄomW,[oe&F?nE!ov-D!?nO.s絺A?Ir?,w%h@}W1}Zu.g܊ٗV3Xh?LttoZ&㕣%ڡ_](>h5YGQ>1;s^P:wzp+w]De=Ɨ>n5sM)a:8wD[Ysn >hH/_γ>hPߙM&f®4Ԇn4dǷfP>_n>/)m*ΝTl :+|YĭuGͽ~R{>ȋޗs].g9xZeZ`4qL՟~,@&۫N.\[]b&\D&sʳm 6;]t*'{8zx澼G-gJN|ƉdywSEˈz"*kb߂ ypKB:cb${;$aON. 9 /L. a . 50 × 10. 9 /L. a. Discontinue BESPONSA if low platelet count persists for greater than 28 days and is suspected to be related to BESPONSA. If prior to BESPONSA treatment. 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..
On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed . Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. The FDA had previously granted Besponsa Priority Review, Breakthrough therapy, and Orphan Drug designation. The U.S. labeling includes a boxed warning on the potential for hepatoxicity, which includes blockage of veins in the liver, known as veno-occlusive disease. If hepatoxicity is observed in patients taking Besponsa, then the treatment should either be stopped or the dose should be lowered . Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC). Inotuzumab recognizes human CD22. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker.. BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults . 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.
 
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