"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
(brentuximab vedotin) for Injection
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent MMAE, and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10.
Brentuximab vedotin has an approximate molecular weight of 153 kDa. Approximately 4 molecules of MMAE are attached to each antibody molecule. Brentuximab vedotin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis.
ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white, preservative-free lyophilized cake or powder in single-use vials. Following reconstitution with 10.5 mL Sterile Water for Injection, USP, a solution containing 5 mg/mL brentuximab vedotin is produced. The reconstituted product contains 70 mg/mL trehalose dihydrate, 5.6 mg/mL sodium citrate dihydrate, 0.21 mg/mL citric acid monohydrate, and 0.20 mg/mL polysorbate 80 and water for injection. The pH is approximately 6.6.
What are the possible side effects of brentuximab vedotin (Adcetris)?
Some people receiving a brentuximab vedotin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, itchy, or if you have a fever, chills, cough, or trouble breathing during the infusion. Infusion reactions often occur within the first 24 hours after the start of your brentuximab vedotin infusion.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or...
Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Adcetris Information
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