New Warning, Pregnancy Data Added to Adcetris Labeling

New Warning, Pregnancy Data Added to Adcetris Labeling
New Warning, Pregnancy Data Added to Adcetris Labeling

The Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) for injection. 

The approved supplement contains updates to the Warning and Precautions for Gastrointestinal Complications, as well as updates that comply with the Pregnancy and Lactation Labeling Rule (PLLR). 

The labeling now includes reports on fatal and serious gastrointestinal (GI) complications including perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocoiltis, neutropenic colitis, and ileus that have occurred in patients treated with Adcetris. Patients with lymphoma with preexisting GI involvement may be at increased risk of perforation. Clinicians are to perform a prompt diagnostic evaluation and treat appropriately if new or worsening GI symptoms occur. 

RELATED: FDA Expands Lymphoma Indication for Adcetris

The Risk Summary for pregnant patients includes data in animal reproduction studies. Adcetris can cause fetal harm based on data from these studies and the drug's mechanism of action. In addition, breastfeeding is not recommended during treatment with Adcetris due to the potential for serious adverse reactions in a breastfed infant (eg, cytopenias, neurologic or GI toxicities). 

Adcetris, a CD30-directed antibody-drug conjugate, is indicated for the treatment of patients with classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of ≥2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates or are at high risk of relapse or progression as post-auto-HSCT consolidation; and for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of ≥1 prior multi-agent chemotherapy regimen.

It is supplied as a 50mg lyophilized powder for IV infusion after reconstitution in single-use vials.

For more information call (855) 473-2436 pr visit Adcetris.com.

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