By now, we all know the importance of transparency in labels whether on foods, prescription drugs, or other products. Recently, the FDA approved a supplement for the treatment of those with classical Hodgkin’s lymphoma, after failure with other methods of treatment.
The supplement, brentuximab vedotin (brand name Adcetris) is an injectable drug supplied as a 50mg lyophilized powder for IV infusion. According to the drug’s website, it is indicated for use in patients with classical HL who are at an increased risk of progression or relapse as consolidation treatment following an autologous hematopoietic stem cell transplant.
While the Food and Drug Administration approved an sBLA, or supplemental Biologics License for the drug manufactured by Seattle Genetics, it also now contains updates regarding possible gastrointestinal complications, and also complies with the PLLR, or Pregnancy and Lactation Labeling Rule.
Reports, including those on GI complications that may be serious or fatal are now included in labeling, as some patients who have been treated with Adcetris have experienced ulcers, perforation, enterocolitis, hemorrhage, and other complications. As with all prescription drugs and biologics, the benefits usually far outweigh the risks, however there are some individuals who should not use certain medicines – and including this pertinent information in pharma labeling helps both physicians and consumers understand the potential risks, an advantage when determining the proper course of treatment.
Safety and full prescribing information can be found on the company’s website at Adcetris.com.
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