Multiple Myeloma Rx Gets New Formulation

FDA approves new subcutaneous formulation of Darzalex

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new formulation of a drug that treats a type of blood cancer.

Originally approved in 2015, Darzalex is used to treat adults with multiple myeloma, a form of blood cancer. It was only available as an injection to be administered into the vein — until now.

This newly approved formulation of Darzalex can be found under the name DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj). It is a subcutaneous formulation, which means it is to be injected under the skin.

According to the manufacturer of Darzalex, the drug's administration time is reduced from hours when given by IV to about three to five minutes when the new formulation is used. This new formulation is based on Halozyme's Enhanze drug delivery technology.

Common side effects of daratumumab include changes in infusion reactions, blood cell counts, feeling tired, nausea/vomiting, diarrhea/constipation and loss of appetite.

The maker of DARZALEX FASPRO™ noted that this new formulation caused fewer infusion-related side effects when compared to the IV formulation.

This medication can cause serious side effects, including but not limited to the following:

  • Infusion reactions
  • Changes in blood tests (This medication can change the results of certain blood tests that determine your blood type.)
  • Decreases in blood cell counts (This medication can decrease white blood cell and platelet counts. White blood cells help fight infections, and platelets help clot blood.)

Speak with your health care provider if you have any questions.