Darzalex Faspro (Daratumumab and Hyaluronidase-Fihj) for Myeloma

Overview
Darzalex Faspro is approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma in adults. This treatment is used in combination with other drugs such as bortezomib, lenalidomide, melphalan, prednisone, thalidomide, and dexamethasone for both newly diagnosed individuals eligible for autologous stem cell transplant and those who are not. It is also used in individuals with relapsed or refractory multiple myeloma who have received at least one prior therapy. Additionally, the drug combination is used as a stand-alone therapy for individuals who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory (resistant) to both. Darzalex Faspro is also known by its drug name, daratumumab and hyaluronidase-fihj.

Darzalex Faspro is a biologic therapy that combines two active ingredients: daratumumab, which is a CD38-directed cytolytic antibody, and hyaluronidase, an enzyme that helps with absorption. Daratumumab targets and binds to a protein called CD38 found on the surface of myeloma cells, helping the immune system identify and destroy these cancerous cells. Hyaluronidase enhances the absorption of daratumumab when administered subcutaneously (under the skin).

How do I take it?
Prescribing information states that Darzalex Faspro is administered as a subcutaneous injection into the abdomen. Individuals are premedicated with a corticosteroid, acetaminophen, and a histamine-1 receptor antagonist before receiving the injection to reduce the risk of infusion-related reactions. Doses are administered over approximately three to five minutes according to the recommended schedule. Darzalex Faspro should be administered exactly as prescribed by a health care provider.

Side effects
Common side effects of Darzalex Faspro vary depending on which drugs it’s combined with. Here are the side effects for each combination, according to the prescribing information:

• Darzalex Faspro-VRd (bortezomib, lenalidomide, and dexamethasone) — Peripheral neuropathy (nerve damage affecting both sensory and motor nerves), peripheral sensory neuropathy (sensory nerve damage causing tingling and numbness), fatigue, edema (swelling), pyrexia (fever), upper respiratory infection, constipation, diarrhea, musculoskeletal pain (pain affecting muscles and bones), insomnia, and rash
• Darzalex Faspro-VMP (bortezomib, melphalan, prednisone) — Upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain
• Darzalex Faspro-Pd (pomalidomide, dexamethasone) — Fatigue, pneumonia, upper respiratory tract infection, and diarrhea
• Darzalex Faspro-Kd (carfilzomib, dexamethasone) — Upper respiratory tract infection, fatigue, insomnia, hypertension (high blood pressure), diarrhea, cough, dyspnea (difficulty breathing), headache, pyrexia, nausea, and peripheral edema (swelling of the limbs)

Rare but serious side effects in individuals being treated for multiple myeloma may include severe hypersensitivity reactions, neutropenia (low levels of neutrophils), and thrombocytopenia (low platelet count). There is also a risk of embryo-fetal toxicity (harm to an embryo, fetus, or unborn infant). Additionally, Darzalex Faspro may interfere with blood cell antibody screening, so those taking the medication should inform blood banks of their treatment.

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Label: Darzalex Faspro (Daratumumab and Hyaluronidase-Fihj — Human Recombinant Injection — DailyMed

Darzalex Faspro — Drugs.com