Darzalex Faspro (Daratumumab and Hyaluronidase-Fihj) for Amyloidosis

Overview

Darzalex Faspro is approved by the U.S. Food and Drug Administration (FDA) for the treatment of newly diagnosed light chain (AL) amyloidosis in adults. This approval is under the FDA’s accelerated approval program, which means the drug was approved based on response rates, and continued approval may depend on results from further clinical trials. To be eligible for this treatment, a person must not have severe cardiac involvement. Darzalex Faspro is also known by its drug name, daratumumab and hyaluronidase-fihj.

Darzalex Faspro is a biologic treatment that combines daratumumab, a type of antibody that targets CD38 proteins on certain cells, and hyaluronidase, an enzyme that helps the drug absorb more easily when injected under the skin. Scientists believe that Darzalex Faspro works by helping the immune system identify and destroy abnormal cells involved in AL amyloidosis.

How do I take it?

Prescribing information states that Darzalex Faspro is administered as a subcutaneous (under the skin) injection into the abdomen (belly). It should be given over a period of approximately three to five minutes. The treatment is typically given on a scheduled basis in combination with bortezomib, cyclophosphamide, and dexamethasone.

A person should be premedicated before each dose with a corticosteroid, acetaminophen (a pain reliever), and an antihistamine to reduce the risk of allergic reactions. Post-treatment medications may also be recommended. Darzalex Faspro should be taken exactly as prescribed by a healthcare provider.

Side effects

Common side effects of Darzalex Faspro include upper respiratory tract infection, diarrhea, peripheral edema (swelling in the limbs), constipation, fatigue, peripheral sensory neuropathy (nerve pain or tingling), nausea, insomnia (difficulty sleeping), headache, pyrexia (fever), dyspnea (shortness of breath), and cough.

Rare but serious side effects may include severe hypersensitivity reactions (such as anaphylaxis), cardiac toxicity in patients with existing heart involvement, severe neutropenia (low levels of a type of white blood cell), and thrombocytopenia (low platelet count). There is also a risk of embryo-fetal toxicity (harm to an unborn baby), so effective contraception is recommended during treatment. Darzalex Faspro can interfere with blood tests needed for transfusions, so people should be typed and screened before starting treatment, and blood banks should be informed if a patient has received this drug.

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