From the Guidelines
Darzalex Faspro is a preferred treatment option for multiple myeloma due to its subcutaneous formulation, which offers a similar efficacy profile and reduced infusion-related reactions compared to intravenous daratumumab, as demonstrated in a randomized trial 1. The subcutaneous formulation of daratumumab and hyaluronidase-fihj has been shown to have a similar overall response rate (ORR), progression-free survival (PFS), and safety profile compared to intravenous daratumumab 1. Key benefits of Darzalex Faspro include:
- Shorter administration time, typically 3-5 minutes 1
- Reduced infusion-related reactions 1
- Comparable efficacy to intravenous daratumumab 1 The standard dose of Darzalex Faspro is 1,800 mg daratumumab/30,000 units hyaluronidase-fihj administered subcutaneously into the abdomen 1. Common side effects of Darzalex Faspro include:
- Fatigue
- Nausea
- Upper respiratory infections
- Injection site reactions Premedication with corticosteroids, antipyretics, and antihistamines is recommended to minimize reactions 1. Darzalex Faspro works by targeting CD38, a protein highly expressed on myeloma cells, enabling immune-mediated tumor cell killing through multiple mechanisms, including antibody-dependent cellular cytotoxicity 1. Patients should be monitored for neutropenia, thrombocytopenia, and potential interference with blood typing, which can persist for up to 6 months after the last dose 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Darzalex Faspro Overview
- Darzalex Faspro, a subcutaneous formulation of daratumumab, has been studied in several clinical trials for the treatment of multiple myeloma 2, 3, 4, 5, 6
- The subcutaneous formulation is designed to reduce infusion times and decrease the rate of infusion reactions compared to the intravenous formulation 2, 6
Efficacy and Pharmacokinetics
- Studies have shown that subcutaneous daratumumab is non-inferior to intravenous daratumumab in terms of efficacy and pharmacokinetics 2, 3, 4
- The overall response rates and trough concentrations of subcutaneous daratumumab were similar to or greater than those of intravenous daratumumab 2, 3, 4
- The subcutaneous formulation has been shown to achieve similar or greater serum concentrations compared to the intravenous formulation 3, 4
Safety and Tolerability
- The subcutaneous formulation of daratumumab has been associated with a lower risk of infusion reactions and decreased administration time compared to the intravenous formulation 2, 3, 4, 5, 6
- The most common adverse events reported with subcutaneous daratumumab were similar to those reported with intravenous daratumumab, including anaemia, neutropenia, and thrombocytopenia 2, 3, 4, 5
- Infusion-related reactions were infrequent and mild, with a median administration time of 5 minutes 5