The new subcutaneous (SQ) formulation daratumumab and hyaluronidase- fihj (DARA SQ) has an even lower incidence of IRRs compared to the IV formulation, 12.7% versus 34.5%, of all grades and 1.5% versus 5.4% of grade 3 respectively (Mateos MV., et al. Lancet; 2020). Given the lower ...
All patients received eight 21-day cycles of 1.3 mg/m2 subcutaneous bortezomib (days 1, 4, 8, and 11) and 20 mg oral dexamethasone (days 1, 2, 4, 5, 8, 9, 11, and 12). Patients in the D-Vd arm received 16 mg/kg intravenous daratumumab once weekly for cycles 1 through 3 and...
Darzalex Faspro is a subcutaneous formulation of Darzalex, an established treatment for multiple myeloma that is given by intravenous infusion over a period of hours. Darzalex Faspro is administered by subcutaneous injection over a much shorter period of approximately three to five minutes. Warnings an...
Previously, in May 2020, subcutaneous daratumumab plus hyaluronidase-fihj was FDA approved for use in adult patients with newly diagnosed or relapsed/refractory multiple myeloma based on data from the COLUMBA (MMY3012) trial, which demonstrated noninferiority in terms of efficacy versus the intravenous...
Injection site: Administer into subcutaneous tissue of the abdomen ~3 inches (7.5 cm) to the right or left of the navel No data are available on performing the injection at other sites of the body Rotate injection sites for successive injections ...
The dose is a flat dose of 1800 mg in 15 mL and it's usually administered as a subcutaneous injection in the abdomen in a person with a 3- to 5-min injection time. What were the data that led to this approval? Could you discuss the phase 3 COLUMBA trial? COLUMBA is the phase 3...
Figure 3 Patients’ feelings before receiving injection of daratumumab. Mean score calculated from five-point Likert scale where 0 means “Not all” and 5 means “Yes totally”. ‡Indicates a significant difference (p<0.05) between the intravenous (IV) and the subcutaneous (SC) modes of admin...
Bortezomib was administered by subcutaneous (SC) injection or intravenous (IV) injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28-day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles...
it could be done in a few hours or even by rapid infusions in 90 minutes. With the subcutaneous administration, you start off faster. It’s just an injection, or a 5-minute procedure. You still have to monitor the patient afterward, but the fact that it’s a quick inject...
DARA SC (15 mL) was given by injection over 3-5 min. The PPK and E-R analyses included data from 3 monotherapy studies (2 phase 1/1b studies [PAVO, MMY1008], and a phase 3 study [COLUMBA; SC and IV arms]). For PPK, serum concentration-time data were used for nonlinear mixed-...