patients with multiple myeloma and 10% of patients with AL amyloidosis. Grade 3-4 systemic administration-related reactions occurred in 1.9% of patients. In patients with multiple myeloma who received DARZALEX FASPRO ® in combination with lenalidomide/dexamethasone or bortezomib/melphalan/prednisone, the most common systemic administration-related reactions were upper respiratory tract infection and pneumonia.
Local Reactions
In the pooled safety population, local injection-site reactions occurred in 12% of patients, including Grade 2 reactions in 1.4% of patients. The most frequent (>1%) local injection-site reactions were injection-site erythema and injection-site pain.
Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroid for DARZALEX FASPRO ® infusions. Monitor patients for systemic administration-related reactions, especially during the first and second infusions. For anaphylactic reactions or severe administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO ® and administer appropriate emergency care.
Infusion-Related Reactions
In the pooled safety population, infusion-related reactions occurred in 10% of patients. Grade 3 infusion-related reactions occurred in 0.9% of patients. The most frequent (>1%) infusion-related reactions were upper respiratory tract infection and headache.
Monitor patients for infusion-related reactions, especially during the first and second infusions. Interrupt DARZALEX FASPRO ® infusion for infusion-related reactions of any severity. Permanently discontinue DARZALEX FASPRO ® for anaphylactic reactions or severe infusion-related reactions and institute appropriate emergency care.
Interference with Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted.
Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO ®.
Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animals, DARZALEX FASPRO ® can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of daratumumab to pregnant cynomolgus monkeys during the period of organogenesis caused increased fetal loss, malformations, and alterations to growth at exposures below those achieved in patients receiving the recommended human dose. Advise pregnant women of the potential risk to a fetus.
ADVERSE REACTIONS
The most common adverse reactions (>20%) were fatigue, nausea, diarrhea, pyrexia, cough, chills, dyspnea, insomnia, muscle spasms, back pain, edema peripheral, upper respiratory tract infection, bronchitis, pneumonia, and upper respiratory tract infection.
Please see full Prescribing Information for DARZALEX FASPRO ®.
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