For patients with 3rd-line+ multiple myeloma (MM)
after a PI and an immunomodulatory agent,
DISCOVER THE POSSIBILITIES
OF SINGLE AGENT EFFICACY
DARZALEX® is a rst-in-class fully human
monoclonal antibody that binds to CD381
Indication
DARZALEX® (daratumumab) is indicated for the treatment of patients with multiple
myeloma who have received at least 3 prior lines of therapy, including a proteasome
inhibitor (PI) and an immunomodulatory agent, or who are double-refractory
to a PI and an imwmunomodulatory agent.
This indication is approved under accelerated approval based on response rate.
Continued approval for this indication may be contingent upon verication and
description of clinical benet in conrmatory trials.
Important Safety Information
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Infusion Reactions
DARZALEX® can cause severe infusion reactions.
Approximately half of all patients experienced a reaction,
most during the rst infusion. Infusion reactions can also occur
with subsequent infusions. Nearly all reactions occurred
during infusion or within 4 hours of completing an infusion.
Prior to the introduction of post-infusion medication in clinical
trials, infusion reactions occurred up to 48 hours after infusion.
Severe reactions have occurred, including bronchospasm,
hypoxia, dyspnea, and hypertension. Signs and symptoms
may include respiratory symptoms, such as cough, wheezing,
larynx and throat tightness and irritation, laryngeal edema,
pulmonary edema, nasal congestion, and allergic rhinitis.
Less common symptoms were hypotension, headache, rash,
urticaria, pruritus, nausea, vomiting, and chills.
Pre-medicate patients with antihistamines, antipyretics, and
corticosteroids. Frequently monitor patients during the entire
infusion. Interrupt infusion for reactions of any severity and
institute medical management as needed. Permanently
discontinue therapy for life-threatening (Grade 4) reactions.
For patients with Grade 1, 2, or 3 reactions, reduce the
infusion rate when re-starting the infusion.
To reduce the risk of delayed infusion reactions, administer
oral corticosteroids to all patients the rst and second
day after all infusio ns. Patients with a history of obstructive
pulmonary disorders may require additional post-infusion
medications to manage respiratory complications.
Consider prescribing short- and long-acting bronchodilators
and inhaled corticosteroids for patients with obstructive
pulmonary disorders.
Interference with Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and
results in a positive Indirect Antiglobulin Test (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®. Type and screen
patients prior to starting DARZALEX®.
Please see brief summary of full Prescribing Information on adjacent page.