Daratumumab (Darzalex®) was originally approved by the U.S. Food and Drug Administration in 2015 with additional indications added since. The most recent new indication was approved in September 2019 for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplantation.
Daratumumab is a CD38-directed cytolytic antibody, which is a type of immunotherapy.
Treatment of adult patients with multiple myeloma, as a monotherapy or in combination with other therapies.
Premedicate with corticosteroids, antipyretics, and antihistamines.
Recommended dose is 16 mg/kg of actual body weight. See full prescribing information for drugs used in combination and schedule.
Give via IV infusion using a 0.22 or 0.2 mcm inline filter.
Titrate per package insert based on volume and dose, and administer postinfusion medications.
Administer weekly for weeks 1–8, then every 2 weeks for weeks 9–24, and then every 4 weeks from week 25 until disease progression.
The most frequently reported adverse reactions (≥ 20%) were infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, bronchitis, pneumonia, and upper respiratory tract infection.
In clinical trials, approximately half of all patients experienced an infusion reaction. Most occurred during the first infusion and were grade 1–2. Have immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur. Frequently monitor patients during the entire infusion. Interrupt infusions for reactions, and permanently discontinue infusions for anaphylactic or life-threatening reactions.
Daratumumab binds to CD38 on red blood cells and results in a positive indirect Coombs test. A type and screen must be done for all patients prior to starting therapy. Positive Coombs tests may occur up to six months after the last administration. Notify the transfusion center that the patient has received daratumumab.
History of severe hypersensitivity to daratumumab or any of the components of the formulation.
Infusion reactions are common and can be severe. Premedications will reduce the likelihood or severity of a reaction. Seek medical assistance right away if you experience shortness of breath or trouble breathing, dizziness or lightheadedness, cough, wheezing, throat tightness, runny or stuffy nose, headache, itching, nausea, vomiting, bruising, bleeding, chills, or fever. Daratumumab can affect the results of blood tests to match your blood type for up to six months after your final dose of daratumumab. Treatment can decrease your white blood cell and platelet counts.
No overall differences in safety or effectiveness were observed between patients aged 65 or older and younger patients. Closely monitor for increased risk of infusion reaction and infection.
Daratumumab is not considered hazardous.
Patient Assistance Programs
A financial assistance program is available at darzalex.com/patient-financial-support.