and DARZALEX FASPRO
Darzalex (daratumumab) is the first laboratory-made monoclonal antibody that targets the CD38 protein on the surface of myeloma cells to be approved by the U.S. Food and Drug Administration (FDA). Darzalex is administered as an intravenous (IV) infusion. The slower the rate of the first infusion (up to 8 hours), the less likely it is that a severe administration-related reaction (ARR) will occur. At your doctor’s discretion, subsequent infusions may be given more rapidly. Split-dosing of the first infusion over two consecutive days is approved by the FDA.
Darzalex Faspro (daratumumab + hyaluronidase-fihj) is a newer formulation of Darzalex that is administered as a subcutaneous (SQ) injection under the skin of your abdomen in only a few minutes. The SQ formulation is as effective as the IV formulation, and it has a reduced risk of an ARR. Nearly all patients are now treated with the SQ formulation.
FDA-approved regimens
Patients are premedicated with a steroid, acetaminophen, and a histamine-1 receptor antagonist. Your doctor may also recommend post-injection medication.
Newly diagnosed multiple myeloma (NDMM)
¡ DVRd [combination of SQ Darzalex Faspro + Velcade® (bortezomib) + Revlimid® (lenalidomide) + dexamethasone] for patients who are eligible for autologous stem cell transplantation (ASCT).
¡ DVTd [in combination with Velcade + thalidomide + dexamethasone] for patients who are ASCT-eligible.
¡ DRd [in combination with Revlimid + dexamethasone] for patients who are ASCT-ineligible.
¡ DVMP [in combination with Velcade + melphalan + prednisone] for patients who are ASCT-ineligible.
Relapsed refractory multiple myeloma (RRMM)
¡ DVd [in combination with Velcade + dexamethasone] for patients who have received at least 1 prior therapy.
¡ DRd [in combination with Revlimid + dexamethasone] for patients who have received at least 1 prior therapy.
¡ DPd [in combination with Pomalyst® (pomalidomide) + dexamethasone] for patients have received at least 1 prior therapy.
¡ DKd [in combination with Kyprolis® (carfilzomib) + dexamethasone] for patients who have received 1 to 3 prior lines of therapy.
¡ Monotherapy [as a single agent] for patients who have received at least 3 prior lines of therapy.
Possible side effects
Side effects that occurred in 20% or more of patients in the Darzalex registration clinical trials were infusion reactions, fatigue, nausea, back pain, fever, cough, and upper respiratory tract infection.
You might experience diarrhea, shortness of breath, trouble sleeping, muscle spasms, vomiting, neuropathy, and lung infection (pneumonia). Promptly report your concerns to your doctor, who will assess if a dose reduction is appropriate.
Special precautions
¡ Hypersensitivity: Your doctor will discontinue treatment for life-threatening reactions.
¡ Darzalex may cause your blood cell counts to drop: Your doctor will monitor your complete blood counts (CBC) and will monitor you for signs of infection.
¡ Interference with cross-matching and red blood cell antibody screening: You will be screened prior to starting treatment in case you subsequently need a blood transfusion. Blood banks should be informed that you have received Darzalex.
¡ Patients with prior hepatitis B (HBV) virus infection: In clinical trials with Darzalex, HBV reactivation was reported in less than 1% of patients,
but there were fatal cases. You will get preventive antiviral medication and will be monitored before, during, and after treatment with Darzalex.
¡ Risk of herpes zoster (“shingles”) infection: A small percentage of patients in Darzalex clinical trials developed shingles. You must take preventive antiviral medication within 1 week of starting Darzalex and continue for 3 months after stopping Darzalex.
¡ Embryo-fetal toxicity: Females of reproductive potential must use effective contraception during treatment and for 3 months after stopping Darzalex treatment.
¡ In patients with IgG kappa myeloma: Your M-protein will be monitored with serum immunofixation electrophoresis (sIFE) testing to assess response to treatment and/or disease progression. This is because Darzalex has been known to interfere with the results of serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE) tests.
Darzalex assistance program
If you are prescribed Darzalex or Darzalex Faspro, you can sign up for the “DARZALEX withMe” program. Visit darzalex.com or call 1.833.565.9631 Monday–Friday, 8 a.m. – 8 p.m. (ET) for help with personalized appointment reminders, access to nurse educators, and referrals to organizations that may provide assistance relevant to the patient’s needs.