Darzalex (daratumumab)
Janssen Oncology · Anti-CD38 Monoclonal Antibody
What is Darzalex? Darzalex (daratumumab) is an anti-CD38 monoclonal antibody by Janssen approved for multiple myeloma in multiple treatment lines — both as monotherapy and in numerous combination regimens. Darzalex Faspro is the subcutaneous formulation.
About Darzalex
| Brand Name | Darzalex |
| Generic / INN | daratumumab |
| Drug Class | Anti-CD38 Monoclonal Antibody |
| Manufacturer | Janssen Oncology |
| Administration | Intravenous (IV) infusion or subcutaneous injection |
| FDA Approval | 2015 |
FDA-Approved Uses for Darzalex
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Multiple myeloma — newly diagnosed, transplant-eligible (VTd, VRd, D-VMP)
- Multiple myeloma — newly diagnosed, transplant-ineligible (D-Rd, D-VMP)
- Multiple myeloma — relapsed/refractory (multiple combinations: D-Pd, D-Kd, D-Vd, D-Rd, monotherapy)
- Light chain (AL) amyloidosis — with bortezomib, cyclophosphamide, dexamethasone (daratumumab SC)
How Does Darzalex Work?
Daratumumab targets CD38 — a transmembrane glycoprotein highly expressed on myeloma cells. It kills myeloma cells through multiple mechanisms: complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and induction of apoptosis.
Dosage & Administration
IV regimen: complex schedule (weekly × 8, every 2 weeks × 16, then every 4 weeks). SC (Darzalex Faspro): 1800 mg fixed dose, approximately 3–5 minutes — dramatically faster than IV. Specific dosing schedules depend on the combination regimen.
Warnings, Precautions & Side Effects
General Warning
Infusion-related reactions — very common with IV (pre-medication required); significantly less with SC. Neutropenia, thrombocytopenia. Infections (hepatitis B reactivation screening required). Embryo-fetal toxicity. Interference with serologic testing (cross-reacts with blood typing assays).
Common Side Effects
- Infusion-related reactions (IV)
- Upper respiratory infections
- Fatigue
- Nausea
- Anemia
- Neutropenia
- Thrombocytopenia
- Diarrhea
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Darzalex is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Darzalex. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part B covers this IV medication when administered in a clinical setting. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Darzalex
Darzalex is an anti-CD38 antibody approved for multiple myeloma across nearly every treatment line. It kills myeloma cells through multiple immune mechanisms and has become a backbone of most modern myeloma regimens.
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is the subcutaneous formulation — given as a 3–5 minute injection rather than the 3–7 hour IV infusion, with significantly fewer infusion reactions.
Yes — daratumumab binds CD38 on red blood cells used in lab tests, causing false-positive results in indirect antiglobulin tests (blood typing). Patients must inform transfusion services they are receiving daratumumab.
Darzalex IV is covered by Medicare Part B; Darzalex Faspro (SC) coverage may be Part B or Part D depending on where administered. Prior authorization required.
Related Medications & Conditions
Related Medications
Sarclisa (isatuximab) · Velcade (bortezomib) · Revlimid (lenalidomide) · Kyprolis (carfilzomib) · Abecma (idecabtagene vicleucel)
Related Conditions
Multiple myeloma · AL amyloidosis · Relapsed/refractory myeloma