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.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
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).
- Infusion-related reactions
- Neutropenia
- Thrombocytopenia
- Hepatitis B reactivation
- Blood typing interference
- Embryo-fetal toxicity
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