Darzalex® Daratumumab Injection

Description

Brand Names Across Regions

Darzalex (USA, EU, UK, Canada, Australia), Darzalex Faspro (subcutaneous combination with hyaluronidase – US), Darzalex SC (Europe, Australia)

What is Daratumumab?

Daratumumab is a human IgG1κ monoclonal antibody designed to target CD38, a surface protein highly expressed on multiple myeloma cells and other hematologic malignancies. Marketed primarily under the brand name Darzalex by Janssen Pharmaceuticals, daratumumab is used in combination regimens for the treatment of newly diagnosed and relapsed/refractory multiple myeloma, AL amyloidosis, and other off-label applications under physician discretion.

Daratumumab was the first CD38-targeting antibody approved for clinical use, changing the therapeutic landscape of multiple myeloma.

Source: Mayo Clinic

Daratumumab Mechanism of Action

Daratumumab binds to CD38 on plasma cells, leading to direct oncolytic effects through multiple immune mechanisms:

• Complement-dependent cytotoxicity (CDC)

• Antibody-dependent cellular cytotoxicity (ADCC)

• Antibody-dependent cellular phagocytosis (ADCP)

• Apoptosis induction via crosslinking

Additionally, it modulates immune suppressor cells such as regulatory T cells and B cells in the bone marrow microenvironment, further enhancing anti-myeloma activity.

Source: NIH PubMed

On-label and Off-label Uses

On-label Indications

• Newly diagnosed multiple myeloma (NDMM) in transplant-eligible and ineligible patients

• Relapsed or refractory multiple myeloma (RRMM)

• Light chain (AL) amyloidosis

• In combination with regimens such as lenalidomide, dexamethasone, bortezomib, carfilzomib, pomalidomide, and daratumumab subcutaneous preparations

Off-label Uses

• Chronic lymphocytic leukemia (CLL)

• T-cell prolymphocytic leukemia

• Autoimmune hemolytic anemia in select refractory cases

These uses are supported by ongoing clinical trials or case studies and must be evaluated for safety and efficacy by a medical provider.

Daratumumab Dose and Administration

Daratumumab injection is available in two standard concentrations: 100mg/5mL and 400mg/20mL vials for intravenous infusion. The standard daratumumab dose is weight-independent and usually fixed at:

• 16 mg/kg IV weekly in initial cycles for multiple myeloma

• 1800 mg SC (subcutaneous Darzalex Faspro), with pre-mixed hyaluronidase for faster administration

Infusion time for IV daratumumab can exceed 6–7 hours initially, though newer subcutaneous formulations reduce this to approximately 5 minutes.

Source: Darzalex US Prescribing Info

Daratumumab Subcutaneous Formulation

Subcutaneous daratumumab (Darzalex Faspro) offers the same efficacy as IV formulation with fewer infusion-related reactions and faster administration. This formulation combines daratumumab with recombinant human hyaluronidase PH20 and is administered as a fixed 1800 mg dose weekly or monthly depending on the treatment phase.

Benefits include:

• Reduced infusion-related reactions

• Greater patient convenience

• Lower healthcare resource utilization

Source: New England Journal of Medicine

Daratumumab Side Effects

The most common side effects include:

• Infusion-related reactions (especially during the first IV dose)

• Fatigue

• Nausea

• Cough

• Upper respiratory tract infections

• Constipation

Serious risks may include neutropenia, thrombocytopenia, and hepatotoxicity. Use of daratumumab may also interfere with blood compatibility testing due to its binding to CD38 on red blood cells. Blood typing should be completed prior to treatment initiation.

Source: FDA Label

Daratumumab Cost, Price, and Sales

Darzalex Cost and Availability

• Darzalex 400 mg price ranges from $3,000 to $6,000 per vial depending on market

• Daratumumab cost per year may exceed $120,000 without insurance

• Darzalex buy online options are available through licensed international pharmacies

As of 2024, generic daratumumab is not yet widely available, but several biosimilars are in development or under review.

Darzalex Sales and Market Impact

Janssen Darzalex has achieved global sales exceeding $7 billion annually, making it one of the top-selling hematology drugs worldwide.

Source: Evaluate Pharma

Daratumumab vs Darzalex Generic

No FDA-approved darzalex generic is currently available. While biosimilar versions are in clinical stages, only branded Darzalex and Darzalex Faspro are available for use in North America, the EU, and Australia.

Patients can explore alternative purchasing channels for darzalex buy online at reduced rates.

FAQ

What is Daratumumab used for?
Daratumumab is used to treat multiple myeloma and AL amyloidosis, either alone or in combination with other drugs.

What are common daratumumab side effects?
Fatigue, nausea, infections, and infusion reactions are common. Some patients may experience blood count abnormalities.

How is daratumumab administered?
It can be given via IV infusion or subcutaneous injection, depending on the formulation.

Is there a darzalex generic available?
Currently, there is no generic daratumumab, although biosimilars are under development.

How much does Darzalex cost?
The darzalex 400 mg price ranges from $3,000 to $6,000. Yearly costs can exceed $100,000.