Darzalex (daratumumab)

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Darzalex (daratumumab)

How to buy Darzalex (daratumumab): You can order Darzalex (daratumumab) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Multiple Myeloma
Marketing Authorisation Holder Janssen-Cilag International N.V.
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 20 milligram / millilitre

What is Darzalex (daratumumab) for?

Darzalex (daratumumab) is a medicine used to treat multiple myeloma. Daratumumab is a human CD38-directed monoclonal antibody indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent1,2,8; or as second-line treatment of multiple myeloma in combination with other medicines, namely lenalidomide and dexamethasone, or bortezomib and dexamethasone1,3,8.

How does Darzalex (daratumumab) work?

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, producing an abnormal protein and pushing out other healthy blood cells from the bone marrow4.

Daratumumab is a monoclonal antibody that works by helping certain cells in the immune system attack these cancer cells4. One of the antigens expressed on the surface of multiple myeloma cells is called CD38. Anti-CD38 antibodies, like daratumumab, target multiple myeloma cells by binding to the CD38 antigen and then signaling the patient’s immune system to attack the tumour5.

Is Darzalex (daratumumab) approved?

Darzalex (daratumumab) was approved for multiple myeloma as monotherapy* by:

  • FDA (USA) on November 16, 20154

  • EMA (EU) on May 20, 20162

  • TGA (AUS) on July 17, 20178

*for the treatment of patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent3,4,8

Daratumumab is also indicated as second-line treatment in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone1,3,7,8

How is Darzalex (daratumumab) taken?

The recommended dose is 16 mg/kg body weight according to the following schedule.

As monotherapy and in combination with lenalidomide and low-dose dexamethasone:

  • weekly infusions for week 1–8 (total of 8 infusions)

  • from week 9–24 every 2 weeks (total of 8 infusions)

  • from week 25 onwards until disease progression every four weeks1,3

In combination with bortezomib and dexamethasone:

  • weekly infusions for week 1–9 (total of 9 infusions)

  • from week 10–24 every 3 weeks (total of 5 infusions)

  • from week 25 onwards until disease progression every four weeks1

Complete information about daratumumab dosage and administration can be found in the resources section.

Note: Consult your treating doctor for personalised dosing.

Are there any known side effects of Darzalex (daratumumab)?

Common side effects

The most common side effects adverse reactions (incidence ≥20%) listed in the prescribing information include: 

  • infusion reactions
  • neutropenia
  • thrombocytopenia
  • fatigue
  • nausea
  • diarrhea
  • muscle spasms
  • back pain
  • pyrexia
  • cough
  • dyspnea
  • peripheral edema
  • peripheral sensory neuropathy
  • upper respiratory tract infection.

Serious side effects

The serious side effects adverse reactions listed in the prescribing information include: 

  • infusion reactions
  • neutropenia
  • thrombocytopenia

Use in a specific population

Darzalex (daratumumab) may cause fetal myeloid or lymphoid-cell depletion and decreased bone density. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Darzalex and any potential adverse effects to the breast-fed child.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3,8.

More Information
Working ingredient daratumumab
Shipping method Cold chain (temperature controlled)
Therapeutic Area Oncology
Oncology Multiple Myeloma
Indication Relapsed multiple myeloma
Administration Intravenous
Mode of Action Monoclonal antibody (immunotherapy)
Strength 20
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Janssen-Cilag International N.V.
HS Code 30021091
CAS Number 945721-28-8

The approvals of daratumumab as monotherapy were partly based on two studies that returned positive results. In study MMY2002 31 of the 106 patients treated with daratumumab experienced a complete or partial reduction in their tumour burden (overall response rate (ORR) = 29.2%; 95% confidence interval (CI) 20.8, 38.9), which lasted for an average of 7.4 months 6,1,3. The median overall survival (OS) was 17.5 months3. The second study (GEN501), involving 42 participants, resulted in a complete or partial reduction of the tumour for 36% of the patients. The median duration of response was not reached and after 15.2 months 74% of the patients were still alive3.

The approval of daratumumab in combination with lenalidomide and dexamethasone was based on a study which compared treatment with daratumumab in combination with lenalidomide and dexamethasone (DLD) (N = 286) to lenalidomide and dexamethasone (LD) alone (N = 283) in 569 patients with multiple myeloma who had received at least one prior treatment. The OS in the DLD was 91.3% vs 74.6%. The median progression free survival (mPFS) was 18.4 months in the LD group while it was not reached in the DLD arm. The risk of disease progression or death in the DLD group was reduced by 63% in the DLD arm compared to the LD arm1.

The approval of daratumumab in combination with bortezomib and dexamethasone was based on a study which compared treatment with daratumumab in combination with bortezomib and dexamethasone (DBD) (N = 251) to bortezomib and dexamethasone (BD) alone (N = 247) in 498 patients with multiple myeloma who had received a median of 2 prior treatments. The mPFS was 7.2 months in the BD group while it was not reached in the DBD arm. The risk of disease progression or death in the BD group was reduced by 61% in the DBD arm compared to the BD arm1.


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.