Buy Darzalex (Daratumumab)
Price range: €395.00 through €1,185.00
Darzalex (Daratumumab) is a human, CD38-directed monoclonal antibody for the treatment of multiple myeloma.
Who is Darzalex (daratumumab) suitable for?
Darzalex (daratumumab) is indicated for patients with:
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Newly diagnosed multiple myeloma for which autologous stem cell transplantation is not an option (first-line treatment). For this indication, it is used in combination with bortezomib, melphalan, and prednisone.
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Patients with multiple myeloma who have received at least one prior therapy (second-line treatment). For this indication, it is used in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.
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Patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (third-line therapy). For this indication, it is used in combination with pomalidomide and dexamethasone.
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Multiple myeloma patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are doubly refractory to a PI and an immunomodulatory agent (fourth-line treatment). For this indication, it is used as monotherapy.
How does Darzalex (Daratumumab) work?
Multiple myeloma is a form of blood cancer that originates in infection-fighting plasma cells (a type of white blood cell) in the bone marrow. These cancer cells multiply, produce an abnormal protein, and crowd out other healthy blood cells from the bone marrow.
Daratumumab is a monoclonal antibody that helps certain immune system cells attack these cancer cells. 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 tumor.
Where was Darzalex (daratumumab) approved?
Darzalex (daratumumab) has been approved for the treatment of multiple myeloma by:
- Food and Drug Administration (FDA), USA:
- May 7, 2018 as first-line therapy in combination with bortezomib, melphalan and prednisone.
- November 21, 2016 as second-line therapy in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone.
- June 16, 2017 as third-line therapy in combination with pomalidomide and dexamethasone.
- November 16, 2015 as a four-line therapy.
- EMA (EU) on 20. May 2016.
- Health Canada am 29. Juni 2016.
- TGA (AUS) on July 17, 2017
- Medsafe am 20. November 2017.
How is Darzalex (daratumumab) taken?
The recommended dose is 16 mg/kg body weight according to the following scheme.
As monotherapy and in combination with lenalidomide and low-dose dexamethasone:
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Weekly infusions for weeks 1–8 (8 infusions in total)
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from week 9–24 every 2 weeks (a total of 8 infusions)
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From week 25 until the disease progresses, every four weeks.
In combination with bortezomib and dexamethasone:
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Weekly infusions for weeks 1–9 (9 infusions in total)
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from week 10–24 every 3 weeks (a total of 5 infusions)
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From week 25 until the disease progresses, every four weeks.
In combination with bortezomib, melphalan and prednisone (6-week cycle):
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Weekly infusions for weeks 1–6 (6 infusions in total)
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from week 7–54 every 3 weeks (a total of 16 infusions)
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From week 55 until the disease progresses, every four weeks
Detailed information on the dosage and administration of daratumumab can be found in the “Resources” section.
Note: Ask your doctor about an individual dosage.
Are there any known adverse reactions or side effects of Darzalex (daratumumab)?
Common side effects
The most common side effects (frequency ≥20%) listed in the prescribing information include:1:
- Infusion reactions
- Neutropenia (low white blood cell count)
- Thrombocytopenia (low platelet count)
- fatigue
- Nausea (feeling sick)
- Diarrhea
- Vomit
- Muscle cramps
- Back pain
- Pyrexie (Fieber)
- Cough
- Dyspnea (shortness of breath)
- Dizziness (feeling lightheaded, dizzy, or loss of balance)
- insomnia
- peripheral edema (fluid accumulation in the limbs)
- peripheral sensory neuropathy
- Upper respiratory tract infection.
Serious side effects
Serious side effects listed in the prescribing information include:
- Infusion reactions
- neutropenia
- Thrombocytopenia.
| Quantity |
100mg / 5mL ,400mg / 20mL |
|---|
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