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darzalex 400mg/20ml vial
دارزالكس 400مجم/20مل فيال
daratumumab · 400mg/20ml
55808EGP
Available
Active ingredient
daratumumab
Strength
400mg/20ml
Form
vial
Manufacturer
janssen cilag > soficopharm
Route
injection

Uses

Daratumumab is an anti-CD38 monoclonal antibody indicated for treatment of multiple myeloma in adults, including newly diagnosed patients ineligible for autologous stem cell transplant (in combination with lenalidomide/dexamethasone, bortezomib/melphalan/prednisone, or bortezomib/thalidomide/dexamethasone) and patients with relapsed or refractory multiple myeloma after at least one prior therapy.

Do not use if

Contraindicated in patients with a history of severe hypersensitivity reactions (such as anaphylaxis) to daratumumab or any component of the formulation.

Side effects

The most common adverse reactions include infusion-related reactions (fever, chills, nausea, cough), fatigue, neutropenia, thrombocytopenia, anemia, and infections. Infusion-related reactions are most common with the first infusion.

Warnings

Infusion-related reactions may be severe; premedicate and monitor patients during and after infusion. Increased risk of serious infections; monitor for signs of infection. Daratumumab interferes with blood bank compatibility testing (anti-CD38 reactivity); inform blood bank of treatment. Embryo-fetal toxicity: avoid during pregnancy.

How it works

Daratumumab is an IgG1-kappa human monoclonal antibody that binds to CD38, a transmembrane glycoprotein highly expressed on multiple myeloma cells. It induces tumor cell death through multiple mechanisms including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and apoptosis.

Storage

Store refrigerated at 2°C–8°C (36°F–46°F). Do not freeze or shake. Protect from light.