darzalex

darzalex Uses, Dosage, Side Effects, Food Interaction and all others data.

darzalex is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab. It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.

darzalex was granted FDA approval on 16 November 2015.

darzalex is a monoclonal antibody that targets and induces apoptosis in cells that highly express CD38, including multiple myeloma cells. It has a long duration of action as it is given every 1-4 weeks. Patients should be counselled regarding the risk of hypersensitivity, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interferences with cross-matching and red blood cell antibody screening.

Trade Name darzalex
Availability Prescription only
Generic Daratumumab
Daratumumab Other Names Daratumumab
Related Drugs Darzalex, Revlimid, Velcade, Pomalyst, Ninlaro, Kyprolis
Weight 20mg/ml, , 400mg, 100mg
Type Injection, Solution, Concentrate, Infusion, Intravenous Solution
Formula C6466H9996N1724O2010S42
Weight 145391.67 Da
Protein binding

Data regarding protein binding of daratumumab in serum is not readily available.

Groups Approved
Therapeutic Class
Manufacturer Janssen Pharmaceutica N,v,, Janssen-cilag Ltd, Janseen Pharmaceuticals
Available Country Saudi Arabia, Australia, Canada, United Kingdom, India, United States,
Last Updated: September 19, 2023 at 7:00 am
darzalex
darzalex

Uses

darzalex is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma.

darzalex is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma. Subcutaneous daratumumab with hyaluronidase is also indicated alone or in combination for the treatment of multiple myeloma.

darzalex is also used to associated treatment for these conditions: Multiple Myeloma (MM), Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed Or Refractory Multiple Myeloma

How darzalex works

CD38 is a glycoprotein present on the surface of hematopoietic cells and is responsible for a number of cell signalling functions. darzalex is an immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that targets CD38. Cancers like multiple myeloma overexpress CD38, allowing daratumumab to have higher affinity for these cells. This binding allows daratumumab to induce apoptosis, antibody dependent cellular phagocytosis, and antibody and complement-dependent cytotoxicity. Antibody dependent cellular phagocytosis is mediated by the FC region of the antibody inducing phagocytes such as macrophages, antibody dependent cellular cytotoxicity is mediated by the FC region of the antibody inducing effector cells such as natural killer cells, and complement dependent cytotoxicity is mediated by the FC region of the antibody binding to and inducing complement protein activity.

Toxicity

Data regarding overdoses of daratumumab are not readily available. Patients should be treated with symptomatic and supportive measures.

Food Interaction

No interactions found.

darzalex Disease Interaction

Moderate: cytopenias, infusion reactions

Volume of Distribution

darzalex intravenous monotherapy has a volume of distribution of 4.7 ± 1.3L and the combination therapy has a volume of distribution of 4.4 ± 1.5L. Subcutaneous daratumumab has a volume of distribution of the central compartment of 5.2L and a volume of distribution of the peripheral compartment of 3.8L.

Elimination Route

Subcutaneous daratumumab reaches a Cmax of 592µg/mL compared to intravenous daratumumab, which reaches a Cmax of 688µg/mL. The AUC of subcutaneous daratumumab is 4017µg/mL*day compared to intravenous daratumumab, which has an AUC of 4019µg/mL*day.

Half Life

Intravenous daratumumab has a terminal half life of 18 ± 9 days. Subcutaneous daratumumab has a half life of 20 days.

Clearance

Intravenous daratumumab has a clearance of 171.4 ± 95.3mL/day. Subcutaneous daratumumab has a clearance of 119mL/day.

Elimination Route

Monoclonal antibodies are metabolized to amino acids used for synthesis of new proteins or are eliminated by the kidneys.

Innovators Monograph

You find simplified version here darzalex

*** Taking medicines without doctor's advice can cause long-term problems.
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