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DARZALEX 400 mg per 20 ml 20 mg/ml Concentrate for solution for infusion 20ml Vial

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DARZALEX 400 mg/20 ml is a prescription medication containing daratumumab, a CD38-directed monoclonal antibody used to treat multiple myeloma. It is administered via intravenous infusion under medical supervision to target and destroy cancer cells. This medication helps improve treatment outcomes and prolong survival in patients.

Product Details


DARZALEX (daratumumab) 400 mg/20 ml Concentrate for solution for infusion is a highly specialized medication indicated for the treatment of multiple myeloma.
It is a human CD38-directed monoclonal antibody that targets and binds to the CD38 protein expressed on the surface of multiple myeloma cells and other cell types.
This binding leads to the death of cancer cells through several immune-mediated mechanisms, providing a critical therapeutic option for patients with this challenging blood cancer.

Benefits of Use


DARZALEX offers significant benefits in the management of multiple myeloma, often in combination with other anti-myeloma agents.
It helps to improve overall response rates, prolong progression-free survival, and enhance the depth of response in both newly diagnosed and relapsed/refractory multiple myeloma patients.
Its targeted action specifically addresses cancer cells, contributing to better disease control and patient outcomes.

How to Use


1. A healthcare provider will prepare the solution by diluting the concentrate in an appropriate infusion solution.
2. The solution will then be administered intravenously over several hours.
3. The dose and frequency of administration will be determined by your doctor based on your specific condition, weight, and response to treatment.
4. Pre-medication (e.g., corticosteroids, antihistamines, antipyretics) may be administered before each infusion to reduce the risk of infusion-related reactions.

Caution & Warnings


  • Infusion-related reactions are common and can be severe. These may include chills, shortness of breath, throat tightness, cough, and wheezing. Patients are monitored closely during and after infusions.
  • May cause neutropenia (low white blood cell count) and thrombocytopenia (low platelet count), increasing the risk of infection and bleeding.
  • Serious infections, including bacterial, viral, and fungal infections, have been reported.
  • Can interfere with blood typing and cross-matching results due to daratumumab binding to CD38 on red blood cells. Inform blood transfusion centers that you are receiving Darzalex.
  • Consult your doctor if you experience fever, signs of infection, or unusual bleeding.
  • Not recommended for use in pregnant or breastfeeding women. Effective contraception should be used during and for a period after treatment.
  • This medication must be administered under the supervision of a healthcare professional experienced in the treatment of multiple myeloma.

Ingredients


Active Ingredient: Daratumumab.
Other Ingredients: L-histidine, L-histidine monohydrochloride monohydrate, mannitol, polysorbate 20, sodium chloride, water for injection.
More Information
Gtin 602233214
Recommended Sale Price 7266.5
Is Wasfaty Product No
Brand Not Defined
Ingredient Name DARATUMUMAB
SFDA Reg. No 602233214
IBC 602233214
Drug Type Prescription
Scientific Name Daratumumab
Strength 400 mg
Strength Unit mg
Form Concentrate for solution for infusion
Admin Route Intravenous
Size 20 ml
Size Unit ml
Package Types Vial
Package Size 1 vial
shelfLife 24 months
Storage conditions Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light.
Refrigerator Storage Yes
Distribute area Global