Darzalex 400mg Injection

About

Daratumumab is a human IgG1 kappa monoclonal antibody that targets the CD38 protein, which is highly expressed on the surface of multiple myeloma cells and other hematopoietic cells. By binding to CD38, daratumumab initiates a cascade of immune-mediated cell death mechanisms, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). It also induces apoptosis directly and modulates the activity of regulatory T cells, myeloid-derived suppressor cells, and natural killer cells.

This medication is approved for the treatment of multiple myeloma, often in combination with other agents, for patients who have received prior therapy or as a first-line treatment. Its unique mechanism of action provides a significant therapeutic option for patients with this challenging hematologic malignancy. Due to its intravenous administration and potential for infusion-related reactions, it is typically given in a controlled clinical setting with appropriate premedication and monitoring.

Uses

• Treatment of newly diagnosed multiple myeloma in combination with other therapies.
• Treatment of relapsed or refractory multiple myeloma in combination with other therapies.
• Monotherapy for multiple myeloma patients who have received at least three prior lines of therapy.
• Treatment of multiple myeloma in patients who are ineligible for autologous stem cell transplant.

Directions For Use

This medication is administered as an intravenous infusion by a healthcare professional. Premedication is required to reduce the risk of infusion-related reactions.

Benefits

• Targets CD38 protein on myeloma cells specifically.
• Induces multiple immune-mediated cell death pathways.
• Effective in relapsed/refractory multiple myeloma.
• Can be used in combination or as monotherapy.
• Improves response rates and progression-free survival.
• Offers a significant treatment option for multiple myeloma.

Side Effects

• Infusion-related reactions (chills, dyspnea, cough)
• Fatigue
• Nausea
• Diarrhea
• Upper respiratory tract infection
• Cough
• Pyrexia
• Back pain
• Anemia
• Thrombocytopenia
• Neutropenia
• Peripheral sensory neuropathy

Safety Measures

• Alcohol - No specific contraindication with alcohol, but excessive use should be avoided due to general health considerations and potential for exacerbating fatigue.
• Pregnancy - Daratumumab is not recommended during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception during and for 3 months after treatment.
• Breastfeeding - It is unknown if daratumumab is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for 3 months after the last dose.
• Liver - No specific dose adjustment is typically required for mild to moderate hepatic impairment, but caution is advised, and liver function should be monitored.
• Kidney - No specific dose adjustment is typically required for mild to moderate renal impairment, but caution is advised, and kidney function should be monitored.
• Lung - Monitor for respiratory adverse reactions, including infusion-related reactions and interstitial lung disease; manage symptoms promptly.

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