DARZALEX

Mfd. by :- Darzalex (Fulfilled By : Magicine Pharma)

Darzalex

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Magicine Pharma is registered with the Government Of NCT, India, Ministry Of Health in Government of Delhi, India, registration number DL-RAJ-122372 and as a wholesale distributor, department file No. 44208.

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Brand name - Darzalex 

Generic name - Daratumumab 

Type - Whole antibody 

Manufacturer - Janssen Biotech, Inc. 

Composition - 20 mg Daratumumab per mL 

Storage - Store Darzalex in a refrigerator at 2°C to 8°C (36°F to 46°F). 

Dosage form - Injection 

Strength - 100mg/5mL 

Packaging - Single dose vial 

Indication - Used in the treatment of multiple myeloma in adults 

Description 

Daratumumab is an anticancer drug. It is used in the treatment of multiple myeloma. Multiple myeloma is a type of cancer that affects white blood cells, also known as plasma cells. Darzalex is a monoclonal antibody, which is directed against CD38, a molecule present on myeloma cells. It's believed that Darzalex induces tumor cell death through multiple immune-mediated mechanisms of action,8,9 in addition to apoptosis, in which a series of molecular steps in a cell lead to its death. 

Ingredients of Darzalex 

The active ingredient of Darzalex is Daratumumab. 

Pharmacodynamics of Darzalex

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. 

Mechanism of action 

Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumor cells, as well as other cell types and tissues at various levels. CD38 protein has multiple functions such as receptor-mediated adhesion, signaling and enzymatic activity. 

Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumor cells. Based on in vitro studies, daratumumab may utilize multiple effector functions, resulting in immune-mediated tumor cell death. These studies suggest that daratumumab can induce tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis in malignancies expressing CD38. A subset of myeloid-derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs), and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis. T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation. Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow. In addition, T-cell receptor DNA sequencing verified that T-cell clonality was increased with daratumumab treatment, indicating immune-modulatory effects that may contribute to clinical response. 

Daratumumab induced apoptosis in vitro after Fc mediated cross-linking. In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity. The significance of these in vitro effects in a clinical setting, and the implications on tumour growth, are not well-understood. 

Pharmacodynamic effects of Darzalex

Natural killer (NK) cell and T-cell count. 

NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis. Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56dim) NK cells in peripheral whole blood and bone marrow were observed with daratumumab treatment. However, baseline levels of NK cells did not show an association with clinical response.  

Usage of medicine of Darzalex

Darzalex is used in the treatment of multiple myeloma, which is a type of cancer. 

Side effects of Darzalex

Common side effects 

  • dizziness 

  • weakness 

  • muscle spasms  

  • nausea  

  • vomiting 

  • diarrhea 

  • constipation 

  • decrease in appetite 

  • trouble while sleeping 

  • shortness of breath 

  • cough 

  • upper respiratory infection 

  • bronchitis 

  • body aches 

  • joint or back pain 

  • drowsiness 

  • high blood pressure 

  • fatigue 

Serious side effects 

  • trouble in breathing 

  • tightness in throat 

  • feeling light-headed  

  • coughing 

  • runny or stuffy nose 

  • nausea or vomiting 

  • headache 

  • itching 

  • coughing up phlegm 

  • fever and chills 

  • shortness of breath 

  • chest pain 

  • yellowing of skin 

  • numbness or tingling 

  • burning pain 

  • sensitivity 

  • weakness in hands or feet 

  • swelling of the arms or legs 

  • stretched skin 

  • dents on skin 

  • low level of platelets 

Dosage of Darzalex

The dosage is based on your medical condition and requirement. Please ask your healthcare provider for the same. 

Warning and precautions of Darzalex

  • Avoid performing or indulging in activities that could cause injury. 

  • Avoid exposure to the sun.  

  • Avoid drinking alcoholic beverages, in general.  

  • You may be at risk of getting infected, therefore try to avoid crowds. 

  • Report every side effect to your healthcare provider. Your healthcare provider can prescribe you the needed medications for the same.  

Self care tips 

  • Drink plenty of water, unless you are instructed otherwise. 

  • Wash your hands often. 

  • Use an electric razor and a soft toothbrush to minimize bleeding. 

  • You may take anti-nausea medications as prescribed by your healthcare provider to avoid nausea. Also, eat small and frequent meals. 

  • Get plenty of rest. 

  • Maintain good nutrition. 

  • Remain active. You may indulge in easy activities like daily walks. 

Ques-1 What is Darzalex? 

Ans-1 Darzalex is an anticancer drug, used in the treatment of multiple myeloma. 

Ques-2 How should I take Darzalex? 

Ans-2 Please consult your healthcare provider. 

Ques-3 What are the possible side effects of Darzalex? 

Ans-3 The common side effects of Darzalex include fever, chills, vomiting, nausea, fatigue, stomach ache, body ache, weakness and trouble in sleeping. There can be other side effects of Darzalex as well. Please consult your healthcare provider if you experience these or other side effects. 

Ques-4 In what strength is it available? 

Ans-4 It is available in the strength of 100mg/5mL. 

Ques-5 What happens if I miss a dose? 

Ans-5 If you miss a dose, do not double the dose to catch up. Please ask your healthcare provider. 

Ques-6 What should I avoid while consuming this medicine? Ans-6 Avoid drinking alcoholic beverages.  

Ques-7 What are self care tips? 

Ans-7 Maintain a nutritional diet. Drink plenty of fluids. Take proper rest. You may experience side effects such as vomiting and nausea. To deal with them, do not overeat. Eat small and frequent meals. 

Ques-8 Can I take this medicine during pregnancy? 

Ans-8 Please ask your healthcare provider because Darzalex may cause fetal harm. 

Ques-9 Can I drive after taking this medicine? 

Ans-9 If you experience side effects such as dizziness and headache, avoid driving and operating machines. 

Ques-10 What are the storage conditions? 

Ans-10 Store Darzalex in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. 

Above Content has been reviewed by Professionals