Mfd. by :- Darzalex (Fulfilled By : Magicine Pharma)
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.
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 - 400mg
Packaging - Single dose vial
Indication - Used in the treatment of multiple myeloma in adults
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.
The active ingredient of Darzalex is Daratumumab.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
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.
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.
Darzalex is used in the treatment of multiple myeloma, which is a type of cancer.
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
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
The dosage is based on your medical condition and requirement. Please ask your healthcare provider for the same.
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.
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.
Ans-1 Darzalex is an anticancer drug, used in the treatment of multiple myeloma.
Ans-2 Please consult your healthcare provider.
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.
Ans-4 It is available in the strength of 400mg.
Ans-5 If you miss a dose, do not double the dose to catch up. Please ask your healthcare provider.
Ans-6 Avoid drinking alcoholic beverages.
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.
Ans-8 Please ask your healthcare provider because Darzalex may cause fetal harm.
Ans-9 If you experience side effects such as dizziness and headache, avoid driving and operating machines.
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.
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