1. Indications and Usage
\nMonotherapy:
\nIndicated for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
\nCombination Therapy:
\nIndicated in combination with:
\nLenalidomide and Dexamethasone: For patients with previously untreated multiple myeloma (ineligible for autologous stem cell transplant) or previously treated multiple myeloma.
\nBortezomib and Dexamethasone: For patients with previously untreated multiple myeloma.
\nPomalidomide and Dexamethasone: For patients with previously treated multiple myeloma.
\nIsatuximab, Pomalidomide and Dexamethasone: For patients with previously treated multiple myeloma.
\n2. Dosage and Administration
\nRoute of Administration:
\nIntravenous (IV) Infusion: For Darzalex (IV formulation).
\nSubcutaneous (SC) Injection: For Darzalex Faspro (SC formulation).
\nRecommended Dosage (IV Formulation):
\nDose: 16 mg\/kg body weight.
\nSchedule (Monotherapy\/Combination):
\nWeeks 1\u20138: Once weekly.
\nWeeks 9\u201324: Every other week.
\nWeek 25 onwards: Every 4 weeks.
\nNote: For the first infusion, the dose can be split over two consecutive days (8 mg\/kg each day) to reduce infusion reactions.
\nPremedication:
\nAdminister acetaminophen, an antihistamine, and a corticosteroid prior to each infusion to mitigate infusion-related reactions (IRR).
\n3. Mechanism of Action
\nCD38 Targeting:
\nDaratumumab binds to CD38, a type III transmembrane glycoprotein expressed on myeloma cells and various immune regulatory cells.
\nCytotoxicity and Immunomodulation:
\nIt induces tumor cell death through multiple mechanisms:
\n1. Immune Mediation: Antibody-Dependent Cellular Cytotoxicity (ADCC), Complement-Dependent Cytotoxicity (CDC), and Antibody-Dependent Cellular Phagocytosis (ADCP).
\n2. Direct Apoptosis: Binding to CD38 induces direct apoptosis.
\n3. Immunomodulation: Depletes CD38+ immunosuppressive regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs), thereby enhancing T-cell and NK-cell responses.
\n4. Safety and Warnings
\nInfusion-Related Reactions (IRR):
\nOccur in a significant percentage of patients, primarily during the first infusion. Symptoms include nasal congestion, cough, throat irritation, and dyspnea. Close monitoring is required.
\nInterference with Laboratory Tests:
\nDaratumumab binds to the CD38 antigen on red blood cells, causing a positive direct antiglobulin test (DAT). It can also interfere with serum protein electrophoresis (SPEP) and immunofixation (IFE)assays, potentially complicating the assessment of treatment response.
\nInfections:
\nIncreased risk of serious bacterial, fungal, and viral infections. Prophylactic antiviral therapy (e.g., acyclovir) is recommended.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal harm; pregnancy testing is recommended before initiation.
\n5. Adverse Reactions
\nMost Common (Incidence \u226520%):
\nInfusion-related reactions.
\nFatigue.
\nMusculoskeletal pain.
\nNausea, diarrhea, cough.
\nAsthenia.
\nHematologic toxicities: Neutropenia, Thrombocytopenia, Anemia, Leukopenia.
\n6. Drug Interactions
\nImmunosuppressive Agents:
\nConcomitant use with other immunosuppressive therapies may increase the risk of infection.
\nVaccines:
\nAvoid live virus vaccines during treatment.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Daratumumab.
\nAppearance: Clear, colorless to slightly yellowish liquid.
\nStorage: Store at 2\u00b0C\u20138\u00b0C. Do not freeze or shake.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u5146\u73c2 \u00ae(Darzalex\u00ae)
\nGeneric Name: Daratumumab
\nStrength: 100 mg\/5 mL per vial
\nManufacturer: Cilag AG
\nMarketing Authorization Holder: Janssen-Cilag International NV (Belgium); domestic filing entity: Xi’an Janssen Pharmaceutical Ltd.Approval Date in China: July 4, 2019
\nRegistration Number: \u56fd\u836f\u51c6\u5b57S20190029
\nStorage: Refrigerate at 2\u00b0C\u20138\u00b0C (36\u00b0F\u201346\u00b0F) in the original carton to protect from light. Do not freeze or shake. Keep the vial upright. Keep out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Daratumumab\uff08Darzalex\uff09<\/p>\n","protected":false},"featured_media":3840,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25],"product_tag":[],"class_list":["post-3839","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n