1. Indications and Usage
\nChronic Lymphocytic Leukemia (CLL):
\nIndicated for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab, and those who are refractory to fludarabine and have translocation t(14;14) (Arzerra indication).
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Intravenous (IV) Infusion ONLY.
\nRecommended Dosage (CLL):
\nCycle 1, Day 1: 300 mg IV. (Second infusion: 1000 mg IV on Day 8).
\nCycles 2\u20137: 1000 mg IV on Day 1 of each cycle.
\nSchedule: 28-day cycles.
\nPremedication:
\nMandatory premedication with corticosteroids, acetaminophen, and antihistamines prior to each infusion to reduce infusion-related reactions (IRR).
\nDilution:
\nDilute in 0.9% Sodium Chloride Injection.
\n3. Mechanism of Action
\nCD20 Antigen Binding:
\nOfatumumab is an IgG1k human monoclonal antibody that binds to a specific epitope on the CD20 antigen (both small and large extracellular loops).
\nCytotoxicity:
\nIt induces cell lysis through complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).
\n4. Safety and Warnings
\nInfusion-Related Reactions (IRR):
\nCan be severe, including hypotension, bronchospasm, and angioedema. Most frequent and severe during the first infusion.
\nInfections:
\nIncreased risk of serious bacterial, viral (including HBV reactivation), and fungal infections.
\nHepatitis B Reactivation:
\nScreening for HBV is required prior to initiation.
\nTumor Lysis Syndrome (TLS):
\nMonitor electrolytes and renal function.
\n5. Adverse Reactions
\nMost Common:
\nInfusion-related reactions, neutropenia, upper respiratory tract infections, cough, pyrexia, and anemia.
\n6. Drug Interactions
\nLive Vaccines:
\nContraindicated during and after treatment until immune reconstitution.
\nImmunosuppressants:
\nAdditive immunosuppressive effects.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Ofatumumab.
\nAppearance: Clear, colorless solution.
\nStorage: Store at 2\u00b0C\u20138\u00b0C.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u00a0 \u5168\u6b23\u8fbe \u00ae(Kesimpta\u00ae)
\nGeneric Name: Ofatumumab
\nStrength: 20 mg (0.4 mL) per prefilled autoinjector, 1 prefilled autoinjector per box
\nManufacturer: Novartis Pharma Stein AG
\nMarketing Authorization Holder: Novartis Pharmaceuticals Corporation (USA); domestic filing entity: Beijing Novartis Pharma Co., Ltd.
\nApproval Date in China: December 22, 2021
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 SJ20210034
\nStorage: Store at 2\u00b0C\u20138\u00b0C (36\u00b0F\u201346\u00b0F) in the original carton to protect from light. Do not freeze or shake. Keep out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Ofatumumab\uff08Kesimpta\uff09<\/p>\n","protected":false},"featured_media":3834,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[80],"product_cat":[25],"product_tag":[],"class_list":["post-3833","product","type-product","status-publish","has-post-thumbnail","product_brand-novartis","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n