- Indications and Usage Giant Cell Tumor of Bone: Indicated for the treatment of adult patients with unresectable or surgically harmful giant cell tumor of bone (GCTB).
- Dosage and Administration Recommended Dosage: 120 mg administered via subcutaneous injection. Loading Phase: The first three doses are administered at Day 1, Day 8, and Day 15. Maintenance Phase: Subsequent doses are administered every 4 weeks. Concomitant Medications: Calcium and Vitamin D supplementation must be given concurrently to treat and prevent hypocalcemia. Concomitant use with bisphosphonates is not recommended. Administration Details: The drug is for subcutaneous use only and must not be administered intravenously, intramuscularly, or intradermally.
- Mechanism of Action RANKL Inhibition: Narlumosbart is a recombinant humanized monoclonal antibody that binds with high affinity to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL). Osteoclast Inhibition: By binding to RANKL, it inhibits the interaction between RANKL and its receptor RANK on the surface of osteoclast precursors, thereby inhibiting osteoclast formation, function, and survival.
- Safety and Warnings Hypocalcemia: Hypocalcemia may occur. Pre-existing hypocalcemia must be corrected before initiating therapy, and patients must receive calcium and vitamin D supplementation. Osteonecrosis of the Jaw: Osteonecrosis of the jaw has been reported with RANKL inhibitors. A dental examination is recommended prior to starting therapy. Atypical Fractures: Non-typical fractures of the femur have been reported. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, may occur. Congenital and Fetal Toxicity: Can cause fetal harm if administered to pregnant women.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Hypocalcemia, back pain, arthralgia, fatigue, and musculoskeletal pain. Clinical Research Highlights: Clinical trials have demonstrated that narlumosbart can shrink tumors and prevent skeletal-related events in patients with GCTB.
- Drug Interactions Metabolic Pathways: As a monoclonal antibody, narlumosbart is not metabolized by cytochrome P450 (CYP) enzymes or other drug-metabolizing enzymes. Interaction Potential: Drug-drug interactions mediated by CYP enzyme inhibition or induction are not expected.
- Pharmaceutical Information Chemical Composition: Active ingredient: Narlumosbart. Appearance: Clear to slightly opalescent, colorless to pale yellow solution. Packaging: Supplied in single-use pre-filled syringes or vials (e.g., 120 mg/2 mL). Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.
Jinlitai Narlumosbart Injection
Brand Name:津立泰 ®（Jinlitai®）
Generic Name: Narlumosbart
Strength: 120 mg per 1.6 mL vial, single-use vial, 1 vial per box
Manufacturer: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. / 3SBio Inc. (Shanghai) Co., Ltd.
Marketing Authorization Holder: Shanghai Jinmant Biotech Co., Ltd. (CSPC Group subsidiary)
Approval Date in China: September 5, 2023
Registration Number: 国药准字S20230047
Storage: Store refrigerated at 2–8°C, protected from light. Do not freeze or shake violently. Refer to the full package insert for detailed storage specifications.
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