Linvoseltamab (rivosettamab) instruction manual in Chinese

1. Common names: Linvoseltamab, Lynozyfic, rivosettamab (transliteration)

2. Indications:

Linvoseltamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody.

3. Usage and dosage:

1. Medication instructions: Inject Linvoseltamab intravenously according to the ascending protocol to reduce the incidence and severity of cytokine release syndrome (CRS). Administer as intravenous infusion only after dilution with 0.9% Sodium Chloride Injection. Give pre-treatment medications.

Linvoseltamab should be used by a healthcare provider with immediate access to emergency equipment and appropriate medical support to control serious reactions such as cytokine release syndrome (CRS), infusion-related reactions (IRR) and neurotoxicity, including ICANS. Due to the risk of CRS and neurotoxicity (including ICANS), patients should be hospitalized for 24 hours after the first ascending dose and for 24 hours after the second ascending dose.

2. Recommended dosage for intravenous injectionThe recommended dosage of linvoseltamab includes incremental doses of 5 mg, 25 mg and 200 mg, then 200 mg weekly for a total of 10 times, and then 200 mg every two weeks. In patients who achieve and maintain a very good partial response or better partial response at or after Week 24 and receive at least 17 doses of 200 mg, the dosing frequency is reduced to 200 mg every 4 weeks.

4. Adverse reactions:

In clinical studies of linvoseltamab, common adverse reactions (≥20%) included musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache and dyspnea. Common grade 3 or 4 laboratory abnormalities (≥30%) include decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.

5. Supply and storage:

Linvoseltamab injection is a clear to slightly opalescent, colorless to pale yellow solution in single-dose vials. Store unopened vials in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) to avoid light. Do not freeze or shake.

6. Special groups:

1. Women: Linvoseltamab may cause T cell activation and cytokine release; immune activation may affect pregnancy maintenance. Verify pregnancy status in females of reproductive potential before initiating treatment with linvoseltamab. Advise females of childbearing potential to use effective contraception during treatment and for 3 months after the last dose of linvoseltamab. Due to the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with linvoseltamab and for 3 months after the last dose.

7. Mechanism of action:

Linvoseltamab is a bispecific T-cell binding antibody that binds to the CD3 receptor expressed on the surface of T cells and the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, linvoseltamab activates T cells, causes the release of various pro-inflammatory cytokines, and leads to lysis of multiple myeloma cells. Linvoseltamab has antitumor activity in multiple myeloma mouse models.

Reference materials:https://en.wikipedia.org/wiki/Linvoseltamab