Talquetamab-tgvs Application Scope

Talquetamab-tgvs, marketed under the brand name TALVEY™, is a bispecific GPRC5D-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Characteristics of Talquetamab-tgvs

Ingredients: Talquetamab is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) bispecific antibody directed against G protein-coupled receptor family C group 5 member D (GPRC5D) and the cluster of differentiation 3 (CD3) receptors.
Properties: Talquetamab-tgvs binds to GPRC5D on multiple myeloma cells and CD3 on T cells, activating T cells to release cytokines and lyse multiple myeloma cells.
Specification: Available in single-dose vials containing either 3 mg/1.5 mL (2 mg/mL) or 40 mg/1 mL (40 mg/mL) of talquetamab-tgvs.
Packaging Specification: Supplied as a sterile, preservative-free, colorless to light yellow solution in single-dose vials.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved under accelerated approval based on response rate and durability of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Approval Number: FDA approval granted on August 9, 2023.
Date of Revision: Refer to the latest prescribing information for the most current revision date.
Manufacturer: Janssen Biotech, Inc.

Guidelines for the Use of Talquetamab-tgvs:

Dosage and Administration:
- Step-Up Dosing Schedule:
  - Step-Up Dose 1: Administer 0.01 mg/kg subcutaneously on Day 1.
  - Step-Up Dose 2: Administer 0.06 mg/kg subcutaneously on Day 4.
  - First Treatment Dose: Administer 0.4 mg/kg subcutaneously on Day 7, followed by 0.4 mg/kg weekly thereafter.
- Alternative Biweekly Dosing Schedule:
  - Step-Up Dose 1: Administer 0.01 mg/kg subcutaneously on Day 1.
  - Step-Up Dose 2: Administer 0.06 mg/kg subcutaneously on Day 4.
  - Step-Up Dose 3: Administer 0.3 mg/kg subcutaneously on Day 7.
  - First Treatment Dose: Administer 0.8 mg/kg subcutaneously on Day 10, followed by 0.8 mg/kg every two weeks thereafter.
- Administer pre-treatment medications to reduce the risk of cytokine release syndrome (CRS).
Adverse Reactions:
- Common adverse reactions include CRS, skin-related toxicities, dysgeusia, nail disorders, musculoskeletal pain, fatigue, and weight loss.
- Serious adverse reactions may include infections, hepatotoxicity, and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Contraindications:
- No contraindications have been identified based on the current prescribing information.
Precautions:
- Monitor patients for signs and symptoms of CRS and administer supportive care as needed.
- Monitor for signs of neurologic toxicity, including ICANS.
- Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

Talquetamab-tgvs Interactions

Drug Interactions:
- Talquetamab-tgvs may interact with CYP450 substrates; monitor patients for potential interactions.
- Consult a healthcare provider for a comprehensive list of potential drug interactions.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.