Melphalan Flufenamide Application Scope

Pepaxto® is indicated, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.

Melphalan Flufenamide Characteristics

Ingredients: Melphalan flufenamide
Properties: Alkylating agent; peptide–drug conjugate (PDC)
Packaging Specification: 20 mg × 1 vial/box (lyophilized powder for injection)
Storage: Store at 2–8°C; protect from light
Expiry Date: As per package label
Executive Standard: FDA/EMA approval standards
Approval Number: FDA NDA 214383 (withdrawn in US in 2022, still approved in EU)
Date of Revision: Latest EMA SmPC: July 2022
Manufacturer: Oncopeptides AB (Sweden)

Guidelines for the Use of Pepaxto

Dosage and Administration:
- Recommended Dose: 40 mg IV every 28 days (Day 1 of each cycle), combined with dexamethasone
- Administration: Intravenous infusion over 30 minutes
- Missed Dose: Administer as soon as possible; adjust schedule as needed
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Nausea, diarrhea
  - Cytopenias (anemia, thrombocytopenia, neutropenia)
  - Pyrexia
- Serious Adverse Reactions:
  - Severe thrombocytopenia
  - Neutropenia with infections
  - Secondary malignancies
Contraindications:
- Hypersensitivity to excipients
- Pregnancy and breastfeeding
Precautions:
- Monitor blood counts regularly
- Risk of severe cytopenias
- Use contraception during and after treatment
- Adjust dose for severe toxicity

Melphalan Flufenamide Interactions

Limited data on drug–drug interactions
Caution with myelosuppressive agents (additive hematologic toxicity)
No major CYP-mediated interactions identified

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.