PEMETREXED-AFT

What it is

PEMETREXED-AFT is supplied as a sterile lyophilised powder for intravenous infusion available in single dose clear vials. It is available in 100 mg, 500 mg or 1000 mg pemetrexed strengths.

Approved indications

— Malignant pleural mesothelioma, in combination with cisplatin. — Locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology, in combination with cisplatin for initial treatment. — Locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology as monotherapy after prior platinum-based chemotherapy.

Dosing overview

The recommended dose of PEMETREXED-AFT is 500 mg/m² as body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle for both combination use with cisplatin and single agent use. When used with cisplatin, the recommended dose of cisplatin is 75 mg/m² BSA infused over 2 hours approximately 30 minutes after completion of the PEMETREXED-AFT infusion on the first day of each 21-day cycle. Pre-treatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reaction; in clinical trials, dexamethasone 4 mg was given by mouth twice daily the day before, the day of, and the day after PEMETREXED-AFT administration. Patients must be instructed to take a low-dose oral folic acid preparation or a multivitamin containing folic acid on a daily basis, with at least 5 daily doses during the 7-day period preceding the first dose of PEMETREXED-AFT, and dosing continuing during the full course of therapy and for 21 days after the last dose. Patients must also receive one intramuscular injection of vitamin B12 during the week preceding the first dose of PEMETREXED-AFT and every 3 cycles thereafter.

Key safety warnings

Skin rash has been reported in patients not pretreated with a corticosteroid, and pre-treatment with dexamethasone (or equivalent) reduces the incidence and severity of cutaneous reaction. Patients receiving PEMETREXED-AFT should be monitored before each dose with a complete blood count, including a differential and platelet count, and periodic blood chemistry tests should be collected to evaluate renal and hepatic function; absolute neutrophil count (ANC) should be ≥1500 cells/mm³ and platelets ≥100,000 cells/mm³ prior to scheduled administration of any cycle.

Regulatory history

PEMETREXED-AFT was first listed on the ARTG on 25 February 2020 for the 500 mg and 100 mg pemetrexed powder for injection vial strengths.