Pemeta

Pemetrexed USP

Composition: Pemeta: Each vial contains Pemetrexed 100mg as Pemetrexed Disodium Heptahydrate USP lyophilized powder for IV infusion.

Pemeta-500: Each vial contains Pemetrexed 500mg as Pemetrexed Disodium Heptahydrate USP lyophilized powder for IV infusion.

Indications:
Non-Squamous Non-Small Cell Lung Cancer (NSCLC): Pemetrexed is indicated:
• in combination with Pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
• in combination with Cisplatin for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non-small cell lung cancer (NSCLC).
• as a single agent for the maintenance treatment of patients with locally advanced or metastatic, nonsquamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
• as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.

Dosage and Administration:
Recommended Dosage for Non-Squamous NSCLC:
• The recommended dose of Pemetrexed when administered with Pembrolizumab and platinum chemotherapy for the initial treatment of metastatic non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes administered after Pembrolizumab and prior to Carboplatin or Cisplatin on Day 1 of each 21-day cycle for 4 cycles. Following completion of platinum-based therapy, treatment with Pemetrexed with or without Pembrolizumab is administered until disease progression or unacceptable toxicity.

• The recommended dose of Pemetrexed when administered with Cisplatin for initial treatment of locally advanced or metastatic non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes administered prior to Cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
• The recommended dose of Pemeta for maintenance treatment of non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.

• The recommended dose of Pemetrexed for treatment of recurrent non-squamous NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. Or, as directed by the registered physician.

Use in Pregnancy and Lactation: can cause fetal harm when administered to a pregnant woman. There are no available data on Pemetrexed use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Lactation: There is no information regarding the presence of Pemetrexed or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

Packing: Pemeta: Each box contains one vial of 100mg Pemetrexed USP lyophilized powder for IV infusion.

Pemeta-500: Each box contains one vial of 500mg Pemetrexed USP lyophilized powder for IV infusion.

Prescribing Description

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