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.
