Fontrexed 500mg powder for injection

18 TO 65 YEARS OLD
— Pemetrexed in combination with cisplatin
The recommended dose of pemetrexed is 500 mg/m² of body surface area (BSA), administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m² BSA infused over 2 hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle. Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin.

— Pemetrexed as a single agent
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.

— Premedication regimen
To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration. The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day.

65 YEARS OLD AND ABOVE
There has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old. No dose reductions other than those recommended for all patients are necessary.

ADMINISTRATION
Pemetrexed must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy. Pemetrexed should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.

PATIENTS WITH RENAL IMPAIRMENT
(standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m-DTPA serum clearance method)
Pemetrexed is primarily eliminated unchanged by renal excretion. Patients with creatinine clearance of ≥45 ml/minute required no dose adjustments other than those recommended for all patients. There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/minute; therefore, the use of pemetrexed is not recommended.

PATIENTS WITH HEPATIC IMPAIRMENT
No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified. However, patients with hepatic impairment, such as bilirubin >1.5-times the upper limit of normal and/or aminotransferase >3.0-times the upper limit of normal (hepatic metastases absent) or >5.0-times the upper limit of normal (hepatic metastases present), have not been specifically studied.

Malignant pleural mesothelioma
Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. First-line treatment should be a platinum-based with other cytotoxics chemotherapy.
Pemetrexed is indicated as a single-agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy (as second line).Pemetrexed is not indicated for treatment of patients with squamous cell non-small cell lung cancer.