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Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
Date:9/21/2007

ion for cisplatin treatment must be given.

Non-small cell lung cancer: The recommended dose of pemetrexed is 500 mg/m(squared) BSA, given by ten-minute infusion, on day 1 of each 21-day cycle.

Pre-medication: Supplement with 1000 micrograms intramuscular vitamin B12 and oral folic acid (350 to 1000 micrograms) to reduce toxicity (for full details see Summary of Product Characteristics [SPC]). 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 - this should be equivalent to 4mg of dexamethasone administered orally twice a day.

Monitoring: Monitor prior to each dose for complete blood cell count, including a differential white cell count and platelet count. Absolute neutrophil count should be > or = 1,500 cells/mm(cubed) and platelets > or = 100,000 cells/mm(cubed). Prior to each dose, collect blood chemistry tests to evaluate renal and hepatic function. Dose adjustments to pemetrexed and/or cisplatin at the start of a subsequent cycle should be based on nadir haematological counts or maximum non-haematological toxicity. If necessary, delay or withhold treatment in the presence of haematological toxicity, neurotoxicity, and/or impaired hepatic/renal function. (For full information on dose modification see SPC.)

Children and adolescents: Not recommended for use in patients under 18 years of age.

Renal impairment: Patients with creatinine clearance > or = 45 ml/min require no dose adjustment other than those recommended for all patients. Use in patients with creatinine clearance below 45 ml/min is not recommended. See also Warnings and Special Precautions.

Hepatic impairment: Patients with hepatic impairment, such as bilirubin >1.5-times the upper limit of normal and/or transaminase >3.0-times the upper limit of normal (hepatic metastases absent) or >5.0-times the upper limit of normal (hepatic metastases present), have n
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