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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

rom 49 to 79 ml/min) should avoid taking NSAIDs (e.g., ibuprofen) or aspirin at higher dosage, for 2 days before, on the day of, and 2 days following pemetrexed administration.

There is a possible interaction between oral anticoagulants and pemetrexed; therefore, increase the frequency of International Normalised Ratio monitoring (INR) if treating with oral anticoagulants.

Pregnancy and Lactation

Avoid in pregnancy and do not use in breast-feeding women.

Pemetrexed can be genotoxic; sexually mature males are advised not to father a child during treatment and up to 6 months thereafter. Owing to the possibility of irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment. Women of childbearing potential must use effective contraception during treatment.

Driving, etc

It has been reported that pemetrexed can cause somnolence. Patients should be cautioned against driving or operating machinery.

Undesirable Effects

Haematological: Very common: Anaemia, leucopenia, thrombocytopenia, neutropenia. Common: Febrile neutropenia and infection without neutropenia. Uncommon: Pancytopenia.

Gastro-intestinal: Very common: Nausea, vomiting, stomatitis/pharyngitis, anorexia, diarrhoea, constipation. Common: Dyspepsia, abdominal pain. Rare: Colitis.

General: Very common: Fatigue. Common: Fever, conjunctivitis.

Metabolism and nutrition: Common: Dehydration.

Nervous system: Very common: Neuropathy - sensory. Common: Neuropathy - motor, dysgeusia.

Renal and urinary: Very common: Creatinine elevation, creatinine clearance decreased. Common: Renal failure.

Hepatobiliary: Common: SGPT (ALT) elevation and SGOT (AST) elevation, increased GGT. Rare: Cases of hepatitis, potentially serious, have been reported during trials.

Skin and subcutaneous tissue: Very common: Rash/desquamation, alopecia. Common: Urticaria, allergic reaction/hypersensitivity, erythema m
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SOURCE Eli Lilly and Company
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