Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell L... (istory of hepatitis alcoholism or liver ...)

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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

istory of hepatitis, alcoholism, or liver cirrhosis may exacerbate underlying hepatic insufficiency. Caution in patients with impaired hepatic function.

Concurrent radiotherapy (given together or <7 days apart): Gemcitabine has radiosensitising activity and significant toxicity may occur, particularly with large volumes of radiotherapy. It is feasible to administer gemcitabine at lower doses than 1,000mg/meter squared with concurrent radiotherapy with predictable toxicity (see SPC).

Sequential radiotherapy (given >7 days apart): Enhanced toxicity has not occurred when gemcitabine was started after the resolution of acute radiation effects or at least one week after radiation. Enhanced toxicity from radiation therapy following gemcitabine exposure has not occurred.

Precautions

Usage in pregnancy or lactation: Avoid in pregnant or breast-feeding women, since safety has not been established. Experimental animal studies have shown reproductive toxicity.

Patients should be cautioned against driving or operating machinery until they are sure they do not become somnolent.

Adverse Reactions

Haematological: Very common: Anaemia, leucopenia, neutropenia, and thrombocytopenia. Common: Febrile neutropenia. Very rare: Thrombocythaemia.

Hepatobiliary: Very common: Elevation of liver transaminases (AST, ALT) and alkaline phosphatase. Common: Increased bilirubin. Very rare: Serious hepatotoxicity, including liver failure and death, in patients receiving gemcitabine alone or in combination with other potentially hepatotoxic drugs. Rare: Increased gamma-glutamyl transferase (GGT).

Gastro-intestinal: Very common: Nausea or vomiting, which require therapy in about 20% of patients and is rarely dose-limiting. Common: Diarrhoea, oral toxicity (mainly soreness and erythema), and constipation.

Renal: Very common: Proteinuria and haematuria, rarely clinically significant. Rare: Haemolytic uraemic syndrome and renal failure of unkno
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SOURCE Eli Lilly and Company
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