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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

ary, the dose may be either reduced or withheld in the presence of haematological toxicity (see Summary of Product Characteristics [SPC]). For cisplatin dosage adjustment in combination therapy, see the manufacturer's prescribing information.

The elderly: Gemcitabine has been well tolerated by patients over the age of 65 years, and there is no evidence to suggest that dose adjustments are necessary.

Patients with hepatic and renal impairment: Gemcitabine should be used with caution in patients with hepatic insufficiency or with impaired renal function. Clinical studies have not provided sufficient information to allow clear dose recommendation for this patient population.

Periodic checks of liver and kidney functions, including transaminases and serum creatinine, should be performed in patients receiving gemcitabine.

Radical radiotherapy: Gemcitabine should not be used concurrently with radical radiotherapy.

Children: Limited Phase I and II trials in children did not provide sufficient data to establish the efficacy and safety of use of gemcitabine in children.

Contra-indications, Warnings, etc

Contra-indications

Known hypersensitivity to gemcitabine.

Warnings

Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity.

Myelosuppression is short-lived and usually does not result in dose reductions and rarely in discontinuation.

There have been very rare cases of haemolytic uraemic syndrome and/or thrombotic thrombocytopenic purpura (signs of micro-angiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH). If this occurs, discontinue gemcitabine immediately. Renal failure may not be reversible, even with discontinuation, and dialysis may be required.

Gemcitabine use in patients with concurrent liver metastases or pre- existing h
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SOURCE Eli Lilly and Company
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