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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

ot been specifically studied.

Contra-indications

Hypersensitivity to pemetrexed or to any of the excipients. Concomitant yellow fever vaccine. Breast-feeding.

Warnings and Special Precautions

Myelosuppression is usually the dose-limiting toxicity. Patients must be instructed to take folic acid and vitamin B12 as a prophylactic measure. Pre- treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions. Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in combination with other chemotherapeutic agents. Many of the patients in whom these occurred had underlying risk factors including dehydration or pre-existing hypertension or diabetes. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to administration. Serious cardiovascular events, including myocardial infarction and cerebrovascular events, have been uncommonly reported when pemetrexed is given in combination with other cytotoxic agents; most of these patients had pre-existing cardiovascular risk. Concomitant use of live attenuated vaccines is not recommended.

Interactions

Concomitant administration of nephrotoxic drugs and substances that are also tubularly secreted could potentially result in delayed clearance of pemetrexed. If necessary, creatinine clearance should be closely monitored. Patients must avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) with long elimination half-lives for at least 5 days prior to, on the day, and at least 2 days following pemetrexed administration. In patients with normal renal function (creatinine clearance > or = 80 ml/min), high doses of NSAIDs (such as ibuprofen >1600 mg/day) and aspirin at higher dosage (> or = 1.3 g daily) may decrease pemetrexed elimination and increase the occurrence of adverse events. Patients with mild to moderate renal insufficiency (creatinine clearance f
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SOURCE Eli Lilly and Company
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