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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

wn aetiology. GEMZAR should be withdrawn if there is any sign of micro- angiopathic haemolytic anaemia.

Skin and allergic: Very common: Rash, pruritus, and alopecia. Rare: Vesiculation and ulceration. Very rare: Desquamation, bullous skin eruptions, and anaphylaxis.

Respiratory: Very common: Dyspnoea. Bronchospasm occurs uncommonly and is usually mild and transient, but parenteral therapy may be required. In the rare event of pulmonary oedema, interstitial pneumonitis, or adult respiratory distress syndrome (ARDS) gemcitabine should be stopped and supportive care initiated.

Cardiac: Very rare: Myocardial infarct, congestive heart failure, and arrhythmia.

Other: Very common: Influenza-like symptoms (fever, headache, back pain, chills, myalgia, asthenia, and anorexia), cough, rhinitis, malaise, sweating, insomnia, oedema or peripheral oedema, and somnolence. Common: Somnolence, fever, and asthenia. Very rare: Peripheral vasculitis and gangrene.

Combination use in breast cancer: When gemcitabine is used with paclitaxel the frequency of Grade 3 and 4 haematological toxicities increases, particularly neutropenia, although not associated with an increased incidence of infections. Fatigue and febrile neutropenia also occur more frequently with this combination.

Administration site conditions: Rare: Injection site reactions (mainly mild).

For full details of these and other side-effects, please see the Summary of Product Characteristics, approved in your country.

(i) Lilly Oncology, "Understanding Cancer: About Lung Cancer," Eli Lilly and Company, http://www.lillyoncology.com/patients_caregivers/lung_cancer.jsp?reqNavId=4.2.7, (January 19, 2007).

(ii) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?," October 25, 2006, American Cancer Society,

SOURCE Eli Lilly and Company
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