Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/4

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energy and feelings of being tired. Additional very common side effects include nausea and vomiting, diarrhea, hair loss, loss of appetite, inflamed mucous membranes (especially the lining of the mouth), skin rash (which may be itchy, or may progress to become serious), abdominal pain, edema (swelling, usually of the limbs and face), fever, weakness, fatigue, difficulty breathing, cough, constipation, and headache.

Common (≥1% and < 10%)
Common side effects include decreased platelet counts (which may increase the chance of bruising and bleeding after injury), cellulitis (inflammation of tissues under the skin), decreased kidney function, urinary tract infection and other types of infection, difficulty sleeping, loss of body fluid (dehydration), pneumonia, allergic reactions, neuropathy (tingling and/or weakness of the arms, hands, feet, and legs), increased heart rate, conjunctivitis (pink eye), heartburn, taste disturbances, chest pain, heart attack, irregular heart rate, and renal failure.

Uncommon (≥0.1 % and < 1%)
Uncommon side effects reported by those taking pemetrexed include injection site reactions, intestinal obstruction, gastrointestinal bleeding, and formation of blood clots in deep veins.

This information relates to pemetrexed when taken as a single agent. These effects may also be anticipated when pemetrexed is used together with other chemotherapy drugs, but certain side effects may occur more frequently, such as decreased platelet counts, hair loss, decreased kidney function, injection site reactions, intestinal obstruction, gastrointestinal bleeding, and formation of blood clots in deep veins and serious skin reactions. Other chemotherapy drugs and treatment modalities such as radiation will also have their own, often unique, side effect profile and this should be taken into consideration when considering the likely effects of the treatment as a whole.

The majority of these side effects may be experienced by patients receiving most other chemotherapy drugs. Complications of some of the above side effects may lead to life-threatening events such as infections, kidney failure, bleeding, and possibly death. There is slight risk of severe allergic reaction to the drug, which may be life threatening. There is always a risk involved in taking a new drug but every precaution will be taken to minimize the risk

Postmarketing Data
Rare (≥ 0.01 % and < 0. 1%) cases of colitis (inflammation of the lining of the large bowel) have been reported in patients taking pemetrexed. Rare cases of radiation recall (a severe skin reaction) have been reported in patients who have previously received radiotherapy. Rare cases of interstitial pneumonitis (pneumonia involving the connective tissue of the lung) have been reported in patients treated with pemetrexed. Rare cases of edema have been reported in patients treated with pemetrexed.

Side effects can sometimes be serious or life threatening. Your doctor should be informed of all side effects you experience.

H3W-EW-S124 (b)
Version: 26-October-2009
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