Ervex 150 Warnings

Pulmonary Toxicity: There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Erlotinib for treatment of NSCLC, pancreatic cancer or other advanced solid tumors.
Myocardial infarction/ischemia: In the pancreatic carcinoma trial, six patients (incidence of 2.3%) in the Erlotinib/gemcitabine group developed myocardial infarction/ischemia. One of these patients died due to myocardial infarction.
In comparison, 3 patients with the placebo/gemcitabine group developed myocardial infarction (incidence 1.2%) and one died due to myocardial infarction.
Cerebrovascular accident: In the pancreatic carcinoma trial, six patients in the Erlotinib/gemcitabine group developed cerebrovascular accidents (incidence: 2.3%). One of these was hemorrhagic and was the only fatal event.
Microangiopathic Haemolytic Anemia with Thrombocytopenia: In the pancreatic carcinoma trial, two patients in the Erlotinib/gemcitabine group developed microangiopathic haemolytic anemia with thrombocytopenia (incidence: 0.8%).
Use in Pregnancy: Pregnancy Category D: Erlotinib has been shown to cause maternal toxicity with associated embryo/fetal lethality and abortion in rabbits when given at doses that result in plasma drug concentrations of approximately 3 times those in humans (AUCs at 150 mg daily dose).
No teratogenic effects were observed in rabbits or rats.