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TARCEVA
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 TARCEVA
 
Active ingredients: Erlotinib.

Package
(a):
TABLETS: 30 x 25 mg.
This package has been discontinued.
Dosage(a):
Non-small cell lung cancer: 150 mg daily without food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.
Pancreatic cancer: 100 mg daily without food, in combination with gemcitabine. See prescribing information for full details.

Prescribing Restrictions:   
 
Package(b):
TABLETS: 30 x 100 mg.
Dosage(b):
Non-small cell lung cancer: 150 mg daily without food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.
Pancreatic cancer: 100 mg daily without food, in combination with gemcitabine. See prescribing information for full details.

Prescribing Restrictions:   
 
Package(c):
TABLETS: 30 x 150 mg.
Dosage(c):
Non-small cell lung cancer: 150 mg daily without food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.
Pancreatic cancer: 100 mg daily without food, in combination with gemcitabine. See prescribing information for full details.

Prescribing Restrictions:   
 

Indications:
For the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
In combination with gemcitabine, for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Monotherapy for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

Contra-Indications:
See prescribing information for full details.
Special Precautions:
There have been infrequent reports of serious Interstitial Lung Disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. Symptoms started from 5 days to more than 9 months (median 47 days) after initiating therapy. Most of the cases were associated with confounding or contributing factors such as concomitant/prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections.
Pregnancy and lactation: Women of childbearing potential should be advised to avoid pregnancy. Adequate contraceptive methods should be used during therapy, and for at least 2 weeks after completing therapy. Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the fetus. Breast-feeding should be avoided.
Periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) should be considered. Dose reduction or interruption should be considered if changes in liver function are severe. Erlotinib exposure may be increased in patients with hepatic dysfunction. Elevated international normalized ratio and potential bleeding. Patients taking Warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR. The safety and effectiveness in pediatric patients have not been studied. No dosage adjustments are recommended in elderly patients.
In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment should be interrupted pending diagnostic evaluation. Diarrhea can usually be managed with loperamide. Patients with severe diarrhea who are unresponsive to loperamide or who become dehydrated may require dose reduction or temporary interruption of therapy. Patients with severe skin reactions may also require dose reduction or temporary interruption of therapy. When dose reduction is necessary, the dose should be reduced in 50 mg decrements. In patients who are being concomitantly treated with a strong CYP3A4 inhibitor such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole, a dose reduction should be considered should severe adverse reactions occur. Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3. Alternate treatments lacking CYP3A4 inducing activity should be considered. If an alternative treatment is unavailable, a Tarceva dose greater than 150 mg should be considered. Erlotinib is eliminated by hepatic metabolism and biliary excretion. Therefore, caution should be used when treating patients with hepatic impairment. Dose reduction or interruption should be considered should severe adverse reactions occur. See prescribing information for full details.

Side Effects:
Rash, diarrhea, anorexia, fatigue, dyspnea, cough. Nausea, infection, vomiting, stomatitis, pruritis, dry skin, conjunctivitis, keratoconjuntivitis sicca, abdominal pain. Liver function test abnormalities. Serious adverse events reported were G.I. disorders, infections and infestations. See prescribing information for full details.
Drug Interactions:
Co-treatment with the potent CYP3A4 inhibitor ketoconazole and other strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole. Co-treatment with CYP3A4 inducers such as rifabutin, rifapentin, phenytoin, carbamazepine, phenobarbital and St. John's Wort. See prescribing information for full details.

Taken from MEDIC