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TARCEVA (ERLOTINIB): DOSAGE AND ADMINISTRATION

NSCLC

The recommended daily dose of Tarceva (Erlotinib Hydrochloride) for NSCLC is 150 mg taken on an empty stomach at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.

Pancreatic Cancer

The recommended daily dose of Erlotinib Hydrochloride (Tarceva) for pancreatic cancer is 100 mg taken on an empty stomach at least one hour before or two hours after the ingestion of food, in combination with gemcitabine. Treatment should continue until disease progression or unacceptable toxicity occurs.

Dose Modifications

In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment with Tarceva (Erlotinib HCl) should be interrupted pending diagnostic evaluation. If Interstitial Lung Disease (ILD) is diagnosed, Erlotinib HCl (Tarceva) should be discontinued and appropriate treatment instituted as necessary. Discontinue Tarceva (Erlotinib HCl) tablets for hepatic failure or gastrointestinal perforation. Interrupt or discontinue Erlotinib HCl (Tarceva) tablets in patients with dehydration who are at risk for renal failure, in patients with severe bullous, blistering or exfoliative skin conditions, or in patients with acute /worsening ocular disorders.

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 Tarceva tablets dose should be reduced in 50 mg decrements.

In patients who are taking Erlotinib tablets with a strong CYP3A4 inhibitor such as, but not limited to, clarithromycin, atazanavir, indinavir, ketoconazole, itraconazole, nefazodone, ritonavir, nelfinavir, saquinavir, troleandomycin (TAO), telithromycin, voriconazole, or grapefruit or grapefruit juice, a dose reduction should be considered if severe adverse reactions occur. Similarly, in patients who are taking Tarceva with an inhibitor of both CYP3A4 and CYP1A2 like ciprofloxacin, a dose reduction of Erlotinib should be considered if severe adverse reactions occur.

Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3 to 4/5. Use of alternative treatments lacking CYP3A4 inducing activity is strongly recommended. If an alternative treatment is unavailable, an increase in the dose of Tarceva (Erlotinib) should be considered as tolerated at two week intervals while monitoring the patient's safety. The maximum dose of Erlotinib (Tarceva) studied in combination with rifampicin is 450 mg. If the Tarceva (Erlotinib Hydrochloride) dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other inducers. Other CYP3A4 inducers include, but are not limited to rifapentine, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort. These too should be avoided if possible.

Cigarette smoking has been shown to reduce erlotinib exposure. Patients should be advised to stop smoking. If a patient continues to smoke, a cautious increase in the dose of Erlotinib Hydrochloride (Tarceva), not exceeding 300 mg may be considered, while monitoring the patient's safety. However, efficacy and long-term safety (> 14 days) of a dose higher than the recommended starting doses have not been established in patients who continue to smoke cigarettes. If the Tarceva (Erlotinib HCl) dose is adjusted upward, the dose should be reduced immediately to the indicated starting dose upon cessation of smoking.

Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh B), patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Erlotinib HCl (Tarceva). Treatment with this medication should be used with extra caution in patients with total bilirubin > 3 x ULN. Tarceva (Erlotinib HCl) tablets dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range. In the setting of worsening liver function tests, before they become severe, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Erlotinib HCl (Tarceva) tablets dosing should be interrupted or discontinued if total bilirubin is > 3 x ULN and/or transaminases are > 5 x ULN in the setting of normal pretreatment values.

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