Interstitial Lung Disease (ILD)

Discontinue TARCEVA

During diagnostic evaluation for possible ILD

Withhold TARCEVA†

Severe hepatic toxicity that does not improve significantly or resolve within three weeks

Discontinue TARCEVA

In patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline

Withhold TARCEVA† and consider discontinuation

In patients without pre-existing hepatic impairment for total bilirubin levels greater than 3 times the upper limit of normal or transaminases greater than 5 times the upper limit of normal

Withhold TARCEVA† and consider discontinuation

For severe (CTCAE grade 3 to 4) renal toxicity

Withhold TARCEVA† and consider discontinuation

Gastrointestinal perforation

Discontinue TARCEVA

For persistent severe diarrhea not responsive to medical management (e.g., loperamide)

Withhold TARCEVA†

Severe bullous, blistering or exfoliating skin conditions

Discontinue TARCEVA

For severe rash not responsive to medical management

Withhold TARCEVA†

Corneal perforation or severe ulceration

Discontinue TARCEVA

For keratitis of (NCI-CTC version 4.0) grade 3-4 or for grade 2 lasting more than 2 weeks

Withhold TARCEVA†

For acute/worsening ocular disorders such as eye pain

Withhold TARCEVA† and consider discontinuation

If severe reactions occur with concomitant use of strong CYP3A4 inhibitors [such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit or grapefruit juice] or when using concomitantly with an inhibitor of both CYP3A4 and CYP1A2 (e.g., ciprofloxacin)

Reduce TARCEVA by 50 mg decrements; avoid concomitant use if possible

Concomitant use with CYP3A4 inducers, such as rifampin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John’s Wort

Increase TARCEVA by 50 mg increments at 2-week intervals to a maximum of 450 mg as tolerated. Avoid concomitant use if possible

Concurrent cigarette smoking

Increase TARCEVA by 50 mg increments at 2-week intervals to a maximum of 300 mg. Immediately reduce the dose of TARCEVA to the recommended dose (150 mg or 100 mg daily) upon cessation of smoking

Separation of doses may not eliminate the interaction since proton pump inhibitors affect the pH of the upper GI tract for an extended period

Avoid concomitant use if possible

If treatment with an H2-receptor antagonist such as ranitidine is required, separate dosing.

TARCEVA must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist