Tarceva Dosage

Generic name: ERLOTINIB HYDROCHLORIDE 25mg
Dosage form: tablet
Drug class: EGFR inhibitors

Medically reviewed by Drugs.com. Last updated on Dec 2, 2024.

2.1 Selection of Patients with Metastatic NSCLC

Select patients for the treatment of metastatic NSCLC with TARCEVA based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor or plasma specimens.

2.4 Dose Modifications

* For additional information see Warnings and Precautions (5). † Reduce TARCEVA by 50 mg decrements when restarting therapy following withholding treatment for a dose-limiting toxicity that has resolved to baseline or grade ≤ 1. ‡ For additional information see Drug Interactions (7). § For additional information see Clinical Pharmacology (12.3).
Adverse Reactions
Pulmonary*	Interstitial Lung Disease (ILD)	Discontinue TARCEVA
Pulmonary*	During diagnostic evaluation for possible ILD	Withhold TARCEVA†
Hepatic*	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
Renal*	For severe (CTCAE grade 3 to 4) renal toxicity	Withhold TARCEVA† and consider discontinuation
Gastrointestinal*	Gastrointestinal perforation	Discontinue TARCEVA
Gastrointestinal*	For persistent severe diarrhea not responsive to medical management (e.g., loperamide)	Withhold TARCEVA†
Skin*	Severe bullous, blistering or exfoliating skin conditions	Discontinue TARCEVA
Skin*	For severe rash not responsive to medical management	Withhold TARCEVA†
Ocular*	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
Drug Interactions
CYP3A4 inhibitors‡	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
CYP3A4 inducers‡	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 ‡§	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
Proton Pump inhibitors	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
H2-receptor antagonists	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
Antacids	The effect of antacids on erlotinib pharmacokinetics has not been evaluated.	The antacid dose and the TARCEVA dose should be separated by several hours, if an antacid is necessary