ERLOTINIB HYDROCHLORIDE — erlotinib hydrochloride tablet, film coated
Alembic Pharmaceuticals Limited
Erlotinib tablets are indicated for:
- The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)].
Limitations of use:
- Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1, 14.2)].
- Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)].
Erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].
Select patients for the treatment of metastatic NSCLC with erlotinib tablets based on the presence of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in tumor or plasma specimens [See Clinical Studies (14.1, 14.2)]. If these mutations are not detected in a plasma specimen, test tumor tissue if available. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
The recommended daily dose of erlotinib tablets for NSCLC is 150 mg taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs.
The recommended daily dose of erlotinib tablets for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. Take erlotinib tablets on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs [see Clinical Studies (14.5)].
|Pulmonary†||Interstitial Lung Disease (ILD)||Discontinue erlotinib tablets|
|During diagnostic evaluation for possible ILD||Withhold erlotinib tablets*|
|Hepatic†||Severe hepatic toxicity that does not improve significantly or resolve within three weeks||Discontinue erlotinib tablets|
|In patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline||Withhold erlotinib tablets* 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 erlotinib tablets* and consider discontinuation|
|Renal†||For severe (CTCAE grade 3 to 4) renal toxicity||Withhold erlotinib tablets* and consider discontinuation|
|Gastrointestinal†||Gastrointestinal perforation||Discontinue erlotinib tablets|
|For persistent severe diarrhea not responsive to medical management (e.g., loperamide)||Withhold erlotinib tablets*|
|Skin†||Severe bullous, blistering or exfoliating skin conditions||Discontinue erlotinib tablets|
|For severe rash not responsive to medical management||Withhold erlotinib tablets*|
|Ocular†||Corneal perforation or severe ulceration||Discontinue erlotinib tablets|
|For keratitis of (NCI-CTC version 4.0) grade 3 to 4 or for grade 2 lasting more than 2 weeks||Withhold erlotinib tablets*|
|For acute/worsening ocular disorders such as eye pain||Withhold erlotinib tablets* and consider discontinuation|
|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 erlotinib tablets 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 erlotinib tablets 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 erlotinib tablets by 50 mg increments at 2-week intervals to a maximum of 300 mg. Immediately reduce the dose of erlotinib tablets 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.||Erlotinib tablets 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 erlotinib tablets dose should be separated by several hours, if an antacid is necessary|
† For additional information see Warnings and Precautions (5).
* Reduce erlotinib tablets 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).
Erlotinib tablets are available in the following strengths:
Erlotinib tablets 25 mg are round, biconvex, white film-coated tablet debossed with “L55” on one side and plain on other side.
Erlotinib tablets 100 mg are round, biconvex, white film-coated tablet debossed with “L630” on one side and plain on other side.
Erlotinib tablets 150 mg are round, biconvex, white film-coated tablet debossed with “L631” on one side and plain on other side.
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