Drugplain

Erlotinib Hydrochloride 150 mg/1

Erlotinib Hydrochloride · TABLET, FILM COATED · Novadoz Pharmaceuticals LLC

No Recall History
Plain English

Erlotinib Hydrochloride is a tablet, film coated containing erlotinib hydrochloride at 150 mg/1, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.

Key Facts

Brand Name
Erlotinib Hydrochloride
Generic Name
Erlotinib Hydrochloride
NDC Code (Product)
72205-082
Manufacturer
Novadoz Pharmaceuticals LLC
Strength
150 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA214366
Marketing Start
05/11/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death761 reports
diarrhoea325 reports
rash242 reports
neoplasm malignant175 reports
incorrect dose administered168 reports
anaemia155 reports
nausea155 reports
dehydration137 reports
fatigue136 reports
decreased appetite135 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Erlotinib tablet is a kinase inhibitor 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. ( 1.1 ) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) Erlotinib tablet is not recommended for use in combination with platinum-based chemotherapy. ( 1.1 ) 1.1 Non-Small Cell Lung Cancer (NSCLC) 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,…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION NSCLC: 150 mg orally, on an empty stomach, once daily. ( 2.2 ) Pancreatic cancer: 100 mg orally, on an empty stomach, once daily. ( 2.3 ) 2.1 Selection of Patients with Metastatic NSCLC 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. 2.2 Recommended Dose – NSCLC 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. 2.3 Recommended Dose – Pancreatic Cancer 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 be…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS CYP3A4 Inhibitors Co-administration of erlotinib with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor increased erlotinib exposure. Erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2. Increased erlotinib exposure may increase the risk of exposure-related toxicity [ see Clinical Pharmacology (12.3) ]. Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and CYP1A2 inhibitor (e.g., ciprofloxacin). Reduce the erlotinib dosage when co-administering with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor if co-administration is unavoidable [ see Dosage and Administration (2.4) ]. CYP3A4 Inducers Pre-treatment with a CYP3A4 inducer prior to erlotinib decreased erlotinib exposure [ see Clinical Pharmacology (12.3) ] . Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapenti…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease (ILD) [ see Warnings and Precautions (5.1) ] Renal Failure [ see Warnings and Precautions (5.2) ] Hepatotoxicity with or without Hepatic Impairment [ see Warnings and Precautions (5.3) ] Gastrointestinal Perforation [ see Warnings and Precautions (5.4) ] Bullous and Exfoliative Skin Disorders [ see Warnings and Precautions (5.5) ] Cerebrovascular Accident [ see Warnings and Precautions (5.6) ] Microangiopathic Hemolytic Anemia with Thrombocytopenia [ see Warnings and Precautions (5.7) ] Ocular Disorders [ see Warnings and Precautions (5.8) ] Hemorrhage in Patients Taking Warfarin [ see Warnings and Precautions (5.9) ] The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-236…

Frequently Asked Questions

What is Erlotinib Hydrochloride used for?

Erlotinib Hydrochloride contains Erlotinib Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Erlotinib Hydrochloride a controlled substance?

Erlotinib Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Erlotinib Hydrochloride?

The generic name for Erlotinib Hydrochloride is Erlotinib Hydrochloride. There are 9 other brand versions of Erlotinib Hydrochloride.

What is the NDC code for Erlotinib Hydrochloride 150 mg/1?

The NDC (National Drug Code) for Erlotinib Hydrochloride 150 mg/1 is 72205-082, listed by Novadoz Pharmaceuticals LLC.

Product NDC

72205-082

Package NDC

72205-082-30

Other Erlotinib Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)