Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: First-line treatment in metastatic non-small cell lung cancer (NSCLC) Condition: Tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test |
Dose: Oral – 40 mg Frequency: once daily Duration: until disease progression or no longer tolerated by the patient Note: increased if tolerated to up to 50 mg once daily after 3 weeks at initial dose |
|
Indication: Metastatic squamous non-small cell lung cancer Condition: Progressing after platinum-based chemotherapy |
Dose: Oral – 40 mg Frequency: once daily Duration: until disease progression or no longer tolerated by the patient Note: increased if tolerated to up to 50 mg once daily after 3 weeks at initial dose |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Pediatric |
Dose: Not applicable – No approved dosage Note: No approved pediatric dosage available |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Renal impairment Mild-to-moderate (Creatinine Clearance 30-89 mL/min/1.73 m2) |
Dose: PO – Dosage adjustment not necessary Note: No dosage adjustment necessary |
|
Condition: Renal impairment Severe (Creatinine Clearance 15-29 mL/min/1.73 m2) |
Dose: PO – 30 mg Frequency: once daily |
Administration
- Take on empty stomach
- Take 1 hour before or 3 hours after meals
Side Effect
- Diarrhea (75-96%)
- Rash/dermatitis acneiform (70-90%)
- Stomatitis (30-71%)
- Paronychia (11-58%)
- Increased ALT (10-54%)
- Decreased creatinine clearance (49%)
- Increase alkaline phosphate (34-51%)
- Increased AST (7-46%)
- Decreased lymphocytes (38%)
- Dry skin (31%)
- Decreased potassium (11-30%)
- Decreased appetite (25%)
- Pruritus (21%)
- Nausea (21%)
- Epistaxis (17%)
- Decreased weight (17%)
- Rash/dermatitis acneiform, Grade 3 or 4 (7-16%)
- Increased bilirubin (3-16%)
- Diarrhea, Grade 3 or 4 (11-15%)
- Vomiting (13%)
- Cystitis (13%)
- Decreased WBC (12%)
- Cheilitis (12%)
- Rhinorrhea (11%)
- Paronychia, Grade 3 or 4 (1-11%)
- Stomatitis, Grade 3 or 4 (9%)
- Decreased lymphocytes, Grade 3 or 4 (9%)
- Decreased potassium, Grade 3 or 4 (1-8%)
- Stomatitis, Grade 3 or 4 (4%)
- Decreased appetite, Grade 3 or 4 (3%)
- Increased AST, Grade 3 or 4 (1-3%)
- Increase alkaline phosphate, Grade 3 or 4 (2-3%)
- Decreased creatinine clearance (2%)
- Nausea, Grade 3 or 4 (2%)
- Increased ALT, Grade 3 or 4 (1-2%)
- Decreased WBC, Grade 3 or 4 (1%)
- Vomiting, Grade 3 or 4 (1%)
- Cystitis, Grade 3 or 4 (1%)
- Decreased weight, Grade 3 or 4 (1%)
- Increased bilirubin, Grade 3 or 4 (1%)
- Keratitis (0.8%)
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
Strong P-gp inhibitors (e.g. ritonavir, nelfinavir, saquinavir, ciclosporine A, tacrolimus, ketoconazole, itraconazole, erythromycin, verapamil, amiodarone, quinidine)
|
Increased plasma concentration
|
|
Strong P-gp inducers (e.g. rifampin, phenytoin, phernobarbital, carbamazepine)
|
Decreased plasma concentration
|
Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
Dialysis Patients
|
Risk of drug toxicity
|
|
Severe Hepatic/Renal Impairment
|
Risk of drug accumulation
|
Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store at 25°C; excursions permitted to 15°-30°C. Dispense medication in the original container to protect from exposure to high humidity and light.
Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.