Medically reviewed by Drugs.com. Last updated on Dec 13, 2021.
Applies to the following strengths: 250 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
250 mg orally once a day until disease progression or unacceptable toxicity
NOTE: For patients who have difficulty swallowing tablets immerse the tablet in 4 to 8 ounces of water (noncarbonated) and stir until dispersed (about 15 minutes). Drink the liquid or administer through a nasogastric tube. Rinse the container with 4 to 8 ounces of water and drink or administer through nasogastric tube.
- Select patients for the first-line treatment of metastatic NSCLC with this drug based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in their tumor or plasma specimens.
Use: For first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Renal Dose Adjustments
Mild to moderate renal impairment: No adjustment recommended.
Severe renal impairment: Data not available
Liver Dose Adjustments
Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Use with caution.
- Withhold therapy in patients with worsening liver function.
- Permanently discontinue therapy in patients with severe hepatic impairment.
Withhold therapy for up to 14 days for the following adverse drug reactions and resume when fully resolved to Grade 1:
- Acute onset or worsening of pulmonary symptoms (e.g., dyspnea, cough, fever)
- Grade 2 or higher in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations
- Grade 3 or higher diarrhea
- Severe or worsening ocular disorders including keratitis
- Grade 3 or higher skin reactions
Permanently discontinue therapy for:
- Confirmed interstitial lung disease (ILD)
- Severe hepatic impairment
- GI perforation
- Persistent ulcerative keratitis
Concomitant use with strong CYP450 3A4 inducers:
- Avoid concomitant use if possible.
- If concomitant use is required, increase dose to 500 mg orally once a day (in the absence of severe adverse drug reaction); resume at 250 mg dose 7 days after discontinuation of the strong CYP450 3A4 inducer.
Concomitant use with proton-pump inhibitor/H2 receptor antagonist/antacid:
- Avoid concomitant use if possible.
- If concomitant use is required, take this drug 12 hours after the last dose of the proton-pump inhibitor or 12 hours before the next dose of the proton-pump inhibitor.
- Take this drug 6 hours after the last dose of the H2-receptor antagonist or antacid, or 6 hours before the next dose of the H2-receptor antagonist or antacid.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- Therapy should be initiated and supervised by a physician experienced in the use of anticancer therapies.
- This drug should be taken at about the same time each day, with or without food.
- A missed dose should not be taken within 12 hours of the next dose.
- Store in the original package to protect from moisture.
- Hepatic: Liver function testing (periodically during therapy)
- Gastrointestinal: Urea, electrolytes, serum creatinine (in patients at high risk of dehydration)
- Hematologic: INR and PT (in patients concurrently taking warfarin)
- Ocular: Signs/symptoms of ocular disorder (e.g., acute/worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, red eye)
- Respiratory: Acute onset or worsening of ILD-like symptoms (e.g., dyspnea, cough, fever)
- If you take a proton pump inhibitor (PPI), H2 blocker, or antacid medication, talk to your healthcare provider about the best time to take it during therapy with this drug.
- If you miss a dose and it is LESS than 12 hours until your next dose, skip the missed dose; otherwise, take the missed dose as soon as you remember. Do not take a double dose (2 doses at the same time) to make up for a forgotten dose.
- If you have difficulty swallowing solids, talk to your healthcare provider for special instructions on how to take this drug tablet.
- This drug may cause side effects such as unusual physical weakness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.
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