Medically reviewed by Drugs.com. Last updated on Sep 21, 2020.
Applies to the following strengths: 40 mg; 80 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
80 mg orally once a day
Duration of therapy:
-Adjuvant setting: Until disease progression, unacceptable toxicity, or for up to 3 years
Metastatic lung cancer: Until disease progression or unacceptable toxicity
-As adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Renal Dose Adjustments
CrCl 15 to 89 mL/min: No adjustment recommended.
End-stage renal disease (CrCl less than 15 mL/min): No dose recommendation.
Liver Dose Adjustments
Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment OR total bilirubin less than or equal to ULN and AST greater than ULN OR total bilirubin 1 to 3 times ULN and any AST): No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment (total bilirubin between 3 to 10 times ULN and any AST): No dose recommendation.
Strong CYP450 3A Inducers:
-Avoid concomitant use with osimertinib if possible.
-If concurrent use is unavoidable, increase osimertinib dose to 160 mg daily when co-administering with a strong CYP450 3A inducer; resume osimertinib at 80 mg 3 weeks after discontinuation of the strong CYP450 3A4 inducer.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
-Interstitial lung disease (ILD)/Pneumonitis: Permanently discontinue therapy.
-QTc interval greater than 500 msec on at least 2 separate ECGs: Withhold therapy until QTc interval is less than 481 msec or recovery to baseline; if baseline OTc is greater than or equal to 481 msec, then resume at 40 mg dose.
-QTc interval prolongation with signs of life-threatening arrhythmia: Permanently discontinue therapy.
-Symptomatic congestive heart failure: Permanently discontinue therapy.
-Stevens-Johnson syndrome (SJS), Erythema Multiforme Major (EMM): Withhold therapy if suspected and permanently discontinue therapy if confirmed.
-Grade 3 or greater adverse reaction: Withhold therapy for up to 3 weeks.
-If improvement to Grade 0 to 2 within 3 weeks: Resume therapy at 40 to 80 mg once a day.
-If no improvement within 3 weeks: Permanently discontinue therapy.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug can be taken with or without food.
-Take at the same time each day with a full glass of water.
-The tablet should not be crushed, split or chewed; however, it may be dissolved in water if the patient cannot swallow it.
-If a dose is missed, that dose should be skipped and not made up; the next dose should be taken as scheduled.
-For patients who have difficulty swallowing solids disperse tablet in 60 mL (2 ounces) of non-carbonated water only. Stir until tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 mL to 240 mL (4 to 8 ounces) of water and immediately drink. If administration via nasogastric tube is required, disperse the tablet as above in 15 mL of non-carbonated water, and then use an additional 15 mL of water to transfer any residues to the syringe. The resulting 30 mL liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 mL).
-Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86 F).
-Patients with difficulty swallowing solids can disperse the tablet in noncarbonated water and drink the mixture or receive it through a nasogastric tube; the manufacturer product information should be consulted for preparation instructions.
-The drug tablet should not be crushed, heated, or ultrasonicated.
-Cardiovascular: LVEF by ECG or MUGA scan (before treatment initiation and 3-month intervals during treatment); QTc interval with ECG and electrolytes (periodically during treatment in patients with risk factors)
-Respiratory: Worsening respiratory symptoms (e.g., dyspnea, cough, fever; confirm whether ILD)
-Avoid grapefruit, grapefruit juice, and St. John's Wort during therapy.
-Female patients: Use effective contraception during therapy and for 6 weeks after.
-Male patients with female partners: Use effective contraception for 4 months after the last dose.
-Do not breastfeed during therapy and for 2 months after the final dose.
Frequently asked questions
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