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Osimertinib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 1, 2018.

Applies to the following strengths: 40 mg; 80 mg

Usual Adult Dose for Non-Small Cell Lung Cancer

80 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-Take at the same time each day with a full glass of water.
-This drug can be taken with or without food.
-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 missed, it should be made up unless the next dose is due within 12 hours.

Uses:
-For first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
-For previously treated EGFR T790M mutation-positive metastatic NSCLC, as detected by an FDA-approved test, in patients 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.

Dose Adjustments

Strong CYP450 3A inducers:
-Avoid concomitant use if possible.

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.

Grade 3 or higher 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.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-This drug can be taken with or without food.
-If a dose is missed, that dose should be skipped and not made up; the next dose should be taken as scheduled.
-This drug should be taken at the same time each day.

Storage Requirements:
-Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86 F).

Reconstitution/Preparation Techniques:
-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.

Monitoring:
-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)

Patient Advice:
-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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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