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Osimertinib Dosage

Medically reviewed on August 30, 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

Duration of therapy: Until disease progression or unacceptable toxicity

Comments: The presence of a T790M epidermal growth factor receptor (EGFR) mutation in tumor specimens should be confirmed with an FDA-approved test prior to treatment initiation; information on FDA-approved tests available at

Use: Treatment for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Renal Dose Adjustments

-Mild (CrCl 60 to 89 mL/min) or Moderate (CrCl 30 to 59 mL/min) Renal Impairment: No adjustment recommended.
-Severe (CrCl less than 30 mL/min) Renal Impairment or End-Stage Renal Disease: Data not available; no recommended dose.

Liver Dose Adjustments

-Mild Hepatic Impairment (Total bilirubin less than upper limit of normal [ULN] and AST between 1 to 1.5 x ULN OR total bilirubin between 1 and 1.5 x ULN and any AST): No adjustment recommended.
-Moderate (Total bilirubin between 1.5 to 3 x ULN and any AST) or Severe Hepatic Impairment (Total bilirubin between 3 to 10 x ULN and any AST): Data not available; no recommended dose.

Dose Adjustments

Strong CYP450 3A Inhibitors:
-Avoid concomitant use if possible.
-If no alternative exists, monitor patients closely for adverse reactions.

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

Interstitial Lung Disease (ILD)/Pneumonitis:
-Permanently discontinue treatment.

QTc Interval Greater Than 500 msec On At Least 2 Separate ECGs:
-Withhold treatment; resume at 40 mg dose once QTc interval less than 481 msec OR recovery to baseline (if baseline is 481 msec or greater).

QTc Interval Prolongation with Signs/Symptoms of Life-Threatening Arrhythmia:
-Permanently discontinue treatment.

Asymptomatic, Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) of 10% From Baseline and Below 50%:
-Withhold treatment for up to 4 weeks.
-If improved to baseline LVEF, resume treatment.
-If not improved to baseline LVEF, permanently discontinue treatment.

Symptomatic Congestive Heart Failure:
-Permanently discontinue treatment.

Grade 3 or Higher Adverse Reaction:
-Withhold treatment for up to 3 weeks.
-If improvement to Grade 0 to 2 within 3 weeks, resume treatment at 40 to 80 mg once a day.
-If no improvement within 3 weeks, permanently discontinue treatment.


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

Consult WARNINGS section for additional precautions.


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.

Storage Requirements:
-Drug bottles should be stored at 25 degrees Celsius (77 Fahrenheit); excursions permitted to 15 to 30 degrees Celsius (59 to 86 Fahrenheit).

Reconstitution/Preparation Techniques:
-Patients with difficulty swallowing solids can disperse this drug tablet in non-carbonated water in order to drink the mixture or receive it through a naso-gastric tube; the manufacturer product information should be consulted for preparation instructions.
-The drug tablet should not be crushed, heated, or ultrasonicated.

-This drug is under accelerated approval based on tumor response rate and response duration; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
-In 2 blinded independent central review (BICR) clinical trials of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on prior systemic therapy including an EGFR TKI, the objective response rate was 59% (complete response 0.5%, partial response 59%); the majority (96%) of patients had ongoing responses ranging from 1.1 to 5.6 months after a median follow up duration of 4 to 4.2 months.

-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 treatment.
-Female patients: Use effective contraception during treatment and for 6 weeks after the last dose.
-Male patients with female partners: Use effective contraception for 4 months after the last dose.
-Do not breastfeed during treatment 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.