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Osimertinib Dosage

Applies to the following strength(s): 40 mg ; 80 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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: 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 http://www.fda.gov/companiondiagnostics.

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.

Precautions

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.

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.

General:
-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.

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 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.

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