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Tagrisso Dosage

Generic name: OSIMERTINIB 401
Dosage form: tablet, film coated

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

Patient Selection

Confirm the presence of a T790M EGFR mutation in tumor or, in the absence of tumor, plasma specimens prior to initiation of treatment with TAGRISSO [see Indications and Usage (1) and Clinical Studies (14)]. Testing for the presence of the mutation in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. ‚ÄčIf this mutation is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. Information on FDA-approved tests for the detection of T790M mutations is available at http://www.fda.gov/companiondiagnostics.

Recommended Dosage Regimen

The recommended dose of TAGRISSO is 80 mg tablet once a day until disease progression or unacceptable toxicity. TAGRISSO can be taken with or without food.

If a dose of TAGRISSO is missed, do not make up the missed dose and take the next dose as scheduled.

Administration to 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 naso-gastric 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).

Dosage Modification

Adverse Reactions

Table 1 Recommended Dose Modifications for TAGRISSO

Target Organ

Adverse Reactiona

Dose Modification

Pulmonary

Interstitial lung disease (ILD)/Pneumonitis

Permanently discontinue TAGRISSO.

Cardiac

QTc interval greater than 500 msec on at least 2 separate ECGsb

Withhold TAGRISSO until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then resume at 40 mg dose.

QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

Permanently discontinue TAGRISSO.

 

Asymptomatic, absolute decrease in LVEFc of 10% from baseline and below 50%

Withhold TAGRISSO for up to 4 weeks.

If improved to baseline LVEF, resume.
If not improved to baseline, permanently discontinue.
 

Symptomatic congestive heart failure

Permanently discontinue TAGRISSO.

 

Other

Grade 3 or higher adverse reaction

Withhold TAGRISSO for up to 3 weeks.

If improvement to Grade 0-2 within 3 weeks

Resume at 80 mg or 40 mg daily.

 

If no improvement within 3 weeks

Permanently discontinue TAGRISSO.

 

a Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
b ECGs = Electrocardiograms
c LVEF = Left Ventricular Ejection Fraction
QTc = QT interval corrected for heart rate

Drug Interactions

Strong CYP3A4 Inducers
If concurrent use is unavoidable, increase TAGRISSO dosage to 160 mg daily when coadministering with a strong CYP3A inducer. Resume TAGRISSO at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer [see Drug Interactions (7), and Clinical Pharmacology (12.3)].

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