TAGRISSO

TAGRISSO- osimertinib tablet, film coated
AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE

1.1 Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC)

TAGRISSO is indicated as adjuvant therapy after tumor resection in adult 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 [see Dosage and Administration (2.1)].

1.2 First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC

TAGRISSO is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)].

1.3 Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC

TAGRISSO is indicated for the 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 [see Dosage and Administration (2.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients with resectable tumors for the adjuvant treatment of NSCLC with TAGRISSO based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in tumor specimens [see Clinical Studies (14) ] .

Select patients for the first-line treatment of metastatic EGFR-positive NSCLC with TAGRISSO based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in tumor or plasma specimens [see Clinical Studies (14)]. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible.

Select patients for the treatment of metastatic EGFR T790M mutation-positive NSCLC with TAGRISSO following progression on or after EGFR TKI therapy based on the presence of an EGFR T790M mutation in tumor or plasma specimens [see Clinical Studies (14)]. Testing for the presence of the T790M mutation in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If 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 EGFR mutations is available at http://www.fda.gov/companiondiagnostics.

2.2 Recommended Dosage Regimen

The recommended dosage of TAGRISSO is 80 mg tablet once a day. 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.

Treat patients in the adjuvant setting until disease recurrence, or unacceptable toxicity, or for up to 3 years.

Treat patients with metastatic lung cancer until disease progression or unacceptable toxicity.

2.3 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 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).

2.4 Dosage Modifications

Adverse Reactions

Table 1. Recommended Dosage Modifications for TAGRISSO
*
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
QTc = QT interval corrected for heart rate
ECGs = Electrocardiogram

Target Organ

Adverse Reaction *

Dosage Modification

Pulmonary [see Warnings and Precautions (5.1)]

Interstitial lung disease (ILD)/Pneumonitis

Permanently discontinue TAGRISSO.

Cardiac [see Warnings and Precautions (5.2, 5.3)]

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

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.

Symptomatic congestive heart failure

Permanently discontinue TAGRISSO.

Cutaneous [see Warnings and Precautions (5.5)]

Stevens-Johnson syndrome (SJS), Erythema Multiforme Major (EMM)

Withhold TAGRISSO if suspected and permanently discontinue if confirmed.

Other [see Adverse Reactions (6.1)]

Adverse reaction of Grade 3 or greater severity

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.

Drug Interactions

Strong CYP3A4 Inducers If concurrent use is unavoidable, increase TAGRISSO dosage to 160 mg daily when co-administering 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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