Tagrisso

(Osimertinib)

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Dosage & Administration

Adjuvant treatment of early-stage NSCLC:

80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.

Locally advanced, unresectable (stage III) NSCLC:

Following platinum-based chemoradiation therapy, 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Metastatic NSCLC:

80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Locally advanced or metastatic NSCLC:

80 mg orally once daily administered in combination with pemetrexed and platinum-based chemotherapy, with or without food, until disease progression or unacceptable toxicity due to TAGRISSO.

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Tagrisso Prescribing Information

Indications and Usage 09/2024

Indications and Usage 02/2024

Dosage and Administration, Patient Selection 09/2024

Dosage and Administration, Recommended Dosage

and Administration 09/2024

Dosage and Administration, Dosage Modifications 09/2024

Warnings and Precautions, Interstitial Lung

Disease/Pneumonitis (

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) 09/2024

Warnings and Precautions, QTc Interval Prolongation (

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) 09/2024

Warnings and Precautions, Cardiomyopathy (

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) 09/2024

Warnings and Precautions, Keratitis (

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) 09/2024

Warnings and Precautions, Aplastic Anemia (

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) 02/2024

TAGRISSO is a kinase inhibitor indicated for:

•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.
•the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
•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.
•in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
•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 TKI therapy.

Adjuvant treatment of early-stage NSCLC:

80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.

Locally advanced, unresectable (stage III) NSCLC:

Following platinum-based chemoradiation therapy, 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Metastatic NSCLC:

80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Locally advanced or metastatic NSCLC:

80 mg orally once daily administered in combination with pemetrexed and platinum-based chemotherapy, with or without food, until disease progression or unacceptable toxicity due to TAGRISSO.

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