Tagrisso Dosage

Generic name: OSIMERTINIB 40mg
Dosage form: tablet, film coated
Drug class: EGFR inhibitors

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Recommended Evaluation and Testing Before Initiating TAGRISSO

TAGRISSO Monotherapy

•: Before initiating TAGRISSO monotherapy in patients with cardiac risk factors, conduct cardiac monitoring, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3)].
•: Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7)].

TAGRISSO in Combination with Pemetrexed and Platinum-based Chemotherapy

•: Before initiating TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3)].
•: Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7)].

Patient Selection

Adjuvant Treatment of EGFR Mutation-Positive NSCLC

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 (14.1)].

First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC

Select patients for the first-line treatment of locally advanced or 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 (14.2)]. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible.

First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC

Select patients for the first-line treatment of locally advanced or metastatic EGFR-positive NSCLC with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in tumor or plasma specimens [see Clinical Studies (14.3)]. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible.

Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC

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 (14.4)]. 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.

Recommended Dosage and Administration

Recommended Dosage

Table 1 provides the recommended dosage of TAGRISSO by indication.

Table 1: Recommended Dosage of TAGRISSO
Indication	Recommended Dosage of TAGRISSO	Duration of Treatment
Adjuvant Treatment of EGFR Mutation-Positive NSCLC	80 mg tablet orally once daily with or without food	For a total of 3 years or until disease recurrence or unacceptable toxicity
First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC	80 mg tablet orally once daily with or without food	Until disease progression or unacceptable toxicity
First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC	80 mg tablet orally once daily with or without food in combination with pemetrexed and platinum-based chemotherapy Refer to the Prescribing Information for pemetrexed and cisplatin or carboplatin for the respective dosing information.	Until disease progression or unacceptable toxicity due to TAGRISSO
Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC	80 mg tablet orally once daily with or without food	Until disease progression or unacceptable toxicity

Administration

Administer TAGRISSO 80 mg tablet orally once daily with or without food. Tablets may be dispersed in water for patients who have difficulty swallowing, or for nasogastric tube administration [see Dosage and Administration (2.4)].

Missed Dose

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 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). Repeat this step until no pieces remain in the syringe. This will help to ensure that the full prescribed dose of the TAGRISSO is given. The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.

Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 2.

Table 2. Recommended Dosage Modifications for TAGRISSO
* Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). † QTc = QT interval corrected for heart rate ‡ ECGs = Electrocardiograms
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)]	Erythema Multiforme Major (EMM), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN)	Withhold TAGRISSO if suspected and permanently discontinue if confirmed.
Blood and bone marrow [see Warnings and Precautions (5.7)]	Aplastic anemia	Withhold TAGRISSO if aplastic anemia is 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.

Dosage Modifications for Combination Therapy

When TAGRISSO is administered in combination with pemetrexed and platinum-based chemotherapy, modify the dose of any one of the treatments for the management of adverse reactions, as appropriate. For TAGRISSO dose modification instructions, see Table 2. Withhold, reduce the dose or permanently discontinue pemetrexed, cisplatin or carboplatin according to their respective Prescribing Information.

Drug Interactions

Strong CYP3A4 Inducers
Avoid concomitant use of strong CYP3A4 inducers with TAGRISSO. 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)].