Tagrisso Dosage

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

Medically reviewed by Drugs.com. Last updated on Sep 25, 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).
•: Before initiating TAGRISSO, perform complete blood count with differential.

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).
•: Before initiating TAGRISSO, perform complete blood count with differential.

Patient Selection

Table 1 below presents the patient selection criteria for treatment with TAGRISSO.

Table 1: Patient Selection
Select patients for treatment with TAGRISSO based on the presence of a mutation as detected by an FDA-approved test.
Indication	Treatment Regimen	Required Mutation	Source for Testing
Adjuvant Treatment of EGFR Mutation-Positive NSCLC	TAGRISSO monotherapy	EGFR exon 19 deletions or exon 21 L858R mutations	Tumor
Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC	Following completion of platinum-based chemoradiation therapy, TAGRISSO monotherapy	EGFR exon 19 deletions or exon 21 L858R mutations	Tumor
First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC	TAGRISSO monotherapy	EGFR exon 19 deletions or exon 21 L858R mutations	Plasma or tumor
First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC	TAGRISSO in combination with pemetrexed and platinum-based chemotherapy	EGFR exon 19 deletions or exon 21 L858R mutations	Plasma or tumor
Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC	TAGRISSO monotherapy	EGFR T790M Mutation	Plasma or tumor
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 2 provides the recommended dosage of TAGRISSO by indication.

Table 2. 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
Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC	Following platinum-based chemoradiation therapy, 80 mg tablet orally once daily with or without food	Until disease progression 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.

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 3.

Table 3. Recommended Dosage Modifications for TAGRISSO
Target Organ	Adverse Reaction*	Dosage Modification
* 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
Pulmonary (Patients who have not received recent definitive platinum-based chemoradiation therapy)	Any Grade Interstitial lung disease (ILD)/Pneumonitis	Permanently discontinue TAGRISSO.
Pulmonary (Patients who have received recent definitive platinum-based chemoradiation therapy)	Grade 1 ILD/Pneumonitis	Withhold or continue TAGRISSO, as clinically indicated.
	Grade ≥2 ILD/Pneumonitis	Permanently discontinue TAGRISSO.
Cardiac	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	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	Aplastic anemia	Withhold TAGRISSO if aplastic anemia is suspected and permanently discontinue if confirmed.
Other	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.