Dosing

In resectable and metastatic EGFRm NSCLC

TAGRISSO: Convenient once-daily dosing

Convenient, once-daily dosing that may fit into their routine1

TAGRISSO is a once daily 80-mg tablet TAGRISSO is a once daily 80-mg tablet

One 80-mg tablet once a day

Pill image is not actual size.

TAGRISSO tablets can be taken with or without food TAGRISSO tablets can be taken with or without food

With or without food

TAGRISSO can be taken at home TAGRISSO can be taken at home

May be taken at home

TAGRISSO dosing in resectable disease

In resectable disease: Administer TAGRISSO in the adjuvant setting until disease recurrence, unacceptable toxicity, or for up to 3 years. Patients in the ADAURA trial are treated with TAGRISSO for 3 years or until disease recurrence or unacceptable toxicity1*

TAGRISSO dosing in metastatic disease

In metastatic disease: Administer TAGRISSO until disease progression or unacceptable toxicity1*

*Select patients for treatment with TAGRISSO based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations.

TAGRISSO dosing is the same in both the adjuvant and metastatic settings1

  • The starting dose of TAGRISSO is 80 mg orally once a day
    • TAGRISSO comes in 2 prescription strengths, 80 mg and 40 mg, making it easy to adjust your patient’s dose if necessary
  • TAGRISSO can be taken with or without food—whichever your patient prefers
  • Remind your patients about the importance of taking TAGRISSO at the same time every day
  • If your patient misses a dose, they should be instructed to not make up the dose. Tell your patient to take the next dose as scheduled
TAGRISSO is a once-daily pill that can be taken with or without food

For patients who have difficulty swallowing pills1

  • Disperse tablet in 60 mL (2 ounces) of noncarbonated water only
  • Then stir until tablet is dispersed into small pieces (the tablet will not completely dissolve), and swallow immediately
  • The tablet should not be crushed, heated, or ultrasonicated during preparation
  • Patients should rinse the container with 120 mL to 240 mL (4 to 8 ounces) of water and immediately drink
  • TAGRISSO can be dissolved in water and swallowed or given through an NG tube. For administration via NG tube, please see the accompanying complete Prescribing Information

Dose modifications1

  • Some situations may require dose interruption, discontinuation, or adjustment. For dose modifications, please see the accompanying complete Prescribing Information
  • TAGRISSO is also available as a 40-mg tablet

EGFRm, epidermal growth factor receptor mutation positive; L858R, exon 21 leucine 858 arginine substitution; NG, nasogastric; NSCLC, non-small cell lung cancer.

Reference: TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

IMPORTANT SAFETY INFORMATION

  • There are no contraindications for TAGRISSO
  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
  • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
  • Cardiomyopathy occurred in 3% of the 1479 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
  • Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
  • Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
  • Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
  • Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose
  • Most common (≥20%) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough

INDICATIONS

  • 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

  • TAGRISSO is indicated for the first-line treatment of adult patients with metastatic 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

  • 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

For additional information, please see the complete Prescribing Information, including Patient Information.

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