ALL SUBGROUPS

First-line TAGRISSO delivered consistent results across all patient types2

Subgroup analyses of progression-free survival

First-line TAGRISSO reduced the risk of progression or death across all prespecified subgroups*, including patients with or without CNS metastases2

Tagrisso subgroup analysis Tagrisso subgroup analysis

*Exploratory analysis. Subgroup analysis showed consistent results in additional subgroups not pictured here (WHO performance status, EGFR mutation by ctDNA, centrally confirmed EGFR mutation).

Adapted from: Soria et al. N Engl J Med. 2018.

FLAURA study design: Randomized, double-blind, active-controlled trial in 556 patients with metastatic EGFRm NSCLC who had not received prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO (n=279, 80 mg orally, once daily) or EGFR TKI comparator (n=277; gefitinib 250 mg or erlotinib 150 mg orally, once daily). Crossover was allowed for patients in the EGFR TKI comparator arm at confirmed progression if positive for the EGFR T790M resistance mutation. Patients with CNS metastases not requiring steroids and with stable neurologic status were included in the study.1-3

  • The primary endpoint of the study was PFS based on investigator assessment (according to RECIST v1.1)
  • Secondary endpoints included overall response rate, duration of response, overall survival

POSSIBLE SERIOUS ADVERSE REACTIONS

Interrupt or discontinue treatment for certain uncommon adverse reactions1

Tagrisso Adverse Reactions Tagrisso Adverse Reactions

a Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).

b ECGs=Electrocardiograms.

QTc=QT interval corrected for heart rate.

This information does not replace any guidance or protocol given by your institution for managing patients with these symptoms. These are not all the possible side effects patients may experience. Encourage patients to report any and all side effects to their HCPs. They may also report side effects to the FDA at 1-(800)-FDA-1088 or www.fda.gov/medwatch.

MANAGING SIDE EFFECTS

Most common side effects with TAGRISSO

Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite.1

Tips for managing the most common side effects

Educating patients and their caregivers about monitoring for potential uncommon adverse reactions is important. What follows are some helpful tips you may share for managing some of the most common side effects patients taking TAGRISSO may experience. These tips are not a substitute for medical advice from the patient’s healthcare team. Encourage patients to report any and all side effects they may have.


A common side effect of TAGRISSO is skin rash. It may appear on the face, upper chest, and back. It may look red with little bumps and may get worse if skin is exposed to sunlight. Patients may also experience other skin changes such as skin dryness and itching.4


Advise patients to protect their skin by4:

Using gentle skin cleansers

Avoiding the sun when possible

Wearing a hat

Regularly using alcohol-free moisturizers and sunscreen (SPF 30)

Wearing a hat

Encouraging them to talk to their HCP about any rashes they may have. The HCP may prescribe a cream or an anti-inflammatory/steroid

 

Diarrhea is another common mild or moderate (Grade 1 or 2)* side effect, and can usually be managed by doing the following4:

Staying hydrated

Eating small, frequent meals consisting of bland foods (eg, toast, white rice, crackers, eggs)

Using antidiarrheal medications as indicated

Contacting healthcare provider right away if diarrhea worsens

*Grade 1 (mild): no symptoms or mild symptoms, no intervention required; Grade 2 (moderate): minimal intervention indicated.5

DOSING

First-line TAGRISSO offers convenient, once-daily dosing, with or without food

Tagrisso Dosing

One 80-mg tablet, orally, once a day

Take Tagrisso with or without food

TAGRISSO tablets may be taken with or without food

  • TAGRISSO is also available as a 40-mg tablet for patients who may need a dose reduction
  • Patients should be instructed not to make up the dose if a dose is missed, and to take the next dose as scheduled

Please see the full Prescribing Information for more information on dosing, including how to take TAGRISSO for patients who may have difficulty swallowing solids.

RESOURCES

Helping patients access the care they need

AZ Access 360

The AstraZeneca Access 360TM program provides personal support to connect patients to affordability programs and streamline access and reimbursement for TAGRISSO® (osimertinib). To learn more about Access 360, please call 1-844-ASK-A360 (1-844-275-2360) or visit www.MyAccess360.com.

AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. 2. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 3. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125 [protocol]. 4. Hirsh V. Managing treatment-related adverse events associated with EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer. Curr Oncol. 2011;18(3):126-138. 5. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed March 15, 2018.

Important Safety Information Expand

  • There are no contraindications for TAGRISSO

  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.9% of the 1142 TAGRISSO-treated patients; 0.4% 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 1142 TAGRISSO-treated patients in clinical trials, 0.9% were found to have a QTc > 500 msec, and 3.6% 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 2.6% of the 1142 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 3.9% of 908 patients who had baseline and at least one follow-up LVEF assessment. 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 1142 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

  • 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 adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite

Indications

  • TAGRISSO is indicated for the first-line treatment of 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 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


Please see complete Prescribing Information including Patient Information.

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