
In metastatic EGFRm NSCLC
Educate them about the TAGRISSO safety profile
ADVERSE REACTIONS IN ≥ 10% OF TAGRISSO PATIENTS IN THE FLAURA TRIAL1*
TAGRISSO (n=279) | erlotinib/gefitinib (n=277) | |||
---|---|---|---|---|
ADVERSE REACTION | Any grade (%) |
Grade 3 or higher (%) |
Any grade (%) |
Grade 3 or higher (%) |
Gastrointestinal Disorders | ||||
Diarrhea† | 58 | 2.2 | 57 | 2.5 |
Stomatitis | 29 | 0.7 | 20 | 0.4 |
Nausea | 14 | 0 | 19 | 0 |
Constipation | 15 | 0 | 13 | 0 |
Vomiting | 11 | 0 | 11 | 1.4 |
Skin Disorders | ||||
Rash‡ | 58 | 1.1 | 78 | 6.9 |
Dry skin§ | 36 | 0.4 | 36 | 1.1 |
Nail toxicityII | 35 | 0.4 | 33 | 0.7 |
Pruritus¶ | 17 | 0.4 | 17 | 0 |
Metabolism and Nutrition Disorders | ||||
Decreased appetite | 20 | 2.5 | 19 | 1.8 |
Respiratory, Thoracic, and Mediastinal Disorders | ||||
Cough | 17 | 0 | 15 | 0.4 |
Dyspnea | 13 | 0.4 | 7 | 1.4 |
Neurologic Disorders | ||||
Headache | 12 | 0.4 | 7 | 0 |
Cardiac Disorders | ||||
Prolonged QT interval# | 10 | 2.2 | 4 | 0.7 |
General Disorders and Administration Site Conditions | ||||
Fatigue** | 21 | 1.4 | 15 | 1.4 |
Pyrexia | 10 | 0 | 4 | 0.4 |
Infection and Infestation Disorders | ||||
Upper RT1 | 10 | 0 | 7 | 0 |
*NCI CTCAE v4.0.
†One grade 5 (fatal) event was reported (diarrhea) for EGFR-TKI comparator (erlotinib or gefitinib).
‡Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
§Includes dry skin, skin fissures, xerosis, eczema, xeroderma.
IIIncludes nail bed disorder, nail bed inflammation, nail bed infection, nail discoloration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.
¶Includes pruritus, pruritus generalized, eyelid pruritus.
#The frequency of “Prolonged QT Interval” represents reported adverse events in the FLAURA study. Frequencies of QTc intervals of >500 ms or >60 ms are presented in Section 5.2 of the Prescribing Information.
**Includes fatigue, asthenia.
RTI, respiratory tract infection.
The majority of adverse reactions reported in the FLAURA study were Grade 1 or 21,2
Grade 1Mild; no symptoms or only mild symptoms; no intervention necessary
Grade 2Moderate; minimal intervention required
Grade 3Severe/medically significant, but not life-threatening; may require hospitalization
Grade 4Life-threatening; urgent intervention required
Grade 5Death
Grade 1Mild; no symptoms or only mild symptoms; no intervention necessary
Grade 2Moderate; minimal intervention required
Grade 3Severe/medically significant, but not life-threatening; may require hospitalization
Grade 4Life-threatening; urgent intervention required
Grade 5Death
Partner with patients to anticipate and manage adverse reactions
Adverse Reactions
Potential ILD
actions
Potential QTC Interval prolongation/SYMPTOMATIC CONGESTIVE HEART FAILURE
Stevens-Johnson Syndrome (SJS), Erythema Multiforme Major (EMM)
any grade 3 or greater adverse reaction
Adverse Reactions
Potential ILD
actions
Adverse Reactions
Potential QTC Interval prolongation/SYMPTOMATIC CONGESTIVE HEART FAILURE
actions
Adverse Reactions
Stevens-Johnson Syndrome (SJS), Erythema Multiforme Major (EMM)
actions
Adverse Reactions
any grade 3 or greateradverse reaction
actions
Taking action early may help resolve adverse reactions for optimal treatment
Monitor patients during treatment with TAGRISSO1
if your patient
Has congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or takes medication known to prolong the QTc interval
actions
Has cardiac risk factors
if your patient
Has congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or takes medication known to prolong the QTc interval
actions
if your patient
Has cardiac risk factors
actions
What to know about drug interactions1
EFFECT OF OTHER DRUGS ON TAGRISSO1
Reduced exposure to drug. | Increased exposure to drug. | No effect |
---|---|---|
CATEGORY | EFFECT | INTERVENTION |
CATEGORYStrong CYP3A inducers(rifampin/rifampicin, antibiotic, eg, Rifadin) | EFFECT78% reduction in AUC of TAGRISSO | INTERVENTION Avoid if possible; if not possible, increase TAGRISSO to 160 mg dailyResume TAGRISSO at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer |
CATEGORYStrong CYP3A inhibitors(itraconazole, antifungal, eg, Sporanox) | EFFECTNo clinically significant effect | INTERVENTIONNo intervention needed |
CATEGORYGastric acid reducing agents(omeprazole, eg, Prilosec) | EFFECTNot affected | INTERVENTIONNo intervention needed |
EFFECT OF TAGRISSO ON OTHER DRUGS1 | ||
CATEGORYBCRP substrates(rosuvastatin, statin, eg, CRESTOR) | EFFECT35% increase in AUC of BCRP substrate | INTERVENTION Monitor for side effects of the BCRP substrate |
CATEGORYP-GP substrates(fexofenadine, eg, Allegra) | EFFECT56% increase in AUC of P-GP substrate after a single dose, and 27% at steady state | INTERVENTION Monitor for side effects of the P-GP substrate |
CATEGORYCYP3A4 substrates(simvastatin, statin, eg, Zocor) | EFFECTNo clinically significant effect | INTERVENTIONNo intervention needed |
AUC, area under the curve; BCRP, breast cancer resistance protein; CYP, cytochrome P450; P-GP, P-glycoprotein.
ARs, adverse reactions; ECGs, electrocardiograms; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; LVEF, left ventricular ejection fraction; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NSCLC, non-small cell lung cancer; QTc, heart rate-corrected QT interval; TKI, tyrosine kinase inhibitor.
References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf#search=%22ctcae%22. Accessed October 3, 2019. 3. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125.
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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