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ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.

ENSACOVE can cause the following serious adverse reactions. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 5% of patients, including 1.3% Grade 3 and 0.4% Grade 4. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis and immediately withhold ENSACOVE™ if suspected. Permanently discontinue in patients with ILD/pneumonitis.

Hepatotoxicity, including drug-induced liver injury can occur. 59% of patients had increased alanine aminotransferase (ALT), including 5% Grade 3. Increased aspartate aminotransferase (AST) occurred in 58% of patients, including 1.8% Grade 3. Increased bilirubin occurred in 12% of patients, including 2.3% Grade 3 and 0.2% Grade 4. There was one case of drug-induced liver injury. Monitor liver function tests at baseline and every 2 weeks during the first cycle of treatment, and then monthly or as clinically indicated.

Dermatologic Adverse Reactions can occur, including drug reaction with eosinophilia and systemic symptoms (DRESS), rash, pruritus, and photosensitivity. Dermatologic adverse reactions occurred in 80% of patients, including Grade 3 in 14% of patients. Rash occurred in 72% of patients, including Grade 3 in 12% of patients. Pruritus occurred in 32% of patients, including 2.4% Grade 3. There was one Grade 3 case (0.2%) of DRESS. Advise patients to limit direct sun exposure during treatment and for at least 1 week after discontinuation. Monitor for dermatologic adverse reactions during treatment.

Bradycardia occurred in 6% of patients. All bradycardia events were Grade 1 or 2. Monitor heart rate regularly during treatment.

Hyperglycemia. Increased blood glucose occurred in 44% of patients, including Grade 3 in 2.5% (based on laboratory data). Monitor serum glucose periodically during treatment.

Visual Disturbances occurred in 8% of patients (0.2% Grade 3) and included blurred vision, diplopia, photopsia, vitreous floaters, visual impairment, visual field defect, and reduced visual acuity. Advise patients to report visual symptoms during treatment and obtain ophthalmologic evaluation in patients with visual disturbances.

Increased Creatine Phosphokinase (CPK) occurred in 43% of patients who had CPK laboratory data available, with Grade 3 in 1.5% and 0.5% Grade 4. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK periodically during treatment.

Hyperuricemia occurred in 6% of patients, with 0.4% Grade 3 and 0.7% Grade 4. Monitor uric acid periodically during treatment and initiate urate-lowering medications as clinically indicated.

ENSACOVE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.

ENSACOVE contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

The most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.

Drug Interactions: Avoid concomitant use of P-gp inhibitors and moderate or strong CYP3A inhibitors or inducers.

Lactation: Advise women not to breastfeed during treatment and for 1 week after the last dose.

Use in Specific Populations: Avoid use of ENSACOVE in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

Please see additional Important Safety Information in full Prescribing Information

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To report SUSPECTED ADVERSE REACTIONS, contact Xcovery Holdings, Inc. at (866) 367-2268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication and Usage

ENSACOVE (ensartinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

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Important Safety Information

Indication and Usage

Indication and Usage