Brand Name
Ensacove
Generic Name
Ensartinib
View Brand Information FDA approval date: April 30, 2025
Form: Capsule
What is Ensacove (Ensartinib)?
ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase -positive locally advanced or metastatic non-small cell lung cancer as detected by an FDA-approved test [see Dosage and Administration.
Approved To Treat
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Brand Information
ENSACOVE (ensartinib)
1INDICATIONS AND USAGE
ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test
2DOSAGE FORMS AND STRENGTHS
ENSACOVE capsules are available as:
- 25 mg: size 2 capsule, white opaque cap and body, with “X-396” on the cap and “25 mg” on the body printed in blue ink. Each capsule contains the equivalent of 25 mg of ensartinib.
- 100 mg: size 0 capsule, blue opaque cap and yellow opaque body, with “X-396” on the cap and “100 mg” on the body printed in white ink. Each capsule contains the equivalent of 100 mg of ensartinib.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Interstitial Lung Disease/Pneumonitis
- Hepatoxicity
- Dermatologic Adverse Reactions
- Bradycardia
- Hyperglycemia
- Visual Disturbances
- Increased Creatine Phosphokinase
- Hyperuricemia
- FD&C Yellow No. 5 (Tartrazine)
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to ENSACOVE as a single agent in 458 patients with locally advanced or metastatic ALK-positive NSCLC in the following trials: eXALT3 Study (N=143)
TKI-naive ALK-Positive Locally Advanced or Metastatic NSCLC
The safety of ENSACOVE was evaluated in the eXALT3 study
The median age of patients who received ENSACOVE was 54 years (range: 25-86); 50% male; 54% Asian, 43% White; 0.7% Black or African American; and 11% Hispanic or Latino.
Serious adverse reactions occurred in 23% of patients treated with ENSACOVE. Serious adverse reactions that occurred in ≥1% were pneumonia (4.9%), hemorrhage (2.1%), rash (2.1%) and cellulitis (1.4%). One fatal adverse reaction (0.7%) occurred due to bronchopneumonia.
Permanent discontinuation of ENSACOVE due to an adverse reaction occurred in 12% of patients. Adverse reactions which resulted in permanent discontinuation of ENSACOVE (≥1%) included increased blood bilirubin (1.4%), increased conjugated bilirubin (1.4%), increased ALT (2.1%), increased AST (2.1%), and pneumonitis/ILD (2.1%).
Dose interruptions of ENSACOVE due to an adverse reaction occurred in 41% of patients. Adverse reactions which required dose interruptions (≥2%) included rash (13%), increased ALT (6%), edema (2.8%), pruritus (2.8%), pyrexia (2.8%), pneumonia (3.5%), increased AST (2.1%), hemorrhage (2.1%), and decreased appetite (2.1%).
Dose reductions of ENSACOVE due to an adverse reaction occurred in 24% of patients. Adverse reactions which required dose reductions (≥2%) included rash (11%), increased ALT (4.2%), pruritus (2.8%), and edema (2.1%).
Tables 3 and 4 summarize the most frequent adverse reactions and laboratory abnormalities, respectively.
Clinically relevant adverse reactions in <10% of patients who received ENSACOVE included interstitial lung disease, photosensitivity, increased creatinine phosphokinase, bradycardia, and visual disturbances.
5DESCRIPTION
ENSACOVE capsules contain ensartinib, a kinase inhibitor, present as ensartinib hydrochloride with the chemical name 6-amino-5-[(1
ENSACOVE capsules are intended for oral administration and are available in two dosage strengths: 25 mg ensartinib (equivalent to 28.25 mg ensartinib hydrochloride) and 100 mg ensartinib (equivalent to 113.02 mg ensartinib hydrochloride).
The inactive ingredients of ENSACOVE capsules are microcrystalline cellulose and stearic acid. The inactive ingredients of the 25 mg empty capsule shells are hypromellose and titanium dioxide. The inactive ingredients of the 100 mg empty capsules shells are black iron oxide, FD&C Blue No. 1, FD&C Yellow No. 5, hypromellose, red iron oxide, and titanium dioxide.
The imprinting ink for the 25 mg capsules contains butyl alcohol, dehydrated alcohol, FD&C Blue No. 2, isopropyl alcohol, propylene glycol, shellac, and strong ammonia solution. The imprinting ink for the 100 mg capsules contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide.
6HOW SUPPLIED
ENSACOVE (ensartinib) capsules are supplied as follows:
Store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Interstitial Lung Disease (ILD)/Pneumonitis
Inform patients of the risk of severe ILD/pneumonitis during treatment with ENSACOVE. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms
Hepatoxicity
Inform patients of the potential risk of hepatoxicity during treatment with ENSACOVE and of the need to monitor for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin elevations during treatment with ENSACOVE. Advise patients to inform their healthcare provider of any new or worsening symptoms
Dermatologic Adverse Reactions
Inform patients of the potential risk of dermatologic adverse reactions, including rash, pruritus, and photosensitivity during treatment with ENSACOVE. If dermatologic reactions occur, advise patients to limit sun exposure while taking ENSACOVE and for at least 1 week after the final dose
Bradycardia
Advise patients of the risk of bradycardia during treatment with ENSACOVE and to report any symptoms of bradycardia. Advise patients to inform their healthcare provider about the use of any heart or blood pressure medications during treatment with ENSACOVE
Hyperglycemia
Inform patients of the risks of new or worsening hyperglycemia during treatment with ENSACOVE and the need to periodically monitor glucose levels. Advise patients with diabetes mellitus or glucose intolerance that antihyperglycemic medications may need to be adjusted during treatment with ENSACOVE
Visual Disturbances
Advise patients to inform their healthcare provider of any new or worsening vision symptoms during treatment with ENSACOVE
Creatine Phosphokinase (CPK) Elevation
Inform patients of the signs and symptoms of creatine phosphokinase (CPK) elevation and the need for monitoring during treatment with ENSACOVE. Advise patients to inform their healthcare provider of any new or worsening symptoms
Hyperuricemia
Inform patients of the signs and symptoms of hyperuricemia. Advise patients to inform their healthcare provider if they experience signs or symptoms associated with hyperuricemia during treatment with ENSACOVE
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with ENSACOVE and for 1 week after the last dose
Advise males with female partners of reproductive potential to use effective contraception during treatment with ENSACOVE and for 1 week after the last dose
FD&C Yellow No. 5 (tartrazine)
Advise patients that this product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type or asthma-type reactions in certain susceptible persons (e.g., patients who also have aspirin hypersensitivity)
Lactation
Advise women not to breastfeed during treatment with ENSACOVE and for 1 week after the last dose
Administration
Instruct patients to take ENSACOVE once a day with or without food and to swallow ENSACOVE capsules whole
Missed Dose
Advise patients to take ENSACOVE at the same time each day. If a dose is missed, then they should take the missed dose as soon as possible unless the next dose is due within 12 hours. Patients should be instructed not to take 2 doses at the same time to make up for a missed dose. In addition, instruct patients not to take an extra dose if they vomit after taking ENSACOVE
Manufactured for: Xcovery Holdings, Inc. Miami, FL 33131
ENSACOVE is a trademark of Xcovery Holdings, Inc.
©2026, Xcovery Holdings, Inc. All rights reserved.
8PRINCIPAL DISPLAY PANEL - 25 mg
ENSACOVE
Bottle of 30 Capsules
NDC 83076-1025-3
9PRINCIPAL DISPLAY PANEL - 100 mg
ENSACOVE
Bottle of 60 Capsules
NDC 83076-1100-6
