What is ENSARITNIB used for?

ENSARITNIB is used to treat adults with a specific type of lung cancer called ALK-positive non-small cell lung cancer that has spread or is locally advanced.

How should I take ENSACOVE capsules?

Take your ENSACOVE capsules orally once a day at the same time, swallowing them whole without crushing or chewing them.

Can I take ENSARITNIB with food?

Yes, you can take ENSARITNIB either with or without food.

What should I do if I miss a dose of ENSARITNIB?

Take the missed dose as soon as you can, unless your next dose is due within 12 hours; never take two doses at once.

Can ENSARITNIB cause lung problems?

Yes, ENSARITNIB may cause lung inflammation or disease (pneumonitis), so you should watch for new or worsening lung symptoms.

Is ENSARITNIB safe during pregnancy?

No, ENSARITNIB can cause serious harm or death to an unborn baby and should not be used during pregnancy.

What are the most common side effects of ENSACOVE?

The most common side effects include skin rashes, muscle pain, constipation, itching, cough, and nausea.

Does ENSARITNIB interact with other drugs?

Yes, you should avoid using ENSARITNIB with certain drugs called CYP3A inhibitors, CYP3A inducers, or P-gp inhibitors.

Are there any allergies I should know about with ENSARITNIB?

You should not use ENSARITNIB if you are allergic to the medicine or to FD&C Yellow No. 5 (tartrazine).

Should I worry about my blood sugar while on ENSARITNIB?

Yes, ENSARITNIB can cause high blood sugar, so your glucose levels should be monitored periodically.

ensartinib | CAS 1370651-20-9 | GLYMPHUVMRFTFV

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Kinase inhibitor

ENSARITNIB (brand name ENSACOVE) is a kinase inhibitor used to treat certain adults with ALK-positive non-small cell lung cancer (NSCLC) that has spread or is locally advanced, provided they have not taken a previous ALK inhibitor.

How it worksENSARITNIB works by blocking the ALK tyrosine kinase receptor, which helps stop the growth of cancer cells that rely on this specific signal.

Brand names:ENSACOVE

Used for

ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have not previously received an ALK-inhibitor

Conditions

Non-Small-Cell Lung Cancer

Class

Kinase InhibitorALK InhibitorKinase inhibitorRespiratoryHepaticIntegumentaryCardiovascularMetabolicOcularMusculoskeletal

How to take

FormsCapsule

RoutesOral

The recommended dose is 225 mg taken orally once every day, with or without food.

Swallow capsules whole; do not chew, crush, or open them. Take the dose at the same time each day. If you miss a dose, take it as soon as possible unless your next dose is due within 12 hours. Do not take two doses on the same day.

Missed dose: If a dose is missed, take it as soon as possible unless the next dose is due within 12 hours. Do not take 2 doses on the same day.

Key warnings

·Monitor for new or worsening lung symptoms like cough or shortness of breath.
·Regular liver function tests are required.
·Monitor heart rate regularly.
·Check blood sugar levels periodically.
·Report any vision changes immediately.
·Monitor uric acid and CPK levels.

Do not use if

·Do not use ENSARITNIB if you have had a severe allergic reaction to the medicine, FD&C Yellow No. 5 (tartrazine), or any of its other ingredients.

Side effects

Common

RashMuscle and bone painConstipationItchingCoughNauseaSwelling (edema)VomitingFatigueFever

Serious

·Lung disease (interstitial lung disease or pneumonitis)
·Liver problems (hepatotoxicity)
·Skin reactions
·Slow heart rate (bradycardia)
·High blood sugar (hyperglycemia)
·Vision changes
·High levels of creatine phosphokinase (CPK)
·High uric acid levels

Seek help if

·New or worsening breathing issues
·Vision changes
·Severe rash
·Slow heart rate

Interactions

·Avoid using ENSARITNIB with moderate or strong CYP3A inhibitors.
·Avoid using ENSARITNIB with moderate or strong CYP3A inducers.
·Avoid using ENSARITNIB with P-gp inhibitors.
·Known interactions include medicines like LORBRENA, ZYKADIA, ALUNBRIG, ALECENSA, ROZLYTREK, and XAL KORI.

FoodTaking ENSARITNIB with a high-fat meal does not significantly change how the medicine works in your body.

Special populations

PregnancyENSARITNIB can cause harm to an unborn baby. It may cause death to the fetus or structural abnormalities. Females of reproductive potential should use effective birth control during treatment and for one week after the last dose. Men should use effective birth control during treatment and for one week after the last dose.

PediatricThe safety and effectiveness of ENSARITNIB in children has not been established.

GeriatricIn clinical studies, patients 65 and older experienced more serious side effects and more frequent dose changes compared to younger patients.

Talk to your doctor

Monitor

·Liver function
·Fasting blood glucose
·Heart rate
·Visual symptoms
·Creatine phosphokinase (CPK) levels
·Uric acid levels

Questions to ask

·How will ENSARITNIB affect my liver function?
·What should I do if I experience vision changes?
·How often should my blood sugar be checked?
·Are there specific breathing symptoms I should report immediately?

Pharmacokinetics

OnsetSteady state reached within 15 days

Protein binding91.6% bound to human plasma proteins

MetabolismCYP3A4 substrate

Ingredients

Allergens

sulfiteazo dyesFD&C colorsFD&C Yellow No. 5 (tartrazine)

Inactive

microcrystalline cellulosestearic acidhypromellosetitanium dioxideblack iron oxideFD&C Blue No. 1FD&C Yellow No. 5red iron oxidebutyl alcoholdehydrated alcoholFD&C Blue No. 2isopropyl alcoholpropylene glycolshellacammonia solutionsodium hydroxidepovidone

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.