Pronunciation: en-sa-kowv
Generic name: ensartinib
Dosage form: oral capsule

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 20, 2024.

What is Ensacove?

Ensacove is used to treat non-small cell lung cancer (NSCLC) in adults that has spread and is caused by an abnormal ALK gene.

Ensacove’s mechanism of action involves blocking a specific protein in cancer cells called anaplastic lymphoma kinase (ALK). Ensacove prevents ALK from activating other proteins in cells that tell cancer cells to grow. Ensacove belongs to the drug class called kinase inhibitors.

Ensacove gained FDA approval on December 18, 2024. Ensacove (generic name ensartinib) represents a new, first-line treatment option for ALK-positive NSCLC patients. There is no generic Ensacove available.

Ensacove uses

Ensacove is used to treat adults with non-small cell lung cancer (NSCLC):

• that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene,
• that has spread to other parts of your body, and
• who have not received medicines called ALK inhibitors.

Your healthcare provider will perform a test to make sure that Ensacove is right for you.

It is not known if Ensacove is safe and effective in children.

Ensacove side effects

The most common side effects of Ensacove are:

• rash and itching
• tiredness
• muscle or bone pain
• fever
• constipation
• coughing
• nausea
• skin swelling (edema)
• vomiting
• laboratory changes (such as decreased white blood cell counts, increased levels of liver and pancreatic enzymes, changes in blood levels of phosphate, magnesium, sodium, and potassium, decreased protein (hemoglobin) in red blood cells, increased bilirubin blood levels).

These are not all the possible side effects of Ensacove. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects and warnings

Ensacove may cause the following serious side effects.

Lung problems. Ensacove can cause severe or life-threatening swelling (inflammation) of the lungs. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you get any new or worsening symptoms of lung problems during treatment with Ensacove, including:

• trouble breathing or shortness of breath
• cough with or without mucus
• chest pain
• fever.

Liver problems. Ensacove can increase enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and levels of bilirubin in your blood. Tell your healthcare provider if you get new or worsening signs or symptoms of liver problems, including:

• yellowing of your skin or the white part of your eyes
• bleed or bruise more easily than normal
• itchy skin
• dark or brown (tea color) urine
• decreased appetite
• nausea or vomiting
• feeling tired
• pain on the right side of your stomach area.

Skin reactions. Ensacove may cause skin reactions that require treatment. Tell your healthcare provider if you get symptoms of skin reactions, such as rash, itching, or skin swelling.

Slow heart rate (bradycardia). Ensacove can cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with Ensacove. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with Ensacove. Tell your healthcare provider if you take any heart or blood pressure medicines.

High blood sugar (hyperglycemia). Ensacove can increase your blood sugar levels. Hyperglycemia is common with Ensacove treatment but can be serious. If you take medicine for diabetes or glucose intolerance your healthcare provider may change your medicine during treatment with Ensacove. Tell your healthcare provider if you get new or worsening signs and symptoms of hyperglycemia, including:

• feeling very thirsty
• feeling sick to your stomach
• needing to urinate more than usual
• feeling weak or tired
• feeling very hungry
• feeling confused.

Vision problems. Ensacove can cause vision problems. Your healthcare provider may refer you to an eye specialist if you develop new or worsening vision problems during treatment with Ensacove. Tell your healthcare provider if you have any loss of vision or any change in vision, including:

• blurry vision
• light hurting eyes
• double vision
• new or increased floaters
• seeing flashes of light.

Muscle pain, tenderness, and weakness (myalgia). Ensacove can increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Myalgia is common with Ensacove treatment but can be serious. Tell your healthcare provider if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Increased uric acid levels in your blood (hyperuricemia). Ensacove can cause too much uric acid in your blood. Hyperuricemia is common with Ensacove treatment but can be serious. Your healthcare provider may prescribe medicines if you have high blood uric acid levels. Tell your healthcare provider if you develop any of the following symptoms of hyperuricemia:

• red, hot, tender, or swollen joints, especially your big toe
• nausea or vomiting
• pain in your stomach area or sides
• pink or brown urine.

Allergic reactions to FD&C Yellow No. 5 (tartrazine). Ensacove 100 mg capsules contain FD&C Yellow No. 5 (tartrazine) which can cause allergic reactions in certain people, especially people who also have an allergy to aspirin. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with Ensacove.

Your healthcare provider will do certain blood tests before and during treatment with Ensacove to check you for side effects.

If you have serious side effects during treatment with Ensacove, your healthcare provider may change your dose, stop your treatment for some time (temporary), or completely stop treatment with Ensacove.

Before taking

Do not take Ensacove if you are allergic to Ensacove, ensartinib, FD&C No. 5 (tartrazine), or any of the inactive ingredients in Ensacove. See below for a complete list of ingredients in Ensacove.

Before using Ensacove, tell your healthcare provider about all of your medical conditions, including if you:

• have lung or breathing problems
• have liver problems
• have problems with your heartbeat
• have diabetes mellitus or glucose intolerance
• have problems with your vision
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Pregnancy

Ensacove can harm your unborn baby. Your healthcare provider will do a pregnancy test before you start treatment with Ensacove. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ensacove.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with Ensacove and for 1 week after the last dose of Ensacove. Talk to your healthcare provider about birth control choices that are right for you during treatment with Ensacove.

Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Ensacove and for 1 week after the last dose of Ensacove.

Breastfeeding

It is not known if Ensacove passes into your breast milk. Do not breastfeed during treatment with Ensacove and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Related/similar drugs

How should I take Ensacove?

Take Ensacove exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ensacove unless your healthcare provider tells you to.

• Take Ensacove 1 time a day, at the same time each day.
• Swallow Ensacove capsules whole. Do not crush or chew capsules. Do not open or dissolve the contents of the capsule.
• You may take Ensacove with or without food.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take your next dose at your regular time. Do not take 2 doses of Ensacove on the same day to make up for the missed dose

If you vomit after taking a dose of Ensacove, do not take an extra dose. Take your next dose at your regular time.

What should I avoid while taking Ensacove?

Limit your time in the sun during treatment with Ensacove and for at least 1 week after your last dose. Ensacove may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns.

When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.

What other medicines will affect Ensacove?

Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain other medicines may affect the way that Ensacove works and may increase your risk of certain side effects. Especially tell your healthcare provider if you take:

• Moderate or strong CYP3A inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, ritonavir, amiodarone, erythromycin, fluconazole, or miconazole. Do not use with Ensacove.
• Moderate or strong CYP3A inducers, such as rifampicin, dexamethasone, or modafinil. Do not use with Ensacove
• P-gp inhibitors, such as amiodarone or cyclosporine. Do not use with Ensacove

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Ensacove storage

Store Ensacove at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep the capsules in the original bottle because the bottle of Ensacove capsules contains a drying agent (desiccant) to help keep your medicine dry. Do not remove the desiccant from the bottle after opening. Do not open or eat the desiccant.

Keep Ensacove and all medicines out of the reach of children

Ensacove ingredients

Active ingredient: ensartinib hydrochloride

Inactive ingredients: butyl alcohol, dehydrated alcohol, hypromellose, isopropyl alcohol, microcrystalline cellulose, propylene glycol, shellac, stearic acid, and titanium dioxide.

The 25 mg capsules also contain the following inactive ingredients: FD&C Blue No. 2 and strong ammonia solution.

 The 100 mg capsules also contain the following inactive ingredients: black iron oxide, FD&C Blue No. 1, FD&C Yellow No. 5, povidone, red iron oxide, and sodium hydroxide.

Who makes Ensacove?

Xcovery Holdings, Inc. make Ensacove.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer