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Overview: Ensacove is taken for certain types of non-small-cell lung cancer (NSCLC). Common side effects include rash, itching, and muscle or bone pain. Limit sun exposure and use sunscreen while taking Ensacove. Tell your healthcare provider right away if you get a cough or feel short of breath. Also, tell your healthcare provider if you feel lightheaded, dizzy, or like you are going to faint, especially if you take medicine for your heart or blood pressure.

Uses

What is Ensacove used for?

Ensacove (ensartinib) is commonly used to treat certain types of non-small-cell lung cancer (NSCLC).

Navigating ALK-Positive Non-Small-Cell Lung Cancer: What to Know About Ensacove

Ensacove may also be used for other conditions as determined by your healthcare provider.

How does Ensacove work (mechanism of action)?

Ensacove is a specific kind of medicine called a kinase inhibitor. Kinases are enzymes that are responsible for sending and receiving signals in the body. These signals help your cells do important functions such as grow properly. Ensacove targets and blocks the action of anaplastic lymphoma kinase (ALK). Some lung cancers have ALK mutations where ALK sends a signal to proteins in the tumor cells that tell the cells to grow and multiply. When Ensacove blocks the signals sent by ALK, it helps to stop cancer cells from growing and multiplying and makes tumors shrink in size. Your healthcare provider can do a test to see if Ensacove is a good option for your lung cancer.

How is Ensacove supplied (dosage forms)?

Brands and other names

  • Ensacove

Dosage forms and strengths

  • 25 mg, 100 mg oral capsules

How should I store Ensacove?

Ensacove should be stored in the original bottle at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not remove the desiccant (small object) in the bottle. It protects the capsules from moisture.

Side Effects

What are the most common side effects of Ensacove?

The most common side effects of Ensacove are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

There may be other side effects of Ensacove that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ensacove?

While less common, the most serious side effects of Ensacove are described below, along with what to do if they happen.

Severe Allergic Reactions. Ensacove may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Sensitivity to Sunlight. Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking Ensacove. This is called photosensitivity. Use sunscreen (including on your lips) and wear a hat and clothes that cover your skin if you need to be in the sunlight while taking Ensacove and for one week after your last dose. Exposure to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your healthcare provider right away if any of these happen.

Lung Inflammation. Ensacove can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Ensacove. Keep all healthcare appointments, including those for lab work, while you are taking Ensacove. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain, especially on the right side
  • Easy bleeding or bruising
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Heart Rate Changes. Ensacove can make your heart beat slower than normal (bradycardia). Call your healthcare provider right away if you feel lightheaded, dizzy, or if you faint.

High Blood Sugar. Ensacove may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels. Keep all appointments with your healthcare provider to check your blood work. Follow any instructions from your healthcare provider about checking your blood sugar levels at home. Call your healthcare provider if you have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness or tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Vision Problems. Ensacove may increase your risk for vision problems. Tell your healthcare provider if you have any new or worsening vision problems or any of the following symptoms while you are taking Ensacove.

  • Double vision
  • Vision changes, such as blurry vision or sensitivity to light
  • See flashes of light or new or an increased number of floaters

Muscle Problems. Ensacove can cause muscle problems, including muscle damage. Keep all appointments for blood work. Your healthcare provider may check your creatine phosphokinase (CPK) levels. Tell your healthcare provider if you have any unexplained muscle pain, weakness, tenderness, or muscle pain that does not go away.

Increased Uric Acid. Ensacove can increase your uric acid blood levels (hyperuricemia). You may not have any symptoms with high uric acid levels, but it can increase your risk for gout and kidney stones. Your healthcare provider may give you medicine to lower your uric acid levels if they get too high. Tell your healthcare provider if you notice any of the following symptoms of high uric acid levels.

  • Painful joints that are red, swollen, or warm to the touch, especially one of your big toes
  • Pink or brown pee
  • Stomach or side pain
  • Nausea or vomiting

Warnings & Precautions

Who should not use Ensacove?

Allergies to Ingredients. People who are allergic to any of the following should not take Ensacove.

  • Ensacove
  • Ensartinib
  • Tartrazine (also known as FD&C Yellow number 5)
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ensacove.

What should I know about Ensacove before using it?

Do not take Ensacove unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Try to take Ensacove around the same time each day.

Do not share Ensacove with other people, even if they have the same condition as you. It may harm them.

Keep Ensacove out of the reach of children.

Do not chew, crush, open, or dissolve the Ensacove. Swallow it whole. 

People who are 65 or older can be at greater risk for some side effects from Ensacove. Talk to your healthcare provider about your risks if you are in this age group.

If you can get pregnant or get your partner pregnant you should use effective birth control while taking Enscove and for one week after your last dose. See the Pregnancy section for more details.

What should I tell my healthcare provider before using Ensacove?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ensacove is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Lung problems
  • Liver problems
  • Diabetes or high blood sugar
  • Gout
  • Slow heartbeat
  • Vision problems
  • Aspirin sensitivity

Other Medicines and Supplements. Ensacove may interact with other medicines and supplements. Before taking Ensacove, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Ensacove may cause harm to an unborn baby. You may need to have a negative pregnancy test before you start taking Ensacove. You should use effective birth control while you are taking Ensacove and for one week after your last dose. Talk with your healthcare provider about your birth control options. Tell your healthcare provider right away if you are or think you are pregnant.

Breastfeeding. It is not known if Ensacove passes into breast milk. Do not breastfeed while you are taking Ensacove or for one week after your last dose. Talk with your healthcare provider about how you should feed your baby while you are taking Ensacove.

How can I get more information about Ensacove?

For more information about Ensacove, you can visit the manufacturer’s website at xcovery.com/for-patients/ or call them at 561-835-9356.

Interactions

Does Ensacove interact with foods or drinks?

There are no known interactions between Ensacove and foods or drinks.

It is unknown if drinking alcohol will affect Ensacove. The risk of tiredness may be increased if you drink alcohol while taking Ensacove.

Does Ensacove interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ensacove.

  • Ketoconazole, itraconazole (Sporanox, Tolsura), or fluconazole (Diflucan), which is a medicine used for fungal infections
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • St. John’s wort, which is a supplement that may be used to treat depression
  • Clarithromycin, which is a medicine used for bacterial infections
  • Amiodarone (Pacerone and others), which is a medicine used for an irregular heart rhythm
  • A medicine for your heart
  • A blood pressure medicine
  • A medicine for diabetes

Many other medicines may alter the blood levels of Ensacove. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ensacove. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ensacove?

If you or someone else has used too much Ensacove, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

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

If you miss a dose and it is more than 12 hours before you normally take your next dose, take it as soon as you remember. If it is within 12 hours of your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

If you vomit after taking a dose, do not take another dose. Just take your next dose at the usual time.