Ensartinib (Ensacove™)

A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a particular enzyme from working, this medication can slow the growth of cancer cells.

Ensartinib works by targeting and blocking receptors found on the cancer cells called an anaplastic lymphoma kinase (ALK). In some cancers, this receptor is overactive, causing cells to grow and divide too fast. By inhibiting ALK, this medication can slow or stop tumor growth. Your oncology team will test your tumor for this abnormality, which must be present in order to receive the medication.

How to Take Ensartinib

Ensartinib is taken by mouth in capsule form. This medication can be taken with or without food. Swallow the capsules whole; do not crush, chew, break or open the capsules. If you miss a dose, take the missed dose as soon as possible, do not take it if the next dose is due within 12 hours. If you vomit after taking your dose, do not take another dose. Take the next dose at its normally scheduled time. Consult with your pharmacist or provider if you are having trouble swallowing the medication.

You may need to take a number of capsules to achieve the full dose. It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush it down the toilet or throw it in the trash.

Where do I get this medication?

Ensartinib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for the distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources if they are available.

Possible Side Effects of Ensartinib

There are a number of things you can do to manage the side effects of Ensartinib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Rash

Some patients may develop a rash, scaly skin, or red itchy bumps. Use an alcohol-free moisturizer on your skin and lips; avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Be sure to notify your oncology care team of any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Skin Reactions

Report rash, with or without itching (pruritis), sores in your mouth, blistering or peeling skin, as these can become severe and require treatment with corticosteroids.

Hyperuricemia

This medication can cause higher than normal uric acid levels in your blood. This can cause gout and kidney stones. You will have your labs monitored. Call your provider if you have new joint pain or swelling, joints that are hot to the touch, or if your skin becomes shiny and red or purple.

Muscle or Joint Pain/Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy, or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Swelling (Edema)

This medication can cause swelling (edema) in the face, especially around the eyes, and extremities. This can be a sign of other problems, so be sure to report any abnormal swelling to your healthcare team for further evaluation.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Liver Problems

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Low White Blood Cell Count (Leukopenia, Lymphopenia, Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips for preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever, or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with has any vaccinations.

High Blood Sugar 

This medication can cause elevated blood sugar levels in patients with and without diabetes. Your healthcare team will monitor your blood sugar. If you develop increased thirst, urination or hunger, blurry vision, headaches or your breath smells like fruit, notify your healthcare team. Diabetics should monitor their blood sugar closely and report elevations to the healthcare team.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (phosphate, sodium, potassium, magnesium, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Kidney Problems

This medication can cause kidney problems, including an increased creatinine level, which your oncology care team may monitor for using blood tests. Notify your healthcare provider if you notice decreased urine output, blood in the urine, swelling in the ankles, or loss of appetite.

Important but Less Common Side Effects

• Interstitial Lung Disease/Pneumonitis: Patients can develop interstitial lung disease (scarring of the lung tissue) or pneumonitis (inflammation of the lungs) while taking this medication. Notify your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, chest pain, cough, or fever.
• Bradycardia: Bradycardia is a lower-than-normal heart rate, which can be a serious problem. Report any dizziness, light-headedness, and fainting to your provider immediately. Your provider will monitor your heart rate and blood pressure regularly while you are taking this medication.
• Eye Concerns: While taking Ensartinib, some patients may develop visual disturbances, changes in their eyesight, or blindness. Tell your healthcare team if you have any eye pain, swelling, redness, or vision changes, including blurriness and sensitivity to light.
• Muscle Pain and Weakness: This pain can be associated with damage to the muscles which can become severe. Your provider will do blood tests to monitor your creatine phosphokinase level periodically. If you are experiencing any unexplained muscle pain, tenderness, or weakness, notify your provider right away.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 1 week after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication or for one week after your last dose.