Description
Ensartinib is used to treat non-small cell lung cancer (NSCLC) that has spread in patients who have not received other medicines (eg, ALK-inhibitors) and whose tumors have an abnormal anaplastic lymphoma kinase (ALK) gene. Your doctor will perform a test to check for the ALK gene before you use this medicine.
Ensartinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ensartinib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ensartinib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abrocitinib
- Adagrasib
- Alogliptin
- Amiodarone
- Amprenavir
- Apalutamide
- Aprepitant
- Asunaprevir
- Atazanavir
- Atorvastatin
- Azithromycin
- Berotralstat
- Boceprevir
- Bosentan
- Canagliflozin
- Capmatinib
- Captopril
- Carbamazepine
- Carvedilol
- Cenobamate
- Ceritinib
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Clofazimine
- Cobicistat
- Conivaptan
- Crizotinib
- Curcumin
- Cyclosporine
- Dabrafenib
- Daclatasvir
- Danicopan
- Daridorexant
- Darunavir
- Diltiazem
- Diosmin
- Dipyrone
- Dronedarone
- Duvelisib
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including bronchial asthma) in patients with this condition.
- Allergy to tartrazine (yellow dye)—Should not be used in patients with this condition.
- Bradycardia (slow heart beat) or
- Eye or vision problems or
- Hyperglycemia (high blood sugar) or
- Liver disease or
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush or chew it. Do not open or dissolve the contents of the capsule.
You may take this medicine with or without food.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For non-small cell lung cancer:
- Adults—225 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For non-small cell lung cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, take it as soon as you remember. If you miss a dose and it is within 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses on the same day.
If you vomit after taking a dose, take the next dose at the regular time.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in its original bottle. Do not throw the desiccant (drying agent) packet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use effective birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think a pregnancy has occurred with this medicine, tell your doctor right away.
This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to those for lung cancer. Check with your doctor right away if you have a new or worsening cough, fever, or trouble breathing.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen gland, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds during treatment with this medicine and for at least 1 week after the last dose.
Bradycardia (slow heartbeat) may occur while you are using this medicine. Tell your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, or a slow or uneven heartbeat.
This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.
Check with your doctor immediately if blurred vision, difficulty in reading, double vision, seeing flashes or sparks of light, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness after taking this medicine. These may be symptoms of a serious muscle problem.
Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs. These may be symptoms of hyperuricemia (high uric in the blood).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Arm or leg pain
- bleeding gums
- bloody stools
- body aches or pain
- bone pain
- chills
- confusion
- cough
- coughing up blood
- difficulty in moving
- difficulty swallowing
- dizziness
- ear congestion
- fever
- headache
- increased menstrual flow or vaginal bleeding
- loss of voice
- muscle pain or stiffness
- nausea and vomiting
- nosebleeds
- pain, swelling, or redness in the joints
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain or tightness
- general feeling of discomfort or illness
- rapid weight fain
- thickening of bronchial secretions
- tingling of the hands or feet
- unusual weight gain or loss
Incidence not known
- Blurred vision
- chest discomfort
- clay colored stools
- decrease or change in vision
- decreased appetite
- double vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- lightheadedness, dizziness, or fainting
- loss of appetite
- lower back or side pain
- painful or difficult urination
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- slow or irregular heartbeat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- sweating
- swollen glands
- unusual bleeding or bruising
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
- dry skin
- itching skin
- loss or change in taste
- loss or thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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