Description
Zidesamtinib is used to treat ROS1-positive non-small cell lung cancer (NSCLC) that has spread within your chest or to other parts of the body in patients who have received other cancer medicines (eg, ROS1 kinase inhibitor).
Zidesamtinib 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.
This product is available in the following dosage forms:
- Tablet
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 zidesamtinib 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 zidesamtinib 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Berotralstat
- Boceprevir
- Bosentan
- Buprenorphine
- Buserelin
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Darunavir
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:
- Heart rhythm problems (eg, QT prolongation) or
- Lung or breathing problems or
- Mental health problems or
- Nervous system problems—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 using 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 only 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 comes with a patient information leaflet. Read and follow the instructions carefully and make sure you understand them before taking this medicine. Ask your doctor if you have any questions.
Take this medicine at the same time each day, with or without food.
Swallow the tablet whole. Do not split, chew, crush, or dissolve it. Do not take the tablet if it is broken, cracked, or damaged.
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 (tablet):
- For ROS1-positive non-small cell lung cancer:
- Adults—100 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 ROS1-positive 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 a dose is missed within 12 hours, take the missed dose. If a dose is missed by 12 hours or more, skip the missed dose. Take the next dose at the regular scheduled time.
If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed before starting, every 2 weeks during the first month of treatment, and every 1 to 2 months and as needed during treatment with this medicine 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 give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 6 months after your last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant, tell your doctor right away.
This medicine may cause dizziness, memory loss, mental status changes, confusion, hallucinations, having trouble with balance or coordination, or trouble with concentration and attention. Do not drive or do anything else that could be dangerous until you know this medicine affects you.
Check with your doctor right away if you have chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing. These could be symptoms of heart rhythm problems (eg, QT prolongation).
This medicine may cause serious lung or breathing problems (eg, interstitial lung disease, pneumonitis). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.
This medicine may increase your risk of bone fractures. Ask your doctor about ways to keep your bones strong to help prevent fractures.
This medicine may cause muscle problems, including myalgia. Check with your doctor right away if you have difficulty moving, joint pain, muscle aches, cramps, pains, or stiffness, or swollen joints.
Check with your doctor right away if you have nausea or vomiting, upper stomach pain that may spread to your back and get worse with eating, or weight loss. These may be symptoms of pancreas problems.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
- Ankle fracture
- bloating or swelling of the face, arms, hands, lower legs, or feet
- burning, numbness, tingling, or painful sensations
- chest pain, discomfort, or tightness
- cough
- difficulty in moving
- dizziness
- fainting
- fever or chills
- irregular or slow heart rate
- joint pain
- muscle aches, cramps, pains, or stiffness
- rapid weight gain
- shakiness and unsteady walk
- sneezing
- sore throat
- swollen joints
- tingling of hands or feet
- trouble breathing
- unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
- unusual weight gain or loss
- weakness in the arms, hands, legs, or feet
Less common
- Being forgetful
- confusion as to time, place, or person
- discouragement
- fear, nervousness
- feeling sad or empty
- holding false beliefs that cannot be changed by fact
- irritability
- lack of appetite
- loss of interest or pleasure
- seeing, hearing, or feeling things that are not there
- tiredness
- trouble concentrating
- trouble performing routine tasks
- trouble sleeping
- unusual excitement, nervousness, or restlessness
Rare
- Agitation
- loss of memory
- personality changes
- problems with memory
- problems with speech or speaking
- slow speech
- thoughts of killing oneself changes in behavior
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
- Change or loss of taste
- changes in vision
- constipation
- diarrhea
- headache
- swelling or inflammation of the mouth
- unusual tiredness or weakness
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.
DRG-80011974
