Description
Taletrectinib 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. Your doctor will perform a test to see if you have the ROS1 gene before you take this medicine.
Taletrectinib 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:
- Capsule
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 taletrectinib 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 taletrectinib 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Gout or hyperuricemia (high uric acid in the blood) or
- Heart rhythm problems or
- Liver disease or
- Lung or breathing problem—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.
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 on an empty stomach. Do not eat food for at least 2 hours before or 2 hours after taking this medicine.
Take this medicine at the same time each day.
Swallow the capsule whole. Do not open, crush, chew, or dissolve it.
Take this medicine at least 2 hours before or 2 hours after taking antacids.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.
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 ROS1-positive non-small cell lung cancer:
- Adults—600 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you vomit after taking a dose, take the next dose at the regular scheduled 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 2 months of treatment, and every month 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 3 weeks 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 weeks after the last dose. If you think you have become pregnant, tell your doctor right away.
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 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.
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).
Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back or side pain, stomach pain, or swelling of the feet or lower legs. These may be symptoms of hyperuricemia (high uric acid in the blood).
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.
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 make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors during treatment and for at least 5 days after your last dose.
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
- Black, tarry stools
- burning, numbness, tingling, or painful sensations
- chest pain or discomfort
- chills
- cough
- difficulty in moving
- fainting
- fever
- general feeling of discomfort or illness
- increased sensitivity of skin to sunlight
- irregular or slow heart rate
- itching, skin rash
- joint pain
- muscle aches, cramps, pains, or stiffness
- nerve pain
- pain or swelling in the arms or legs without any injury
- painful or difficult urination
- redness or other discoloration of the skin
- severe sunburn
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- swollen joints
- thickening of bronchial secretions
- trouble breathing
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Less common
- Dark urine
- loss of appetite
- nausea or vomiting
- stomach pain, severe
- yellow eyes or skin
Rare
- Blue lips, fingernails, or skin
- dilated neck veins
- no blood pressure or pulse
- stopping of the heart
- swelling of the face, fingers, feet, or lower legs
- unconsciousness
- weight gain
Incidence not known
- Joint pain or stiffness
- lower back, side, or stomach pain
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
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- constipation
- diarrhea
- dizziness
- lack or loss of strength
- loss of taste
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-80007473
