Description
Pexidartinib is used to treat tenosynovial giant cell tumor (TGCT) that is not likely to improve with surgery. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS).
This medicine is available only under a restricted distribution program called Turalio® REMS (Risk Evaluation and Mitigation Strategy) Program.
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 pexidartinib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of pexidartinib have not been performed in the geriatric population.
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.
- Mavacamten
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.
- Acitretin
- Amiodarone
- Apalutamide
- Aprepitant
- Atazanavir
- Avacopan
- Bedaquiline
- Boceprevir
- Bosentan
- Carbamazepine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclosporine
- Cytarabine
- Dabigatran Etexilate
- Dacarbazine
- Danazol
- Dantrolene
- Deferasirox
- Dexlansoprazole
- Diltiazem
- Divalproex Sodium
- Dronedarone
- Eltrombopag Olamine
- Enzalutamide
- Erythromycin
- Esomeprazole
- Ethinyl Estradiol
- Etonogestrel
- Felbamate
- Fentanyl
- Fluconazole
- Flutamide
- Fluvoxamine
- Fosnetupitant
- Fosphenytoin
- Gemtuzumab Ozogamicin
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:
- Liver disease—Use with caution. May make this condition worse.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
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 should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole. Do not crush, chew, or open it.
This medicine must be taken on an empty stomach, at least 1 hour before or 2 hours after eating a meal or snack.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
If you are taking antacids, take them at least 2 hours before or 2 hours after using pexidartinib. If you are also taking an H2 blocker (eg, cimetidine), it is best to take it at least 10 hours before or 2 hours after using pexidartinib.
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 tenosynovial giant cell tumor (TGCT):
- Adults—400 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
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 your next dose at your 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 bottle tightly closed.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed before starting this medicine, every week for the first 8 weeks during treatment, every 2 weeks for the next month, and then every 3 months after to check for liver problems.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills during treatment with this medicine and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week 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.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable 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 (eg, St. John's wort) 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
- Blurred vision
- decreased appetite
- dizziness
- fever
- headache
- itching or skin rash
- loss of appetite
- nausea and vomiting
- nervousness
- pounding in the ears
- slow or fast heartbeat
- swelling of the feet or lower legs
Less common
- Clay colored stools
- confusion
- dark urine
- defects in intelligence, short-term memory, learning ability, and attention
- stomach pain or tenderness
- unusual tiredness or weakness
- 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
- Burning, tingling, numbness or pain in the hands, arms, feet, or legs
- change or loss of taste
- difficulty having a bowel movement (stool)
- hair color changes
- sensation of pins and needles
- stabbing pain
- swelling of the eyes
Less common
- Change in color vision
- changes in skin coloring
- darkening or lightening of skin color
- decrease in vision
- difficulty seeing at night
- double vision, seeing double
- dry mouth
- hair loss, thinning of hair
- increased sensitivity of the eyes to sunlight
- irritation, soreness, or swelling of the mouth
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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