Description
Vorasidenib is used to treat brain tumors (eg, astrocytoma, oligodendroglioma) with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery.
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 vorasidenib in children younger than 12 years of age. 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 vorasidenib 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.
- Abemaciclib
- Acalabrutinib
- Alfentanil
- Astemizole
- Axitinib
- Bosutinib
- Brigatinib
- Capmatinib
- Ceritinib
- Ciprofloxacin
- Cisapride
- Clindamycin
- Cobimetinib
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dasatinib
- Desogestrel
- Dienogest
- Dihydroergotamine
- Dipyrone
- Docetaxel
- Dofetilide
- Dronedarone
- Drospirenone
- Enasidenib
- Enoxacin
- Entrectinib
- Ergotamine
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Everolimus
- Fentanyl
- Fexinidazole
- Flibanserin
- Fluvoxamine
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.
- 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:
- Kidney disease (patients on dialysis) or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Smoking, current—May increase risk for serious side effects.
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 exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole with water. Do not split, crush, or chew it.
Take this medicine at the same time each day. 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 (tablets):
- For treatment of brain tumor:
- Adults and children 12 years of age and older weighing 40 kilograms (kg) or more—40 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
- Children 12 years of age and older weighing less than 40 kg—20 mg once a day. Your doctor may adjust your dose as needed.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For treatment of brain tumor:
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 and it is less than 6 hours, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 6 hours, skip the missed dose and take your next dose at the regular time.
If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual 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.
Do not remove or swallow the drying agent (desiccant canister) in your medicine bottle. The drying agent will protect your medicine from moisture.
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 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 treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Female patients should use another form of birth control (eg, condoms, spermicide) for 3 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 3 months after the last dose. If a pregnancy occurs while using the medicine, tell your doctor right away.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
If you plan to have children, talk with your doctor before using this medicine. 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 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
- Cough
- diarrhea
- fever or chills
- headache
- jerking or shaking of the muscles
- loss of bladder control
- loss of taste or smell
- muscle or body aches
- nausea or vomiting
- sore throat
- stuffy or runny nose
- sudden loss of consciousness
- unusual tiredness or weakness
Incidence not known
- Dark urine
- loss of appetite
- stomach pain, severe
- 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
- Arm or leg pain
- back pain
- constipation
- decreased appetite
- diarrhea
- difficulty in moving
- lack or loss of strength
- muscle or bone pain
- neck pain
- pain, swelling, or redness in the joints
- stomach tenderness
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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