Description
Dordaviprone is used to treat diffuse midline glioma (brain tumor) that has a specific H3 K27M gene mutation and has gotten worse after receiving other treatments. Your doctor will use a special test to look for these mutations.
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 dordaviprone in children younger than 1 year 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 dordaviprone 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:
- Heart failure or
- Heart rhythm problems (eg, QT prolongation, long QT syndrome)—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 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 usually comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use:
- Swallow the capsule whole. If you cannot swallow the capsule whole, you may dissolve it in sports drink, apple juice, lemonade, or water.
- Wash your hands before and after using this medicine.
- Carefully open the capsule by gently pulling and twisting both ends. Slowly empty the contents into the cup. Gently tap the shell to remove any remaining powder.
- Add 1 to 2 tablespoons (about 15 to 30 mL) of liquid into the cup. Gently swirl the liquid before taking or giving the mixture until no large chunks of powder remain. The mixture may look cloudy.
- Give or take the mixture right away or within 2 hours of preparing it. Add another 15 to 30 mL of liquid into the cup and swirl it around to rinse any remaining medicine. Give or take it right away to make sure no medicine is left.
- You may also give this medicine using an oral dosing syringe or through a feeding tube.
- After taking or giving this medicine, throw away empty capsule shells and rinse the cup with warm water. Do not save or reuse empty capsules.
Take this medicine on an empty stomach (at least 1 hour before or 3 hours after a meal).
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 diffuse midline glioma:
- Adults—625 milligrams (mg) once a week. Your doctor may adjust your dose as needed and tolerated.
- Children 1 to younger than 17 years of age weighing 10 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- Weighing 52.5 kilograms (kg) or more—625 milligrams (mg) once a week. The doctor may adjust your child's dose as needed and tolerated.
- Weighing 42.5 kg to less than 52.5 kg—500 mg once a week. The doctor may adjust your child's dose as needed and tolerated.
- Weighing 27.5 kg to less than 42.5 kg—375 mg once a week. The doctor may adjust your child's dose as needed and tolerated.
- Weighing 12.5 kg to less than 27.5 kg—250 mg once a week. The doctor may adjust your child's dose as needed and tolerated.
- Weighing 10 kg to less than 12.5 kg—125 mg once a week. The doctor may adjust your child's dose as needed and tolerated.
- Children younger than 1 year of age or weighing less than 10 kg—Use and dose must be determined by your doctor.
- For diffuse midline glioma:
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 2 days or less, take it as soon as you remember and take the next dose at your regular dosing time. If it is more than 2 days, skip the missed dose and go back to your regular dosing schedule.
If you vomit after taking the medicine, skip the missed dose and go back to your regular dosing schedule.
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.
Throw away unused mixture within 2 hours after preparing it.
Precautions
It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will 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. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 1 month after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cool sweaty skin, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, pale skin, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.
Check with your doctor right away if you have chest pain or discomfort, irregular heartbeat, fainting, or trouble breathing. These may be symptoms of heart rhythm problems (eg, QT prolongation, torsades de pointes).
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
- Arm or leg pain
- blurred vision
- bone pain
- burning, numbness, tingling, or painful sensations
- chest pain
- difficulty in moving
- dizziness
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increase thirst
- increased urination
- joint pain
- muscle or bone pain
- nausea
- nerve pain
- pain in the chest, groin, or legs, especially the calves
- seizures
- severe, sudden headache
- shakiness in the legs, arms, hands, or feet
- slurred speech
- spinal pain
- stomach pain
- sudden loss of coordination
- sweating
- trembling or shaking of the hands or feet
- trouble breathing
- unexplained weight loss
- unsteadiness or awkwardness
- unusual tiredness or weakness
- vision changes
- vomiting
- weakness in the arms, hands, legs, or feet
- weakness of the muscles in your face
Incidence not known
- Chest pain or discomfort
- cough
- difficulty swallowing
- fainting
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow heart rate
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
- Blistering, crusting, irritation, itching, or reddening of the skin
- changes in patterns and rhythms of speech
- cracked, dry, scaly skin
- constipation
- diarrhea
- trouble in speaking
- vomiting
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-80008482
