Description
Tovorafenib is used to treat patients with low-grade glioma (LGG) that has come back and have received other cancer medicines that did not work well. It is only used if the brain tumor has the BRAF V600 mutations. Your doctor will use a special test to look for these mutations. Tovorafenib belongs to the group of medicines called antineoplastics (cancer medicines).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
- 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 tovorafenib in children younger than 6 months of age. Safety and efficacy have not been established because tovorafenib may cause slowed growth in children.
Geriatric
No information is available on the relationship of age to the effects of tovorafenib in geriatric patients.
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
- Carbamazepine
- Ceritinib
- Cisapride
- Clindamycin
- Clopidogrel
- Cobimetinib
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dasatinib
- Deferasirox
- Desogestrel
- Dienogest
- Dihydroergotamine
- Docetaxel
- Dofetilide
- Dronedarone
- Drospirenone
- Entrectinib
- Ergotamine
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Everolimus
- Fentanyl
- Flibanserin
- Gemfibrozil
- Gestodene
- Ivosidenib
- Letermovir
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:
- Bleeding problems or
- Liver disease or
- Skin 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 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.
You may take this medicine with or without food.
Swallow the tablet whole with water. Do not chew, cut, or crush it.
To use the oral liquid:
- Measure the oral liquid with a marked oral syringe. The average household teaspoon may not hold the right amount of liquid.
- You may take or give this medicine by mouth or through a feeding tube.
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 glioma:
- For oral dosage form (suspension):
- Adults and children 6 months of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 380 milligrams per square meter (mg/m[2]) of BSA, taken once a week. Your doctor may adjust your dose as needed and tolerated.
- BSA of 1.40 meter squared (m2) or more—600 mg or 24 milliliters (mL) once a week.
- BSA of 1.26 to 1.39 m2—525 mg or 21 mL once a week.
- BSA of 1.06 to 1.25 m2—450 mg or 18 mL once a week.
- BSA of 0.90 to 1.05 m2—375 mg or 15 mL once a week.
- BSA of 0.84 to 0.89 m2—350 mg or 14 mL once a week.
- BSA of 0.78 to 0.83 m2—300 mg or 12 mL once a week.
- BSA of 0.64 to 0.77 m2—275 mg or 11 mL once a week.
- BSA of 0.55 to 0.63 m2—225 mg or 9 mL once a week.
- BSA of 0.49 to 0.54 m2—200 mg or 8 mL once a week.
- BSA of 0.43 to 0.48 m2—175 mg or 7 mL once a week.
- BSA of 0.36 to 0.42 m2—150 mg or 6 mL once a week.
- BSA of 0.30 to 0.35 m2—125 mg or 5 mL once a week.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- Adults and children 6 months of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 380 milligrams per square meter (mg/m[2]) of BSA, taken once a week. Your doctor may adjust your dose as needed and tolerated.
- For oral dosage form (tablets):
- Adults and children 6 months of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 380 milligrams per square meter (mg/m[2]) of BSA, taken once a week. Your doctor may adjust your dose as needed and tolerated.
- BSA of 1.40 meter squared (m2) or more—600 mg once a week.
- BSA of 1.13 to 1.39 m2—500 mg once a week.
- BSA of 0.90 to 1.12 m2—400 mg once a week.
- BSA of 0.30 to 0.89 m2—Use of oral liquid is recommended.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- Adults and children 6 months of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 380 milligrams per square meter (mg/m[2]) of BSA, taken once a week. Your doctor may adjust your dose as needed and tolerated.
- For oral dosage form (suspension):
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 3 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 3 days, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, take another dose.
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 medicine in its original package. Do not remove the tablet from blisters until right before use.
Throw away the bottle, including unused oral liquid and oral dosing syringe after taking or giving a dose.
Precautions
It is very important that your doctor check your 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 28 days 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 2 weeks after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Some men and women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.
This medicine may cause bleeding problems. Tell your doctor if you have bleeding gums, coughing up blood, difficulty with breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.
This medicine may cause skin reactions (eg, photosensitivity reaction, maculopapular rash). Check with your doctor right away if you have increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
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.
This medicine may cause slowed growth in children. Your child's doctor will need to keep track of your child's height during treatment with this medicine.
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
- Bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- chills
- cough
- diarrhea
- dizziness
- ear congestion
- fever
- general feeling of discomfort or illness
- headache
- increased menstrual flow or vaginal bleeding
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- nausea
- new loss of taste or smell
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- rapid weight gain
- red or black, tarry stools
- red or dark brown urine
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- swelling around the eyes
- swelling or puffiness of the face
- tender, swollen glands in neck
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- trouble swallowing
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- vomiting of blood or material that looks like coffee grounds
Incidence not known
- Dark urine
- increased sensitivity of the eyes to sunlight
- itching
- rash with flat lesions or small raised lesions on the skin
- redness or other discoloration of the skin
- severe sunburn
- skin rash
- 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
- Blistering, crusting, irritation, itching, or reddening of the skin
- changes in hair color
- chapped, red, or swollen lips
- cracked, dry, or scaly skin
- irritation or soreness of the mouth
- loosening of the fingernails
- redness or soreness around the fingernails
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- sores, ulcers, or white spots on lips, tongue, or inside the mouth
- swelling or inflammation 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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