Description
Avapritinib is used to treat a certain type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST) that cannot be treated with surgery or that has spread to other parts of the body (metastatic), and that is caused by a certain platelet-derived growth factor receptor alpha (PDGFRA) gene mutation.
This medicine is also used to treat advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). It is also used to treat indolent systemic mastocytosis (ISM).
Avapritinib belongs to the group of medicines known as antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with avapritinib, you should talk to your doctor about the benefits as well as the risks of using this medicine.
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 avapritinib 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 avapritinib 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Levoketoconazole
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.
- Adagrasib
- Apalutamide
- Aprepitant
- Atazanavir
- Avacopan
- Boceprevir
- Bosentan
- Carbamazepine
- Cenobamate
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclosporine
- Dabrafenib
- Diltiazem
- Dronedarone
- Duvelisib
- Efavirenz
- Enzalutamide
- Erythromycin
- Etravirine
- Fedratinib
- Fexinidazole
- Fluconazole
- Fluvoxamine
- Fosnetupitant
- Fosphenytoin
- Idelalisib
- Imatinib
- Indinavir
- Itraconazole
- Ketoconazole
- Larotrectinib
- Lenacapavir
- Letermovir
- Lonafarnib
- Lopinavir
- Lorlatinib
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:
- Kidney disease, severe (eg, end-stage kidney disease) or
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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. To do so may increase the chance of side effects.
This medicine comes with patient information insert. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Take this medicine with an empty stomach, at least 1 hour before or 2 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 (tablets):
- For treatment of gastrointestinal stromal tumor (GIST):
- Adults—300 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 treatment of advanced systemic mastocytosis (AdvSM):
- Adults—200 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of indolent systemic mastocytosis (ISM):
- Adults—25 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of gastrointestinal stromal tumor (GIST):
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 8 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and it is more than 8 hours until your next dose, take it as soon as possible, and then go back to your regular dosing schedule.
If you vomit after taking a dose, take the next dose at the regular 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.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting avapritinib treatment. Men and women should use an effective form of birth control during treatment and for up to 6 weeks after treatment. If you think you have become pregnant while using this medicine or within 6 weeks after the last dose, tell your doctor right away.
This medicine may cause intracranial hemorrhage (bleeding in the brain). Make sure your doctor knows if you have a bleeding disorder, or any medical condition that increases your chance of bleeding. Call your doctor right away if you have confusion, headache, sudden, severe weakness, nausea, or vomiting.
This medicine may cause changes in mood or behavior, trouble sleeping, or hallucinations (seeing, hearing, or feeling things that are not there). It may also make you drowsy, dizzy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know this medicine affects you.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
If you plan to have children, talk with your doctor before using this medicine. Some men and women using 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
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest tightness
- defects in intelligence, short-term memory, learning ability, and attention
- dizziness
- ear congestion
- headache
- loss of voice
- lower back or side pain
- mood or mental changes
- nervousness
- pale skin
- pounding in the ears
- runny or stuffy nose
- slow or fast heartbeat
- sneezing
- sore throat
- trouble sleeping
- trouble with breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Agitation
- black, tarry stools
- bloody stools
- chest pain
- chills
- confusion
- constipation
- cough
- decreased awareness or responsiveness
- decreased urine output
- depressed mood
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry skin and hair
- dilated neck veins
- fainting
- feeling cold
- fever
- frequent urge to urinate
- gaseous stomach pain
- hair loss
- hoarseness or husky voice
- hostility
- increased sensitivity of the skin to sunlight
- irritability
- lightheadedness
- loss of consciousness
- muscle cramps, stiffness, and twitching
- nausea
- pounding in the ears
- rapid weight gain
- rapid, shallow breathing
- redness or other discoloration of the skin
- seizures
- sensitivity to heat
- severe sleepiness
- severe sunburn
- skin rash
- sneezing
- sore throat
- stomach pain and bloating
- sweating
- swelling of the face, ankles, or hands
- swelling of the finger, feet, or lower legs
- unusual drowsiness, dullness, or feeling of sluggishness
- vomiting of blood or material that looks like coffee grounds
- weight gain or loss
- 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
- Bad unusual or unpleasant (after)taste
- belching
- change in taste
- decreased appetite
- diarrhea
- difficulty in moving
- feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
- hair color changes
- heartburn
- increased tearing
- indigestion
- muscle pain or stiffness
- pain in the joints
- skin rash
- stomach discomfort, upset, or pain
- swelling of the eye, eyelid, or inner lining of the eyelid
- vomiting
Less common
- Redness or pain of the skin
- scaling of the skin on the hands and feet
- tingling of the hands and feet
- ulceration of the skin
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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