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Avapritinib (Oral)

Commonly used brand name(s)

In the U.S.

  • Ayvakit

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for avapritinib

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.

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 avapritinib.

Avapritinib is available only with your doctor's prescription.

Before using avapritinib

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 avapritinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to avapritinib 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.

Interactions with medicines

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 avapritinib, 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 avapritinib 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.

  • Apalutamide
  • Aprepitant
  • Atazanavir
  • Boceprevir
  • Bosentan
  • Carbamazepine
  • Cenobamate
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Diltiazem
  • Dronedarone
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Etravirine
  • Fluconazole
  • Fluvoxamine
  • Fosnetupitant
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Letermovir
  • Lopinavir
  • Lorlatinib
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Rifabutin
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Verapamil
  • Voriconazole

Interactions with food/tobacco/alcohol

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 avapritinib. 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 of avapritinib

Medicines used to treat cancer are very strong and can have many side effects. Before using avapritinib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take avapritinib 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.

Avapritinib comes with patient information insert. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take avapritinib with an empty stomach, at least 1 hour before or 2 hours after a meal.

Dosing

The dose of avapritinib 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 avapritinib. 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 the 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.

Missed dose

If you miss a dose of avapritinib, 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 while using avapritinib

It is very important that your doctor check your progress at regular visits to make sure avapritinib is working properly.

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.

Using avapritinib while you are pregnant can harm your unborn baby. 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 avapritinib or within 6 weeks after the last dose, tell your doctor right away.

Avapritinib 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.

Avapritinib 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 avapritinib affects you.

If you plan to have children, talk with your doctor before using avapritinib. Some men and women using avapritinib 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.

Avapritinib 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
  • chest tightness
  • defects in intelligence, short-term memory, learning ability, and attention
  • dizziness
  • headache
  • mood or mental changes
  • nervousness
  • pale skin
  • pounding in the ears
  • slow or fast heartbeat
  • trouble sleeping
  • trouble with breathing
  • troubled breathing with exertion
  • 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
  • dry skin and hair
  • fainting
  • feeling cold
  • fever
  • hair loss
  • hoarseness or husky voice
  • hostility
  • irritability
  • lightheadedness
  • loss of consciousness
  • muscle cramps, stiffness, and twitching
  • nausea
  • rapid weight gain
  • rapid, shallow breathing
  • seizures
  • sensitivity to heat
  • severe sleepiness
  • sneezing
  • sore throat
  • sweating
  • swelling of the face, ankles, or hands
  • unusual drowsiness, dullness, or feeling of sluggishness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain or loss

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
  • hair color changes
  • heartburn
  • increased tearing
  • indigestion
  • skin rash
  • stomach discomfort, upset, or pain
  • 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.