Avapritinib tablets

What is this medication?

AVAPRITINIB (A va PRI ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It treats systemic mastocytosis and specific digestive tract tumors called GISTs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AYVAKIT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding in the brain
• bulging or weak blood vessel wall
• low platelets
• stroke
• an unusual or allergic reaction to avapritinib, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the tablets whole. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your health care provider's advice.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is due in 8 hours, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• aprepitant
• bosentan
• certain antibiotics like clarithromycin, erythromycin, telithromycin, or troleandomycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• ciprofloxacin
• conivaptan
• cyclosporine
• diltiazem
• dronedarone
• fluvoxamine
• grapefruit juice
• nefazodone
• rifampin
• St. John's Wort
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. It may be some time before you see the benefit from this medicine.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Do not become pregnant while taking this medicine or for 6 weeks after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 6 weeks after stopping it. There is potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• changes in emotions or moods
• hallucinations
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
• unusual bruising or bleeding
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• lack of or loss of appetite
• nausea
• stomach pain
• swelling of the ankles, feet, hands
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.