avapritinib

What is the most important information I should know about avapritinib?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is avapritinib?

Avapritinib is used in adults to treat a certain type of cancer that affects the stomach, esophagus, or intestines. This medicine is used when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Avapritinib is used if your cancer has a specific genetic marker (an abnormal "PDGFRA" gene). Your doctor will test you for this gene.

Avapritinib can also be used in adults to treat certain rare blood disorders, including advanced systemic mastocytosis, aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.

Avapritinib is not recommended for the treatment of advanced systemic mastocytosis in people with low platelet counts.

Avapritinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking avapritinib?

Tell your doctor if you:

• have low platelets counts;
• have bulging or weakening of a blood vessel wall (aneurysm);
• have ever had bleeding in your brain; or
• had a stroke within the last year.

You may need to have a negative pregnancy test before starting this treatment.

Keep using birth control for at least 6 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using avapritinib.

How should I take avapritinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you vomit shortly after taking avapritinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not change your dose or stop taking avapritinib without your doctor's advice.

Your blood may need to be tested often.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking avapritinib?

What are the possible side effects of avapritinib?

• a severe headache, vision problems;
• unusual changes in mood or behavior;
• problems with speech, thinking, or memory;
• confusion, hallucinations (seeing objects or hearing things that are not real);
• severe drowsiness or dizziness;
• trouble sleeping; or
• severe weakness on one side of your body.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, loss of appetite, stomach pain;
• diarrhea, constipation;
• fluid retention, swelling;
• feeling dizzy, weak, or tired;
• muscle weakness;
• watery eyes;
• rash; or
• hair color changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect avapritinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect avapritinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about avapritinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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