Class Name(s):

• 10:00 Antineoplastic Agents

Brand Name(s):

• Avmapki Fakzynja Co-Pack^®

WHY is this medicine prescribed?

Avutometinib and defactinib is used to treat a certain type of ovarian cancer (cancer in the female reproductive organs where eggs are formed). Avutometinib and defactinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signal cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

HOW should this medicine be used?

Avutometinib comes as a capsule and defactinib comes as a tablet to take by mouth. Take avutometinib capsules twice a week (on day 1 and day 4) with food. Take defactinib tablets twice a day with food. Take the capsules and tablets for 3 weeks in a row, followed by a 1 week break (week 4) and then repeat the dosing cycle. Take avutometinib capsules on the same days and around the same times every week. Take defactinib tablets around the same times every day. The length of your treatment depends on how well your body responds to the medications and the side effects that you experience.

Take avutometinib and defactinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets and capsules whole; do not open, split, chew, or crush them.

If you vomit after taking avutometinib capsules or defactinib tablets, do not take another dose. Continue your regular dosing schedule.

Your doctor may lower your dose or stop your treatment if you have certain side effects. Talk to your doctor about how you are feeling during your treatment with avutometinib and defactinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking avutometinib and defactinib,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking avutometinib and defactinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids (Maalox^®, Mylanta^®, Tums^®) take them 2 hours before or 2 hours after taking avutometinib and defactinib.
• the following nonprescription or herbal products may interact with avutometinib and defactinib: antacids (Maalox^®, Mylanta^®, Tums^®); medications for heartburn and indigestion such as cimetidine (Tagamet^®), famotidine (Pepcid^®), esomeprazole (Nexium^®), lansoprazole (Prevacid^®), and omeprazole (Prilosec^®); or St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking avutometinib and defactinib. Do not start any of these medications while taking avutometinib and defactinib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had eye or vision problems, skin problems, high blood pressure, or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking avutometinib and defactinib. You may be required to have a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for 1 month after your last dose. If your partner can become pregnant, use birth control to prevent pregnancy during your treatment and for 4 months after your last dose. Talk to your doctor about birth control methods that you or your partner can use during your treatment. If you or your partner become pregnant while taking avutometinib and defactinib, call your doctor immediately. Avutometinib and defactinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. Do not breastfeed while you are taking avutometinib and defactinib and for 2 weeks after your last dose.
• this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking avutometinib and defactinib.
• plan to avoid unnecessary or prolonged exposure to real and artificial sunlight (tanning beds and sunlamps). Wear protective clothing, sunglasses, and sunscreen with an SPF of 30 or higher. Avutometinib and defactinib may make your skin sensitive to sunlight. Tell your doctor right away if you get a sunburn.
• you should know that avutometinib and defactinib may cause skin reactions and infections, including some that may be severe and life-threatening. Your doctor may tell you to apply certain medications to your skin and take certain medications to prevent or treat skin reactions and infections. If you experience any of the following symptoms, call your doctor immediately: rash; itching; hives; new or worsening acne; dry or cracking skin; blistering, peeling, or shedding skin; blisters or sores in your mouth; or redness or swelling of the face, hands, fingernails, toenails, or soles of feet.
• you should know that avutometinib and defactinib may cause severe eye problems. Your doctor will order an eye exam before you start treatment and regularly during your treatment. Call your doctor right away if you have any of the following symptoms: blurred vision, double vision, loss of vision, seeing floaters, seeing flashes of light, or other vision changes; dry eyes; or eye or eyelid pain, redness, swelling, or itching.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you miss a dose of avutometinib capsules within 24 hours of the time it is usually taken, take the missed dose as soon as you remember it. However, if you miss a dose of the capsules by more than 24 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you miss a dose of defactinib tablets within 6 hours of the time it is usually taken, take the missed dose as soon as you remember it. However, if you miss a dose of the tablets by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Avutometinib and defactinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• heartburn
• sore on the lips, mouth, or throat
• dry mouth
• decreased appetite
• weight loss
• changes in taste
• unusual tiredness or weakness
• swelling of the arms, hands, legs, feet, or ankles
• hair loss
• joint pain or swelling
• numbness, tingling, pain, or burning in arms or legs
• cough, sore throat, runny nose, or other signs of infection

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• pain in upper right part of the stomach, yellowing of the skin or eyes, easy bleeding or bruising, severe nausea and vomiting, or dark-colored urine
• muscle or bone pain; weakness or difficulty moving arms and legs; dark, red, colored urine; or decreased urination
• pale skin, shortness of breath, dizziness, or weakness
• difficult, burning, or painful urination; or cloudy, discolored, bloody, or bad smelling urine
• pain, tenderness, or redness in one leg; sudden shortness of breath; chest pain; or coughing up blood
• unusual bleeding or bruising

Avutometinib and defactinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the containers it came in, tightly closed, and out of reach of children. Store it in the refrigerator. Do not remove the desiccant (drying agent) from the container containing avutometinib capsules.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to avutometinib and defactinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2025.