Avutometinib/defactinib (By mouth)

Treats ovarian cancer.

Brand Name(s):

Avmapki Fakzynja Co-Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Take the capsule at the same time each day.
• Swallow the capsule whole. Do not break, chew, or open it.
• Swallow the tablet whole. Do not break, chew, or crush it.
• Your doctor may give you other medicines (including oral antibiotic, topical steroid medicine) before treatment with this medicine to help prevent skin reactions.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Avmapki™: If a dose is missed by more than 24 hours, skip the missed dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
  • Fakzynja™: If a dose is missed by more than 6 hours, skip the missed dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
  • If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
• Store in the refrigerator. Do not freeze.
• Avmapki™: Do not remove the desiccant (drying agent).

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how avutometinib/defactinib works. Tell your doctor if you are using itraconazole, phenytoin, or a blood thinner (including warfarin).
• Take this medicine at least 2 hours before or 2 hours after taking an antacid (including H2 blocker, proton pump inhibitor).

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 4 months after the last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, skin problems, or a history of eye or vision problems.
• This medicine may cause the following problems:
  • Eye or vision problems
  • Serious skin reactions, including acute generalized exanthematous pustulosis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Liver problems
  • Rhabdomyolysis (severe muscle problem)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Eye pain, itching, redness, or swelling, blurred or changes in vision, seeing flashes of light or floaters
• Muscle pain, tenderness, or weakness
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach upset
• Cough
• Dry skin
• Hair loss
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 7/10/2025