Avmapki-Fakzynja

Do not share this medication with others.

Lab and/or medical tests (such as liver function, eye exams, CPK levels) should be done before you start taking this product and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose of avutometinib, take it as soon as you remember. If it is more than 24 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you miss a dose of defactinib, take it as soon as you remember. If it is more than 6 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle in the refrigerator. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take avutometinib by mouth with food as directed by your doctor, usually twice a week (about 3 days apart) for 3 weeks, then stopping avutometinib for 7 days. This is one cycle of treatment. Keep taking avutometinib this way as directed by your doctor. Swallow the capsules whole. Do not crush, break, or open the capsules.

Take defactinib by mouth with food as directed by your doctor, usually twice a day (about 12 hours apart) for 21 days, then stopping defactinib for 7 days. This is one cycle of treatment. Keep taking defactinib this way as directed by your doctor. Swallow the tablets whole. Do not crush, break, or chew the tablets.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time.

The dosage is based on your medical condition and response to treatment.

Your doctor may prescribe other medications (such as corticosteroids, antibiotics) to help prevent side effects on the skin. Consult your doctor or pharmacist for more details.

Use this product regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Do not increase your dose or use this product more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Medications that reduce stomach acid (such as antacids, proton pump inhibitors/PPIs, H2 blockers) may make defactinib work less well. Do not take PPIs (such as lansoprazole, omeprazole) or H2 blockers (such as famotidine, nizatidine) while using this medication. If you take antacids, take defactinib 2 hours before or 2 hours after taking the antacid.

Since this product can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this product or breathe the dust from this product.

Dry/itchy skin, skin bumps, dry eyes, mouth sores, heartburn, diarrhea, nausea, vomiting, muscle/joint pain, tiredness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this product has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision, loss of vision), eye pain/redness/swelling, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of muscle damage (such as muscle pain/tenderness/weakness, fever, unusual tiredness, change in the amount of urine).

Avutometinib and defactinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to avutometinib or defactinib; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: liver problems, eye problems.

This product may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This product may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this product can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this product or breathe the dust from this product.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using avutometinib and defactinib. Avutometinib and defactinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this product. Women using this product should ask about reliable forms of birth control during treatment and for 1 month after the last dose. Men using this product should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this product.

It is unknown if this product passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this product and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of defactinib from your body, which may affect how defactinib works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.