Avutometinib Capsule; Defactinib Tablets

What is this medication?

AVUTOMETINIB; DEFACTINIB (a VUE toe ME ti nib; dee FAK ti nib) treats ovarian cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): Avmapki Fakzynja

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

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

• Eye or vision problems
• Liver disease
• An unusual or allergic reaction to avutometinib, defactinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label on the same days each week. Do not cut, crush, or chew this medication. Swallow the capsules and tablets whole. Take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tell you to. There may be unused or extra doses in the bottle after you finish the dosing cycle. Talk to your care team if you have questions about your dose.

This medication is taken in cycles. There will be days you do not take it. Talk to your care team if you have questions about when to take your medication. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Take antacids at a different time of day than this medication. Take this medication at least 2 hours before or 2 hours after an antacid.

Talk to your care team about the use of this medication 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 of avutometinib, take it as soon as you can, unless it is more than 24 hours late. If it is more than 24 hours late, skip that dose. Take your next dose on your normal scheduled day. Do not take double or extra doses.

If you miss a dose of defactinib, take it as soon as you can, unless it is more than 6 hours late. If it is more than 6 hours late, skip that dose. Take your next dose at the normal time. Do not take double or extra doses.

If you vomit after taking your dose of avutometinib or defatinib, do not take another dose. Take your next dose at your normal scheduled time.

What may interact with this medication?

• Antacids
• Certain medications for fungal infections, such as itraconazole
• Certain medications for seizures, such as phenytoin
• Stomach acid blockers, such as cimetidine, famotidine, lansoprazole, omeprazole
• Warfarin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 care team for regular checks on your progress. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. To reduce the risk of serious skin reactions, your care team may give you other medications to take. Follow the directions from your care team.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication may cause serious eye and vision problems. You should have regular eye exams while taking this medication. Tell your care team if you have changes in your eyesight.

Talk to your care team if you or your partner may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 month after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 2 weeks after the last dose.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Small spots floating in vision

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

• Bone, joint, or muscle pain
• Diarrhea
• Fatigue
• Nausea
• Skin rash
• Skin reactions on sun-exposed areas
• Vomiting

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 reach of children and pets.

Store in the refrigerator. Keep this medication in the original container. Get rid of any unused medication after the expiration date.

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

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