Avmapki Fakzynja

Pronunciation: ave-MAP-kee Fak-zin-jah
Generic name: avutometinib and defactinib
Dosage form: Avmapki capsules (0.8mg), Fakzynja tablets (200 mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 21, 2025.

What is Avmapki Fakzynja?

Avmapki Fakzynja Co-Pack is a prescription medicine for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) in adult patients with KRAS mutations who have already received systemic therapy. Avmapki Fakzynja co-pack contains Avmapki (avutometinib) capsules and Fakzynja (defactinib) tablets conveniently packaged together. It is the first and only FDA-approved medicine for this KRAS-mutated recurrent LGSOC.

Avmapki capsules are taken twice weekly for the first 3 weeks of each 4-week cycle and Fakzinja tablets are taken twice daily for the first 3 weeks of each 4-week cycle.

Avmapki Fakzynja FDA approval was granted on May 8, 2025, after positive results from the RAMP 201 clinical trial (NCT04625270). This study demonstrated Avmapki Fakzynja had a 44% overall response rate and a duration of response (DoR) from 3.3 to 31.1 months. As this is an accelerated FDA approval, continued approval will depend Phase 3 trial RAMP 301, confirming these results and Avmapki Fakzynja showing a clinical benefit.

What is Low-Grade Serous Ovarian Cancer?

Low-grade serous ovarian cancer (LGSOC) is a rare ovarian cancer that is different from high-grade serous ovarian cancer. LGSOC is slow growing, often recurrent, often affects younger women, and is less responsive to standard platinum-based chemotherapy. Approximately 30 percent of people with LGSOC have a KRAS mutation.

How does Avmapki Fakzynja work?

Avmapki Fakzynja mechanism of action is as a MEK1 inhibitor and a FAK inhibitor.

Avmapki Fakzynja contains avutometinib and defactinib, which work together to reduce cell proliferation. Some cancers depend on mutations that switch on the RAS/RAF/MEK/ERK (MAPK) pathway and lead to uncontrolled cancer growth.

Avmapki (avutometinib) is a MEK1 inhibitor that stops cancer from growing by switching off the MAPK pathway and decreases drug resistance by stopping the MAPK pathway from being reactivated.

FAKZYNJA (defactinib) is a FAK inhibitor, and together with Avmapki, they provide a more complete blockade of cancer growth and drug resistance for RAS/MAPK pathway-dependent tumors.

Avmapki Fakzynja side effects

Common Avmapki Fakzynja side effects

The most common side effects were nausea, tiredness, rash, constipation, diarrhea, muscle and joint pain, itching, dry skin, edema, vomiting, stomach area-pain, acid reflux, dermatitis acneiform, eye disorders, visual impairment, mouth ulcers, shortness of breath, cough, urinary tract infection

Some common laboratory abnormalities were increased creatine phosphokinase, increased aspartate aminotransferase, decreased hemoglobin, increased alanine aminotransferase, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, increased alkaline phosphatase, decreased platelet count, and decreased neutrophil count.

Avmapki Fakzynja Co-Pack may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Serious side effects

Avemapki Fakzinja may cause serious side effects.

Eye problems. Eye problems are common and can be severe. You will see an eye care professional before starting treatment, during treatment, and for any new or worsening eye problems. Tell your healthcare provider (HCP) if you get any new or worsening eye problems, including:

changes in vision, such as blurred vision, double vision, or vision loss
eye pain
dry eye(s)
new or increased floaters (small dark spots or squiggly lines that float across your vision)
eye and eyelid inflammation, including redness, swelling, and itching
light hurting eyes or seeing flashes of light

Severe skin reactions. Skin reactions are common and can be severe or life-threatening. Tell your HCP if you develop any new or worsening skin reactions, including:

skin rash or acne
blisters on your skin
blisters or sores in your mouth
dry skin
redness or swelling of your face, hands, or soles of your feet
peeling of your skin
itching
skin infection

Liver problems. Liver problems are common and can be severe. Treatment with this medicine can increase the level of aspartate aminotransferase, alanine aminotransferase, and bilirubin in your blood. Your HCP will do blood tests before starting each treatment cycle and during treatment to check your liver function. Tell your healthcare provider if you get any signs or symptoms of severe liver problems including:

yellowing of your skin or the white part of your eyes
nausea or vomiting
itchy skin
upper right side stomach pain
feeling very tired
dark or tea colored urine
flu-like symptoms
bleeding or bruising more easily than normal

Muscle problems (rhabdomyolysis). This medicine may cause muscle problems that can be severe. This treatment can increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your HCP will perform blood tests to check your levels of CPK before starting each treatment cycle and during treatment. Tell your healthcare provider if you get any signs or symptoms of increased CPK, including:

weakness or difficulty moving arms and legs
muscle or bone aches or pain that does not go away
dark, red colored urine, or decreased urine output.

Other side effects

This medicine may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

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 the FDA at 1-800-FDA-1088.

What to avoid

Limit your time in the sun. Avmapki Fakzynja can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You may burn more easily and get a severe sunburn. Apply daily sunscreen with a Sun Protection Factor (SPF) of 30 or greater and wear a hat and clothes that cover your skin to protect against sunburn. Talk to your healthcare provider if you get a sunburn.

Warning

Avmapki Fakzynja may cause severe side effects, including eye problems, severe skin reactions, liver problems, and rhabdomyolysis.

This medicine can harm an unborn baby. Patients, both men and women, should be warned of the potential risk to a fetus and are advised to use effective contraception.

Men and women of reproductive potential should be advised that this medicine may impair fertility.

You should not use this medicine while breastfeeding and for 2 weeks after the last dose.

Before taking this medicine

Before taking Avmapki Fakzynja, tell your healthcare provider about all of your medical conditions, including if you:

have a history of eye or vision problems
have had severe skin reactions
have liver problems

Pregnancy

Tell your healthcare provider (HCP) if you are pregnant or plan to become pregnant. As this medicine can harm your unborn baby.

Females who are able to become pregnant. Your healthcare provider should do a pregnancy test before you start treatment with this medicine. You should use effective birth control (contraception) during treatment and for 1 month after the last dose of Avmapki Fakzynja. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with this medicine.

Males with a female partner who is able to become pregnant. You should use effective birth control (contraception) during treatment and for 4 months after the last dose of this medicine.

Breastfeeding

Tell your healthcare provider (HCP) if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of this medicine.

How should I take Avmapki Fakzynja?

Avmapki capsules are taken twice weekly for the first 3 weeks of each 4-week cycle, and Fakzinja tablets are taken twice daily for the first 3 weeks of each 4-week cycle.

Avmapki capsules: Take each dose at the same time. Swallow the capsules whole. Do not chew, break, or open the capsules. If you miss a dose of AVMAPKI by more than 24 hours, skip the missed dose and take the next scheduled dose as prescribed by your healthcare provider. Do not take two doses at the same time to make up for a missed dose.

Fakzinja tablets: Swallow the tablets whole. Do not chew, break, or crush the tablets. If you take antacids, take Fakzinja tablets 2 hours before or 2 hours after taking the antacid. If you miss a dose of Fakzinja by more than 6 hours, skip the missed dose and take the next scheduled dose as prescribed by your healthcare provider. Do not take two doses at the same time to make up for a missed dose.

General administration information

Take Avmapki Fakzynja exactly as directed by your healthcare provider. You should not change your dose or stop taking this medicine without talking to your healthcare provider.

Your healthcare provider may change your dose, temporarily stop, or completely stop your treatment, if you develop certain side effects.

If you vomit after taking Avmapki capsules or Fakzinja tablets, do not take an additional dose. Take the next scheduled dose as prescribed by your healthcare provider.

Avmapki Fakzynja dosing information

Recommended Avmapki dose: 3.2 mg (4 capsules) twice weekly, on Day 1 and Day 4, for the first 3 weeks of each 4-week cycle.

Recommended Fakzynja dose: 200 mg (1 tablet) twice daily for the first 3 weeks of each 4-week cycle.

Dose modifications: If you develop certain side effects, your healthcare provider may change your dose, temporarily stop, or completely stop your treatment.

Avmapki Fakzynja co-pack

Avmapki Capsules: avutometinib 0.8 mg

Fakzynja Tablets: defactinib 200 mg

Avmapki Fakzynja interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Avmapki Fakzynja may affect the way other medicines work, and other medicines may affect how Avmapki Fakzynja works. Especially tell your healthcare provider if you take:

Not all possible drug interactions are listed here

Storage

Store capsules and tablets in the refrigerator between 36⁰F to 46⁰F (2⁰C to 8⁰C) in the original bottles.

Ingredients

Avmapki (avutometinib) capsules

Active ingredient: avutometinib

Inactive ingredients: magnesium stearate, mannitol, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.

The capsule shell contains carrageenan, hypromellose, potassium chloride, purified water, and titanium oxide.