Prescription medicine
Avutometinib and defactinib Brand names: Avmapki; first approved as Avmapki Fakzynja Co-Pack (Copackaged)
Avutometinib and defactinib (Avmapki) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the avutometinib and defactinib FDA label on DailyMed (effective May 1, 2025, Verastem Inc.); the NDA 219616 record on Drugs@FDA; every avutometinib and defactinib label on DailyMed.
Highlights of the record
FDA label of May 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- May 8, 2025 Avmapki Fakzynja Co-Pack (Copackaged), Verastem Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 29, 2042 Avmapki Fakzynja Co-Pack capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 794 through July 30, 2026
What is avutometinib and defactinib used for?
From the label: indications and usageAVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. […]
Source: FDA drug label (AVMAPKI FAKZYNJA CO-PACK), Verastem Inc., effective May 1, 2025 (SPL set 65889527-1406-45df-8a85-e2690dcf427d), via openFDA; the full label on DailyMed
What does the patient leaflet for avutometinib and defactinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking AVMAPKI FAKZYNJA CO-PACK?Limit your time in the sun. AVMAPKI FAKZYNJA CO-PACK 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.
From the patient leaflet: How should I store AVMAPKI FAKZYNJA CO-PACK?Store AVMAPKI capsules and FAKZYNJA tablets in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original bottles. The AVMAPKI capsules and FAKZYNJA tablets come in child-resistant bottles. Keep AVMAPKI FAKZYNJA CO-PACK and all medicines out of the reach of children.
Source: FDA drug label (AVMAPKI FAKZYNJA CO-PACK), Verastem Inc., effective May 1, 2025 (SPL set 65889527-1406-45df-8a85-e2690dcf427d), via openFDA; the full label on DailyMed
Is there a generic for avutometinib and defactinib (Avmapki)?
No generic avutometinib and defactinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Avmapki Fakzynja Co-Pack capsules: the compound patent runs to August 21, 2029, and the last listed entry to December 29, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the avutometinib and defactinib label say about other medicines?
The avutometinib and defactinib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK. ( 7.1 ) Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin. ( 7.2 ) Gastric acid reducing agents: |
Source: FDA drug label (AVMAPKI FAKZYNJA CO-PACK), Verastem Inc., effective May 1, 2025 (SPL set 65889527-1406-45df-8a85-e2690dcf427d), via openFDA; the full label on DailyMed
What do FAERS reports show for avutometinib and defactinib?
The FDA Adverse Event Reporting System holds 794 reports that list avutometinib and defactinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 85 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Avutometinib and defactinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other