See below for information about keeping patients on track with Avmapki® Fakzynja® Co‑Pack (avutometinib capsules; defactinib tablets)
Recurrent KRAS-mutated LGSOC:
Optimizing care for your patients
Summary
Important safety considerations and optimizing care for patients
Recommendations for mitigating adverse events (AEs) with Avmapki Fakzynja Co‑Pack
For adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy
Dear Karleigh,
Help your adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who are currently receiving Avmapki Fakzynja Co‑Pack by proactively monitoring and managing potential AEs.1
Important Safety Information: Warnings include risk of ocular toxicities, serious skin toxicities, hepatotoxicity, rhabdomyolysis, and embryo-fetal toxicity.1
Phase 2 RAMP 201 Trial Results: Most AEs were manageable, mainly with dose holds or reductions (see additional information below). 14% of participants with KRAS-mutated recurrent LGSOC discontinued Avmapki Fakzynja Co‑Pack due to an AE.1,2
The AEs leading to permanent discontinuation included elevations in creatine phosphokinase, dyspnea, malaise, decreased glomerular filtration rate, hyperbilirubinemia, increased alanine aminotransferase, and abdominal pain (1.8% each).1
Explore resources below
that can support you and your practice with AE monitoring and management
Get the “What to Know” brochure
A concise overview of clinical information on Avmapki Fakzynja Co‑Pack, including baseline testing and monitoring for AEs.
Understand dosing modifications
Review recommended dose modifications to help manage AEs associated with Avmapki Fakzynja Co‑Pack.
Explore an expert's perspectives and additional resources
Go to the Support and Resources page for important treatment resources including a video of Dr. Robert Holloway, a gynecologic oncologist, discussing his approach to treating patients with Avmapki Fakzynja Co‑Pack.
INDICATION
Avmapki 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold Avmapki Fakzynja Co‑Pack for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue Avmapki Fakzynja Co‑Pack for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARs), occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue Avmapki Fakzynja Co‑Pack based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue Avmapki Fakzynja Co‑Pack based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue Avmapki Fakzynja Co‑Pack based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: Avmapki Fakzynja Co‑Pack can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with Avmapki Fakzynja Co‑Pack.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with Avmapki Fakzynja Co‑Pack.
Warfarin: Avoid concomitant use of Avmapki Fakzynja Co‑Pack with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of Avmapki Fakzynja Co‑Pack with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer Fakzynja 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations
Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.
AF-US-2026-0094 10/26
Avmapki and Fakzynja are registered trademarks of Verastem, Inc.
For US healthcare professionals only.
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This content is sponsored by Verastem, Inc., and ION Oncology Practice Network has not independently reviewed or verified the information provided by Verastem, Inc.
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