Dosing Information - Avmapki™ Fakzynja™ Co-Pack HCP

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Avmapki Fakzynja Co-Pack dosing schedule is based on a 4-week cycle1

The dosing schedule of 3 weeks on and 1 week off may help mitigate the 
accumulation of toxicities and contribute to a low discontinuation rate.1,2

Product images shown are not actual size.
*Capsules and tablets should be swallowed whole. Capsules and tablets should not be chewed, broken, opened, or crushed.

  • If your patient misses a dose (Avmapki by >24 hours or Fakzynja by >6 hours): they should skip the missed dose and take the next scheduled dose as prescribed. They should not take two doses at the same time to make up for a missed dose1
  • If your patient vomits after taking Avmapki or Fakzynja: they should not take an additional dose. They should take the next scheduled dose as prescribed1
  • If your patient takes antacids: they should 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, they should take Fakzynja 2 hours before or 2 hours after the administration of a locally acting antacid. See additional Drug Interactions1

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Adverse events were manageable mainly with dose holds or reductions1,2*

Use dose modifications to help manage adverse reactions associated with Avmapki Fakzynja Co‑Pack.

Patients maintained a high relative dose intensity (mean actual/planned cumulative dose) for both Avmapki (0.82) and Fakzynja (0.75).3

Adverse events were manageable mainly with dose holds or reductions, allowing most patients to have prolonged exposure and remain on treatment until disease progression. This was demonstrated by the high relative dose intensity, and the 14% discontinuation rate due to adverse reactions.1,2

Dosing modifications for adverse events1

Avmapki™ capsule
Avmapki™ capsule
Fakzynja™ tablet

Product images shown are not actual size.

Recommended Dose Reductions for Adverse Reactions1

Dose Level Avmapki Capsule Fakzynja Tablet
Starting dose 3.2 mg twice weekly for first 3 weeks of each 4-week cycle 200 mg twice daily for first 3 weeks of each 4-week cycle
Dose reduction 2.4 mg twice weekly for first 3 weeks of each 4-week cycle 200 mg once daily for first 3 weeks of each 4-week cycle
Permanently discontinue both Avmapki and Fakzynja in patients unable to tolerate after one dose reduction of both products.

Avmapki Fakzynja Co‑Pack Dosage Modifications1

Adverse Reaction Severity* Dose Modification
Keratitis Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected distance visual acuity Withhold Avmapki Fakzynja Co-Pack until resolved to nonconfluent superficial keratitis, then resume at same dose.
Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/20 or worse Withhold Avmapki Fakzynja Co-Pack until resolved to nonconfluent superficial keratitis, then resume at reduced dose.
Corneal perforation Permanently discontinue Avmapki Fakzynja Co-Pack.
Blurred vision BCVA worse than baseline but no worse than 20/200 Withhold Avmapki Fakzynja Co-Pack until resolution to baseline or 20/40, whichever is worse, then resume treatment at same dose.
BCVA 20/200 or worse Withhold Avmapki Fakzynja Co-Pack until resolution to baseline or 20/40, whichever is worse, then resume at reduced dose.
Conjunctivitis Confluent superficial punctate staining, moderate to severe vasodilation Withhold Avmapki Fakzynja Co-Pack until resolution to nonconfluent superficial keratitis, then resume at same dose.
Conjunctival ulcer or neovascularization Withhold Avmapki Fakzynja Co-Pack until resolution to nonconfluent superficial keratitis, then resume at reduced dose.
Retinal Pigment Epithelial (RPE) Detachment N/A
  • First occurrence
    • Repeat Optical Coherence Tomography (OCT) examination in two weeks.
  • First follow-up OCT examination and RPE present
    • Reduce dose of Avmapki Fakzynja Co-Pack
    • Repeat OCT examination in two weeks
  • Second follow-up OCT examination and RPE present and/or loss of 1 line in BCVA
    • Withhold Avmapki Fakzynja Co-Pack
    • Repeat OCT examination in two weeks
  • Third follow-up OCT examination
    • RPE resolving/resolved, resume at reduced dose.
    • No resolution, permanently discontinue Avmapki Fakzynja Co-Pack.
Rash Grade ≤2

Consider withholding Avmapki Fakzynja Co-Pack if rash does not respond to supportive care or recurs after resolution to Grade ≤1.

Dose reduce Avmapki Fakzynja Co-Pack for intolerable Grade 2.
Grade 3

Withhold Avmapki Fakzynja Co-Pack until resolved to Grade 2 then resume at reduced dose. Resume at same dose if resolved to Grade ≤1.

Permanently discontinue Avmapki Fakzynja Co-Pack for recurrent Grade 3 despite dose reduction.
Grade 4 Permanently discontinue Avmapki Fakzynja Co-Pack.
Hepatotoxicity Grade 2
  • Withhold Avmapki Fakzynja Co-Pack for:
    • Grade 2 hyperbilirubinemia (without Gilbert’s syndrome) with Grade ≤1 increase in AST and/or ALT until hyperbilirubinemia Grade ≤1, then resume at same dose.
    • Grade 2 hyperbilirubinemia with Grade 2 increase in AST and/or ALT until hyperbilirubinemia Grade ≤1 or baseline, then resume at same dose.
  • Permanently discontinue Avmapki Fakzynja Co-Pack for Grade 2 hyperbilirubinemia associated with Grade >2 increase in AST and/or ALT.
Grade 3
  • Withhold Avmapki Fakzynja Co-Pack for:
    • if Grade 3 hyperbilirubinemia is associated with Grade ≤1 increase in AST and/or ALT until hyperbilirubinemia Grade ≤1 or at baseline, then resume at same dose.
    • if recurrent Grade 3 hyperbilirubinemia is associated with Grade ≤1 increase in AST and/or ALT until hyperbilirubinemia Grade ≤2 or at baseline, then resume at reduced dose.
    • if Grade 3 increased AST and/or ALT is not associated with hyperbilirubinemia until Grade ≤2 or at baseline, then resume at reduced dose.
  • Permanently discontinue Avmapki Fakzynja Co-Pack for Grade 3 hyperbilirubinemia associated with Grade ≥2 increase in AST and/or ALT.
Grade 4
  • Withhold Avmapki Fakzynja Co-Pack for:
    • Grade 4 hyperbilirubinemia associated with Grade ≤1 increase in AST and/or ALT and if resolves within one week resume at reduced dose.
  • Permanently discontinue Avmapki Fakzynja Co-Pack for:
    • Grade 4 increase in AST and/or ALT.
    • Grade 4 hyperbilirubinemia associated with Grade ≤1 increase in AST and/or ALT that does not resolve within 1 week.
  • Grade 4 hyperbilirubinemia associated with Grade ≥2 increase in AST and/or ALT.
Increased Blood Creatine Phosphokinase (CPK) Grade 3

Withhold Avmapki Fakzynja Co-Pack, if improves to Grade ≤1 within three weeks resume at same dose.

Permanently discontinue Avmapki Fakzynja Co-Pack for CPK elevation longer than three weeks.
Grade 4

Withhold Avmapki Fakzynja Co-Pack, if improves to Grade ≤1 within three weeks resume at reduced dose.

Permanently discontinue Avmapki Fakzynja Co-Pack for CPK elevation longer than three weeks.
Any grade CPK elevation with rhabdomyolysis or other event related to CPK elevation Permanently discontinue Avmapki Fakzynja Co-Pack.
Other Adverse Reactions Grade 2 Consider withholding Avmapki Fakzynja Co-Pack if adverse reaction does not respond to supportive care or recurs after resolution to Grade ≤1.
Grade 3
  • First occurrence:
  • Withhold Avmapki Fakzynja Co-Pack until resolved to baseline or Grade ≤1 then resume at reduced dose.
  • Second occurrence:
  • Withhold Avmapki Fakzynja Co-Pack until resolved to baseline or Grade ≤1 then resume at reduced dose.
  • Permanently discontinue Avmapki Fakzynja Co-Pack for recurrent Grade 3 despite dose reduction.
Grade 4 Permanently discontinue Avmapki Fakzynja Co-Pack.
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ACCESS AND SUPPORT

BCVA, best corrected visual acuity; INR, International Normalized Ratio; N/A, not applicable.
*Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
References: 1. Avmapki Fakzynja Co‑Pack. Prescribing Information. Verastem Inc; 2025. 2. Banerjee SN, et al. J Clin Oncol. 2025;43(25):2782-2792. 
3. Data on file, Verastem Inc; 2025.

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.

Adverse Reactions

  • The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

  • 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.

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