Ziftomenib (ziftomenib)-Komzifti instruction manual Chinese introduction

1. Common name:ziftomenib, ziftomenib

Product name:Komzifti

Other names: Ziftomeni, KO-382, KO-539

2. Indications:

Ziftomenib - Komzifti is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a sensitizing nucleophosmin1 (NPM1) mutation for whom there are no satisfactory alternative treatments.

3. Usage and dosage:

1. Patient selection: Based on the presence of NPM1 mutations, patients with relapsed or refractory AML are selected to be treated with ziftomenib. There are currently no FDA-approved methods for detecting NPM1 mutations.

2. Recommended dose: The recommended dose of ziftomenib is 600 mg orally once daily until disease progression or unacceptable toxicity occurs. Do not start ziftomenib until the white blood cell (WBC) count has dropped below 25 x 10⁹/L. For patients with undiagnosed disease progression or unacceptable toxicity, treatment for at least 6 months is recommended to allow time for clinical response.

3. Medication management: Take ziftomenib once a day on an empty stomach ziftomenib orally at about the same time every day, and swallow the capsule whole. Do not open, break or chew capsules.

4. Missed dose: If a dose of ziftomenib is missed or not taken at the normal time, the dose should be taken on the same day as soon as possible and at least 12 hours before the next scheduled dose. Back to normal schedule the next day. Do not take 2 doses within 12 hours of

5. Dosage adjustment:

Avoid the concomitant use of proton pump inhibitors (PPIs) withziftomenib; avoid the concomitant use of histamine-2 (H2) receptor antagonists or locally acting antacids withziftomenib. If simultaneous use cannot be avoided:

1) TakingTake ziftomenib 2 hours before or 10 hours after H2 receptor antagonist.

2) Before taking topical antacidsTake ziftomenib on or after 2 hours.

4. Adverse reactions:

In clinical studies of ziftomenib, common adverse reactions (≥20%) included infection by unknown pathogens, bleeding, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, differentiation syndrome, pruritus, fever, neutropenia, and elevated transaminases. Common laboratory abnormalities (≥10%) include increased aspartate aminotransferase, decreased potassium, decreased albumin, increased alanine aminotransferase, decreased sodium, increased creatinine, increased alkaline phosphatase, increased bilirubin, and increased potassium.

5. Supply and storage:

Zitomenib200 mg capsules are white and stored at 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C and 30°C (59°F and 86°F)

6. Taboo:

None.

7. Mechanism of action:

Ziftomenib is a menin inhibitor that blocks the interaction between menin and lysine [K]-specific methyltransferase 2A (KMT2A). Acute leukemia can be driven by mutations in NPM1 that recruit the wild-type menin-KMT2A complex to the promoters of leukemogenic genes. Susceptible NPM1 mutations are defined as mutations that result in loss of nucleolar localization signals and insertion of new nuclear export signals, leading to cytoplasmic accumulation of mutant NPM1 protein, disrupting normal cell function and driving leukemogenesis through altered gene expression.

Pharmacological disruption of the menin-KMT2A protein-protein interaction by ziftomenib blocks the oncogenic activity of mutant NPM1, which induces differentiation of leukemic cells, as evidenced by increased expression of differentiation markers. In nonclinical studies,ziftomenib demonstrated in vitro and in vivo antitumor activity in NPM1 mutant leukemia models.

8. Listing situation:

1. Original research version

China: Not yet listed

United States: 2025-11-13 (trade name: Komzifti)

2. Imitation version: None

Reference materials:https://www.drugs.com/komzifti.html