Drug Summary
What Is Komzifti?
Komzifti (ziftomenib) is a menin inhibitor indicated for the treatment of adult patients
with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
What Are Side Effects of Komzifti?
Side effects of Komzifti include:
- infection,
- bleeding,
- diarrhea,
- nausea,
- fatigue,
- fluid retention (edema),
- musculoskeletal pain,
- differentiation syndrome,
- itching,
- febrile neutropenia,
- increased transaminases,
- increased aspartate aminotransferase,
- decreased potassium,
- decreased albumin,
- increased alanine aminotransferase,
- decreased sodium,
- increased creatinine,
- increased alkaline phosphatase,
- increased bilirubin, and
- increased potassium.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Komzifti
The recommended dosage of Komzifti is 600 mg orally once daily until disease progression or unacceptable toxicity.
Komzifti In Children
Safety and effectiveness of Komzifti in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Komzifti?
Komzifti may interact with other medicines such as:
- strong or moderate CYP3A4 inhibitors,
- strong or moderate CYP3A4 inducers,
- proton pump inhibitors (PPIs),
- H2 receptor antagonists and antacids, and
- drugs that prolong the QTc interval.
Tell your doctor all medications and supplements you use.
Komzifti During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Komzifti; it may harm a fetus. The pregnancy status of patients who can become pregnant should be verified prior to initiating Komzifti. Patients who can become pregnant are advised to use effective contraception during treatment and for 6 months following the last dose of Komzifti. Patients with partners who can become pregnant are advised to use effective contraception during treatment with Komzifti and for 3 months after the last dose. It is unknown if Komzifti passes into breast milk. Because of the potential for
adverse reactions in the breastfed child, breastfeeding is not advised during treatment with Komzifti and for 2 weeks after the last dose.
Additional Information
Our Komzifti (ziftomenib) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 FDA at 1-800-FDA-1088.