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KOMZIFTI is the only FDA-approved menin inhibitor that offers once daily dosing

Convenient once daily oral dosing

Consider how KOMZIFTI could fit into your daily routine

Swallow
3 capsules (total 600 mg) once a day

Do not break, open, or chew the capsules

On an empty
stomach

Take KOMZIFTI at least 1 hour before or 2 hours after a meal

Around
the same time each day

Be sure to follow your doctor’s instructions exactly on how to take KOMZIFTI. It’s normal to wonder if your treatment is working. Your doctor may keep you on KOMZIFTI for at least 6 months to allow time for your treatment to work, unless your disease progresses or you experience unacceptable side effects. Do not change your dose or stop taking KOMZIFTI without talking to your healthcare provider.

If you miss a dose or did not take it at your regularly scheduled time

  • Take the dose as soon as you remember and at least 12 hours prior to your next scheduled dose
  • Then return to your normal schedule the next day
  • Do not take 2 doses within 12 hours of each other to make up for the missed dose

Tips to help you remember to take KOMZIFTI

  • Consider setting a daily alarm with a label that reads “Take KOMZIFTI”
  • Pair taking KOMZIFTI with a daily routine, like brushing your teeth
  • Ensure that the daily routine allows you to take KOMZIFTI on an empty stomach
  • If you live with someone, tell them you’re taking KOMZIFTI and that it’s important you take it at around the same time daily
  • Place a calendar in a visible spot, and cross off each day after you’ve taken your medication

If you are taking other medications, let your doctor know

  • Inform your doctor about any other medicines you are taking
    • This includes other prescriptions, as well as over-the-counter medicines, vitamins, and herbal supplements
  • KOMZIFTI and other medicines may affect each other, causing side effects
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist
  • If you take medicine to reduce stomach acid:
    • Avoid taking a proton pump inhibitor (PPI) medicine with KOMZIFTI
    • Take KOMZIFTI either 2 hours before or 10 hours after taking an H2 receptor blocker medicine
    • Take KOMZIFTI either 2 hours before or 2 hours after taking a locally acting antacid medicine (such as calcium carbonate)

Curious about a term or definition?

What is KOMZIFTI?

KOMZIFTI is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation whose AML has come back or did not improve after previous treatment(s) and who have no other satisfactory treatment options.

Your healthcare provider will perform a test to make sure that KOMZIFTI is right for you.

It is not known if KOMZIFTI is safe and effective in children.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.

Important Safety Information

What is the most important information I should know about KOMZIFTI?

KOMZIFTI can cause serious side effects including:Differentiation Syndrome: Differentiation syndrome is a condition that affects your blood cells that is common during treatment with KOMZIFTI and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI. Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI:

  • fever
  • joint or bone pain
  • dizziness
  • shortness of breath or trouble breathing
  • cough
  • chest pain
  • rapid weight gain
  • rash
  • decreased urine output
  • swelling of hands, feet, ankles, or legs

If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine. Your healthcare provider will monitor you until your signs and symptoms improve.

Changes in electrical activity of your heart (QT prolongation).
Changes in the electrical activity of your heart may lead to irregular heartbeats (rhythm) that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with KOMZIFTI. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you have shortness of breath, or if you feel your heart beating irregularly or fast during treatment with KOMZIFTI.

Before taking KOMZIFTI, tell your healthcare provider about all of your medical conditions, including if you:

  • have any heart problems, including a condition called long QT syndrome.
  • have problems with abnormal levels of salts in your blood (electrolytes), such as potassium and magnesium levels.
  • are pregnant or plan to become pregnant. KOMZIFTI can harm your unborn baby.
  • Females who are able to become pregnant:
    • Your healthcare provider will perform a pregnancy test before you start treatment with KOMZIFTI.
    • Use effective birth control (contraception) during treatment with KOMZIFTI and for 6 months after the last dose.
  • Males who have female partners who are able to become pregnant:
    • Use effective birth control (contraception) during treatment with KOMZIFTI and for 3 months after the last dose.
    • Talk to your healthcare provider about birth control methods you can use during this time.
  • are breastfeeding or plan to breastfeed. It is not known if KOMZIFTI passes into your breast milk. Do not breastfeed during your treatment with KOMZIFTI and for 2 weeks after your last dose.

Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KOMZIFTI and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

The most common side effects of KOMZIFTI include:

  • infections including bacterial infections
  • bleeding
  • diarrhea
  • nausea
  • feeling tired
  • swelling in the arms and legs
  • muscle, bone, and joint pain
  • itching
  • fever with decreased white blood cell counts
  • changes in liver function tests

Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with KOMZIFTI if you develop certain side effects during treatment with KOMZIFTI.

KOMZIFTI may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of KOMZIFTI. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is KOMZIFTI?

KOMZIFTI is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation whose AML has come back or did not improve after previous treatment(s) and who have no other satisfactory treatment options.

Your healthcare provider will perform a test to make sure that KOMZIFTI is right for you.

It is not known if KOMZIFTI is safe and effective in children.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.

Important Safety Information

What is the most important information I should know about KOMZIFTI?

KOMZIFTI can cause serious side effects including:Differentiation Syndrome: Differentiation syndrome is a condition that affects your blood cells that is common during treatment with KOMZIFTI and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI. Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI:

  • fever
  • joint or bone pain
  • dizziness
  • shortness of breath or trouble breathing
  • cough
  • chest pain
  • rapid weight gain
  • rash
  • decreased urine output
  • swelling of hands, feet, ankles, or legs

If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine. Your healthcare provider will monitor you until your signs and symptoms improve.

Changes in electrical activity of your heart (QT prolongation).
Changes in the electrical activity of your heart may lead to irregular heartbeats (rhythm) that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with KOMZIFTI. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you have shortness of breath, or if you feel your heart beating irregularly or fast during treatment with KOMZIFTI.

Before taking KOMZIFTI, tell your healthcare provider about all of your medical conditions, including if you:

  • have any heart problems, including a condition called long QT syndrome.
  • have problems with abnormal levels of salts in your blood (electrolytes), such as potassium and magnesium levels.
  • are pregnant or plan to become pregnant. KOMZIFTI can harm your unborn baby.
  • Females who are able to become pregnant:
    • Your healthcare provider will perform a pregnancy test before you start treatment with KOMZIFTI.
    • Use effective birth control (contraception) during treatment with KOMZIFTI and for 6 months after the last dose.
  • Males who have female partners who are able to become pregnant:
    • Use effective birth control (contraception) during treatment with KOMZIFTI and for 3 months after the last dose.
    • Talk to your healthcare provider about birth control methods you can use during this time.
  • are breastfeeding or plan to breastfeed. It is not known if KOMZIFTI passes into your breast milk. Do not breastfeed during your treatment with KOMZIFTI and for 2 weeks after your last dose.

Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KOMZIFTI and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

The most common side effects of KOMZIFTI include:

  • infections including bacterial infections
  • bleeding
  • diarrhea
  • nausea
  • feeling tired
  • swelling in the arms and legs
  • muscle, bone, and joint pain
  • itching
  • fever with decreased white blood cell counts
  • changes in liver function tests

Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with KOMZIFTI if you develop certain side effects during treatment with KOMZIFTI.

KOMZIFTI may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of KOMZIFTI. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.