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Overview: Komzifti is a medicine used to treat certain people with acute myeloid leukemia. Diarrhea, nausea, and tiredness are common side effects. Keep all appointments to have your blood checked. Tell your health care provider right away if you faint or get a fever, cough, rash, dizziness, or swelling in your arms, legs, hands, or feet. Get emergency help if you have chest pain, trouble breathing, or changes in your heartbeat.

Uses

What is Komzifti used for?

Komzifti (ziftomenib) is commonly used to treat certain people with acute myeloid leukemia.

Komzifti may also be used for other conditions as determined by your health care provider.

How does Komzifti work (mechanism of action)?

Some people with acute myeloid leukemia have a genetic change, called a nucleophosmin 1 (NPM1) mutation. The genetic change facilitates an interaction between two proteins that drives the development of leukemia. 

Komzifti is known as a menin inhibitor. The medicine blocks the protein interaction and allows for the development of normal blood cells. Komzifti may lower the number of immature cells in your bone marrow and increase the number of mature blood cells that get released into your bloodstream. As a result, you may not need as many red blood cell or platelet transfusions. 

How is Komzifti supplied (dosage forms)?

Komzifti is available in a 200 mg capsule that is taken by mouth.

How should I store Komzifti?

Komzifti should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Komzifti?

The most common side effects of Komzifti are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Komzifti that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Komzifti?

While less common, the most serious side effects of Komzifti are described below, along with what to do if they happen.

Severe Allergic Reactions. Komzifti may cause allergic reactions, which can be serious. Stop taking Komzifti and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Komzifti may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint, feel lightheaded, short of breath, or dizzy, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Differentiation Syndrome. Komzifti can cause a serious side effect called differentiation syndrome, which is a reaction caused by the rapid increase of mature blood cells. This reaction has happened as soon as 3 days and up to 46 days after starting Komzifti. Differentiation syndrome is serious and can lead to organ damage or even death, if not treated early. Call your health care provider right away or get emergency help if you have any of the following symptoms of differentiation syndrome.

  • Fever
  • Joint or bone pain
  • Chest pain
  • Cough or shortness of breath
  • Rash
  • Confusion
  • Dizziness or lightheadedness
  • Fast weight gain
  • Swelling of the arms, legs, neck, groin, or underarm area
  • Reduced need to pee

Warnings & Precautions

Who should not use Komzifti?

Allergies to Ingredients. People who are allergic to any of the following should not take Komzifti.

  • Komzifti
  • Ziftomenib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Komzifti.

What should I know about Komzifti before using it?

Do not take Komzifti unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Komzifti with other people, even if they have the same condition as you. It may harm them.

Keep Komzifti out of the reach of children.

Try to take Komzifti about the same time each day. Consider setting a timer to help you remember. 

Swallow capsules whole. Do not open, break, or chew the capsules.

Komzifti may need to be paused or stopped if you get certain side effects. Your dose may also need to be lowered. Closely follow the directions from your health care provider. Do not stop Komzifti or change your dose without talking with your health care provider.

Keep all appointments to have your blood checked. These results are needed by your health care provider to help you safely take Komzifti.

If you can become pregnant, use effective birth control during your treatment with Komzifti and for 6 months after your last dose. If you can get your partner pregnant, use effective birth control during treatment with Komzifti and for 3 months after your last dose.

Komzifti may make it hard for you to get pregnant or get your partner pregnant. If you may wish to have a child one day, talk to your health care provider.

What should I tell my health care provider before using Komzifti?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Komzifti is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Komzifti may interact with other medicines and supplements. Before taking Komzifti, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Komzifti can cause fetal harm. If you can become pregnant, your health care provider will likely check to make sure that you are not pregnant before starting Komzifti. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while taking Komzifti or for 2 weeks after your last dose. It is not known if Komzifti passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Komzifti?

For more information about Komzifti, you can visit the drugmaker’s website at www.komzifti.com or call them at 844-587-2662.

Interactions

Does Komzifti interact with foods or drinks?

Take Komzifti on an empty stomach. This means take your medicine 1 hour before eating or 2 hours after eating. Food may increase the chance of side effects from Komzifti.

It is unknown if drinking alcohol will affect Komzifti, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Komzifti interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Komzifti.

  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • An antacid [or supplement or laxative] containing calcium, aluminum, magnesium, or iron
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis

Many other medicines may alter the blood levels of Komzifti, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Komzifti. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Komzifti?

If you or someone else has used too much Komzifti, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Komzifti?

If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.