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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.

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