IMPORTANT SAFETY INFORMATION

What are the possible side effects of Niktimvo?

Niktimvo may cause serious side effects, including:

Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.

The most common side effects of Niktimvo include:

• infections 
• increased blood level of liver enzymes
• decreased blood level of phosphate
• low red blood cell count (anemia)
• muscle, bone, or joint pain
• increased blood level of pancreatic enzymes
• low energy
• increased blood level of calcium
• increased blood level of a muscle enzyme
• increased blood level of a bone enzyme
• nausea
• headache
• diarrhea
• cough
• fever
• shortness of breath

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

Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had liver problems.
• are pregnant or plan to become pregnant. Niktimvo may harm your unborn baby. 

  Females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with Niktimvo.
  • You should use an effective method of birth control during your treatment and for 30 days after your last dose of Niktimvo. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Niktimvo.
• are breastfeeding or plan to breastfeed. It is not known if Niktimvo passes into your breast milk. Do not breastfeed during treatment and for 30 days after your last dose of Niktimvo.

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

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.

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

You may also report side effects to Incyte Medical Information at 1-855-463-3463.