"The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases."...
Read this Patient Information before you start taking Jakafi and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is Jakafi?
Jakafi is a prescription medicine used to treat certain types of myelofibrosis.
It is not known if Jakafi is safe or effective in children.
What should I tell my healthcare provider before taking Jakafi?
Before taking Jakafi, tell your healthcare provider if you:
- have an infection
- have or had tuberculosis (TB), or have been in close contact with someone who has TB
- have or have had liver problems
- have or have had kidney problems or are on dialysis. If you are on dialysis, Jakafi should be taken after your dialysis
- have had skin cancer in the past
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if Jakafi will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Jakafi passes into your breast milk. You and your healthcare provider should decide if you will take Jakafi or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking Jakafi with certain other medicines may affect how Jakafi works.
Especially tell your healthcare provider if you take medicine for:
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Jakafi?
- Take Jakafi exactly as your healthcare provider tells you.
- Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.
- You can take Jakafi with or without food.
- Jakafi may also be given through certain nasogastric
- Tell your healthcare provider if you cannot take Jakafi by mouth. Your healthcare provider will decide if you can take Jakafi through a nasogastric tube.
- Ask your healthcare provider to give you specific instruction on how to properly take Jakafi through a nasogastric tube.
- Do not drink grapefruit juice while taking Jakafi. Grapefruit juice can affect the amount of Jakafi in your blood.
- If you take too much Jakafi call your healthcare provider or go to the nearest hospital emergency room department right away. Take the bottle of Jakafi with you.
- If you miss a dose of Jakafi, take your next dose at your regular time. Do not take 2 doses at the same time.
- You will have regular blood tests during your treatment with Jakafi. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests.
What are the possible side effects of Jakafi?
Jakafi can cause serious side effects including:
Low blood cell counts: Jakafi may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If you develop bleeding, stop Jakafi and call your healthcare provider. Your healthcare provider will do a blood test to check your blood cell counts before you start Jakafi and regularly during your treatment with Jakafi. Tell your healthcare provider right away if you develop any of these symptoms:
- unusual bleeding
- shortness of breath
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection:
- painful skin rash or blisters
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.
The most common side effects of Jakafi include:
- low platelet count
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Incyte Corporation at 1-855-463-3463.
How should I store Jakafi?
- Store Jakafi at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Jakafi and all medicines out of the reach of children.
General information about the safe and effective use of Jakafi:
Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use Jakafi for a condition for which it is not prescribed. Do not give Jakafi to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Jakafi. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
For more information call 1-855-463-3463 or go to www.jakafi.com.
What are the ingredients in Jakafi?
Active ingredient: ruxolitinib phosphate
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, sodium starch glycolate, povidone and hydroxypropyl cellulose
Last reviewed on RxList: 12/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Jakafi Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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