Jakafi (ruxolitinib) works by blocking certain enzymes in the body that affect blood cell production.
Jakafi is used to treat myelofibrosis or polycythemia vera, which are bone marrow disorders that affect your body"s ability to produce blood cells.
Jakafi may also be used for purposes not listed in this medication guide.
Important information
You should not use Jakafi if you are allergic to ruxolitinib, or if you have severe kidney disease.
Before you take Jakafi, tell your doctor if you have liver or kidney disease, if you are on dialysis, or if you are pregnant.
You should not breast-feed while you are using this medicine.
To be sure Jakafi is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine the best dose for you to use. When you first start taking Jakafi, your blood will need to be tested every 2 to 4 weeks. Do not miss any follow-up visits to your doctor.
Grapefruit and grapefruit juice may interact with Jakafi and can affect the amount of the medication in your blood. Discuss the use of grapefruit products with your doctor.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use Jakafi if you are allergic to it.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Jakafi is safe for you, tell your doctor if you have:
Using Jakafi may increase your risk of developing skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for.
FDA pregnancy category C. It is not known whether Jakafi will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether ruxolitinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ruxolitinib.
How should I take Jakafi?
Take Jakafi exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take this medicine with or without food.
The Jakafi tablet can also be given through a nasogastric (NG) feeding tube as follows:
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Place the tablet into 40 milliliters of water, stirring occasionally for 10 minutes.
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When the tablet is completely dispersed, place the mixture into a syringe attached to the NG tube.
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Push the plunger down to empty the syringe into the tube. Then flush the tube with 75 milliliters of water to wash the contents down.
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You must give the mixture within 6 hours after placing the tablet into the water.
To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. This will help your doctor determine the best dose for you to use. When you first start taking Jakafi, your blood will need to be tested every 2 to 4 weeks. Do not miss any follow-up visits to your doctor.
You should not stop using this medicine suddenly. Follow your doctor"s instructions about tapering your dose.
Store at room temperature away from moisture and heat.
Jakafi dosing information
Usual Adult Dose for Myeloproliferative Disorders:
Initial Dose:
-Platelets greater than 200 x 10(9)/L: 20 mg orally twice a day
-Platelets 100 to 200 x 10(9)/L: 15 mg orally twice a day
-Platelets 50 to less than 100 x 10(9)/L: 5 mg orally twice a day
Maximum dose:
-Starting platelets 100 x 10(9)/L or greater: 25 mg twice a day
-Starting platelets 50 to less than 100 x 10(9)/L: 10 mg twice a day
Duration of therapy: 6 months if no spleen reduction or symptom improvement
Comments:
-Doses may be titrated based on safety and efficacy.
-If efficacy is considered insufficient and platelet and neutrophil counts are adequate, doses may be increased by a maximum of 5 mg twice daily.
-The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2 week intervals.
Uses: Intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Jakafi?
Grapefruit and grapefruit juice may interact with ruxolitinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Jakafi.
Jakafi side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Jakafi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may be similar to the symptoms of myelofibrosis. Call your doctor at once if you have a serious side effect such as:
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pain or burning when you urinate;
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nausea, vomiting, weakness;
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blisters or painful skin rash;
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changes in the size, shape, or color of a mole or skin lesion;
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low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
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low platelets--easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
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low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.
Common Jakafi side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Jakafi?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Jakafi, especially:
This list is not complete. Other drugs may interact with ruxolitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
