Generic name: ruxolitinib (RUX oh LI ti nib)
Brand name: Jakafi
Drug class: Multikinase inhibitors
Jakafi (ruxolitinib) works by blocking certain enzymes in the body that affect blood cell production.
Jakafi is used in adults to treat myelofibrosis or polycythemia vera, which are bone marrow disorders that that affect your body's ability to produce blood cells.
Jakafi is also used to treat acute graft versus host disease (GVHD) in adults and children 12 years of age and older who have taken corticosteroids and they did not work well enough.
Jakafi is usually given after other treatments have failed.
Warnings
You should not use Jakafi if you are allergic to ruxolitinib, or if you have severe kidney disease.
Before you take this medicine, 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 this medicine, 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 ruxolitinib.
Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
To make sure Jakafi is safe for you, tell your doctor if you have ever had:
- any type of chronic infection;
- kidney disease (or if you are on dialysis);
- liver disease (especially hepatitis B);
- skin cancer; or
- high cholesterol or triglycerides (types of fat in the blood).
Using Jakafi may increase your risk of developing skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for.
It is not known whether ruxolitinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breastfeed while you are using Jakafi, and for at least 2 weeks after your last dose.
Jakafi is not approved to treat myelofibrosis or polycythemia vera in anyone younger than 18 years old.
How should I take Jakafi?
Take Jakafi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Your doctor may occasionally change your dose. You will need frequent medical tests to help your doctor determine the best dose. When you first start taking Jakafi, your blood will need to be tested every 2 to 4 weeks.
You may take Jakafi with or without food. The Jakafi tablet can also be given through a nasogastric (NG) feeding tube.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Store at room temperature away from moisture and heat.
You should not stop using Jakafi suddenly. Follow your doctor's instructions about tapering your dose.
You may be given other medications to help prevent infection. Keep using these medicines for as long as your doctor has prescribed.
Dosing information
Usual Adult Dose for Myeloproliferative Disorder:
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 medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Grapefruit may interact with ruxolitinib and lead to unwanted side effects. Avoid the use of grapefruit products.
Jakafi side effects
Get emergency medical help if you have 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:
- blisters or painful skin rash;
- changes in the size, shape, or color of a mole or skin lesion;
- problems with speech, thought, vision, or muscle movement (these symptoms may start gradually and get worse quickly);
- nausea, vomiting, weakness, general ill feeling;
- pain or burning when you urinate;
- low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
- signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.
Common Jakafi side effects include:
- low blood cell counts;
- fluid retention;
- diarrhea;
- dizziness; or
- headache.
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.
What other drugs will affect Jakafi?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially fluconazole.
This list is not complete and many other drugs may interact with ruxolitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.