Pronunciation: RUX oh LI ti nib

Brand: Jakafi


slide 1 of 4, Jakafi,

5 mg, round, white, imprinted with INCY, 5

Image of Jakafi
slide 1 of 4


slide 2 of 4, Jakafi,

10 mg, round, white, imprinted with INCY, 10

Image of Jakafi
slide 2 of 4


slide 3 of 4, Jakafi,

15 mg, oval, white, imprinted with INCY, 15

Image of Jakafi
slide 3 of 4


slide 4 of 4, Jakafi,

20 mg, oblong, white, imprinted with INCY, 20

Image of Jakafi
slide 4 of 4

What is the most important information I should know about ruxolitinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is ruxolitinib?

Ruxolitinib is used in adults to treat myelofibrosis or polycythemia vera, which are bone marrow disorders that affect your body's ability to produce blood cells.

Ruxolitinib is also used to treat graft versus host disease in adults and children at least 12 years old.

Ruxolitinib is usually given after other treatments have failed.

Ruxolitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ruxolitinib?

You should not use ruxolitinib if you are allergic to it.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also, tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have or have ever had:

  • any type of infection;
  • shingles (herpes zoster);
  • a blood clot, stroke, heart attack, or other heart problems;
  • low white or red blood cell counts;
  • any type of cancer;
  • are a current or past smoker;
  • kidney disease (or if you are on dialysis);
  • liver disease (especially hepatitis B); or
  • high cholesterol or triglycerides (types of fat in the blood).

It is not known if ruxolitinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Ruxolitinib is not approved for the treatment of myelofibrosis or polycythemia vera by anyone younger than 18 years old.

How should I take ruxolitinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor may occasionally change your dose. You will need frequent medical tests to help your doctor determine the best dose.

You may take ruxolitinib with or without food. The ruxolitinib tablet can also be given through a nasogastric (NG) feeding tube.

Read and carefully follow any Instructions for Use provided with the medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you are on dialysis, ruxolitinib should be taken after your dialysis.

Using ruxolitinib may increase your risk of developing other cancers. Ask your doctor about this risk.

Store at room temperature away from moisture and heat.

You should not stop using ruxolitinib suddenly. Follow your doctor's instructions about tapering your dose.

You may be given other medications to help prevent infection. Keep taking these medicines for as long as your doctor has prescribed.

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 should I avoid while taking ruxolitinib?

Grapefruit may interact with ruxolitinib and cause side effects. Avoid consuming grapefruit products.

What are the possible side effects of ruxolitinib?

Get emergency medical help if you have signs of an allergic reaction: 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:

  • 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;
  • cold sores around your mouth, skin sores or blisters, itching, tingling, skin rash, burning pain in your thigh or lower back;
  • pain in your arms, back, neck, jaw, or stomach;
  • signs of a stroke --sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
  • signs of a blood clot deep in the body --pain, swelling, or warmth in one leg;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of infection --fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
  • 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 side effects may include:

  • low blood cell counts;
  • swelling;
  • infection;
  • bruising;
  • 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 ruxolitinib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially fluconazole.

This list is not complete and many other drugs may affect ruxolitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about ruxolitinib.

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