Ruxolitinib

Generic Name: ruxolitinib (RUX-oh-LI-ti-nib)
Brand Name: Jakafi

Ruxolitinib is used for:

Treating certain types of myelofibrosis. It may also be used for other conditions as determined by your doctor.

Ruxolitinib is a kinase inhibitor. It works by blocking certain substances (JAK1 and JAK2) that are involved in myelofibrosis.

Do NOT use ruxolitinib if:

  • you are allergic to any ingredient in ruxolitinib
  • you have a serious infection
  • you have certain severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using ruxolitinib:

Some medical conditions may interact with ruxolitinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have anemia, low blood platelet levels, or low white blood cell counts
  • if you have an infection (including an infection that will not go away), a history of infection that keeps coming back, a history of tuberculosis (TB), or a positive skin test for TB, or if you have recently been in close contact with someone who has had TB
  • if you are on dialysis or have a history of liver or kidney problems

Some MEDICINES MAY INTERACT with ruxolitinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole), conivaptan, macrolide antibiotics (eg, clarithromycin), mibefradil, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of ruxolitinib's side effects
  • Rifampin because it may decrease ruxolitinib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if ruxolitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ruxolitinib:

Use ruxolitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ruxolitinib. Talk to your pharmacist if you have questions about this information.
  • Take ruxolitinib by mouth with or without food. If you cannot take ruxolitinib by mouth, talk to your doctor.
  • Do not eat grapefruit or drink grapefruit juice while you use ruxolitinib without first checking with your doctor.
  • Do not stop taking ruxolitinib without talking with your doctor. If you need to stop ruxolitinib, your doctor may gradually lower your dose.
  • Continue to take ruxolitinib even if you feel well. Do not miss any doses.
  • If you miss a dose of ruxolitinib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ruxolitinib.

Important safety information:

  • Ruxolitinib may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use ruxolitinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose or stop taking ruxolitinib without checking with your doctor.
  • Tell your doctor or dentist that you take ruxolitinib before you receive any medical or dental care, emergency care, or surgery.
  • If you are on dialysis, do not take your dose of ruxolitinib before your dialysis treatment. Take your dose after your dialysis treatment is finished. Check with your doctor if you have any questions.
  • Ruxolitinib may lower the ability of your body to fight infection, including shingles. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, chills, or increased or painful urination. Symptoms of shingles may include painful skin rash or blisters.
  • Some patients treated with ruxolitinib have developed serious infections, such as progressive multifocal leukoencephalopathy (PML). Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination). Discuss any questions or concerns with your doctor.
  • Ruxolitinib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Ruxolitinib is not a cure for myelofibrosis. Signs and symptoms are expected to return if ruxolitinib is stopped. Discuss any questions or concerns with your doctor.
  • Some patients have had very bad health problems after stopping ruxolitinib. Call your doctor right away if you stop ruxolitinib and you have fever, trouble breathing, symptoms of low blood pressure (eg, severe dizziness or fainting), unusual bruising or bleeding, or symptoms of organ problems (eg, decreased urination, dark urine, pale stools, persistent loss of appetite, right-upper stomach pain, yellowing of the skin or eyes). You may need to start taking ruxolitinib again.
  • Lab tests, including complete blood cell counts, may be performed while you use ruxolitinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ruxolitinib while you are pregnant. It is not known if ruxolitinib is found in breast milk. Do not breast-feed while taking ruxolitinib.

Possible side effects of ruxolitinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; gas; headache; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); painful skin rash or blisters; shortness of breath; symptoms of infection (eg, fever; chills; persistent cough or sore throat; increased or painful urination; nausea; vomiting); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ruxolitinib:

Store ruxolitinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ruxolitinib out of the reach of children and away from pets.

General information:

  • If you have any questions about ruxolitinib, please talk with your doctor, pharmacist, or other health care provider.
  • Ruxolitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ruxolitinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ruxolitinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ruxolitinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ruxolitinib.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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