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Ruxolitinib

Brand names: Jakafi

What is ruxolitinib used for?

  • Ruxolitinib is used to treat myelofibrosis.
  • It is used to treat polycythemia vera.
  • Ruxolitinib is also used to treat graft-versus-host disease (GVHD).

Before taking ruxolitinib, tell your doctor:

  • If you are allergic to ruxolitinib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have an infection.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have any of these health problems: Low white blood cell count, low platelet count, or low red blood cell count.
  • If you are taking fluconazole.
  • If you are breast-feeding. Do not breast-feed while you take ruxolitinib and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with ruxolitinib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ruxolitinib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take ruxolitinib?

  • Tell all of your health care providers that you take ruxolitinib. This includes your doctors, nurses, pharmacists, and dentists.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have had TB (tuberculosis) or have been close to someone who has TB, talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your skin checked as you have been told by your doctor.
  • Avoid grapefruit and grapefruit juice.
  • Some patients have had very bad health problems after stopping ruxolitinib. Do not stop taking ruxolitinib without calling your doctor. Call your doctor right away if you stop ruxolitinib and you have a fever, trouble breathing, signs of low blood pressure like very bad dizziness or passing out, or any bruising or bleeding. Call your doctor right away if you stop ruxolitinib and you have signs of organ problems like a change in how much urine is passed, dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. You may need to start taking ruxolitinib again.
  • Treatment with ruxolitinib may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
  • Some viral infections like herpes zoster have become active again with ruxolitinib. Tell your doctor if you have ever had a viral infection like herpes zoster. Talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ruxolitinib while you are pregnant.

How is ruxolitinib best taken?

Use ruxolitinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking ruxolitinib as you have been told by your doctor or other health care provider, even if you feel well.
  • Take with or without food.
  • Those who have feeding tubes may also use the tablet. Mix each tablet with 40 mL of water. Stir for 10 minutes. Give within 6 hours of mixing. Flush the feeding tube with water before and after ruxolitinib is given.
  • If you are on dialysis and are taking ruxolitinib on the day you get dialysis, take it after your dialysis. If you have questions, talk with your doctor.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of ruxolitinib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
  • Painful skin rash with blisters.
  • Upset stomach or throwing up.
  • Shortness of breath.
  • Feeling tired or weak.
  • Swelling.
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with ruxolitinib. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
  • Certain types of skin cancer have happened in people taking ruxolitinib. Call your doctor right away if you have a change in color or size of a mole, or any new or changing skin lump or growth.

What are some other side effects of ruxolitinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Diarrhea or constipation.
  • Dizziness.
  • Headache.
  • Muscle spasm.
  • Stomach pain.
  • Weight gain.
  • Gas.
  • Nose or throat irritation.
  • Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out ruxolitinib?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ruxolitinib, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ruxolitinib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 ruxolitinib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated May 19, 2020.