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.

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.

Ruxolitinib comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take ruxolitinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ruxolitinib exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

If you are being treated for myelofibrosis or PV your doctor may start you on a low dose of ruxolitinib for the first four weeks of treatment, and gradually increase your dose after that time, not more than once every 2 weeks. If you are being treated for acute GVHD your doctor may start you on a low dose of ruxolitinib and may increase your dose after at least 3 days of therapy. If you are being treated for acute or chronic GVHD your doctor may gradually lower your dose of ruxolitinib after at least 6 months of therapy.

If you can not have food by mouth and have a nasogastric (NG) tube, your doctor may tell you to take ruxolitinib through the nasogastric (NG) tube. Your doctor or pharmacist will explain how to prepare ruxolitinib to give through an NG tube.

Your doctor will order blood tests before and during your treatment to see how you are affected by this medication. Your doctor may increase or decrease your dose of ruxolitinib during your treatment, or may tell you to stop taking ruxolitinib for awhile. This depends on how well the medication works for you, your lab test results, and if you experience side effects. Talk to your doctor about how you are feeling during your treatment. Continue to take ruxolitinib even if you feel well. Do not stop taking ruxolitinib without talking to your doctor. If your doctor decides to stop your treatment with ruxolitinib, your doctor may decrease your dose gradually.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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.

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 ruxolitinib, 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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

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 of ruxolitinib 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.

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.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.