When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to ruxolitinib.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• If you receive dialysis treatments, take this medicine after your treatment.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how ruxolitinib works. Tell your doctor if you are using any of the following:
  
  • Boceprevir, conivaptan, mibefradil, nefazodone, or telaprevir
  • Medicine to treat an infection (including clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole)
  • Medicine to treat HIV infection (including indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, high cholesterol, any type of infection, or a history of tuberculosis or skin cancer. Tell your doctor if you are on dialysis.
• This medicine may cause the following problems:
  
  • Increased risk for skin cancer
  • Increased cholesterol levels
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often. Infections include progressive multifocal leukoencephalopathy (a brain infection) and herpes zoster.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination
• Clumsiness, weakness on one side of your body, trouble speaking, trouble seeing, confusion
• Fever, chills, cough, night sweats, sore throat, body aches
• Painful or burning skin rash or blisters
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach pain
• Headache, dizziness
• Muscle spasms

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088