Ruxolitinib (rux-oh-LI-ti-nib)

Treats myelofibrosis, polycythemia vera, and acute and chronic graft-versus-host disease (GVHD).

Brand Name(s):

Jakafi

When This Medicine Should Not Be Used:

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.
• If you cannot swallow the tablet whole, you may dissolve it in about 40 milliliters (mL) of water, with stirring, for about 10 minutes. Take the mixture using a nasogastric tube within 6 hours. Then, rinse the tube with about 75 mL of water.
• 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 medicines can affect how ruxolitinib works. Tell your doctor if you are using erythromycin, fluconazole, ketoconazole, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B), heart or blood vessel disease, high cholesterol, any type of infection (including tuberculosis, herpes simplex, shingles, progressive multifocal leukoencephalopathy), or a history of skin cancer. Tell your doctor if you are on dialysis or if you are a current or past smoker.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• This medicine may cause the following problems:
  • Increased risk of serious infections
  • Increased risk of cancer (including lymphoma, skin cancer)
  • Increased risk of serious heart or blood vessel disease, including heart attack or stroke
  • Blood clots, including deep vein thrombosis, pulmonary embolism, arterial thrombosis
  • Increased cholesterol levels or fats in the blood
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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
• Black, tarry stools, swollen glands, weight loss, yellow skin and eyes
• Burning or stinging of the skin, painful cold sores or blisters on the body, lips, nose, eyes, or genitals
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Clumsiness, weakness on one side of your body, trouble speaking, trouble seeing, confusion
• Coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Fever, chills, cough, night sweats, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• 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