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

Treats atopic dermatitis and nonsegmental vitiligo.

Brand Name(s):

Opzelura

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• This medicine is not for long-term use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply 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.

• This medicine should not be used together with azathioprine or cyclosporine.
• Some medicine can affect how ruxolitinib works. Tell your doctor if you are using erythromycin, ketoconazole, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease (including hepatitis B or C), heart or blood vessel disease, any type of infection (including tuberculosis, shingles), diabetes, lung disease, high cholesterol, a weak immune system, or a history of skin cancer. Tell your doctor if you are a current or past smoker.
• Do not breastfeed during treatment and for at least 4 weeks after the last dose.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of cancer, including lymphoma, skin cancer
  • Increased risk of serious heart or blood vessel problems, including heart attack or stroke
  • Increased risk of blood clots (including deep vein thrombosis, pulmonary embolism, arterial thrombosis), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease
  • High cholesterol or fats in the blood
• Do not use this medicine to treat a skin problem your doctor has not examined.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Call your doctor if your symptoms do not improve or if they get worse.
• 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
• Change in how much or how often you urinate, bloody or cloudy urine, lower back or side pain
• Chest pain that may spread to your arms, jaw, back, or neck, coughing up blood, trouble breathing, nausea, unusual sweating, fainting
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Pain in the ear, change in hearing
• 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:

• Blemishes, itching, or redness where the medicine is applied
• Burning, itching, and pain in the hairy areas of the skin
• Diarrhea

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