Ruxolitinib Topical Cream

What is this medication?

RUXOLITINIB (RUX oh LI ti nib) is a medicine that targets proteins in cells and stops them from growing. It is used on the skin to treat eczema.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Opzelura

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Heart disease
• Hepatitis
• High cholesterol
• Infection such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• Low blood counts (white cells, platelets, or red blood cells)
• Smoke tobacco cigarettes
• Stroke
• An unusual or allergic reaction to ruxolitinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your hands, only wash your hands before use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

Apply a thin film of the medication to the affected area.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

• Azathioprine
• Baricitinib
• Biologic medications such as adalimumab, certolizumab, etanercept, golimumab, infliximab
• Certain antibiotics like clarithromycin, chloramphenicol, erythromycin, and telithromycin
• Certain medications for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
• Certain medications for seizures like carbamazepine, phenobarbital, fosphenytoin, phenytoin, and primidone
• Cyclosporine
• Enzalutamide
• Fedratinib
• Idelalisib
• Lumacaftor; ivacaftor
• Ribociclib
• Rifampin
• St. John's wort
• Tofacitinib
• Upadacitinib

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not breast-feed while taking this medicine or for 4 weeks after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• anemia (trouble breathing; feeling faint; lightheaded; falls, unusually weak or tired)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• feeling faint; lightheaded; falls, unusually weak or tired
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.