Opzelura contains the active ingredient ruxolitinib phosphate, which is a Janus kinase inhibitor. It is formulated as a cream for topical use, with each gram containing 15 mg of ruxolitinib. Key inactive ingredients include cetyl alcohol, dimethicone, and glyceryl stearate SE.

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.

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). To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication 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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded -Infection—fever, chills, cough, or sore throat -Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Unusual bruising or bleeding Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Acne -Diarrhea -Headache -Runny or stuffy nose -Sore throat

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.

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

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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication. This medication may increase your risk of getting an infection. Call your care team 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 medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications 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 medication. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication. Do not breast-feed while taking this medication or for 4 weeks after stopping it.

What are the most serious risks of this medication?

This medicine can increase the risk of having a heart attack or stroke. This medicine increases the risk of blood clots. This medicine can lower your body’s ability to fight infections. You may get more infections while taking this medicine. Any infection you get could become serious and even deadly. This medicine may increase the risk of cancer. This medicine may increase the risk of death in some patients.