(rux'' oh li' ti nib)

Brand Name(s): Opzelura^®

IMPORTANT WARNING:

Using topical ruxolitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), a lung disease, hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV; an ongoing liver infection), or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys or the Southwest where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: azathioprine (Azasan, Imuran), baricitinib (Olumiant), cyclosporine (Gengraf, Neoral, Sandimmune), fedratinib (Inrebic), methotrexate (Xatmep, Trexall), mycophenolate (Cellcept), pimecrolimus (Elidel), tacrolimus (Astagraf, Envarsus XR, Prograf, Protopic), tofacitinib (Xeljanz), and upadacitinib (Rinvoq).

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; coughing up bloody mucus; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; urination that is frequent, painful, or causes a burning feeling; diarrhea; stomach pain; or excessive tiredness.

You may be infected with tuberculosis (TB, a type of lung infection), but not have any symptoms of the disease. In this case, using topical ruxolitinib may increase the risk that your infection will become more serious and that you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medicine to treat this infection before you begin using ruxolitinib. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever.

Ruxolitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers such as skin cancer. Tell your doctor if you have or have ever had any type of cancer or if you are a current or past smoker. Your doctor will check your skin during your treatment with topical ruxolitinib for signs of skin cancer.

Ruxolitinib may increase the risk of serious and potentially fatal heart-related events such as heart attack or stroke. Tell your doctor if you are a current or past smoker, or have had a heart attack or other heart problems. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; pain in arms, back, neck, jaw, or stomach; sudden, severe headache; cold sweat; sudden, severe nausea or vomiting; speech problems; dizziness or faintness; or weakness or numbness of an arm or a leg.

Ruxolitinib may increase the risk of serious and possibly life-threatening blood clot in the lungs or legs. Tell your doctor if you have or have ever had a blood clot in your legs or lungs. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; cough; pain, warmth, redness, swelling, or leg tenderness; cold sensation in the arms, hands, or legs; or muscle pain.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to ruxolitinib.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with topical ruxolitinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) {or the manufacturer's website} to obtain the Medication Guide.

Talk to your doctor about the risk(s) of using ruxolitinib.

WHY is this medicine prescribed?

Topical ruxolitinib is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Ruxolitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Topical ruxolitinib comes as a cream to apply to the skin. It is usually applied twice a day to the affected area. To help you remember to apply topical ruxolitinib, apply it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical ruxolitinib exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Topical ruxolitinib is for use on the skin only. Be careful not to get ruxolitinib in your eyes, mouth, or genital area.

Apply a thin layer of topical ruxolitinib to all affected areas of your skin. Wash your hands with soap and water to remove any leftover ruxolitinib. Do not wash your hands if you are treating them with topical ruxolitinib.

What SPECIAL PRECAUTIONS should I follow?

Before using topical ruxolitinib,

• tell your doctor and pharmacist if you are allergic to ruxolitinib, any other medications, or any of the ingredients in topical ruxolitinib. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using topical ruxolitinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had high cholesterol or triglycerides (fatty substances in the blood), anemia, a low number of red or low white blood cells, or heart problems.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using topical ruxolitinib, call your doctor.

• tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with topical ruxolitinib and for 4 weeks after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra topical ruxolitinib to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Topical ruxolitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nose or throat pain
• stuffy or runny nose
• ear pain, discharge, and other signs of infection
• diarrhea
• hives
• red skin or pimple

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using topical ruxolitinib and call your doctor immediately:

• unusual bleeding or bruising

Topical ruxolitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 20, 2024.