Abrocitinib is used in adults to treat moderate-to-severe eczema (atopic dermatitis) that did not respond to other treatments and is not well controlled with other medicines or in adults who cannot tolerate other treatments.

Abrocitinib may also be used for purposes not listed in this medication guide.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Abrocitinib may increase your risk of certain cancers, such as lymphoma, lung cancer, and skin cancer. Ask your doctor about your risk.

Call your doctor at once if you have:

• signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance; or

• signs of an infection--fever, sweating, or chills, cough or shortness of breath, weight loss, burning when you urinate or urinating more often than usual, or feeling very tired.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You should not start taking abrocitinib if you have any kind of infection unless your doctor tells you to.

Take the medicine once a day, at the same time each day.

You may take abrocitinib with or without food.

Swallow the tablet whole with water and do not crush, chew, or break it.

Your doctor should perform blood tests before you start taking abrocitinib and during treatment with this medicine.

Abrocitinib may increase your risk of certain cancers, such as lymphoma, lung cancer, and skin cancer. Ask your doctor about your risk.

Store in the original package at room temperature away from moisture and heat.

Usual Adult Dose for Atopic Dermatitis:

100 mg orally once a day
-Maximum dose: 200 mg/day
Duration of therapy: If no adequate response is achieved with 100 mg/day after 12 weeks, the dose can be increased to 200 mg/day. Discontinue if inadequate response is seen after this dosage increase.

Comments:
-This drug should not be used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or immunosuppressants.
-This drug can be used with or without topical corticosteroids.

Use: Refractory moderate to severe atopic dermatitis in patients, whose condition has not been adequately controlled with other systemic drug products.

Usual Pediatric Dose for Atopic Dermatitis:

100 mg orally once a day
-Maximum dose: 200 mg/day
Duration of therapy: If no adequate response is achieved with 100 mg/day after 12 weeks, the dose can be increased to 200 mg/day. Discontinue if inadequate response is seen after this dosage increase.

Comments:
-This drug should not be used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or immunosuppressants.
-This drug can be used with or without topical corticosteroids.

Use: Refractory moderate to severe atopic dermatitis in pediatric patients 12 years of age and older, whose condition has not been adequately controlled with other systemic drug products.

You should not use abrocitinib with other medicines that prevent blood clots during the first 3 months of treatment. You can take aspirin (up to a dose of 81 mg each day) during this time if prescribed by your doctor.

Tell your doctor if you:

• have an infection;

• are a current or past smoker;

• have had a stroke, a heart attack, or other heart problems;

• have kidney or liver problems;

• have low platelet or white blood cell counts;

• have eye problems, such as cataracts or retinal detachment; or

• have recently received or are scheduled to receive a vaccine.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

It is not known if abrocitinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of abrocitinib on the baby.

It may be harder for you to get pregnant while you are using abrocitinib.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Avoid receiving a "live" vaccine while you are being treated with abrocitinib.

Abrocitinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abrocitinib may cause serious side effects. Call your doctor at once if you have:

• worsening eye problems, eye pain, or changes in your vision;

• signs of an infection--fever, sweating, or chills, muscle aches, cough or shortness of breath, weight loss, painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of abrocitinib may include:

• flu-like symptoms, tingly or painful blistering rash on one side of your body;

• abnormal lab results;

• pain and burning when you urinate, painful urination;

• nausea, vomiting, stomach pain;

• mouth and throat pain;

• skin infection, rash;

• cold sores;

• high blood pressure;

• pimples;

• headache;

• dizziness; or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• digoxin;

• aspirin; or

• medicines that prevent blood clots.

This list is not complete. Other drugs may affect abrocitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.