abrocitinib

What is the most important information I should know about abrocitinib?

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.

• 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.

What is abrocitinib?

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.

What should I discuss with my healthcare provider before taking abrocitinib?

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 this medicine.

How should I take abrocitinib?

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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking abrocitinib?

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

What are the possible side effects of abrocitinib?

• 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 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.

What other drugs will affect abrocitinib?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about abrocitinib.