Abrocitinib (a-broe-SYE-ti-nib)

Treats atopic dermatitis.

Brand Name(s):

Cibinqo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the tablet whole with water. Do not crush, split, or chew it
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours before the next dose, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with medicine that prevents blood clots during the first 3 months of treatment.
• Some medicines can affect how abrocitinib works. Tell your doctor if you are using dabigatran, digoxin, fluconazole, fluvoxamine, metformin, midazolam, rifampin, rosuvastatin, birth control pills (including ethinyl estradiol, levonorgestrel), or medicine that weaken your immune system.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B or C), blood problems, cancer or a history of cancer, diabetes, lung disease, HIV, or a history of tuberculosis. Tell your doctor if you have a current infection or an infection that keeps coming back, or if you are a current or past smoker.
• Do not breastfeed during treatment and for at least 1 day after the last dose.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of certain cancers (including lymphoma, lung cancer, skin cancer)
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease
  • High cholesterol in the blood
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, slow or fast heartbeat, lightheadedness, dizziness
• Chest pain that may spread, trouble breathing, coughing up blood, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088