Abrocitinib Oral Tablets

What is this medication?

ABROCITINIB (a broe sye ti nib) treats atopic dermatitis. It works on the immune system. It belongs to a group of medicines called JAK inhibitors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CIBINQO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood clots
• Cancer
• Diabetes (high blood sugar)
• Eye disease such as cataracts or retinal detachment
• Heart disease
• High blood pressure
• High cholesterol
• Immune system problems
• Infection especially a viral infection such as chickenpox, cold sores, or herpes
• Infection such as tuberculosis (TB) or other bacterial, fungal or viral infection
• Kidney disease
• Liver disease
• Low blood counts (white cells, platelets, or red blood cells)
• Lung or breathing disease (asthma, COPD)
• Organ transplant
• Recent or upcoming vaccine
• Smoke tobacco cigarettes
• Stroke
• An unusual or allergic reaction to abrocitinib, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

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, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Abciximab
• Anagrelide
• Cangrelor
• Cilostazol
• Clopidogrel
• Dipyridamole
• Eptifibatide
• Live vaccines
• Pentoxifylline
• Prasugrel
• Ticagrelor
• Ticlopidine
• Tirofiban
• Vorapaxar

This medicine may also interact with the following medications:

• Aspirin
• Baricitinib
• Biologic medicines such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, tralokinumab, ustekinumab
• Dabigatran
• Digoxin
• Fluconazole
• Fluvoxamine
• Medicines that lower your chance of fighting infection
• Rifampin
• 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 done while you are taking this medication.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide fever.

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.

Do not breast-feed an infant while taking this medication or for 1 day after stopping it.

This medication may make it more difficult to get pregnant. Talk to your care team if you are concerned about your fertility.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication.

Tell your care team right away if you have any change in your eyesight.

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, or tongue
• 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, sore throat, wounds that don't heal, pain or trouble passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing of the eyes or skin, unusual weakness or fatigue
• Low red blood cell counts—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
• Sudden changes in vision
• Unusual bleeding or bruising

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Acne
• Nausea
• Sore throat
• Stomach pain
• Vomiting

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.

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). Keep this medication in the original container. Get rid of any unused medication after the expiration date.

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.