CIBINQO (abrocitinib)

Important Safety Information and Indication

CIBINQO may cause serious side effects, including:

Serious infections. CIBINQO can lower your immune system’s ability to fight infections. Do not start CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body, have occurred in people taking CIBINQO or other similar medicines. Some people have been hospitalized or died from these infections. Your risk of developing shingles may increase while taking CIBINQO.

Your healthcare provider should test you for TB before treatment with CIBINQO and monitor you closely for signs and symptoms of TB infection during treatment.

Before and after starting CIBINQO, tell your doctor right away if you have an infection, are being treated for one, or have symptoms of an infection, including:

CIBINQO can make you more likely to get infections or worsen infections you have. If you get a serious infection, your healthcare provider may stop treatment with CIBINQO until your infection is controlled.

There is an increased risk of death in people 50 years and older who have at least one heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK) inhibitor (such as CIBINQO).

Cancer and immune system problems. CIBINQO may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People, especially current or past smokers, have a higher risk of certain cancers, including lymphoma and lung cancers, while taking a JAK inhibitor. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment. Limit the amount of time you spend in sunlight and avoid using tanning beds or sunlamps. When in the sun, wear protective clothing and use SPF 30+ sunscreen. This is especially important if you have very fair skin or a family history of skin cancer. Tell your healthcare provider if you have ever had any type of cancer.

There is an increased risk of major cardiovascular (CV) events such as heart attack, stroke or death in people 50 years and older who have at least one heart disease (CV) risk factor and are taking a JAK inhibitor, especially for current or past smokers.

Some people taking CIBINQO have had major cardiovascular events.

Get emergency help right away if you develop any symptoms of a heart attack or stroke while taking CIBINQO, including:

Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking CIBINQO. This may be life-threatening. Blood clots in the veins of the legs and lungs have happened more often in people 50 years and older, with at least one heart disease (CV) risk factor, taking a JAK inhibitor. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past.

Stop taking CIBINQO and get medical help right away if you have any signs and symptoms of blood clots including swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing.

Changes in certain laboratory test results. Your doctor should do blood tests before and during treatment with CIBINQO to check your lymphocyte, neutrophil, red blood cell, and platelet counts. You should not take CIBINQO if these counts are too low. Your healthcare provider may stop treatment for a period of time if there are changes in these blood test results.
Increased cholesterol levels. You may also have increases in the amount of fat found in your blood. Your doctor should check your cholesterol about 4 weeks after you start CIBINQO and then as needed.

Do not take CIBINQO with medicines that prevent blood clots (antiplatelet medicines) during the first 3 months of treatment. You can take low-dose aspirin (≤81 mg daily) during this time, if prescribed.

Before taking CIBINQO, tell your healthcare provider if you:

The most common side effects of CIBINQO include common cold, nausea, headache, herpes simplex including cold sores, increased blood level of creatine phosphokinase, dizziness, urinary tract infection, tiredness, acne, vomiting, mouth and throat pain, flu, stomach flu, bacterial skin infection, high blood pressure, allergic skin rash to something you contacted, stomach pain, shingles, and low platelet count.

Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people treated with CIBINQO. Call your healthcare provider right away if you have any sudden changes in your vision.

CIBINQO may cause fertility problems in females, which may affect the ability of females to get pregnant. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of CIBINQO.

What is CIBINQO?

CIBINQO is a prescription medicine to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis) that did not respond to other treatment and is not well controlled with prescription medicines, including biologics, or when they cannot be tolerated.

It is not known if CIBINQO is safe and effective in children under 12 years of age.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide.