CIBINQO (Abroticinib)

What is this medication?

Cibinqo (abrocitinib) tablets are used to treat eczema (atopic dermatitis) that is moderate to severe in patients who have not found relief with topical medications or are not able to use them. Cibinqo is a once-a-day tablet that can be used by adults and children over 12 years of age.

Eczema may be caused by an overactive immune system leading to inflammation which causes dry, itchy skin and eczema flare-ups. Janus kinase (JAK) is an enzyme thought to play a role in skin inflammation. Cibinqo works by blocking the JAK1 activity, decreasing inflammation which helps reduce itching and improves skin condition.

Cibinqo belongs to a class of medications called JAK inhibitors (Janus kinase inhibitors).

Cibinqo received FDA-approval on January 14, 2022.

How should I take this medication?

Take Cibinqo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. You should not start taking this medicineif you have any kind of infection unless your doctor tells you to.

Cibinqo directions:
Cibinqo is a tablet that is taken once a day, at the same time each day.
You may take Cibinqo 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 Cibinqo and during treatment with this medicine.
Cibinqo may increase your risk of certain cancers, such as lymphoma, lung cancer, and skin cancer. Ask your doctor about your risk.

Cibinqo dosing information:
Usual Cibinqo Dose for Atopic Dermatitis:
Dose: 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 12 years of age and older, whose condition has not been adequately controlled with other systemic drug products.
Cibinqo tablets are available as: 50mg, 100mg, 200mg.

What if I miss a dose?

Take Cibinqo 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.

How should I store this medication?

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
• Keep in original package.
• The container closure system is child resistant.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction to Cibinqo:

• hives;
• difficult breathing;
• swelling of your face, lips, tongue, or throat.

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 Cibinqo 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.