What is Cibinqo (abrocitinib) for?

Cibinqo (abrocitinib) is a treatment for moderate-to-severe atopic dermatitis, or eczema. It’s for adults and teens 12 and older who need systemic therapy.

It comes in film-coated tablets, with 100 mg or 200 mg of abrocitinib in each.

How does Cibinqo (abrocitinib) work?

Atopic dermatitis (AD) is a chronic condition where the immune system attacks healthy skin. It’s a relapsing inflammatory skin condition.

Abrocitinib, the active substance in Cibinqo, targets enzymes called Janus kinase-1 (JAK1). These enzymes are key in inflammation seen in AD. By blocking JAK1, abrocitinib reduces inflammation and symptoms of AD.

Where has Cibinqo (abrocitinib) been approved?

Cibinqo (abrocitinib) has been approved for atopic dermatitis treatment by:

• The Medicines and Healthcare products Regulatory Agency (MHRA), UK on September 9, 2021.
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on September 30, 2021.
• The European Medicines Agency (EMA) on December 10, 2021.
• The Food and Drug Administration (FDA), USA on January 20, 2022.

Cibinqo (abrocitinib) received a Promising Innovative Medicine (PIM) designation from the MHRA.

This medicine may also be approved in other regions. If you have questions about its approval in a specific country, contact our support team.

How is Cibinqo (abrocitinib) taken?

The standard dosage is:

• Starting dose: 200 mg once a day. Your doctor may start you on 100 mg once a day if you’re over 65, an adolescent (12 to 17 years old), or have certain medical history or conditions.
• Maintenance dose, the dose may be lowered to 100 mg once daily, or raised to 200 mg once daily, based on how you respond or how you tolerate the medicine

The maximal dose is 200 mg once daily.

The tablets must be swallowed whole and taken with or without food.

Cibinqo may be used alone or with other eczema medicines applied to the skin (topical).

If you have kidney problems that are moderate-to-severe, or if you are prescribed certain other medicines (see official prescribing information), the maintenance dose of Cibinqo will be 50 mg or 100 mg once a day.

If you have severe kidney problems, the starting dose of Cibinqo will be 50 mg once a day. Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or platelet counts.

Complete information about Cibinqo (abrocitinib) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.1

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Cibinqo (abrocitinib)?

Common adverse reactions

The most common side effects (≥10% of patients) listed in the prescribing information include:

• Feeling sick in the stomach (nausea)
• Cold sores (herpes simplex)
• Vomiting
• Upper abdominal pain
• Headache
• Dizziness
• Acne
• Increase in an enzyme called creatine phosphokinase, shown by blood test

Serious adverse reactions

The serious side effects listed in the prescribing information include:

• Shingles (herpes zoster), a painful skin rash with blisters and fever
• Eczema herpeticum or Kaposi’s varicelliform eruption
• Blood clots in the lungs, legs or pelvis

Use in a specific population

Cibinqo may harm your unborn baby. If you’re a female who can get pregnant, avoid getting pregnant and breastfeeding. Use effective birth control during treatment and for at least 1 month after stopping.

Talk to your doctor if you get pregnant. This medicine should not be used during pregnancy.

Before starting treatment, tell your doctor about all medicines you take and your medical conditions.

For a full list of side effects and adverse reactions, see the official prescribing information.

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