What is Cibinqo (abrocitinib) for?

Cibinqo (abrocitinib) is a JAK inhibitor indicated to treat moderate-to-severe atopic dermatitis, or eczema, in adults and adolescents 12 years and older who are candidates for systemic therapy.^[1]

It is available in film-coated tablets form, each containing 100 mg or 200 mg abrocitinib.^[1]

How does Cibinqo (abrocitinib) work?

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition in which the body’s immune system attacks healthy skin cells.^[2]

The active substance in Cibinqo, abrocitinib, acts on enzymes known as Janus kinase-1 (JAK1). These enzymes play an important role in the process of inflammation that is seen in atopic dermatitis. By blocking JAK1’s action, abrocitinib helps reduce the inflammation and other symptoms of atopic dermatitis.^[2]

Where has Cibinqo (abrocitinib) been approved?

Cibinqo (abrocitinib) was approved for the treatment of people with atopic dermatitis by:

• The Medicines and Healthcare products Regulatory Agency (MHRA), UK on September 9, 2021.^[3]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on September 30, 2021.^[4]
• The European Medicines Agency (EMA) on December 10, 2021.^[5]
• The Food and Drug Administration (FDA), USA on January 20, 2022.^[6]

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

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Cibinqo (abrocitinib) taken?

The standard dosage is:^[1]

• Starting dose: 200 mg once a day. Your doctor may give you the lower starting dose of 100 mg once a day if you are over 65 years old, if you are an adolescent (12 to 17 years old), or if you 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.^[1]

The tablets must be swallowed whole and taken with or without food.^[1]

Cibinqo may be used on its own or together eczema medicines that you apply to the skin (topical).^[1]

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.^[1]

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.^[1]

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:^[1]

• 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 adverse reactions listed in the prescribing information include:^[1]

• 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 cause harm to your unborn baby. Females who can become pregnant should avoid pregnancies and breastfeeding and use effective birth control (contraception) during treatment with Cibinqo and for at least 1 month after the last dose. Talk to your doctor if you become pregnant, as this medicine should not be used during pregnancy.^[1]

Before starting with treatment, tell your doctor about all of the medicines you take and your medical conditions.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Patient Information Leaflet [MHRA]: Cibinqo (abrocitinib) [PDF]
Pfizer, Sep 2021

2. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis; JADE MONO-1
Simpson EL, et al., The Lancet, Jul 2020

3. UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Pfizer, Sep 2021

4. Japan’s MHLW Approves Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents with Moderate to Severe Atopic Dermatitis
Pfizer, Sep 2021

5. European Commission Approves Pfizer’s Cibinqo® (abrocitinib) for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis
Pfizer, Dec 2021

6. FDA approves Janus kinase inhibitors Rinvoq and Cibinqo despite safety concerns
Press release, Jan 2022