Description

Indication & Scope

Abrocitinib is for adolescents aged 12 years and older and adults with refractory moderate-to-severe atopic dermatitis who have inadequate response to, intolerance of, or contraindications to systemic therapies such as corticosteroids and biologics, covering the therapeutic field of dermatological inflammatory immune disorders.

Drug class
Orally administered highly selective JAK1 small-molecule tyrosine kinase inhibitor.
Mechanism
It reversibly binds to the ATP-binding pocket of JAK1 and selectively blocks JAK1 kinase activity, suppressing downstream STAT signaling of key inflammatory mediators including IL-4, IL-13, IL-31 and TSLP to rapidly relieve pruritus, skin inflammation and lesions, with minimal inhibition on JAK2, JAK3 and TYK2 for improved safety profile.
Clinical use
Oral once daily, standard 100mg; up to 200mg for poor response. Backed by Phase 3 JADE trials. Relieves itch within 24h, improves lesions evidently at Week 12 with 52-week lasting effect. Effective for patients failed biologics. Monotherapy for moderate-severe atopic dermatitis; avoid combined immunosuppressants.

Specification

Generic Name	Abrocitinib Tablets
Brand Name	Cibinqo
Ingredient	Active ingredient: Abrocitinib; Excipients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol, triacetin, iron oxide red
Dosage Form	Film-coated tablet 100mg
Package	14 tablets per bottle
Conditions Treated	Refractory moderate-to-severe atopic dermatitis in patients aged 12 years and older with inadequate response, intolerance or contraindications to systemic corticosteroids and biologics
Taboos	Hypersensitivity to abrocitinib or any excipients; concomitant antiplatelet therapy except low-dose aspirin ≤81mg daily within the first 3 months of treatment; severe active infection; severe hepatic impairment
Place of origin	Germany (Manufacturer base); Marketing Authorization Holder: Pfizer Inc., USA
Prescription type	Prescription Drug (Rx only)
Storage Conditions	Store below 30°C, keep tightly closed, avoid moisture and direct sunlight
Manufacturer	Pfizer Manufacturing Deutschland GmbH; Marketing Authorization Holder: Pfizer Inc.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	HJ20220030 (100mg)
Date of Revision	April 2024 (latest indication expansion for adolescents)
Shelf Life	24 months

How to use ?

Recommended Dose: Patients aged 12 and above start with 100mg daily. Boost to 200mg after 12 weeks if ineffective, then cut back to 100mg once controlled; max dose 200mg daily.

Time：Take orally at the same time every day, with or without food.

Instructions for use: Swallow the film-coated tablet whole with water; do not chew, crush or split the tablet. Discontinue treatment if severe adverse reactions occur as directed by physician.

Interaction: Strong CYP2C19 inhibitors cap daily dose at 100 mg; avoid strong CYP2C19 inducers. Skip immunosuppressants/live vaccines, and other antiplatelets within the first 3 months except low-dose aspirin.

Side effects: Common side effects include nausea, diarrhea, headache, acne and upper respiratory infections. Severe risks cover severe infections, thromboembolism, abnormal liver enzymes, lipid elevation, low platelets, gastrointestinal perforation and potential malignancy.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is the drug abrocitinib used for?

Abrocitinib treats moderate to severe atopic dermatitis, a chronic skin disorder marked by dry, itchy skin and red scaly lesions.

Is abrocitinib an immunosuppressant?

Abrocitinib suppresses immunity and weakens infection resistance, so it is contraindicated for patients with active severe infections.

Is abrocitinib safe for long term use?

Clinical and lab tests show no unexpected safety risks, supporting long-term use for moderate-severe atopic dermatitis.

How long does it take for abrocitinib to work?

Once-daily 100 mg abrocitinib quickly relieves itch from Day 1 and delivers lasting skin improvement for moderate-severe atopic dermatitis, with good tolerability and consistent safety up to 72 weeks.