Registered South Africa · SAHPRA

CIBINQO 50 mg

ABROCITINIB

57/13.12/0226 dermatologicals INN generic

What it does

Abrocitinib is a medication used to treat certain skin conditions, particularly eczema.

Commonly used for: eczema, atopic dermatitis

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
57/13.12/0226
Registration date
2025/04/29
Expiry date
-
Status
Registered
Active ingredient
ABROCITINIB
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
D11AH - Agents for dermatitis, excluding corticosteroids
Drug group
DERMATOLOGICALS
RxNorm RxCUI
2591476
Manufacturer / MAH
-
Applicant / LTR
Pfizer Laboratories (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:29:40 · updated 2026-09-30 04:12:31

Drug Interactions

11
Check interactions

Severe (2)

Abrocitinib - increases risk of generalised infection (possibly life-threatening)

Live vaccines are predicted to increase the risk of generalised infection (possibly life-threatening) when given with abrocitinib. Avoid.

Severe Theoretical

Abrocitinib - decreases exposure

NNRTIs(efavirenz)arepredictedtodecreasetheexposureto abrocitinib.Avoid.oTheoretical

Severe Theoretical

Unknown (9)

Abrocitinib - increases exposure

Fluconazole is predicted to increase the exposure to abrocitinib. Adjust abrocitinib dose, p. 1380.

Unknown Study

Abrocitinib - decreases exposure

Efavirenzispredictedtodecreasetheexposuretoabrocitinib. Avoid.oTheoretical

Unknown Theoretical

Abrocitinib - decreases exposure

Rifampicinispredictedtodecreasetheexposuretoabrocitinib. Avoid.oStudy

Unknown Study

Ciclosporin - increases exposure

Abrocitinibmightincreasetheexposuretociclosporin. oTheoretical

Unknown Theoretical

Dabigatran - increases exposure

Abrocitinib slightly increases the exposure to thrombin inhibitors (dabigatran). Acalabrutinib → see TABLE 4 p. 1517 (antiplatelet effects)

Unknown Study

Digoxin - increases exposure

Abrocitinibmightincreasetheexposuretodigoxin.o Theoretical

Unknown Theoretical

Everolimus - increases exposure

Abrocitinibmightincreasetheexposuretoeverolimus. oTheoretical

Unknown Theoretical

Sirolimus - increases exposure

Abrocitinibmightincreasetheexposuretosirolimus.o Theoretical

Unknown Theoretical

Thrombin Inhibitors - increases exposure

Abrocitinib slightly increases the exposure to thrombin inhibitors (dabigatran). Acalabrutinib → see TABLE 4 p. 1517 (antiplatelet effects)

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Abrocitinib is a medication used to treat certain skin conditions, particularly eczema.

What it treats

  • eczema
  • atopic dermatitis

How it works

Abrocitinib works by reducing inflammation and itching in the skin.

Who it's for

This medication is for adults and children with moderate to severe eczema that hasn't improved with other treatments.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Abrocitinib

BNF-referenced

Abrocitinib is an oral Janus kinase (JAK) inhibitor used primarily for the treatment of moderate to severe atopic dermatitis in adults and adolescents. It functions by inhibiting the JAK pathway, which plays a crucial role in the signaling of various cytokines involved in inflammatory responses. This reduction in inflammation helps alleviate symptoms associated with atopic dermatitis.

Indications

  • Moderate to severe atopic dermatitis in adults and adolescents
  • Inflammatory skin conditions

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Initially 100 mg once daily, increased to 200 mg once daily if necessary and tolerated.

Mechanism of action

Abrocitinib selectively inhibits JAK1, an enzyme that is part of the JAK/STAT signaling pathway. By blocking JAK1, abrocitinib interrupts the transmission of signals from cytokines that contribute to inflammation and autoimmune responses, leading to reduced inflammatory activity and symptom relief in conditions like atopic dermatitis.

Pharmacodynamics

The pharmacodynamic effects of abrocitinib include a decrease in pro-inflammatory cytokines, leading to reduced inflammation and improvement in skin lesions associated with atopic dermatitis. The onset of action may vary, but many patients may experience symptomatic relief within a few days of initiating therapy.

Pharmacokinetics

Abrocitinib is administered orally and is primarily metabolized by cytochrome P450 enzymes, particularly CYP2C19 and CYP3A4. Its bioavailability can be affected by food, with higher absorption observed when taken with food. The drug has a half-life of approximately 5 to 10 hours, allowing for once-daily dosing. Renal and hepatic function may influence drug clearance, and dose adjustments may be necessary in patients with impaired function.

Contra-indications

  • Clinically significant active infection
  • History of deep vein thrombosis or pulmonary embolism
  • Neutrophil count less than 1.6 x 10^9 cells/litre
  • Hemoglobin less than 8 g/dL
  • Platelet count less than 150 x 10^9 cells/litre
  • Untreated latent tuberculosis

Adverse effects

  • Abdominal pain
  • Acne
  • Dizziness
  • Headache
  • Increased risk of infection
  • Nausea
  • Vomiting
  • Dyslipidaemia
  • Lymphopenia
  • Thrombocytopenia
  • Herpes virus reactivation

Interactions

  • Severe: live vaccines (increases risk of generalized infection, possibly life-threatening)
  • Severe: NNRTIs (decreases exposure)
  • Unknown: ciclosporin (increases exposure)
  • Unknown: digoxin (increases exposure)
  • Unknown: everolimus (increases exposure)
  • Unknown: sirolimus (increases exposure)
  • Unknown: thrombin inhibitors (increases exposure)
  • Unknown: dabigatran (increases exposure)
  • Unknown: fluconazole (increases exposure)
  • Unknown: efavirenz (decreases exposure)

Precautions

  • Patients should be up-to-date with vaccinations before starting treatment
  • Consider anti-tuberculosis therapy for patients with untreated latent tuberculosis
  • Discontinue treatment if deep vein thrombosis or pulmonary embolism occurs during treatment
  • Females of childbearing potential should use effective contraception during treatment and for one month after

Pregnancy

Avoid-limited information available.

Breast-feeding

Avoid-no information available.

Storage

Store in a refrigerator (2–8°C) and protect from light.

Formulations

  • Abrocitinib 100 mg tablet
  • Abrocitinib 200 mg tablet
BNF 85 (British National Formulary) p.1400 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Abrocitinib

PubChem CID 78323835

Molecular formula: C14H21N5O2S

Biological pathways

Atopic dermatitis mechanism and therapies WikiPathways

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.