Abrocitinib
CIBINQO
What it isSelective JAK1 inhibitor; refractory moderate to severe atopic dermatitis.
Why this oneFaster itch relief than dupilumab, and it is oral rather than injected.
What limits itThe JAK class warnings apply. CYP2C19 variation changes exposure; screen for tuberculosis and hepatitis B.
FDA-approved for
- Refractory moderate-to-severe atopic dermatitis (2022)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Atopic dermatitis, moderate-to-severe | Adults | 100 mg QD | 100 mg QD (lowest efficacious dose) | 200 mg QD (only if inadequate response to 100 mg; discontinue if inadequate on 200 mg) |
| Atopic dermatitis, moderate-to-severe | Peds >=12 yr | 100 mg QD | 100 mg QD | 200 mg QD (same escalation rule as adults) |
| Atopic dermatitis — CYP2C19 poor metabolizers (known/suspected) | All ages >=12 yr | 50 mg QD | 50 mg QD | 100 mg QD (if inadequate response; discontinue if inadequate on 100 mg) |
Renal Mild (eGFR 60-89): no adjustment. Moderate (30-59): 50 mg QD, may increase to 100 mg QD if inadequate response. Severe (15-29)/ESRD incl. renal replacement: not recommended
Hepatic Mild-moderate (Child-Pugh A/B): no adjustment. Severe (C): not recommended (avoid)
Instructions
- Oral; with or without topical corticosteroids
- Missed dose: take ASAP unless <12 h to next dose, then skip
- Before initiation: TB evaluation, viral hepatitis screen, CBC (do not start if platelets <150k, ALC <500, ANC <1000, or Hb <8 g/dL); complete immunizations incl. herpes zoster
- Taking a strong CYP2C19 inhibitor: reduce to 50 mg QD (may increase to 100 mg QD if inadequate response)
- Discontinue for platelets <50k (follow CBC until >100k); hold for ALC <500, ANC <1000, or Hb <8 g/dL until recovered; CBC at baseline, 4 wk after start and 4 wk after dose increase
- Discontinue if serious/opportunistic infection develops
Contraindications
- Antiplatelet therapies (except aspirin <=81 mg/day) during the first 3 months of treatment
Cautions
- Serious/opportunistic infections incl. TB, herpes zoster, pneumonia — avoid with active serious infection; monitor for TB during treatment
- Higher all-cause mortality (incl. sudden CV death) with another JAK inhibitor vs TNF blockers in RA patients >=50 yr with CV risk
- Malignancy incl. lymphoma and lung cancer (JAK class); current/past smokers at added risk
- MACE (CV death, MI, stroke); discontinue if MI or stroke occurs
- Thrombosis: DVT/PE and arterial thrombosis — avoid in patients at risk
- Hypoglycemia in patients with diabetes on antidiabetic therapy
- Laboratory abnormalities: thrombocytopenia, lymphopenia, neutropenia, anemia; lipid elevations
- Avoid live vaccines prior to, during, and immediately after treatment
Adverse reactions
- Nasopharyngitis
- Nausea
- Headache
- Herpes simplex
- Increased CPK
- Dizziness
- UTI
- Fatigue
- Acne
- Vomiting
- Herpes zoster (200 mg)
- Thrombocytopenia (200 mg)
Pregnancy Insufficient human data; animal studies: dystocia and fetal skeletal variations at ~11x MRHD (rats). Pregnancy exposure registry 1-877-311-3770
Lactation Advise not to breastfeed during treatment and for 1 day after last dose (present in rat milk ~5x plasma)
⚠ BOXED WARNINGS
- Serious infections
- Mortality
- Malignancy
- Major adverse cardiovascular events
- Thrombosis
Classes and tags
Clinical profile
Mechanism of action: Abrocitinib ballicule
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