Abrocitinib Application Scope

Indication: Treatment of adults and adolescents (≥12 years; weight ≥25 kg) with refractory, moderate-to-severe atopic dermatitis (eczema) whose disease is not adequately controlled with other systemic therapies (including biologics) or when use of those therapies is inadvisable. Not recommended in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

Abrocitinib Characteristics

Ingredients:
- Active: Abrocitinib (free base).
- Inactive (excipients): Dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin.
Properties: White to pale-colored powder; molecular formula C14H21N5O2S; molecular weight 323.42 g/mol; water solubility ~0.04 mg/mL at 25 °C.
Packaging Specification: Film-coated tablets: 50 mg (pink, oval; “PFE” / “ABR 50”), 100 mg (pink, round; “PFE” / “ABR 100”), 200 mg (pink, oval; “PFE” / “ABR 200”). Common U.S. bottle count: 30 tablets (child-resistant).
Storage: Store at 20–25 °C (68–77 °F); excursions 15–30 °C (59–86 °F) permitted. Keep in original package; child-resistant closure.
Expiry Date: See batch-specific outer carton/bottle label (varies by lot and market). (General labeling does not fix a single expiry period.)
Executive Standard: U.S. Full Prescribing Information (USPI) / FDA-approved labeling.
Approval Number: U.S. NDA 213871 (CIBINQO, abrocitinib tablets).
Date of Revision: February 2023 (USPI revision).
Manufacturer: Pfizer Inc.

Guidelines for the Use of CIBINQO

Dosage and Administration:
- Recommended Dose: 100 mg once daily. If inadequate response after ~12 weeks, increase to 200 mg once daily; discontinue if still inadequate.
- Missed Dose: Take as soon as possible unless <12 hours before next dose; otherwise skip and resume schedule.
Adverse Reactions:
- Common (≥1%):
  - nasopharyngitis, nausea, headache, herpes simplex, increased CPK, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis; also reported: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, thrombocytopenia.
- Serious /Warnings (boxed class warnings apply to JAK inhibitors):
  - serious infections; mortality; malignancy; major adverse cardiovascular events (MACE); venous/arterial thrombosis; significant laboratory abnormalities (platelets, lymphocytes, lipids); retinal detachment reported. Live vaccines should be avoided during treatment. Baseline TB/viral hepatitis screening and CBC required; CBC again at 4 weeks and after dose increases.
Contraindications: Concomitant antiplatelet therapy during the first 3 months of treatment (except low-dose aspirin ≤81 mg/day).
Precautions:
- Infections: Do not start in patients with active serious infection; monitor closely.
- Laboratory Monitoring: CBC at baseline, 4 weeks after initiation, and 4 weeks after dose increases; monitor lipids/platelets per clinical guidance.
- Immunizations: Avoid live vaccines prior to, during, and immediately after therapy; bring vaccinations up to date before starting.
- Pregnancy & Lactation: Human data insufficient; breastfeeding not recommended during treatment. Discuss pregnancy intentions with healthcare provider.

Abrocitinib Interactions

Strong CYP2C19 or CYP2C9 inducers: Avoid (may reduce efficacy).
Moderate–strong inhibitors of both CYP2C19 and CYP2C9: Avoid (increase exposure/adverse reactions).
Strong CYP2C19 inhibitors: Reduce dose to 50 mg once daily (may increase to 100 mg if needed).
P-gp substrates with narrow therapeutic index (e.g., digoxin): monitor and/or adjust substrate dose.
Antiplatelet drugs: contraindicated in first 3 months (except low-dose aspirin ≤81 mg).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.