Abrocitinib

What it is used for

CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

How it is taken

The recommended dose is 100 mg once daily. If response is not adequate, the dose may be increased to 200 mg once daily. For patients with moderate renal impairment or who are CYP2C19 poor metabolizers, the starting dose is 50 mg once daily, which may be increased to 100 mg once daily if needed. Take with or without food at the same time each day. Swallow tablets whole with water. If a dose is missed, take it as soon as possible unless it is less than 12 hours before the next dose; then skip the missed dose.

Warnings

• WARNING: Serious infections, increased risk of death, cancer, major cardiovascular events, and blood clots.
• CIBINQO increases the risk of serious infections (e.g., tuberculosis, herpes, pneumonia) that may lead to hospitalization or death.
• A higher rate of all-cause mortality, including sudden cardiovascular death, was seen with another JAK inhibitor in rheumatoid arthritis patients.
• Malignancies, including lymphoma and lung cancer, have occurred. Smokers have additional risk.
• Major adverse cardiovascular events (heart attack, stroke) have occurred. Discontinue if a heart attack or stroke happens.
• Blood clots (deep vein thrombosis, pulmonary embolism) have occurred, some fatal. Avoid use in patients at risk.

Common side effects

• Nasopharyngitis (common cold)
• Nausea
• Headache
• Herpes simplex (cold sores)
• Increased blood creatine phosphokinase
• Dizziness
• Urinary tract infection
• Fatigue
• Acne
• Vomiting
• Impetigo
• Oropharyngeal pain
• Hypertension
• Influenza
• Gastroenteritis
• Contact dermatitis
• Upper abdominal pain
• Abdominal discomfort
• Herpes zoster (shingles)
• Thrombocytopenia (low platelets)

Interactions

Strong inhibitors of CYP2C19: reduce dose to 50 mg once daily (may increase to 100 mg if needed). Avoid use with moderate to strong inhibitors of both CYP2C19 and CYP2C9, or strong inducers of CYP2C19 or CYP2C9. CIBINQO may increase levels of P-gp substrates (e.g., digoxin); monitor or adjust dose. Antiplatelet drugs (except low-dose aspirin ≤81 mg daily) are contraindicated during the first 3 months of treatment.