Upadacitinib

Inhibition of selective activation of JAK1, blocking the intracellular signaling cascade of the JAK–STAT pathway, resulting in reduced inflammatory responses.

Active psoriatic arthritis: Treatment of adults with an inadequate response to one or more DMARDs or intolerance to these medications.
Moderate to severe atopic dermatitis: Treatment of adults with insufficient response or intolerance to conventional topical therapies.

Yes

Atopic dermatitis: Partially time-limited limitation; monotherapy or combination therapy with topical corticosteroids in adult patients with severe atopic dermatitis (IGA 4, SCORAD > 50, EASI ≥ 21.1) when treatment with topical medications, phototherapy, and systemic treatment with a conventional immunosuppressant (minimum 1 month, excluding systemic corticosteroids) has not achieved adequate disease control, is not recommended, or has been discontinued due to clinically relevant adverse effects.
Reimbursement is not granted in combination with other systemic therapies for AD.

Psoriatic arthritis: Prescription only by rheumatology specialists.
Adults ≥ 18 years with active psoriatic arthritis as monotherapy or in combination with DMARDs when response to prior DMARD therapy has been inadequate.

Tablets: 15 mg (to be taken whole, regardless of meals)

CBC, liver enzymes, creatinine, lipid profile, urinalysis, pregnancy test, CRP, screening for HBV, HCV, HIV, and tuberculosis (optional chest X-ray), update of vaccination status (including varicella/herpes zoster vaccination).

CBC, CRP, transaminases, lipid panel, creatinine, β-HCG.

Months 1 and 2, then every 3 months; lipid profile at month 2, then every 6 months.

Oral.

15 mg once daily, with or without food.

12 weeks.

Avoid live vaccines immediately before and during treatment.

Combination with potent immunosuppressants such as azathioprine, cyclosporine, tacrolimus, biologic DMARDs, or other JAK inhibitors (not studied and not recommended).

Caution in patients with increased skin cancer risk (regular examinations recommended).

Thromboembolic events (requires immediate evaluation and treatment).

Risk factors for gastrointestinal perforation.

Patients > 75 years (increased adverse events including serious infections).

Patients > 65 years.

Patients at increased risk for malignancies (higher incidence including lung cancer, lymphoma, NMSC).

14.057

Infections, severe hypersensitivity reactions, lymphopenia < 0.5 × 10⁹/L, neutropenia < 1 × 10⁹/L, hemoglobin < 80 g/L; suspected drug-induced liver injury (elevated transaminases), serious infection, thromboembolic event, active herpes zoster infection (case-by-case decision).

Insufficient data.

Hypersensitivity to the active substance or excipients.

Active, serious infections (including localized infections).

Use in end-stage renal disease (GFR < 15 mL/min/1.73 m²) not studied (no dose adjustment needed in mild to severe renal impairment).

Severe hepatic impairment (Child-Pugh C; no dose adjustment required for Child-Pugh A or B).

Lymphopenia < 0.5 × 10⁹/L, neutropenia < 1 × 10⁹/L, hemoglobin < 80 g/L.

Limited data in pregnancy and lactation (teratogenicity and transfer into breast milk demonstrated in animal studies).

Very common: Upper respiratory tract infections (22.6% for 15 mg), acneiform skin eruptions

Common: Neutropenia, cough, nausea, abdominal pain, fever, fatigue, elevated CPK, weight gain, herpes zoster / herpes simplex infection, urinary tract infections, influenza, anemia, urticaria, headache

Occasional: Pneumonia, oral candidiasis, hypertriglyceridemia, NMSC, elevated ALT, elevated AST, hypercholesterolemia

Screening prior to therapy initiation; cases of reactivation reported.
Consultation with a hepatologist recommended if HBV DNA is detected during treatment.

Insufficient data.

Insufficient data.

CYP3A4 inhibitors (e.g., ketoconazole, grapefruit)

CYP3A4 inducers (e.g., rifampicin)

CYP2D6 inhibitors (no clinically relevant effect)

TB prophylaxis required before starting therapy.
Consultation with a TB specialist regarding anti-TB treatment on a case-by-case basis.
Patients should be monitored for signs and symptoms of TB, including those with a negative baseline screening.

Insufficient data.