RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.1
Precautions and Special Considerations
Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC
- Active tuberculosis (TB) or active serious infections
- Severe hepatic impairment
- Pregnancy
RINVOQ should only be used if no suitable treatment alternatives are available in patients: - 65 years of age and older; - patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers); - patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Serious & opportunistic infections including TB
- RINVOQ increases the risk of serious infections and opportunistic infections, including tuberculosis and herpes zoster; RINVOQ should not be used in patients with active TB or active serious infections, including localised infections.
Malignancy and NMSC
- Lymphoma, other malignancies and NMSCs have been reported in patients treated with RINVOQ.
- Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Pregnancy and breastfeeding
- RINVOQ must not be used during pregnancy or during breastfeeding.
Use in patients ≥65 years of age
- Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed with another JAK inhibitor, RINVOQ should only be used in these patients if no suitable treatment alternatives are available.
- The recommended dose for long-term use in patients ≥65 years of age is 15mg once daily.
Thrombosis - DVT and PE
- Events of thrombosis (including DVT and PE) were observed. Use RINVOQ with caution in patients with an increased risk of thrombosis and re-evaluate periodically for VTE risk. Promptly evaluate and discontinue RINVOQ in patients with suspected VTE.
- Promptly evaluate and discontinue RINVOQ in patients with suspected VTE.
GI perforation
- RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation.
Major adverse cardiovascular events
- Events of MACE were observed in clinical studies of RINVOQ.
- Patients with history of cardiovascular events should only be given RINVOQ if no suitable treatment alternatives are available.
- Monitor for lipid elevation and manage according to guidelines.
Vaccination
- Use of live, attenuated vaccines during or immediately prior to RINVOQ therapy is not recommended.
List of excipients
Tablet Contents
- Microcrystalline cellulose
- Hypromellose
- Mannitol
- Tartaric acid
- Silica, colloidal anhydrous
- Magnesium stearate
Film coating
- Poly(vinyl alcohol)
- Macrogol
- Talc
- Titanium dioxide (E171)
- Iron oxide black (E172) (15 mg strength only)
- Iron oxide red (E172)
- Iron oxide yellow (E172) (45 mg strength only)
Adverse Reactions1
In the placebo-controlled atopic dermatitis clinical trials, the most commonly reported adverse reactions (≥2% of patients) with upadacitinib 15 mg or 30 mg were upper respiratory tract infection (25.4%), acne (15.1%), herpes simplex (8.4%), headache (6.3%), blood CPK increased (5.5%), cough (3.2%), folliculitis (3.2%), abdominal pain (2.9%), nausea (2.7%), neutropenia (2.3%), pyrexia (2.1%), and influenza (2.1%).1
§§ELEVATE: AbbVie defines "ELEVATE" as the raising of the standards of care in AD patients, measured by WP-NRS and EASI score, treated with Dupilumab vs RINVOQ at week 16 of the head to head trials.2,3
FIND OUT MORE ABOUT RINVOQ
REFERENCES
- RINVOQ® (upadacitinib) Summary of Product Characteristics, available at www.medicines.ie.
- Silverberg JI, Bunick CG, Hong HC, et al. Efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: week 16 results of an open-label randomized efficacy assessor-blinded head-to-head phase IIIb/IV study (Level Up). Br J Dermatol. 2024;192(1):36-45.
- Blauvelt A, Ladizinski B, Prajapati VH, et al. Efficacy and safety of switching from dupilumab to upadacitinib versus continuous upadacitinib in moderate-to-severe atopic dermatitis: Results from an open-label extension of the phase 3, randomized, controlled trial (Heads Up). J Am Acad Dermatol. 2023 Sep;89(3):478-485.
IE-RNQD-260020 Date of Preparation: May 2026
