The most commonly reported adverse drug reactions are upper respiratory tract infections, nausea, blood creatine phosphokinase (CPK) increased and cough. The most common serious adverse reactions were serious infections.

Contraindications: Hypersensitivity to active substance or excipients, active tuberculosis (TB) or active serious infections, severe hepatic impairment and pregnancy.

Serious infections: Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ. Treatment should be interrupted if a patient develops a serious or opportunistic infection and until the infection is controlled. As there is a higher incidence of infections in the elderly ≥75 years of age, caution should be used when treating this population.

Tuberculosis (TB): Patients should be screened for TB before starting on RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of RINVOQ in patients with previously untreated latent TB, or in patients with risk factors for TB infection. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

Viral reactivation: Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with RINVOQ. lf a patient develops herpes zoster, consider interruption of RINVOQ therapy until the episode resolves. If hepatitis B virus DNA is detected while receiving RINVOQ, a liver specialist should be consulted.

Venous thromboembolism: RINVOQ should be used with caution in patients at high risk for deep venous thrombosis (DVT)/pulmonary embolism (PE). lf clinical features of DVT/PE occur, RINVOQ treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation.

Malignancy: Malignancies were observed in clinical studies. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Cardiovascular risk: Patients treated with RINVOQ should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Vaccinations: Use of live, attenuated vaccines during or immediately prior to RINVOQ therapy is not recommended. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement with current immunisation guidelines.

lmmunosuppressive medicinal products: Combination with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, and bDMARDs or other JAK inhibitors has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

Hepatic transaminase elevations: Monitor liver enzymes at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. In such cases therapy should be interrupted until this diagnosis is excluded.

Absolute Neutrophil Count (ANC), Absolute Lymphocyte Count (ALC) and haemoglobin levels: ANC <1 x10⁹ cells/L, ALC <0.5 x 10⁹ cells/L and haemoglobin levels <8 d/dL were reported in ≤1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted in patients with these haematological abnormalities observed during routine patient management.

Lipids: RINVOQ treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.