^*For licensed indications in Rheumatology & Gastroenterology, refer to prescribing information on link above
 

Important safety information for RINVOQ^®(upadacitinib) in Atopic Dermatitis.¹

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

RINVOQ should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of Atopic Dermatitis.

Some patients may not be suitable for RINVOQ^® (upadacitinib). You are strongly advised to read the prescribing information, which can be found HERE and at the top of this webpage, safety information which can be found HERE and below, Summary of Product Characteristics (SmPC) and Risk Materials which are available online in the Electronic Medicines Compendium (EMC) from the links below.

RINVOQ Great Britain EMC SmPC & Risk Materials:

15mg: SmPC CLICK HERE & Risk Materials CLICK HERE
30mg: SmPC CLICK HERE & Risk Materials CLICK HERE

RINVOQ Northern Ireland EMC SmPC & Risk Materials:

15mg: SmPC CLICK HERE & Risk Materials CLICK HERE
30mg: SmPC CLICK HERE & Risk Materials CLICK HERE

RINVOQ is contraindicated in patients;

• with hypersensitivity to the active substance or to any of the excipients,
• with active tuberculosis (TB) or active serious infections,
• with severe hepatic impairment,
• who are pregnant.

Cautions (See Prescribing Information and SmPC for full details including screening and monitoring requirements):

RINVOQ should only be used if no suitable treatment alternatives are available in patients;

• 65 years of age or older,
• with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers),
• with malignancy risk factors (e.g., current malignancy or history of malignancy).

RINVOQ is contraindicated in pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of RINVOQ. RINVOQ should not be used during breast feeding. A decision must be made whether to discontinue breast-feeding or to discontinue RINVOQ therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Female adolescent patients and/or their parents/caregivers should be informed about the need to contact the treating healthcare professional once the patient experiences menarche whilst taking RINVOQ.

Concomitant potent immunosuppressive medicines are not recommended. Contraindicated in active serious infections (including tuberculosis). Increased risk of serious infection and viral reactivation (including herpes simplex and zoster reactivation) during treatment. Live attenuated vaccinations during or immediately prior to RINVOQ not recommended. Cautions apply in patients ≥65 years, patients with malignancy risk factors; lymphoma and malignancies (including nonmelanoma skin cancer) have been reported. Haematological abnormalities: do not start, or temporarily interrupt existing therapy if: ANC < 1 x 10⁹ cells/L, ALC < 0.5 x 10⁹ cells/L or haemoglobin < 8 g/dL. Haematological abnormalities have been reported. Caution in patients with risk factors for: gastrointestinal perforation (e.g. diverticular disease, NSAIDs, corticosteroids, opioids); cardiovascular disease/major adverse cardiac events; venous thromboembolism; severe renal and hepatic impairment (not recommended in end-stage renal impairment and to be used with caution and dose adjustments in severe renal impairment, contraindicated in severe hepatic impairment). Hepatic transaminase elevations, increase in lipids including total cholesterol during treatment and hypersensitivity reactions have been reported. Reports of hypoglycaemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycaemia occurs. Dosing adjustment may be required with CYP3A4 inhibitors/inducers (see SmPC), avoid food/drink containing grapefruit.

Dosing in Atopic Dermatitis

The recommended dose of RINVOQ is 15mg or 30mg once daily based on individual patient presentation. The 30mg dose is not recommended for patients 12-17yrs & ≥65yrs and other specific patient groups. The lowest effective dose to maintain response should be used.

Consideration should be given to discontinuing RINVOQ treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment.

30mg once daily is not recommended for AD patients receiving chronic treatment with strong cytochrome P450 (CYP) 3A4 inhibitors. The 30mg dose is not recommended for patients 12-17 yrs & >65 yrs, and other specific patient groups, see SmPC via links above.

Adverse reactions

For adverse reactions, please refer to the prescribing information and the RINVOQ Summary of Product Characteristics available online in the Electronic Medicines Compendium via the links above.