Important safety information for RINVOQ®⯆ (upadacitinib)
CLICK HERE for RINVOQ prescribing information.
RINVOQ should be initiated and supervised by Healthcare Professionals experienced in the diagnosis and treatment of conditions for which RINVOQ is licensed.
Some patients may not be suitable for RINVOQ®⯆ (upadacitinib). You are strongly advised to read the prescribing information, which can be found CLICK HERE , safety information 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
45mg: 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
45mg: 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. For indication(s) licensed in adolescents, 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 non-melanoma 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. RINVOQ dosing adjustment may be required with CYP3A4 inhibitors/inducers (see SmPC), avoid food/drink containing grapefruit.
Adverse reactions
For adverse reactions, please refer to the prescribing information and the RINVOQ SmPC available online in the EMC.
Atopic Dermatitis
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.
Dosing in Atopic Dermatitis
Adults
The recommended dose of RINVOQ is 15 mg or 30 mg once daily based on individual patient presentation.
- A dose of 15 mg is recommended for patients at higher risk of VTE, MACE and malignancy.
- A dose of 30 mg once daily may be appropriate for patients with high disease burden who are not at higher risk of VTE, MACE and malignancy or patients with an inadequate response to 15 mg once daily.
- The lowest effective dose to maintain response should be used.
For patients ≥65 years of age, the recommended dose is 15 mg once daily.
Adolescents (from 12 to 17 years of age)
The recommended dose of RINVOQ is 15 mg once daily for adolescents weighing ≥30 kg.
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.
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthrits
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Dosing in Rheumatological Conditions
Rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS)
The recommended dose of RINVOQ is 15 mg once daily.
Consideration should be given to discontinuing treatment in patients with axial spondyloarthritis who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Dosing in Ulcerative colitis
Induction
The recommended induction dose of RINVOQ is 45 mg once daily for 8 weeks. For patients who do not achieve adequate therapeutic benefit by week 8, RINVOQ 45 mg once daily may be continued for an additional 8 weeks. RINVOQ should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Maintenance
The recommended maintenance dose of RINVOQ is 15 mg or 30 mg once daily based on individual patient presentation:
- A dose of 15 mg is recommended for patients at higher risk of VTE, MACE and malignancy.
- A dose of 30 mg once daily may be appropriate for some patients, such as those with high disease burden or requiring 16 week induction treatment who are not at higher risk of VTE, MACE and malignancy or who do not show adequate therapeutic benefit to 15 mg once daily.
- The lowest effective dose to maintain response should be used.
For patients ≥65 years of age, the recommended dose is 15 mg once daily. Patients receiving strong inhibitors of CYP 3A4 the recommended induction dose is 30mg once daily and maintenance dose is 15 mg once daily.
Crohn’s disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Dosing in Crohn’s disease
Induction
The recommended induction dose of RINVOQ is 45 mg once daily for 12 weeks.
Maintenance
The recommended maintenance dose of RINVOQ is 15 mg or 30 mg once daily based on individual patient presentation:
- A dose of 15 mg is recommended for patients at higher risk of VTE, MACE and malignancy.
- A dose of 30 mg once daily may be appropriate for patients with high disease burden who are not at higher risk of VTE, MACE and malignancy or who do not show adequate therapeutic benefit to 15 mg once daily.
- A dose of 30 mg once daily may be appropriate for patients who have not achieved adequate therapeutic benefit after the initial 12-week induction. For these patients, RINVOQ should be discontinued if there is no evidence of therapeutic benefit after 24 weeks of treatment.
- The lowest effective dose to maintain response should be used.
For patients ≥65 years of age, the recommended dose is 15 mg once daily. Patients receiving strong inhibitors of CYP 3A4 the recommended induction dose is 30mg once daily and maintenance dose is 15 mg once daily.
UK-UPAD-230138. Date of preparation: January 2024
