Key safety considerations for RINVOQ1
WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
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.
Do not use live, attenuated vaccines during, or immediately prior to RINVOQ treatment.
Thrombosis – DVT and PE
Events of thrombosis (including DVT, PE, arterial thrombosis) have occurred. Avoid RINVOQ 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.
Pregnancy and breastfeeding
RINVOQ should not be used during pregnancy (category D) or during breastfeeding.
Major adverse cardiovascular events
Events of MACE were observed in clinical studies of RINVOQ.
Monitor for lipid elevation and manage according to guidelines.
Malignancy and NMSC
Lymphoma, other malignancies and NMSCs have been reported in patients treated with RINVOQ. A higher rate of malignancies, driven by NMSC was observed with RINVOQ 30 mg compared to RINVOQ 15 mg.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
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 15 mg once daily.
GI perforation
RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation.
Mortality
In a large, randomised, post-marketing safety study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years of age and older with at least one additional cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with tofacitinib compared to TNF inhibitors. Mortality was mainly due to cardiovascular events, infections and malignancies.
Refer to the Product Information for full safety information, initiation assessments, monitoring, drug interactions and dosing recommendations.
2 TRIALS IN UC: Consisting of 3 Phase 3 studies: U‑ACHIEVE Induction U‑ACCOMPLISH (Induction); and U‑ACHIEVE Maintenance
8 TRIALS IN RA: SELECT‑EARLY, SELECT‑NEXT, SELECT‑COMPARE, SELECT‑MONOTHERAPY, SELECT‑BEYOND, SELECT‑CHOICE, SELECT‑SUNRISE, SELECT‑CHINA
2 TRIALS IN PsA: SELECT‑PsA 1, SELECT‑PsA 2
2 TRIALS IN AS: SELECT-AXIS 1, SELECT-AXIS 2 (Study 1)
5 TRIALS IN AD: RISING‑UP, MEASURE‑UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP
1 TRIAL IN NON-RADIOGRAPHIC AS: SELECT-AXIS 2 (Study 2)
Overview of AE rates per 100 PYs with RINVOQ 15 mg and 30 mg
Objective: This assessment reviewed safety data for RINVOQ maintenance therapy in UC in the context of the known long-term safety profile of RINVOQ in its approved indications.
Table adapted from Colombel et al. 2022; only approved RINVOQ doses are shown here.
*Patients who were RINVOQ 45 mg QD 8-week induction responders and were enrolled into maintenance treatment for 52 weeks. †Includes two Phase 3 studies; includes adults and adolescents. ‡Includes six Phase 3 studies; may include patients receiving concomitant methotrexate. §Includes two Phase 3 studies.
Results cannot be compared between studies.
With RINVOQ maintenance treatment in UC through 52 weeks
AEs of special interest were pre-specified based on previous studies with RINVOQ or other JAK inhibitors, eg, serious infection, herpes zoster, malignancy, MACEs and VTEs. MACEs and VTEs were adjudicated by an independent external adjudication committee.
*Patients who were RINVOQ 45 mg QD 8-week induction responders and were enrolled under the protocol for 52 weeks maintenance treatment. †Defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. ‡Defined as deep vein thrombosis and pulmonary embolism (fatal and non-fatal).
REFERENCES
- RINVOQ Product Information.
- Danese S et al. Lancet 2022;399(10341):2113–28
- Colombel JF et al. ECCO 2022, 16–19 February 2022, P573. In: J Crohns Colitis 2022;16(Suppl 1):514.
- Deodhar A et al. Arthritis Rheumatol 2022;74(1):70–80.
- Van der Heijde D, et al. Ann Rheum Dis 2022;0:1–9. doi:10.1136/annrheumdis-2022-222608.
- Kameda H et al. Rheumatology (Oxford) 2020;59(11):3303–13
- Zeng X et al. Int J Rheum Dis 2021;24(12):1530–9.
- Rubbert-Roth A et al. N Engl J Med 2020;383(16):1511–21.
WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients: Refer to Product Information. |
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-220272. August 2023