A selective JAK inhibitor with safety experience in 7 indications1
Safety profile established in 22 Phase 3 RINVOQ trials1-6
>17,500
PATIENT-YEARS SAFETY EXPERIENCE
ACROSS ALL INDICIATIONS1
| 22 | PHASE 3 TRIALS1-6 |
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.
Major adverse cardiovascular events (MACE)
Events of MACE were observed in clinical studies of RINVOQ. Events, including myocardial infarction, were more common in older patients and in patients who were current or past smokers. Monitor for lipid elevation and manage according to guidelines.
Pregnancy and breastfeeding
RINVOQ should not be used during pregnancy (category D) or during breastfeeding.
Vaccination
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.
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.
Immunosuppressive medicinal products
Combination with other potent immunosuppressants such as azathioprine, cyclosporin, tacrolimus, and biologic DMARDs or other JAK inhibitors has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.
Viral reactivation
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) and hepatitis B virus reactivation, were reported in clinical studies. If a patient develops herpes zoster, consider temporarily interrupting RINVOQ until the episode resolves. Screen for viral hepatitis and monitoring for reactivation before starting and during therapy with RINVOQ. If hepatitis B virus DNA is detected while receiving RINVOQ, consult a liver specialist.
Refer to full Product Information for additional considerations for use of RINVOQ in your patients.
RINVOQ's Phase 3 clinical trials
3 TRIALS IN CD: Consisting of 2 induction studies followed by a maintenance treatment and long-term extension study: U-EXCEL, U-EXCEED, U-ENDURE
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
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)
REFERENCES
- RINVOQ Product Information.
- 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.
- Katoh N, et al. Dermatol Ther (Heidelb). 2023;13(1):221–34.
- Blauvelt A, et al. JAMA Dermatol. 2021;157(9):1047–55.
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-RNQG-240035. March 2024