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Rinvoq is a brand name for Upadacitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which upadacitinib is indicated. Posology Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis The recommended dose of upadacitinib 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.
4 Giant cell arteritis The recommended dose of upadacitinib is 15 mg once daily in combination with a tapering course of corticosteroids. 4). Based upon the chronic nature of giant cell arteritis, upadacitinib 15 mg once daily can be continued as monotherapy following discontinuation of corticosteroids.
Treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice. Atopic dermatitis The recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation. 4).
4) or patients with an inadequate response to 15 mg once daily. • In adolescents (12 to 17 years of age) weighing at least 30 kg, a dose of 15 mg is recommended. If the patient does not respond adequately to 15 mg once daily, the dose can be increased to 30 mg once daily.
• The lowest effective dose to maintain response should be used. 4). Concomitant topical therapies Upadacitinib can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used for sensitive areas such as the face, neck, and intertriginous and genital areas.
Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment. Ulcerative colitis Induction The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.
1). Upadacitinib should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. 4). 4) or who do not show adequate therapeutic benefit to 15 mg once daily. • The lowest effective dose to maintain response should be used.
4). In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care. Crohn’s disease Induction The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.
2%). 1%). 2%). 4). The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical studies and post-marketing experience.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100). The frequencies in Table 3 are based on the higher of the rates for adverse reactions reported with RINVOQ in clinical trials of rheumatologic disease (15 mg), atopic dermatitis (15 mg and 30 mg), ulcerative colitis (15 mg, 30 mg and 45 mg), or Crohn’s disease (15 mg, 30 mg, and 45 mg).
When notable differences in frequency were observed between indications, these are presented in the footnotes below the table. Table 3 Adverse reactions System Organ Class Very common Common Uncommon Infections and infestations Upper respiratory tract infections (URTI)a Bronchitisa,b Herpes zostera Herpes simplexa Folliculitis Influenza Urinary tract infection Pneumoniaa,h Oral candidiasis Diverticulitis Sepsis Neoplasms benign, malignant and unspecified (including cysts and polyps) Non-melanoma skin cancerf Blood and lymphatic system disorders Anaemiaa Neutropeniaa Lymphopenia Immune system disorders Urticariac,g Serious hypersensitivity reactionsa,e Metabolism and nutrition disorders Hypercholesterolaemiaa,b Hyperlipidaemiaa,b Hypertriglyceridaemia Nervous system disorders Headachea,j Dizziness Ear and labyrinth disorders Vertigoa Respiratory, thoracic and mediastinal disorders Cough 15 Gastrointestinal disorders Abdominal paina Nausea Gastrointestinal perforationi Skin and subcutaneous tissue disorders Acnea,c,d,g Rasha General disorders and administration site conditions Fatigue Pyrexia Peripheral oedemaa,k Investigations Blood CPK increased ALT increasedb AST increasedb Weight increasedg a Presented as grouped term b In atopic dermatitis trials, the frequency of bronchitis, hypercholesterolaemia, hyperlipidaemia, ALT increased, and AST increased was uncommon.
g. current malignancy or history of malignancy) 8 Use in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), upadacitinib should only be used in these patients if no suitable treatment alternatives are available.
In patients 65 years of age and older, there is an increased risk of adverse reactions with upadacitinib 30 mg once daily. 8). Immunosuppressive medicinal products Combination with other potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin, 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.
Serious infections Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. 8) and cellulitis. Cases of bacterial meningitis and sepsis have been reported in patients receiving upadacitinib. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
3). Consider the risks and benefits of treatment prior to initiating upadacitinib in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or • with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection.
A patient who develops a new infection during treatment with upadacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to antimicrobial therapy.
1. 4). 2). 6).
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For patients who have not achieved adequate therapeutic benefit after the initial 12-week induction, prolonged induction for an additional 12 weeks with a dose of 30 mg once daily may be considered. For these patients, upadacitinib should be discontinued if there is no evidence of therapeutic benefit after 24 weeks of treatment.
4). 4) or who do not show adequate therapeutic benefit to 15 mg once daily. • The lowest effective dose to maintain response should be used. 4). In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
5). 8). Dose interruption Treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
6 Table 1 Laboratory measures and monitoring guidance Laboratory measure Action Monitoring guidance Absolute Neutrophil Count (ANC) Treatment should be interrupted if ANC is < 1 x 109 cells/L and may be restarted once ANC returns above this value Evaluate at baseline and then no later than 12 weeks after initiation of treatment.
Thereafter evaluate according to individual […]
c In rheumatologic disease trials, the frequency was common for acne and uncommon for urticaria. d In ulcerative colitis trials, the frequency was common for acne. e Serious hypersensitivity reactions including anaphylactic reaction and angioedema f Most events reported as basal cell carcinoma and squamous cell carcinoma of skin g In Crohn’s disease, the frequency was common for acne, and uncommon for urticaria and weight increased.
h Pneumonia was common in Crohn’s disease and uncommon across other indications. i Frequency is based on Crohn’s disease clinical trials. j Headache was very common in the giant cell arteritis trial. k Frequency is based on the giant cell arteritis trial.
9% in the placebo group. 0% in the MTX group. 7 events per 100 patient-years. 6% in the placebo group. 4% in the MTX group. 8 events per 100 patient-years. The most common serious infection was pneumonia. The rate of serious infections remained stable with long-term exposure.
Opportunistic infections (excluding tuberculosis) In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic […]
Upadacitinib therapy may be resumed once the infection is controlled. A higher rate of serious infections was observed with upadacitinib 30 mg compared to upadacitinib 15 mg. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes.
2). 9 Tuberculosis Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy. 3). Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Patients should be monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
8). The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib. If a patient develops herpes zoster, interruption of upadacitinib therapy should be considered until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical studies. Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical studies.
If hepatitis B virus DNA is detected while receiving upadacitinib, a liver specialist should be consulted. Vaccination No data are available on the response to vaccination with live vaccines in patients receiving upadacitinib. Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended.
1). Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including upadacitinib. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors.
A higher rate of malignancies […]