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RINVOQ is a brand name for Upadacitinib, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). RINVOQ (upadacitinib) Page 17 of 108 Immune RINVOQ should not be used concomitantly with other potent immunosuppressants. Concomitant use of RINVOQ with other potent immunosuppressants (such as azathioprine, cyclosporine, tacrolimus), biologic DMARDs, or other JAK inhibitors has not been evaluated in clinical studies.
2 Drug Interactions Overview). Immunizations No data are available on the response to vaccination with live vaccines in patients receiving RINVOQ. Live or attenuated vaccines should not be used immediately prior to or during RINVOQ therapy.
The interval between live vaccinations and initiation of RINVOQ therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Prior to initiating RINVOQ treatment, it is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.
2 Pharmacodynamics). 2 Pharmacodynamics).
Infections Serious Infections:
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. 2 Clinical Trial Adverse Reactions). Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis were reported with RINVOQ.
A higher rate of serious infections was observed with RINVOQ 30 mg compared to RINVOQ 15 mg. RINVOQ should not be initiated in patients with active infections including chronic or localized infections. Consider the risks and benefits of treatment prior to initiating RINVOQ 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 traveled in areas of endemic tuberculosis or endemic mycoses; or • With underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ. Interrupt RINVOQ if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with RINVOQ 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 RINVOQ should be interrupted if the patient is not responding to antimicrobial therapy.
Do not resume RINVOQ treatment until the infection is controlled.
Tuberculosis:
Patients should be screened for tuberculosis (TB) before starting RINVOQ therapy. RINVOQ should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of RINVOQ in patients with previously untreated latent TB or active TB in whom an adequate RINVOQ (upadacitinib) Page 18 of 108 course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
). 1.
Pediatrics Pediatrics (< 18 years of age):
The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis or Crohn’s disease have not yet been established.
3 Pharmacokinetics). , steroid or biologic) or when use of those therapies is inadvisable. The safety and efficacy of RINVOQ in adolescents weighing < 40 kg and in children aged 0 to less than 12 years with atopic dermatitis have not yet been established.
3 Pharmacokinetics). 2.
Geriatrics Geriatrics (≥ 65 years of age):
Caution should be used when treating geriatric patients with RINVOQ. There are limited data in patients 75 years of age and older. 3 Pharmacokinetics). 2. Contraindications RINVOQ is contraindicated in patients who are hypersensitive to upadacitinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. RINVOQ (upadacitinib) Page 7 of 108 3. 2 Clinical Trial Adverse Reactions). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt RINVOQ until the infection is controlled. Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy.
Treatment for latent infection should be considered prior to RINVOQ use. • Invasive fungal infections, including cryptococcosis and pneumocystosis. • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
2 Clinical Trial Adverse Reactions). If a patient develops herpes zoster, consider temporarily interrupting RINVOQ until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ.
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.
However, cases of hepatitis B reactivation were still reported in patients enrolled in the clinical studies of RINVOQ. If hepatitis B virus DNA is detected while receiving RINVOQ, a liver specialist should be consulted.
Monitoring and Laboratory Tests Hematology:
Lymphocyte counts, neutrophil counts, and hemoglobin should be evaluated before initiating RINVOQ treatment and thereafter according to routine patient management. 2 Recommended Dose and Dosage Adjustment and 7 WARNINGS AND PRECAUTIONS).
Lipids:
Assessment of lipid parameters should be performed at baseline, 12 weeks after initiation of RINVOQ treatment and thereafter according to the clinical guidelines for hyperlipidemia. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
Liver Enzyme Elevations:
Liver enzymes should be evaluated before initiating RINVOQ treatment and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to […]
Treatment with RINVOQ should not be initiated in patients with active infections including chronic or localized infections. The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy (see 7 WARNINGS AND PRECAUTIONS).
MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with RINVOQ. An increase in malignancies, including lung cancer, were observed in rheumatoid arthritis (RA) patients 50 years or older with at least one additional cardiovascular (CV) risk factor who were taking a different JAK inhibitor, compared with tumour necrosis factor (TNF) inhibitors.
Caution should be applied when using RINVOQ in geriatric patients, patients who are current or past smokers, and patients with other malignancy risk factors (see 7 WARNINGS AND PRECAUTIONS). THROMBOSIS Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors, including RINVOQ, for inflammatory conditions.
Many of these adverse events were serious and some resulted in death. RA patients 50 years or older with at least one additional CV risk factor had a higher rate of all-cause mortality and thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis in a clinical trial with a different JAK inhibitor compared to TNF inhibitors.
Consider the risks and benefits prior to treating patients who may be at increased risk for thrombosis. Discontinue RINVOQ and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS AND PRECAUTIONS). MAJOR ADVERSE CARDIOVASCULAR EVENTS Major adverse cardiovascular events, including non-fatal myocardial infarction, were observed more frequently in RA patients 50 years or older with at least one additional CV risk factor in a clinical trial with a different JAK inhibitor compared to TNF inhibitors.
Caution should be applied when using RINVOQ in geriatric patients, patients who are current or past smokers, and patients with other CV risk factors (see 7 WARNINGS AND PRECAUTIONS). RINVOQ (upadacitinib) Page 8 of 108 4. 1. Dosing Considerations • RINVOQ should not be initiated in patients with active infections including chronic or localized infections (see 7 WARNINGS AND PRECAUTIONS).
5 x 109 cells/L, absolute neutrophil count (ANC) less than 1 x 109 cells/L, or hemoglobin level less than 80 g/L (see 7 WARNINGS AND PRECAUTIONS). 3 Pharmacokinetics). • RINVOQ should not be used concomitantly with other potent systemic […]