2023 Meeting Magazine - 25

IMPORTANT SAFETY INFORMATION FOR RINVOQ (upadacitinib)1
SERIOUS INFECTIONS
Patients treated with RINVOQ are at increased risk for developing serious
infections that may lead to hospitalization or death. 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 (TB), which may present with pulmonary or extrapulmonary
disease. Test patients for latent TB before RINVOQ use and during therapy.
Consider treatment for latent TB infection prior to RINVOQ use.
* Invasive fungal infections, including cryptococcosis and pneumocystosis.
* Bacterial, viral, including herpes zoster, and other infections due to
opportunistic pathogens.
Carefully consider the risks and benefits of treatment with RINVOQ prior to
initiating therapy in patients with chronic or recurrent infection. Monitor patients
closely for the development of signs and symptoms of infection during and after
treatment with RINVOQ, including the possible development of TB in patients who
tested negative for latent TB infection prior to initiating therapy.
MORTALITY
In a large, randomized, postmarketing safety study comparing another Janus
kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid
arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk
factor, a higher rate of all-cause mortality, including sudden CV death, was
observed with the JAK inhibitor. Consider the benefits and risks for the individual
patient prior to initiating or continuing therapy with RINVOQ.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated
with RINVOQ.
In a large, randomized, postmarketing safety study comparing another JAK
inhibitor with TNF blockers in RA patients, a higher rate of malignancies
(excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in
current or past smokers) was observed with the JAK inhibitor. Patients who are
current or past smokers are at additional increased risk.
With RINVOQ, consider the benefits and risks for the individual patient prior to
initiating or continuing therapy, particularly in patients with a known malignancy
(other than a successfully treated NMSC), patients who develop a malignancy when
on treatment, and patients who are current or past smokers. NMSCs have been reported
in patients treated with RINVOQ. Periodic skin examination is recommended for patients
who are at increased risk for skin cancer. Advise patients to limit sunlight exposure by
wearing protective clothing and using sunscreen.
MAJOR ADVERSE CARDIOVASCULAR EVENTS
In a large, randomized, postmarketing study comparing another JAK inhibitor
with TNF blockers in RA patients ≥50 years old with at least one CV risk factor,
a higher rate of major adverse cardiovascular events (MACE) (defined as
cardiovascular death, myocardial infarction, and stroke) was observed with
the JAK inhibitor. Patients who are current or past smokers are at additional
increased risk. Discontinue RINVOQ in patients that have experienced a
myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing
therapy with RINVOQ, particularly in patients who are current or past smokers and
patients with other CV risk factors. Patients should be informed about the symptoms of
serious CV events and the steps to take if they occur.
THROMBOSIS
Thrombosis, including deep venous thrombosis, pulmonary embolism, and
arterial thrombosis have occurred in patients treated with JAK inhibitors used to
treat inflammatory conditions. Many of these adverse events were serious and
some resulted in death.
In a large, randomized, postmarketing study comparing another JAK inhibitor to
TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher
rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in patients
at risk. Patients with symptoms of thrombosis should discontinue RINVOQ and be
promptly evaluated.
HYPERSENSITIVITY
RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib
or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis
and angioedema, were reported in patients receiving RINVOQ in clinical trials. If
a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and
institute appropriate therapy.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ.
Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation
(e.g., patients with a history of diverticulitis and patients taking NSAIDs or
corticosteroids). Promptly evaluate patients presenting with new onset abdominal
pain for early identification of GI perforation.
LABORATORY ABNORMALITIES
Neutropenia
Treatment with RINVOQ was associated with an increased incidence of neutropenia
(absolute neutrophil count [ANC] <1000 cells/mm3
recommended in patients with an ANC <1000 cells/mm3
baseline and thereafter according to routine patient management.
). Treatment with RINVOQ is not
. Evaluate neutrophil counts at
Please see Brief Summary of full Prescribing Information on adjacent pages of this advertisement.
© 2023 AbbVie. All rights reserved.
RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-RNQR-230547 September 2023 Printed in U.S.A.
Lymphopenia
Absolute lymphocyte counts (ALC) <500 cells/mm3
were reported in RINVOQ-treated
patients. Treatment with RINVOQ is not recommended in patients with an ALC
<500 cells/mm3
management.
. Evaluate at baseline and thereafter according to routine patient
Anemia
Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ-treated
patients. Treatment should not be initiated or should be interrupted in patients with
hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine
patient management.
Lipids
Treatment with RINVOQ was associated with increases in lipid parameters, including
total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density
lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for
the management of hyperlipidemia. Evaluate patients 12 weeks after initiation of
treatment and thereafter according to the clinical guidelines for hyperlipidemia.
Liver enzyme elevations
Treatment with RINVOQ was associated with increased incidence of liver enzyme
elevation compared to placebo. Evaluate at baseline and thereafter according to
routine patient management. Prompt investigation of the cause of liver enzyme
elevation is recommended to identify potential cases of drug-induced liver injury.
If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
are observed during routine patient management and drug-induced liver injury is
suspected, RINVOQ should be interrupted until this diagnosis is excluded.
EMBRYO-FETAL TOXICITY
Based on findings in animal studies, RINVOQ may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the potential risk
to a fetus. Advise females of reproductive potential to use eff ective contraception
during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy
status of females of reproductive potential prior to starting treatment with RINVOQ.
VACCINATION
Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior
to initiating RINVOQ, patients should be brought up to date on all immunizations,
including varicella zoster or prophylactic herpes zoster vaccinations, in agreement
with current immunization guidelines.
MEDICATION RESIDUE IN STOOL
Reports of medication residue in stool or ostomy output have occurred in patients
taking RINVOQ. Most reports described anatomic or functional GI conditions with
shortened GI transit times. Instruct patients to contact their healthcare provider if
medication residue is observed repeatedly. Monitor patients clinically and consider
alternative treatment if there is an inadequate therapeutic response.
LACTATION
There are no data on the presence of RINVOQ in human milk, the eff ects on the
breastfed infant, or the eff ects on milk production. Available data in animals have
shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not
recommended during treatment with RINVOQ and for 6 days after the last dose.
HEPATIC IMPAIRMENT
RINVOQ is not recommended for use in patients with severe hepatic impairment.
ADVERSE REACTIONS
The most common adverse reactions in RINVOQ clinical trials were upper respiratory
tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia,
acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis,
abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like
illness, elevated liver enzymes, rash, and anemia.
Inform patients that retinal detachment has been reported in clinical trials with
RINVOQ. Advise patients to immediately inform their healthcare provider if they
develop any sudden changes in vision while receiving RINVOQ.
Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30 mg, and 45 mg
extended-release tablets.
References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc; 2023. 2. Data on file,
AbbVie Inc. ABVRRTI74946. 3. Genovese MC, Fleischmann R, Combe B, et al. Safety and e icacy
of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying
anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet.
2018;391(10139):2513-2524. 4. Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic
arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021;80(3):312-320. 5. Data on file,
AbbVie Inc. ABVRRTI75077. 6. Data on file, AbbVie Inc. ABVRRTI75043. 7. Data on file, AbbVie Inc.
ABVRRTI75042. 8. Mease P, McLean RR, Blachley T, et al. Impact of achieving ASDAS LDA on disease
activity and patient-reported outcome measures among patients with ankylosing spondylitis treated
with biologic DMARDs. Poster presented at: The American College of Rheumatology Convergence;
November 5-9, 2021; E-Congress. 9. van der Heijde D, Baraliakos X, Sieper J, et al. E icacy and safety
of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind,
randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022;81(11):1515-1523. doi:10.1136/ard2022-222608
10. Deodhar A, Van den Bosch F, Poddubnyy D, et al. Upadacitinib for the treatment of
active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebocontrolled,
phase 3 trial. Lancet. 2022;400(10349):369-379. doi:10.1016/S0140-6736(22)01212-0

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2023 Meeting Magazine

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