NORTH CHICAGO, Ill.,
Dec. 3, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced an update to the U.S. Prescribing
Information and Medication Guide for RINVOQ®
(upadacitinib) for the treatment of adults with moderate to severe
rheumatoid arthritis (RA). This update follows a Drug Safety
Communication (DSC) issued on Sept. 1,
2021 by the U.S. Food and Drug Administration (FDA)
following its final review of the post-marketing study, ORAL
Surveillance, evaluating XELJANZ® (tofacitinib) in
patients with RA.1 The results of this study showed a
higher rate of major adverse cardiac events (MACE), malignancy,
mortality and thrombosis in XELJANZ (a Janus kinase (JAK)
inhibitor) versus TNF blockers.1 The DSC and this label
update apply to the class of systemically administered FDA-approved
JAKs indicated for the treatment of RA and other inflammatory
diseases.1
Based on this class-wide update, the U.S. label for RINVOQ will
now include additional information about the risks of malignancy
and thrombosis, and the addition of mortality and MACE (defined as
cardiovascular death, myocardial infarction and stroke) risks
within the Boxed Warnings and Warnings and Precautions
sections.1 The indication has also been updated to
the following: RINVOQ is indicated for the treatment of adults with
moderately to severely active rheumatoid arthritis who have had an
inadequate response or intolerance to one or more TNF
blockers.1
"RINVOQ is an important treatment option for people living with
rheumatoid arthritis, especially those who have not been able to
achieve remission or low disease activity. We remain committed to
continue generating evidence that support its benefit-risk
profile across many inflammatory conditions," said Michael Severino, M.D., vice chairman and
president, AbbVie.
Supplemental New Drug Applications (sNDAs) for upadacitinib
(RINVOQ) in atopic dermatitis, psoriatic arthritis, ankylosing
spondylitis and ulcerative colitis remain under review by the
FDA.
About RINVOQ® (upadacitinib)
Discovered and
developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor
that is being studied in several immune-mediated inflammatory
diseases. Based on enzymatic and cellular assays, RINVOQ
demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3,
and TYK-2.2 The relevance of inhibition of specific JAK
enzymes to therapeutic effectiveness is not currently
known. RINVOQ 15 mg is approved by the U.S. Food and Drug
Administration (FDA) for adults with moderately to severely active
rheumatoid arthritis who have had an inadequate response or
intolerance to one or more TNF blockers. RINVOQ 15 mg is also
approved by the European Commission for adults with moderate to
severe active rheumatoid arthritis, adults with active psoriatic
arthritis and adults with active ankylosing
spondylitis. RINVOQ is approved by the European Commission for
adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to
severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid
arthritis, atopic dermatitis, psoriatic arthritis, axial
spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell
arteritis and Takayasu arteritis are ongoing.3-10
Important Safety Information about RINVOQ®
(upadacitinib)
RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat moderate to severe
rheumatoid arthritis in adults when one or more tumor necrosis
factor (TNF) blockers have been used and did not work well or could
not be tolerated. It is not known if RINVOQ is safe and effective
in children under 18 years of age.
What is the most important information I should know about
RINVOQ?
RINVOQ may cause serious side effects,
including:
- Serious infections. RINVOQ can lower the ability of your
immune system to fight infections. Some people have had serious
infections while taking RINVOQ, including tuberculosis (TB) and
infections caused by bacteria, fungi, or viruses that can spread
throughout the body. Some people have died from these infections.
Your healthcare provider (HCP) should test you for TB before
starting RINVOQ and check you closely for signs and symptoms of TB
during treatment with RINVOQ. You should not start taking RINVOQ if
you have any kind of infection unless your HCP tells you it is
okay. You may be at higher risk of developing shingles (herpes
zoster).
- Increased risk of death in people 50 years and older who
have at least 1 heart disease (cardiovascular) risk
factor.
- Cancer and immune system problems. Lymphoma and other
cancers, including skin and lung cancers, can happen. People taking
RINVOQ have a higher risk of certain cancers, including lymphoma
and lung cancer, especially if you are a current or past
smoker.
- Increased risk of major cardiovascular (CV) events such as
heart attack, stroke, or death in people 50 years and older who
have at least 1 heart disease (CV) risk factor, especially if you
are a current or past smoker.
- Blood Clots. Blood clots in the veins of the legs or
lungs and arteries can happen in some people taking RINVOQ. This
may be life-threatening and cause death. Blood clots in the veins
of the legs and lungs have happened more often in people who are 50
years and older and with at least 1 heart disease (CV) risk
factor.
- Tears in the stomach or intestines and changes in certain
laboratory tests can happen. Your HCP should do blood tests before
you start taking RINVOQ and while you take it. Your HCP may stop
your RINVOQ treatment for a period of time if needed because of
changes in these blood test results.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that
won't go away or keeps coming back, or have symptoms of an
infection such as:
̶
Fever, sweating, or chills
̶
Shortness of breath
̶
Warm, red, or painful skin or sores on your body
|
̶
Muscle aches
̶
Feeling tired
̶
Blood in phlegm
̶
Diarrhea or stomach pain
|
̶
Cough
̶
Weight loss
̶
Burning when urinating or urinating more often than
normal
|
- Have TB or have been in close contact with someone with
TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), or blood clots in the veins of your legs or lungs,
diverticulitis (inflammation in parts of the large intestine), or
ulcers in your stomach or intestines.
- Have other medical conditions including liver problems, low
blood cell counts, diabetes, chronic lung disease, HIV, or a weak
immune system.
- Live, have lived, or have traveled to parts of the country that
increase your risk of getting certain kinds of fungal infections,
such as the Ohio and Mississippi
River valleys and the Southwest. If you are unsure if you've been
to these areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine.
People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on animal
studies, RINVOQ may harm your unborn baby. Your HCP will check
whether or not you are pregnant before you start RINVOQ. You should
use effective birth control (contraception) to avoid becoming
pregnant while taking RINVOQ and for at least 4 weeks after your
last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. You should not breastfeed while taking RINVOQ and
for at least 6 days after your last dose.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. RINVOQ and other medicines may affect each other,
causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
Ask your HCP or pharmacist if you are not sure if you are taking
any of these medicines.
What should I do or tell my HCP AFTER starting
RINVOQ?
- Tell your HCP right away if you have any symptoms of an
infection. RINVOQ can make you more likely to get infections or
make any infections you have worse.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while taking RINVOQ, including:
-
- discomfort in the center of your chest that lasts for more than
a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your HCP right away if you have any signs or symptoms of
blood clots during treatment with RINVOQ, including:
– Swelling
– Pain or tenderness
in the leg
|
– Sudden unexplained chest pain
– Shortness of breath
|
- Tell your HCP right away if you have a fever or stomach-area
pain that does not go away, and a change in your bowel habits.
What are the common side effects of RINVOQ?
These
include upper respiratory tract infections (common cold, sinus
infections), nausea, cough, and fever. These are not all the
possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day
with or without food. RINVOQ is available in 15 mg extended-release
tablets. Do not split, break, crush, or chew the tablet. Take
RINVOQ exactly as your HCP tells you to use it.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Rheumatology
For more than 20 years,
AbbVie has been dedicated to improving care for people living with
rheumatic diseases. Our longstanding commitment to discovering and
delivering transformative therapies is underscored by our pursuit
of cutting-edge science that improves our understanding of
promising new pathways and targets in order to help more people
living with rheumatic diseases reach their treatment goals. For
more information on AbbVie in rheumatology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us
at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2020 Annual Report on Form 10-K, which
has been filed with the Securities and Exchange Commission, as
updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments, except as required by law.
References:
1. FDA requires warnings about increased risk of serious
heart-related events, cancer, blood clots, and death for JAK
inhibitors that treat certain chronic inflammatory conditions.
FDA.gov. 2021. Available at
https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death.
Accessed: November 2021.
2. RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
3. Burmester G.R., et al. Safety and efficacy of upadacitinib in
patients with rheumatoid arthritis and inadequate response to
conventional synthetic disease-modifying anti-rheumatic drugs
(SELECT-NEXT): a randomised, double-blind, placebo-controlled phase
3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
4. A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed: November 2021.
5. A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
Disease Who Have Inadequately Responded to or Are Intolerant to
Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02365649.
Accessed: November 2021.
6. A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03725202.
Accessed: November 2021.
7. A Study Comparing Upadacitinib (ABT-494) to Placebo in
Participants With Active Psoriatic Arthritis Who Have a History of
Inadequate Response to at Least One Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104374.
Accessed: November 2021.
8. A Study to Compare Safety and Efficacy of Upadacitinib to
Dupilumab in Adult Participants With Moderate to Severe Atopic
Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03738397.
Accessed: November 2021.
9. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult
Participants With Axial Spondyloarthritis (SELECT AXIS 2).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT04169373.
Accessed: November 2021.
10. A Study to Evaluate the Efficacy and Safety of Upadacitinib in
Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov.
2020. Available
at https://clinicaltrials.gov/ct2/show/record/NCT04161898.
Accessed: November 2021.
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