-- AbbVie to present 30 abstracts demonstrating its
leadership in neuroscience, including continued migraine treatment
research across the spectrum of the disease, commitment to patients
with advanced Parkinson's disease, and new studies in spasticity
and cervical dystonia
NORTH
CHICAGO, Ill., March 29,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that data from its neuroscience portfolio will be
presented at the 2022 American Academy of Neurology (AAN) Annual
Meeting, to be held in Seattle
from April 2-7, and virtually April
24-26.
The data, which include an updated analysis of AbbVie's newest
migraine medicine atogepant (QULIPTA™) along with other
results from across its migraine portfolio, underscore the
company's dedication to developing and delivering treatments that
will make a meaningful difference to people living with migraine.
Additional study results focus on data on a new treatment modality
for advanced Parkinson's disease as well as new research on
carbidopa/levodopa enteral suspension (DUOPA®). New data
on onabotulinumtoxinA (BOTOX®) for the treatment of
spasticity and cervical dystonia will also be presented.
"AbbVie's strong presence at AAN reaffirms our unwavering
commitment to preserving personhood for people affected by
neurological disorders," said Michael
Gold, M.D., Therapeutic Area Head, Neuroscience Development,
AbbVie. "We're particularly excited about developments and advances
across the full spectrum of migraine that demonstrate our
innovation and commitment to improving the lives of people with
migraine."
Investigators will present data from multiple studies on
migraine, including real-world patient-reported outcomes on the
effectiveness of ubrogepant (UBRELVY®) in those also
taking a calcitonin gene-related peptide (CGRP) monoclonal antibody
(mAb); a post-hoc analysis that reports the significant magnitude
of monthly migraine day reduction in responders to atogepant; and
real-world data showing persistence and costs in patients treated
with onabotulinumtoxinA or a CGRP mAb.
Researchers will also present six-month interim results from a
Phase 3 study on the safety and efficacy of
foscarbidopa/foslevodopa (ABBV-951), a levodopa/carbidopa pro-drug
administered as a 24-hour continuous, subcutaneous infusion being
studied for the treatment of people with advanced Parkinson's
disease who are not well controlled on oral medications.
AbbVie abstracts and presentation details for the 2022 AAN
Annual Meeting program are outlined below. Posters will be
available during and for 30 days following the meeting.
Abstract
Title
|
Presentation
Details
All times
PST
|
Migraine
|
Atogepant – an
orally-administered CGRP antagonist – attenuates activation of
meningeal nociceptors by Cortical Spreading Depression
(CSD)
|
Oral Presentation
(#003)
Wednesday, April
6
3:54 PM
|
Impact of Monthly
Headache Days on Migraine-Related Quality of Life: Results from the
CaMEO Study
|
Oral Presentation
(#002)
Sunday, April
3
1:12 PM
|
Monthly Migraine Days,
Acute Medication Use Days, and Migraine-Specific Quality of Life in
Responders to Atogepant: A Post Hoc Analysis
|
Oral Presentation
(#008)
Wednesday, April
6
4:54 PM
|
Characterizing
Pre-headache (Prodrome) Features of Migraine Attacks: Results from
the CaMEO Study
|
Oral Presentation
(#004)
Sunday, April
3
1:36 PM
|
Relative Frequency,
Healthcare Resource Utilization, and Costs of Diagnosed
Drug-Induced Headache and Potential Acute Medication Overuse in
Patients with Migraine
|
Oral Presentation
(#009)
Sunday, April
3
2:36 PM
|
Within-Person Analysis
of Ubrogepant Treatment of Mild Versus Moderate-Severe Headache
Pain during a Phase 3 Long-Term Safety Extension Trial
|
Oral Presentation
(#006)
Wednesday, April
6
4:30 PM
|
Evaluation of the
Pharmacokinetic Interaction and Safety of Coadministered Atogepant
and Topiramate
|
Poster
(#004)
Saturday, April
2
11:45 AM – 12:45
PM
|
Evaluation of the
Long-Term Safety and Tolerability of Oral Atogepant 60 Mg Once
Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week,
Multicenter Extension to the ADVANCE Trial
|
Poster
(#001)
Saturday, April
2
5:30 PM – 6:30
PM
|
Post-hoc Analysis of
Safety in Phase 3 Atogepant ADVANCE Trial Participants with or
without Cardiovascular Disease Risk Factors
|
Poster
(#005)
Saturday, April
2
11:45 AM – 12:45
PM
|
Atogepant 60 mg
Once-Daily Shows Efficacy for the Preventive Treatment of Migraine:
Results from a 52-Week Open-Label Extension Trial
|
Poster
(#001)
Saturday, April
2
8:00 AM – 9:00
AM
|
Decrease in Body Weight
with Once-Daily Atogepant for the Preventive Treatment of Migraine:
A Post Hoc Analysis
|
Poster
(#002)
Saturday, April
2
8:00 AM – 9:00
AM
|
Real-World Persistence
and Costs Among Patients with Chronic Migraine Treated with
OnabotulinumtoxinA or CGRP mAbs: A Retrospective Claims Analysis
Study
|
Poster
(#004)
Tuesday, April
5
8:00 AM – 9:00
AM
|
PREDICT preempt
fixed-dose, fixed site and follow the pain
|
Poster
(#003)
Wednesday, April
6
11:45 AM – 12:45
PM
|
Treatment Satisfaction
and Optimization with Real-World Use of Ubrogepant for the Acute
Treatment of Migraine in Combination with an Anti-Calcitonin
Gene–Related Peptide Monoclonal Antibody Preventive: Results from
the COURAGE Study
|
Poster
(#001)
Tuesday, April
5
8:00 AM – 9:00
AM
|
Within-Person
Consistency of Acute Treatment Success with Ubrogepant: Results
from a Long-term Safety Study
|
Poster
(#003)
Tuesday, April
5
11:45 AM – 12:45
PM
|
Real-World
Effectiveness of Ubrogepant for the Acute Treatment of Migraine
When Used in Combination with an Anti-Calcitonin Gene–Related
Peptide Monoclonal Antibody Preventive: Results from the COURAGE
Study
|
Poster
(#003)
Tuesday, April
5
8:00 AM – 9:00
AM
|
Real-World
Effectiveness of Ubrogepant Among Participants with Prior Treatment
Failure: Subgroup Analysis from the UNIVERSE Study
|
Poster
(#001)
Tuesday, April
5
5:30 PM – 6:30
PM
|
A Novel Approach to
Defining Success in the Acute Treatment of Migraine: Demonstrating
Therapeutic Benefit at 1-Hour Post-Dose in the Pooled ACHIEVE I and
ACHIEVE II Trials
|
Poster
(#002)
Wednesday, April
6
11:45 AM – 12:45
PM
|
Advanced Parkinson's
Disease
|
The clinical and
humanistic value of "good on-time" among patients with advanced
Parkinson's disease: A real-world study from 7 countries
|
Poster
(#005)
Monday, April
4
8:00 AM – 9:00
AM
|
Safety and Efficacy of
24-Hour/Day Subcutaneous Infusion of Foslevodopa/Foscarbidopa in
Advanced Parkinson's Disease During a Phase 3 Study: 6-Month
Interim Results
|
Oral Presentation
(#009)
Monday, April 4
5:06 PM
|
Real-world Effect of
Age on Long-term Effectiveness and Safety of Levodopa-Carbidopa
Intestinal Gel: A Post Hoc Analysis from the Prospective,
Multinational, Observational DUOGLOBE Study
|
Poster
(#007)
Monday, April
4
5:30 PM – 6:30
PM
|
Long-term Motor and
Non-Motor Symptom Benefits in Patients with Advanced Parkinson's
Disease Treated with Levodopa-Carbidopa Intestinal Gel by Baseline
Hoehn & Yahr Stage: Analysis of the DUOGLOBE Study
|
Poster
April 24-26
Virtual
|
Long-term Motor and
Non-Motor Symptom Benefits in Patients with Advanced Parkinson's
Disease Treated With Levodopa-Carbidopa Intestinal Gel: Final
Analysis of the 36-Month DUOGLOBE Real-world Multinational
Observational Study
|
Poster
April 24-26
Virtual
|
Spasticity
|
Neutralizing Antibody
Conversion with OnabotulinumtoxinA from Global Studies Across
Multiple Indications in nearly 30,000 Patient Records: A
Meta-Analysis
|
Oral Presentation
(#010)
Sunday, April
3
5:18 PM
|
Healthcare Resource
Utilization and Costs Among Patients with Stroke-related Spasticity
Before and After Treatment with OnabotulinumtoxinA
|
Poster
(#006)
Thursday, April
7
8:00 AM – 9:00
AM
|
Real-world botulinum
toxin type A treatment patterns in patients with
spasticity
|
Poster
(#004)
Thursday, April
7
11:45 AM – 12:45
PM
|
A Virtual Reality
Platform to Facilitate Training on Treatment of Lower Limb
Spasticity with OnabotulinumtoxinA
|
Oral Presentation
(#003)
Wednesday, April
6
3:54 PM
|
Cervical
Dystonia
|
Impact of Disease
Severity on Presentation Subtype and OnabotulinumtoxinA Utilization
in Patients with Cervical Dystonia: Results from the CD PROBE
Completer Population
|
Poster
(#006)
Thursday, April
7
11:45 AM – 12:45
PM
|
Current perspectives on
the management of cervical dystonia among global
clinicians
|
Poster
(#007)
Thursday, April
7
11:45 AM – 12:45
PM
|
Real-world botulinum
toxin type A treatment patterns in patients with cervical
dystonia
|
Poster
(#005)
Thursday, April
7
11:45 AM – 12:45
PM
|
A full list of all 30 AbbVie abstracts accepted for presentation
at the 2022 AAN Annual Meeting can be found here.
About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is
a solution of carbidopa and levodopa prodrugs for continuous
subcutaneous infusion that is being investigated for the treatment
of advanced Parkinson's disease.
About QULIPTA™ (atogepant)
QULIPTA™, which was approved by the U.S. Food and Drug
Administration (FDA) in September
2021, is available in the United
States as the first and only oral calcitonin gene-related
peptide (CGRP) receptor antagonist (gepant) specifically developed
for the preventive treatment of episodic migraine. CGRP and its
receptors are expressed in regions of the nervous system associated
with migraine pathophysiology, and studies have shown that CGRP
levels are elevated during migraine attacks. QULIPTA blocks CGRP
through a once-daily dose and is available in three strengths – 10
mg, 30 mg and 60 mg.
QULIPTA™ USE AND U.S. IMPORTANT SAFETY INFORMATION
QULIPTA is a prescription medicine used for the preventive
treatment of episodic migraine in adults.
Before taking QULIPTA, tell your healthcare provider about
all your medical conditions, including if you:
- Have kidney problems or are on dialysis
- Have liver problems
- Are pregnant or plan to become pregnant. It is not known if
QULIPTA will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if
QULIPTA passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby while taking
QULIPTA
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. QULIPTA may affect the way other
medicines work, and other medicines may affect how QULIPTA works.
Your healthcare provider may need to change the dose of QULIPTA
when taken with certain other medicines.
The most common side effects of QULIPTA are nausea,
constipation, and fatigue. These are not all the possible side
effects of QULIPTA.
Please see full Prescribing Information.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About UBRELVY® (ubrogepant)
UBRELVY® is an orally administered calcitonin
gene-related peptide (CGRP) receptor antagonist (gepant) for the
acute treatment of migraine with or without aura in adults that is
an option for a wide range of patients who experience migraine
attacks. UBRELVY® is the first pill of its kind to
directly block CGRP, a protein released during a migraine attack,
from binding to its receptors.
UBRELVY® USE AND U.S. IMPORTANT SAFETY
INFORMATION
UBRELVY® is a prescription medicine used for the
acute treatment of migraine attacks with or without aura in adults.
UBRELVY® is not used to prevent migraine headaches.
Who should not take UBRELVY® (ubrogepant)?
Do not take UBRELVY® if you are taking medicines
known as strong CYP3A4 inhibitors, such as ketoconazole,
clarithromycin, or itraconazole.
What should I tell my healthcare provider before taking
UBRELVY®?
Tell your healthcare provider about all your medical conditions,
including if you:
- Have liver problems
- Have kidney problems
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Your healthcare
provider can tell you if it is safe to take UBRELVY®
with other medicines.
What are the most common side effects of
UBRELVY®?
The most common side effects are nausea (4%) and sleepiness (3%).
These are not all of the possible side effects of
UBRELVY®.
Please see full Prescribing Information.
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
About BOTOX®
(onabotulinumtoxinA)
BOTOX® was first approved by the FDA in 1989 for two
rare eye muscle disorders –
blepharospasm and strabismus in adults. Today,
BOTOX® is FDA-approved for 12 therapeutic indications,
including chronic migraine, overactive bladder, leakage of urine
(incontinence) due to overactive bladder caused by a neurologic
condition in adults and in pediatric patients five years of age and
older, cervical dystonia, adult and pediatric spasticity, and
severe underarm sweating (axillary hyperhidrosis).
BOTOX® (onabotulinumtoxinA)
Important Information
Indications
BOTOX® is
a prescription medicine that is injected into muscles
and used:
- To treat overactive bladder symptoms such as a strong need to
urinate with leaking or wetting accidents (urge urinary
incontinence), a strong need to urinate right away (urgency), and
urinating often (frequency) in adults 18 years and older when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and
older with overactive bladder caused by a neurologic disease who
still have leakage or cannot tolerate the side effects after trying
an anticholinergic medication
- To treat overactive bladder due to a neurologic disease in
children 5 years of age and older when another type of medicine
(anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with chronic migraine who have
15 or more days each month with headache lasting 4 or more hours
each day in people 18 years or older
- To treat increased muscle stiffness in people 2 years of age
and older with spasticity
- To treat the abnormal head position and neck pain that happens
with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years of
age and older
BOTOX® is
also injected into the skin to treat the symptoms
of severe underarm sweating (severe
primary axillary hyperhidrosis) when medicines
used on the skin (topical) do not work
well enough in people 18 years and
older.
It is not known whether
BOTOX® is safe and
effective to prevent headaches in
patients with migraine
who have 14 or fewer headache days each
month (episodic migraine).
BOTOX® has not been shown to help people perform task-specific
functions with their upper limbs or
increase movement in joints that are
permanently fixed in position by stiff muscles.
It is not known whether BOTOX® is
safe and effective for severe sweating anywhere other
than your armpits.
U.S. IMPORTANT SAFETY
INFORMATION
BOTOX® may cause
serious side effects that can
be life threatening. Get medical help right
away if you
have any of these problems any time (hours
to weeks) after injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, and trouble swallowing
There has not been a confirmed serious
case of spread of toxin effect away from
the injection site when BOTOX® has
been used at the recommended dose to
treat chronic migraine, severe
underarm sweating, blepharospasm, or strabismus.
BOTOX® may cause loss of strength or
general muscle weakness, vision
problems, or dizziness within hours to
weeks of taking BOTOX®. If this
happens, do not drive a car, operate
machinery, or do other dangerous activities.
Do not receive
BOTOX® if you: are allergic
to any of the ingredients
in BOTOX® (see Medication Guide for
ingredients); had an allergic
reaction to any other
botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA),
or Xeomin® (incobotulinumtoxinA);
have a skin infection at
the planned injection site.
Do not receive BOTOX® for
the treatment of urinary incontinence if
you: have a urinary tract infection (UTI)
or cannot empty your bladder on your own
and are not routinely catheterizing.
Due to the risk of
urinary retention (not being able to empty the bladder), only
patients who are
willing and able to initiate catheterization post treatment, if
required, should be considered for
treatment.
Patients treated for overactive
bladder:
In clinical
trials, 36 of the 552 patients had to self-catheterize for
urinary retention
following treatment with BOTOX® compared to 2 of the 542 treated with placebo.
The median duration of post-injection catheterization for these
patients treated with BOTOX® 100 Units (n = 36) was 63
days (minimum 1 day to maximum 214 days) as compared to a median
duration of 11 days (minimum 3 days to maximum 18 days) for
patients receiving placebo (n = 2).
Patients with diabetes mellitus
treated with BOTOX® were
more likely to develop
urinary retention than nondiabetics.
Adult Patients treated for overactive bladder
due to neurologic disease:
In clinical
trials, 30.6% of patients (33/108)
who were not using clean intermittent
catheterization (CIC) prior
to injection, required catheterization for
urinary
retention following treatment with BOTOX® 200 Units
as compared to 6.7% of
patients (7/104) treated with placebo. The median duration of post-injection
catheterization for
these patients treated with BOTOX® 200 Units
(n = 33) was 289 days (minimum
1 day to maximum 530 days) as
compared to a median duration of 358 days
(minimum 2 days to maximum 379 days) for
patients receiving placebo (n = 7).
Among patients not using CIC at
baseline, those with MS were
more likely to require CIC
post injection than those with SCI.
The dose of
BOTOX® is not
the same as, or comparable to, another
botulinum toxin product.
Serious and/or immediate
allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness,
or feeling faint. Get medical help
right away if you experience symptoms; further
injection of BOTOX® should be discontinued.
Tell your doctor about all your
muscle or nerve conditions, such as
ALS or Lou Gehrig's
disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk
of serious side
effects, including difficulty swallowing and
difficulty breathing from typical doses
of BOTOX®.
Tell your doctor if you have any
breathing-related problems. Your
doctor may monitor you for breathing problems
during treatment with BOTOX® for
spasticity or for
detrusor overactivity associated with a neurologic
condition. The risk of developing lung
disease in patients with reduced lung
function is
increased in patients receiving BOTOX®.
Cornea problems have been
reported. Cornea (surface of the eye)
problems
have been reported in some people receiving BOTOX® for
their blepharospasm, especially
in people with certain nerve disorders.
BOTOX® may cause the eyelids
to blink
less, which could lead to the surface of the eye being exposed to air
more than is usual. Tell your doctor if
you experience any problems with your eyes
while receiving BOTOX®. Your
doctor may treat your eyes with drops,
ointments, contact lenses, or
with an eye patch.
Bleeding behind the eye has been
reported. Bleeding behind the eyeball has
been reported in some people receiving BOTOX® for
their strabismus. Tell your doctor if
you notice any new visual
problems while receiving BOTOX®.
Bronchitis and upper respiratory tract
infections (common colds) have been reported. Bronchitis was
reported more frequently in adults receiving
BOTOX® for upper limb spasticity. Upper
respiratory infections were also
reported more frequently in
adults with prior breathing-related
problems with spasticity. In pediatric patients treated
with BOTOX® for upper limb spasticity, upper respiratory
tract infections were reported more frequently. In pediatric
patients treated with BOTOX® for lower limb spasticity,
upper respiratory tract infections were not reported more
frequently than placebo.
Autonomic dysreflexia in
patients treated for overactive bladder due to
neurologic disease. Autonomic
dysreflexia associated with intradetrusor injections
of BOTOX® could occur in
patients treated for detrusor
overactivity associated with a neurologic
condition and may require prompt medical
therapy. In clinical trials, the incidence
of autonomic dysreflexia was greater in adult
patients treated with BOTOX®
200 Units
compared with placebo (1.5% versus
0.4%, respectively).
Tell your doctor about all your
medical conditions, including if you: have or
have had bleeding problems; have plans
to have surgery; had surgery on your
face; weakness
of forehead muscles; trouble raising your
eyebrows; drooping
eyelids; any other abnormal facial
change; have symptoms of a urinary tract
infection (UTI) and are being treated for
urinary incontinence (symptoms of a
urinary tract
infection may include pain or burning
with urination, frequent
urination, or fever); have problems emptying your
bladder on your own and are
being treated for
urinary incontinence; are pregnant or plan to become pregnant
(it is not known if BOTOX®
can harm your unborn baby); are breastfeeding or
plan to (it is
not known if BOTOX® passes into breast milk).
Tell your doctor
about all the medicines you
take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements. Using BOTOX® with
certain other medicines
may cause serious side effects. Do not
start any new medicines until you have told your
doctor that you have received
BOTOX® in the past.
Tell your doctor if you received any other
botulinum toxin product in the last 4
months; have received injections of botulinum toxin such as Myobloc®, Dysport®,
or Xeomin® in the past (tell your
doctor exactly
which product you received); have
recently received an antibiotic
by injection; take muscle relaxants; take an allergy
or cold medicine; take
a sleep medicine; take aspirin-like products or blood
thinners.
Other side effects
of BOTOX® include:
dry mouth, discomfort or pain at the
injection site, tiredness, headache, neck pain, eye problems: double vision,
blurred vision, decreased eyesight, drooping eyelids, swelling of your
eyelids, dry eyes; drooping eyebrows; and upper respiratory
tract infection. In adults being treated for urinary incontinence,
other side effects include urinary tract infection and painful
urination. In children being treated for urinary incontinence,
other side effects include urinary tract infection and bacteria in
the urine. If you have difficulty fully emptying your bladder on
your own after receiving BOTOX®, you may need to use
disposable self-catheters to empty your bladder up to a few times
each day until your bladder is able to start emptying again.
For more information refer
to the Medication Guide or talk with your
doctor.
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.
Please see BOTOX® full
Product Information, including Boxed Warning and
Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
About DUOPA® (carbidopa/levodopa)
DUOPA
enteral suspension is a prescription medicine used for treatment of
advanced Parkinson's disease. DUOPA contains two medicines:
carbidopa and levodopa.
U.S. Important Safety Information
What is the most important safety information I should know
about DUOPA?
- Stomach and intestine (gastrointestinal) problems and
problems from the procedure you will need to have to receive DUOPA
(gastrointestinal procedure-related problems) may
occur. Some of these problems may require surgery and may
lead to death.
-
- Serious side effects may include: a blockage of
your stomach or intestines (bezoar); stopping movement through
intestines (ileus); drainage, redness, swelling, pain, feeling of
warmth around the small hole in your stomach wall (stoma); bleeding
from stomach ulcers or your intestines; inflammation of your
pancreas (pancreatitis); infection in your lungs (pneumonia); air
or gas in your abdominal cavity; skin infection around the
intestinal tube, pocket of infection (abscess), or infection in
your blood (sepsis) or abdominal cavity may occur after surgery;
stomach pain, nausea, or vomiting.
- Tell your healthcare provider right away if you have any of the
following symptoms of stomach and intestine problems and
gastrointestinal procedure-related problems: stomach (abdominal)
pain; constipation that does not go away; nausea or vomiting;
fever; blood in your stool; or a dark tarry stool.
Your healthcare provider will talk to you about the stoma
procedure. Before the stoma procedure, tell your
healthcare provider if you ever had a surgery or problems with your
stomach.
Talk to your healthcare provider about what you need to do to
care for your stoma. After the procedure, you and your
healthcare provider will need to regularly check the stoma for any
signs of infection.
Do not take DUOPA if you currently take or have
recently taken (within 2 weeks) a medication for depression called
a non-selective monoamine oxidase (MAO) inhibitor. Ask your
healthcare provider or pharmacist if you are not sure if you take
an MAO inhibitor.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Using DUOPA with certain
other medicines, including medications for high blood pressure, MAO
inhibitors, antipsychotics, metoclopramide, isoniazid, and iron or
vitamin supplements, may cause serious side effects. High-protein
foods may affect how DUOPA works. Tell your healthcare provider if
you change your diet.
DUOPA may cause serious side effects. Talk to your doctor
before starting DUOPA and while on DUOPA if you have had or have
any of these:
- Falling asleep during normal daily activities without
warning. DUOPA may cause you to fall asleep while you are
doing daily activities such as driving, which may result in an
accident. This can happen as late as one year after starting
DUOPA. Do not drive or operate machinery until you
know how DUOPA affects you. Tell your healthcare provider if you
take medicines that can make you sleepy, such as sleep medicines,
antidepressants, or antipsychotics.
- Low blood pressure when you stand or sit up
quickly. After you have been sitting or lying down, stand
up slowly to help reduce dizziness, nausea, sweating, or fainting
until you know how DUOPA affects you.
- Seeing, hearing, or feeling things that are not
real (hallucinations).
- Unusual urges. Some people taking medicines for
Parkinson's disease, including DUOPA, have reported urges such as
excessive gambling, compulsive eating, compulsive shopping, and
increased sex drive.
- Depression and suicide. DUOPA can cause or worsen
depression. Pay close attention to changes in your mood, behavior,
thoughts, or feelings. Call your healthcare provider right away if
you feel depressed or have thoughts of suicide.
- Uncontrolled sudden movements (dyskinesia). If you
have new dyskinesia or your dyskinesia gets worse, tell your
healthcare provider. This may be a sign that your dose of DUOPA or
other Parkinson's medicines may need to be adjusted.
- Progressive weakness or numbness or loss of
sensation in the fingers or feet (neuropathy).
- Heart attack or other heart problems. Tell your
healthcare provider if you have experienced increased blood
pressure, a fast or irregular heartbeat, or chest pain.
- Abnormal blood tests. DUOPA may cause changes in
certain blood tests, especially certain hormone and kidney function
blood tests.
- Worsening of the increased pressure in your
eyes (glaucoma). The pressure in your eyes should be
checked after starting DUOPA.
Do not stop using DUOPA or change your dose unless you are
told to do so by your healthcare provider. Tell your healthcare
provider if you develop withdrawal symptoms such as fever,
confusion, or severe muscle stiffness.
The most common side effects of DUOPA
include: complications of tubing placement procedure,
swelling of legs and feet, nausea, high blood pressure
(hypertension), depression, and mouth and throat pain.
Please see the full Prescribing
Information, including Medication Guide, for additional
information about DUOPA.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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.
About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with
migraine disease. We advance science that enables health care
providers to care for people impacted across the spectrum of
migraine. Through education and partnerships with the migraine
community, we strive to help those with migraine navigate barriers
to care, access effective treatments and reduce the impact of
migraine on their lives.
Our portfolio of therapies, which serves the varying needs of
people living with migraine, includes BOTOX®
(onabotulinumtoxinA), the first FDA-approved, preventive treatment
for adults with chronic migraine; UBRELVY® (ubrogepant),
the first FDA-approved oral calcitonin gene-related peptide (CGRP)
receptor antagonist (gepant), indicated for the acute treatment of
migraine with or without aura in adults; and QULIPTA™ (atogepant),
an oral CGRP antagonist for the preventive treatment of episodic
migraine in adults.
About AbbVie in Neuroscience
At AbbVie, our commitment
to preserve the personhood of those living with neurological and
psychiatric disorders is unwavering. Every challenge in this
uncharted territory makes us more determined and drives us harder
to discover and deliver solutions for patients, care partners and
clinicians. AbbVie's Neuroscience portfolio consists of approved
therapies in neurological and psychiatric disorders, including
bipolar I disorder, major depressive disorder, migraine,
Parkinson's disease, post-stroke spasticity, schizophrenia and
others along with a robust pipeline.
We have a strong investment in neuroscience research, with our
Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience
Discovery site in Ludwigshafen, Germany, where our research and resilience in
these challenging therapeutic areas is yielding a deeper
understanding of the pathophysiology of neurological and
psychiatric disorders, and identifying targets for potential
disease-modifying therapeutics aimed at making a difference in
people's lives.
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 2021 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.
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SOURCE AbbVie