Approved Drug Label (PDF)
5
Warnings and Precautions
5.11 Withdrawal Symptoms
(Newly
added subsection)
Symptoms
including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain
have been reported during taper or after discontinuation of dopamine agonists,
including MIRAPEX ER. These symptoms generally do not respond to levodopa.
Prior
to discontinuation of MIRAPEX ER, patients should be informed about potential
withdrawal symptoms, and monitored during and after discontinuation. In case of
severe withdrawal symptoms, a trial re- administration of a dopamine agonist at
the lowest effective dose may be considered.
5.3 Impulse Control/Compulsive Behaviors
(Additions and/or
revisions underlined)
Case reports and the results of cross-sectional
studies suggest that patients can experience intense urges to gamble, increased
sexual urges, intense urges to spend money, binge eating, and/or other intense
urges, and the inability to control these urges while taking one or more of the
medications, including MIRAPEX ER, that increase central dopaminergic tone. In
some cases, although not all, these urges were reported to have stopped when
the dose was reduced or the medication was discontinued. Because patients may
not recognize these behaviors as abnormal, it is important for prescribers to
specifically ask patients or their caregivers about the development of new or
increased gambling urges, sexual urges, uncontrolled spending or other urges
while being treated with MIRAPEX ER for Parkinson’s disease. Physicians
should consider dose reduction or stopping the medication if a patient develops
such urges while taking MIRAPEX ER.
A total of 1056 patients with Parkinson’s disease
who participated in two MIRAPEX ER placebo-controlled studies of up to 33 weeks
duration were specifically asked at each visit about the occurrence of these
symptoms. A total of 14 of 387 (4%) treated with MIRAPEX ER tablets, 12 of 388
(3%) treated with immediate-release pramipexole tablets, and 4 of 281 (1%)
treated with placebo reported compulsive behaviors, including pathological
gambling, hypersexuality, and/or compulsive buying
5.4 Hallucinations and Psychotic-like Behavior
(Additions and/or
revisions underlined)
In
placebo-controlled clinical trials in Parkinson's disease, hallucinations
(visual or auditory or mixed) were reported in 25 of 387 (6%) patients treated
with MIRAPEX ER tablets compared to 5 of 281 (2%) patients receiving placebo.
Hallucinations led to discontinuation of treatment in 5 of 387 (1%) patients on
MIRAPEX ER tablets.
Age
appears to increase the risk of hallucinations attributable to pramipexole. In
placebo-controlled clinical trials in Parkinson’s disease, hallucinations were
reported in 15 of 162 (9%) patients ?65 years of age taking MIRAPEX ER tablets
compared to 10 of 225 (4%) patients <65 years of age taking MIRAPEX ER
tablets.
Postmarketing
reports with dopamine agonists, including MIRAPEX ER, indicate that patients with
Parkinson’s disease may experience new or worsening mental status and behavioral
changes, which may be severe, including psychotic-like behavior during
treatment with MIRAPEX ER or after starting or increasing the dose of MIRAPEX
ER. Other drugs prescribed to improve the symptoms of Parkinson’s disease can
have similar effects on thinking and behavior. This abnormal thinking and
behavior can consist of one or more of a variety of manifestations including
paranoid ideation, delusions, hallucinations, confusion, psychotic-like
behavior, symptoms of mania (e.g., insomnia, psychomotor agitation), disorientation,
aggressive behavior, agitation, and delirium.
Patients
with a major psychotic disorder should ordinarily not be treated with dopamine
agonists, including MIRAPEX ER, because of the risk of exacerbating the psychosis.
In addition, certain medications used to treat psychosis may exacerbate the
symptoms of Parkinson’s disease and may decrease the effectiveness of MIRAPEX
ER [see Drug Interactions (7.1)].
6
Adverse Reactions
(Addition of the
following to the bulleted line listing)
6.2 Postmarketing Experience
(Additions and/or
revisions underlined)
The
following adverse reactions have been identified during post-approval use of
MIRAPEX immediate-release or MIRAPEX ER tablets, primarily in Parkinson’s
disease patients. Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure. Decisions
to include these reactions in labeling are typically based on one or more of
the following factors: (1) seriousness of the reaction, (2) frequency of
reporting, or (3) strength of causal connection to pramipexole tablets.
Cardiac
Disorders: cardiac failure Gastrointestinal Disorders: vomiting
General Disorders
and Administration Site Conditions: withdrawal symptoms [see Warnings and Precautions (5.11)]
Metabolism and
Nutrition Disorders: syndrome
of inappropriate antidiuretic hormone secretion (SIADH), weight increase
Musculoskeletal
and Connective Tissue Disorders: postural deformity [see Warnings and
Precautions (5.6)] Nervous System Disorders: syncope
Skin and
Subcutaneous Tissue Disorders: skin reactions (including erythema, rash,
pruritus, urticaria)
There
are postmarketing reports of patients noticing tablet residue in their stool
that resembles a swollen MIRAPEX ER whole tablet or swollen pieces of the
tablet. Some patients have reported worsening of their Parkinson’s disease
symptoms when tablet residue was observed. If a patient reports tablet residue
with worsening of their Parkinson’s symptoms, prescribers may need to re-evaluate
their medications.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Additions and/or
revisions underlined)
…
Hallucinations
and Psychotic-like Behavior
Inform
patients that hallucinations and other psychotic-like behavior can occur. In
patients with Parkinson’s disease, the elderly are at a higher risk than
younger patients [see Warnings and
Precautions (5.4)].
Withdrawal-Emergent
Hyperpyrexia and Confusion
Advise
patients who have been prescribed a lower dose or who have been withdrawn from
the drug to notify their healthcare provider if they have symptoms such as
fever, muscular rigidity or altered consciousness [see Warnings and Precautions
(5.10)].
Withdrawal
Symptoms
Advise
patients that withdrawal symptoms may occur during or after discontinuation or
dose reduction of MIRAPEX ER. Advise patients who have been prescribed a lower
dose or who have been withdrawn from the drug to notify their healthcare
provider if they have withdrawal symptoms such as apathy, anxiety, depression,
fatigue, insomnia, sweating, or pain. Notify patients that in case of severe
withdrawal symptoms, a trial re- administration of a dopamine agonist at the
lowest effective dose may be considered [see Warnings and Precautions (5.11)].
Pregnancy
Because
the teratogenic potential of pramipexole has not been completely established in
laboratory animals, and because experience in humans is limited, advise women
to notify their physicians if they become pregnant or intend to become pregnant
during therapy [see Use in Specific
Populations (8.1)].
Lactation
Because
of the possibility that pramipexole may be excreted in breast milk, advise
women to notify their physicians if they intend to breast-feed or are
breast-feeding an infant [see Use in
Specific Populations (8.2)].
PATIENT INFORMATION
(Additions and/or
revisions underlined)
…
How should I take
MIRAPEX ER?
MIRAPEX
ER is taken once daily.
Your
doctor will tell you how much MIRAPEX ER to take and when to take it. Do not
take more or less MIRAPEX ER than your doctor tells you to.
Swallow
MIRAPEX ER whole. Do not chew, crush, or cut MIRAPEX ER.
MIRAPEX
ER can be taken with or without food. Taking MIRAPEX ER with food may lower
your chances of getting nausea.
You
may see something that looks like a swollen original tablet or swollen pieces
of the original tablet in your stool. If this happens, tell your doctor.
If
you miss a dose of MIRAPEX ER it should be taken as soon as possible, but no
later than 12 hours after your regularly scheduled time. If it is later than 12
hours, the missed dose should be skipped and the next dose should be taken on
the following day at your regularly scheduled time. Do not double your next MIRAPEX ER dose.
Do not stop taking
MIRAPEX ER without talking to your doctor first. If your doctor tells you to
stop taking MIRAPEX ER, you should ask your doctor for specific instructions on
how to slowly and safely discontinue taking MIRAPEX ER. If you stop taking
MIRAPEX ER you may have withdrawal symptoms (see “withdrawal symptoms” under
“What are the possible side effects of
MIRAPEX ER?”).
…
hallucinations and
other psychotic-like behavior (seeing visions, hearing sounds or feeling
sensations that are not real, confusion, excessive suspicion, aggressive
behavior, agitation, delusional beliefs and disorganized thinking). The chances of
having hallucinations or other psychotic-like changes are higher in people
taking MIRAPEX ER for Parkinson’s disease who are elderly (age 65 or older).
If you have hallucinations or other psychotic-like
changes, talk with your doctor right away.
uncontrolled
sudden movements (dyskinesia). If you have new dyskinesia, or your
existing dyskinesia gets worse, tell your doctor.
posture changes. Talk with your
doctor if you have posture changes you cannot control. These may include your
neck bending forward, bending forward at the waist, or tilting sideways when
you sit, stand, or walk.
withdrawal
symptoms.
MIRAPEX ER is a dopamine agonist medicine. Dopamine agonist medicines,
including MIRAPEX ER, can cause withdrawal symptoms as your dose is slowly
lowered (tapered) or when treatment with MIRAPEX ER is stopped. Tell your
doctor right away if you get any of the following withdrawal symptoms:
After you have stopped taking MIRAPEX ER,
your doctor may need to restart you at a low dose of MIRAPEX ER if you get
severe withdrawal symptoms.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
Addition of the following:
5.6 Postural Deformity
Postural deformities,
including antecollis, camptocormia (Bent Spine Syndrome), and pleurothotonus (Pisa
Syndrome), have been reported in patients after starting or increasing the dose
of MIRAPEX. Postural deformity may occur
several months after starting treatment or increasing the dose. Reducing the dose
or discontinuing MIRAPEX has been reported to improve postural deformity in some
patients, and should be considered if postural deformity occurs.
6
Adverse Reactions
Addition of the following:
6.2 Post Marketing Experience
Reformatted and revised information:
Cardiac Disorders: cardiac failure
Gastrointestinal Disorders: vomiting
Metabolism and Nutrition Disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH), weight
increase
Musculoskeletal and Connective Tissue Disorders:
postural deformity
Nervous System Disorders: syncope
Skin and Subcutaneous Tissue Disorders: skin reactions (including erythema, rash, pruritus, urticarial)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
What are the possible
side effects of MIRAPEX? MIRAPEX may cause serious side effects, including:
Addition of the
following:
posture changes. Talk with your doctor if you have posture
changes you cannot control. These may include your neck bending forward, bending
forward at the waist, or tilting sideways when you sit, stand, or walk.
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