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INDICATION
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DHIVY is a combination of carbidopa (an aromatic amino acid
decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated
for the treatment of Parkinson’s disease, post-encephalitic parkinsonism,
and symptomatic parkinsonism that may follow carbon monoxide
intoxication or manganese intoxication.
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IMPORTANT SAFETY INFORMATION
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CONTRAINDICATIONS
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DHIVY is contraindicated in patients
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Currently taking a nonselective monoamine oxidase (MAO) inhibitor
(e.g., phenelzine, linezolid, and tranylcypromine) or have recently
(within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently.
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With known hypersensitivity to any component of DHIVY.
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WARNINGS AND PRECAUTIONS
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Falling Asleep During Activities of Daily Living and Somnolence:
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Patients taking carbidopa/levodopa alone or with other dopaminergic
drugs have reported suddenly falling asleep without prior warning of
sleepiness while engaged in activities of daily living (including the
operation of motor vehicles), which has resulted in accidents. Although
many patients reported somnolence while on dopaminergic medications,
some perceived that they had no warning signs (sleep attack), such as
excessive drowsiness, and believed that they were alert immediately
prior to the event. Sudden onset of sleep has been reported to occur
more than 1 year after the initiation of treatment.
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Advise patients of the potential to develop drowsiness and specifically
ask about factors that may increase the risk for somnolence with
DHIVY, such as concomitant sedating medications and the presence
of sleep disorders. Because some events may occur well after the
start of DHIVY treatment, reassess patients for drowsiness or sleepiness
and be aware that patients may not acknowledge drowsiness or
sleepiness until directly questioned. Consider discontinuing DHIVY
in patients who report significant daytime sleepiness or episodes of
falling asleep during activities that require active participation. If
treatment with DHIVY continues, patients should be advised not to
drive and to avoid other potentially dangerous activities that might
result in harm if the patients become somnolent. There is insufficient
information to establish that dose reduction will eliminate episodes of
falling asleep while engaged in activities of daily living.
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Withdrawal-Emergent Hyperpyrexia and Confusion: A symptom
complex that resembles neuroleptic malignant syndrome
(characterized by elevated temperature, muscular rigidity, altered
consciousness, and autonomic instability), with no other obvious
etiology, has been reported in association with rapid dose reduction,
withdrawal of, or changes in dopaminergic therapy. Avoid sudden
discontinuation or rapid dose reduction in patients taking DHIVY.
If the decision is made to discontinue DHIVY, the dose should be
tapered to reduce the risk of hyperpyrexia and confusion.
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Cardiovascular Ischemic Events: In patients with a history of
myocardial infarction who have residual atrial, nodal, or ventricular
arrhythmias, cardiac function should be monitored in an intensive
cardiac care facility during the period of initial dosage adjustment.
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Hallucinations/Psychotic-Like Behavior: Hallucinations and
psychotic-like behavior have been reported with dopaminergic
medications. In general, hallucinations present shortly after the
initiation of therapy and may be responsive to dose reduction in
levodopa. Patients with a major psychotic disorder should not be
treated with DHIVY because of the risk of exacerbating psychosis.
In addition, medications that antagonize the effects of dopamine
used to treat psychosis may exacerbate the symptoms of Parkinson’s
disease and may decrease the effectiveness of DHIVY.
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Impulse Control/Compulsive Behaviors: Case reports suggest that
patients can experience an intense urge 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 DHIVY, that increase central dopaminergic
tone and that are generally used for the treatment of Parkinson’s disease.
Because patients may not recognize these behaviors as abnormal, it is
important for prescribers to specifically ask patients or the caregivers
about the development of new or increased gambling urges, sexual urges,
uncontrolled spending, or other urges while being treated with DHIVY.
Consider dosage reduction or stopping the medication if a patient
develops such urges while taking DHIVY.
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Dyskinesia: DHIVY can cause dyskinesias that may require a dosage
reduction of DHIVY or other medications used for the treatment of
Parkinson’s disease.
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Peptic Ulcer Disease: Treatment with DHIVY may increase the
possibility of upper gastrointestinal hemorrhage in patients with a
history of peptic ulcer.
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Glaucoma: DHIVY may cause increased intraocular pressure in
patients with glaucoma. Monitor intraocular pressure in patients with
glaucoma after starting DHIVY.
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Laboratory Tests: DHIVY may cause a positive Coombs test or false-
positive
reaction for urinary ketone bodies when a test tape is used for
determination of ketonuria. This reaction will not be altered by boiling
the urine specimen. False-negative tests may result with the use of
glucose-oxidase methods of testing for glucosuria. Cases of falsely
diagnosed pheochromocytoma in patients on carbidopa/levodopa
therapy have been reported. Caution should be exercised when
interpreting the plasma and urine levels of catecholamines and their
metabolites in patients on carbidopa/levodopa therapy.
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Depression/Suicidality: All patients should be observed carefully for
the development of depression with concomitant suicidal tendencies.
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DRUG INTERACTIONS
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Monitor patients taking selective MAO-B inhibitors and DHIVY; this
combination may be associated with severe orthostatic hypotension.
Coadministration with dopamine D2 receptor antagonists, isoniazid,
iron salts, or metoclopramide may reduce the effectiveness of DHIVY.
Concurrent administration with antihypertensive drugs may result in
postural hypotension, necessitating a dose reduction of the
antihypertensive drug. Coadministration with dopamine-depleting
agents is not recommended.
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ADVERSE REACTIONS
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The most common adverse reactions reported with carbidopa/levodopa
tablets have included dyskinesias, such as choreiform, dystonic, and
other involuntary movements, and nausea.
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Please see full Prescribing Information.
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References: 1. DHIVY. Package insert. Avion Pharmaceuticals, LLC; 2021.
2. SINEMET. Package insert. Merck Sharp & Dohme Corp.; 2020. 3. Beach D. Accu-Break’s innovative tablet technology – 2016 advancements. ONdrugDelivery Magazine. 2016;69:39-40.
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