IMPORTANT SAFETY
INFORMATION & INDICATION
CONTRAINDICATIONS
DHIVY is contraindicated in patients
- 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.
- With known hypersensitivity to any component of DHIVY.
WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: 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.
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.
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.
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.
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.
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.
Dyskinesia: DHIVY can cause dyskinesias that may require a
dosage reduction of DHIVY or other medications used for the treatment of Parkinson’s
disease.
Peptic Ulcer Disease: Treatment with DHIVY may increase the
possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
Glaucoma: DHIVY may cause increased intraocular pressure in
patients with glaucoma. Monitor intraocular pressure in patients with glaucoma after
starting DHIVY.
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.
Depression/Suicidality: All patients should be observed
carefully for the development of depression with concomitant suicidal tendencies.
DRUG INTERACTIONS
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.
ADVERSE REACTIONS
The most common adverse reactions reported with carbidopa/levodopa tablets have included
dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.
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.
You may report side effects to Avion Pharmaceuticals, LLC at 1-888-612-8466 or to the FDA at 1-800-FDA-1088.
Please click here for full Prescribing
Information.