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Clinical Trial Experience
Adverse Events Incidence in Controlled Clinical Studies
APOKYN® (apomorphine) has been administered to 550 Parkinson's disease patients who were taking some form of L-Dopa along with other Parkinson's disease medications. Eighty-six percent of patients were taking a concomitant dopamine agonist. All patients had some degree of spontaneously occurring hypomobility (“off episodes”) at baseline. Adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using MEDDRA dictionary terminology.
The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.
The most extensive experience with apomorphine in randomized, controlled trials comes from a multicenter randomized placebo-controlled parallel group trial conducted in apomorphine-na´ve PD patients treated for up to 4 weeks (Table 1). Individual apomorphine doses in this trial ranged from 2-10 mg, optimized to achieve control of symptoms comparable to each patient's response to his or her usual dose of L-dopa. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.
Table 1 : Summary of Adverse Events Occurring in Two or More
n = 20
n = 9
|Any Adverse Reaction||17||85||8||89|
|Drowsiness or Somnolence||7||35||0||0|
|Nausea and/or Vomiting||6||30||1||11|
|Dizziness or Postural Hypotension||4||20||0||0|
|Hallucination or Confusion||2||10||0||0|
|Edema/Swelling of Extremities||2||10||0||0|
Other Adverse Events Observed During All Phase 2/3 Clinical Trials
APOKYN (apomorphine) has been administered to 550 patients; 89% had at least one adverse event (AE). The most common AEs in addition to those in Table 1 (occurring in at least 5% of the patients and at least plausibly related to treatment) in descending order were injection site complaint, fall, arthralgia, insomnia, headache, depression, urinary tract infection, anxiety, congestive heart failure, limb pain, back pain, Parkinson's disease aggravated, pneumonia, confusion, sweating increased, dyspnea, fatigue, ecchymosis, constipation, diarrhea, weakness, and dehydration.
Post Marketing Experience
In addition to the adverse events reported during clinical trials, the following adverse reactions have been identified during post-approval use of APOKYN® (apomorphine) 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. The following psychiatric disorders were reported: impulse control symptoms, pathological gambling, and increased libido (including hypersexuality).
Drug Abuse And Dependence
Potential for Abuse
A rarely reported motivation for apomorphine abuse (escalation of dose beyond prescribed frequency) is the use of apomorphine to attempt to avoid all symptoms of all “off” events when “off” events occur frequently. A second, rarely reported, motivation for apomorphine abuse is a psychosexual reaction related to the stimulation of penile erection and increase in libido. Adverse events that have been reported in males with overuse include frequent penile erections, atypical sexual behavior, heightened libido, dyskinesias, agitation, confusion, and depression. No studies have been conducted to evaluate the potential for dependence when apomorphine is used as acute (rescue) treatment of “off” episodes in the patients with “on/off” or “wearing-off” effects associated with late stage Parkinson's disease.
Read the Apokyn (apomorphine) Side Effects Center for a complete guide to possible side effects
Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with drugs of the 5HT3 antagonist class (including, for example, ondansetron, granisetron, dolasetron, palonosetron, and alosetron) is contraindicated (see CONTRAINDICATIONS).
Antihypertensive Medications and Vasodilators
The following adverse events were experienced more commonly in patients receiving concomitant antihypertensive medications or vasodilators (n = 94) compared to patients not receiving these concomitant drugs (n = 456): hypotension 10% vs 4%, myocardial infarction 3% vs 1%, serious pneumonia 5% vs 3%, serious falls 9% vs 3%, and bone and joint injuries 6% vs 2%. The mechanism underlying many of these events is unknown, but may represent increased hypotension (see WARNINGS: Symptomatic Hypotension).
Since apomorphine is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of APOKYN (apomorphine) . Patients with major psychotic disorders, treated with neuroleptics, should be treated with dopamine agonists only if the potential benefits outweigh the risks.
Drugs Prolonging the QT/QTc Interval
Caution should be exercised when prescribing apomorphine concomitantly with drugs that prolong the QT/QTc interval (see WARNINGS: QT Prolongation and Potential for Proarrhythmic Effects).
Drug/Laboratory Test Interactions
There are no known interactions between APOKYN (apomorphine) and laboratory tests.
Read the Apokyn Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.
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