Apokyn Side Effects

Please note - some side effects for Apokyn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Apokyn - for the Consumer

Apokyn

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Apokyn:

Dizziness; drowsiness; headache; pain, swelling, or redness at the injection site; runny nose; yawning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; confusion; difficulty moving; fainting; falling asleep without warning; falling down; fast or irregular heartbeat; hallucinations; mental or mood changes such as depression; painful or prolonged erection; severe dizziness, nausea, or vomiting; shortness of breath; sudden uncontrollable movements; sweating; swelling of the arms, hands, legs, or feet; unusual changes in sexual behavior, desire, or ability; vision changes.

Apokyn Side Effects - for the Professional

Apokyn

Clinical Trial Experience

Adverse Events Incidence in Controlled Clinical Studies:

Apokyn® 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-naïve 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.

Other Adverse Events Observed During All Phase 2/3 Clinical Trials:

Apokyn 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® 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).

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included severe nausea (31%) and vomiting (11%) at the recommended doses of apomorphine.

In clinical trials conducted in the USA, patients were treated with trimethobenzamide for 3 days prior to initiation of treatment with apomorphine, and were directed to continue it for at least 6 weeks. The number of patients stopping apomorphine treatment due to nausea was 3% and due to vomiting was 2%.

Cardiovascular

Cardiovascular side effects have included syncope (2%). QT and QTc prolongation have been reported in very rare cases. Apomorphine may cause dose-related decreases in systolic and diastolic blood pressure. Severe orthostatic hypotension, hypotension and/or syncope that resulted in drug withdrawal have been reported in less than 1% of patients in clinical trials.

Psychiatric

Psychiatric side effects have included hallucinations (14%). Slowing down of cognitive performance has been reported after apomorphine use in a small number of patients with Parkinson's disease. The mechanism of action is not fully understood.

Other

Other side effects have included falling asleep during activities of daily living. There have been reports in the literature of patients suddenly falling asleep without prior warning, soon after receiving apomorphine subcutaneous injections.

Local

Local side effects have included reactions at the injection site, such as bruising (16%), granuloma (4%), and pruritus (2%).

Other

Drug abuse and dependence have been reported rarely by patients with Parkinson's disease. These cases are characterized by frequent dosing leading to hallucinations, dyskinesia, and abnormal behavior.

Nervous system

Nervous system side effects have included symptoms resembling neuroleptic malignant syndrome associated with the rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy. Migraine attacks have been reported to occur following injection of apomorphine in two postmenopausal women who had experienced migraines before menopause several years earlier.

Genitourinary

Genitourinary side effects have included priapism in some patients.

Other

Drug tolerance to apomorphine after long periods of drug treatment has been observed in some studies. The decline in dopaminergic responsiveness was most noticeable with drug administrations set at 2-hour intervals.

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