The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of labeling:
- Nausea and Vomiting [see WARNINGS AND PRECAUTIONS]
- Syncope [see WARNINGS AND PRECAUTIONS]
- Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
- Hallucinations/Psychotic-Like Behavior [see WARNINGS AND PRECAUTIONS]
- Dyskinesias [see WARNINGS AND PRECAUTIONS]
- Coronary Events [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment per total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in practice.
In placebo-controlled trials, most patients received only one subcutaneous dose of APOKYN. All patients received concomitant levodopa and 86% received a concomitant dopamine agonist. All patients had some degree of spontaneously occurring periods of hypomobility (“off episodes”) at baseline.
The most common adverse reactions (APOKYN incidence at least 10% greater than placebo incidence) observed in a placebo-controlled trial were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucination/confusion, and edema/swelling of extremities.
Table 1 presents the most common adverse reactions reported by APOKYN-naïve Parkinson's disease patients who were enrolled in a randomized placebo-controlled, parallel group trial and who were treated for up to 4 weeks (Study 1) [see Clinical Studies Individual APOKYN doses in this trial ranged from 2 mg to 10 mg, and were titrated to achieve tolerability and control of symptoms.
Table 1: Adverse Reactions Occurring in Two or More APOKYN-Treated Patients in Study 1
(n = 20) %
(n = 9) %
|Drowsiness or Somnolence||35||0|
|Nausea and/or Vomiting||30||11|
|Dizziness or Postural Hypotension||20||0|
|Hallucination or Confusion||10||0|
|Edema/Swelling of Extremities||10||0|
Other Adverse Reactions
Injection Site Reactions
Patients treated with APOKYN subcutaneous injections during clinical studies, 26% of patients had injection site reactions, including bruising (16%), granuloma (4%), and pruritus (2%).
In addition to those in Table 1, the most common adverse reactions in pooled APOKYN trials (occurring in at least 5% of the patients) in descending order were injection site reaction, 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.