KYNMOBI (Page 3 of 7)

5.13 Priapism

Apomorphine may cause prolonged painful erections in some patients. Severe priapism may require surgical intervention.

5.14 Retinal Pathology in Albino Rats

In a 2-year carcinogenicity study of apomorphine in albino rat, retinal atrophy was detected at all subcutaneous doses tested (up to 0.8 mg/kg/day or 2 mg/kg/day in males or females, respectively). Retinal atrophy/degeneration has been observed in albino rats treated with other dopamine agonists for prolonged periods (generally during 2-year carcinogenicity studies). Retinal findings were not observed in a 39-week subcutaneous toxicity study of apomorphine in monkey at doses up to 1.5 mg/kg/day. The clinical significance of the finding in rat has not been established but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (e.g., disk shedding) may be involved.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling:

  • Nausea and Vomiting [see Warnings and Precautions (5.1)]
  • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.2)]
  • Hypersensitivity [see Warnings and Precautions (5.3)]
  • Syncope/Hypotension/Orthostatic Hypotension [see Warnings and Precautions (5.4)]
  • Oral Mucosal Irritation [see Warnings and Precautions (5.5)]
  • Falls [see Warnings and Precautions (5.6)]
  • Hallucinations/Psychotic Behavior [see Warnings and Precautions (5.7)]
  • Hemolytic Anemia [see Warnings and Precautions (5.8)]
  • Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.9)]
  • Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.10)]
  • QTc Prolongation and Potential for Proarrhythmic Effects [see Warnings and Precautions (5.11)]
  • Fibrotic Complications [see Warnings and Precautions (5.12)]
  • Priapism [see Warnings and Precautions (5.13)]
  • Retinal Pathology in Albino Rats [see Warnings and Precautions (5.14)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

KYNMOBI safety data presented below is derived from a randomized, double blind, placebo-controlled study in patients with Parkinson’s disease (Study 1) [see Clinical Studies (14)]. Study 1 included a titration phase, in which 141 patients received at least one dose of KYNMOBI, followed by a placebo-controlled 12-week maintenance phase. The mean age of patients in Study 1 was 63 years (range 43 to 86 years); 63% of patients were male, and 93% were Caucasian.

The most common adverse reactions (incidence at least 10% in patients treated with KYNMOBI and with an incidence greater than placebo) were nausea, oral/pharyngeal soft tissue swelling, oral/pharyngeal soft tissue pain and paraesthesia, dizziness, and somnolence.

Adverse reactions led to discontinuation of KYNMOBI in 9% of patients in the titration phase, and 28% of patients in the maintenance phase, compared with 7% of patients on placebo (in the maintenance phase). The most common adverse reactions leading to discontinuation during the maintenance phase were oral/pharyngeal soft tissue swelling, oral mucosal erythema, and nausea/vomiting.

Table 1 presents the adverse reactions that occurred in at least 5% of patients treated with KYNMOBI during the maintenance phase of Study 1, and with an incidence greater than in patients who received placebo.

Table 1: Adverse Reactions Reported by at Least 5% of Patients Treated with KYNMOBI during the Maintenance Phase of Study 1, and with an Incidence Greater than Placebo
Titration Maintenance
KYNMOBI (N=141) % KYNMOBI (N=54) % Placebo (N=55) %

1 Includes lip swelling, lip edema, oropharyngeal swelling, gingival edema, edema mouth, swollen tongue, and pharyngeal edema

2 Includes throat irritation, glossodynia, oral pain, oral paresthesia, oropharyngeal pain, gingival pain, and oral hypoesthesia

3 Includes lip ulceration, oral mucosal blistering, stomatitis, cheilitis, and tongue ulceration

4 Includes hypersensitivity, swelling face, oral allergy syndrome and urticaria

Gastrointestinal disorders Nausea Oral/pharyngeal soft tissue swelling1 Oral/pharyngeal soft tissue pain and paraesthesia2 Oral ulceration and stomatitis3 Oral mucosal erythema Vomiting Dry mouth 21122441 2815137776 4020400
Nervous system disorders Somnolence Dizziness Headache 11118 1396 200
Respiratory, thoracic , and mediastinal disorders Rhinorrhea 6 7 0
General disorders and administration site conditions Fatigue 3 7 0
Injury, poisoning , and procedural complications Fall Laceration 41 66 20
Skin and subcutaneous tissue disorders Hyperhidrosis 4 6 4
Immune system disorders Hypersensitivity4 0 6 0

Less Common Adverse Reactions

Other adverse reactions, including hallucinations, delusions, and impulse control disorder, have been reported in patients treated with KYNMOBI [see Warnings and Precautions (5.7, 5.9)].

Vital Sign Changes

Blood Pressure

Decreases in blood pressure have been observed in patients treated with KYNMOBI. During the titration phase of Study 1, syncope, pre-syncope, hypotension, or orthostatic hypotension were reported as adverse reactions in 4% of patients treated with KYNMOBI. During the maintenance phase of Study 1, syncope, pre-syncope, hypotension, or orthostatic hypotension were reported as adverse reactions in 2% of patients treated with KYNMOBI, compared with 0% of patients who received placebo [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.2)].

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