d by 60% of subjects following administration of INBRIJA and 0% followingadministration of placebo. Following administration of INBRIJA, 10 subjects (40%) hadtemporary reductions from baseline (between 15% and 59%) for FEV1; 4 of these subjects alsohad a reduction in FEV1 following administration of placebo. Subjects with a reduction in FEV1remained asymptomatic and did not require rescue treatment.
5.7 Glaucoma
INBRIJA may cause increased intraocular pressure in patients with glaucoma. Monitor patientsfor increased intraocular pressure during therapy with INBRIJA.
5.8 Laboratory Test Abnormalities
Abnormalities in laboratory tests may include elevations of liver function tests such as alkalinephosphatase, AST, ALT, lactic dehydrogenase (LDH), and bilirubin. Abnormalities in blood ureanitrogen (BUN), hemolytic anemia and positive direct antibody test have also been reported.Patients taking levodopa or carbidopa-levodopa may have increased levels of catecholaminesand their metabolites in plasma and urine giving false positive results suggesting the diagnosis ofpheochromocytoma in patients on levodopa and carbidopa-levodopa.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed below and elsewhere in the labeling:
Falling Asleep During Activities of Daily Living and Somnolence [see Warnings andPrecautions (5.1)]
Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions(5.2)]
Hallucinations/Psychosis [see Warnings and Precautions (5.3)]
Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.4)]
Dyskinesia [see Warnings and Precautions (5.5)]
Bronchospasm in Patients with Lung Disease [see Warnings and Precautions (5.6)]
Glaucoma [see Warnings and Precautions (5.7)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in Study 1
Table 1 lists the adverse reactions that occurred in at least 2% of patients with Parkinson’sdisease who were treated with INBRIJA 84 mg and higher than placebo for OFF periods inStudy 1 [see Clinical Studies (14)]. Study 1 was a double-blind, placebo-controlled study, inwhich 114 patients received INBRIJA 84 mg (two 42 mg capsules) for an average of 2 doses perday, to a maximum of 5 times a day, and 112 patients received placebo. INBRIJA-treated
patients were 45-82 years of age (mean 63.5 years of age) and were predominantly male (72%)and white (94%). All patients were also treated with oral carbidopa/levodopa.
The most commonadverse reactions (≥ 5% and higher than placebo) in Study 1 were cough, nausea, upperrespiratory tract infection, and sputum discolored.
Table 1: Adverse Reactions at an Incidence ≥2% and More Frequent with INBRIJA
than with Placebo in Study 1
Adverse Reactions INBRIJA 84 mg
N=114
%
Placebo
N=112
%
Respiratory, thoracic and mediastinal disorders
Cough
Sputum discolored
Nasal discharge discoloration
Oropharyngeal pain
15
5
2
2
2
0
0
0
Gastrointestinal disorders
Nausea
Vomiting
5
3
3
0
Infections and infestations
Upper respiratory tract infection
Nasopharyngitis
Bronchitis/pneumonia
6
3
2
3
2
0
Nervous system disorders
Dyskin |
