NATESTO

Adverse Drug Reaction Overview In the Phase 3 clinical study of 306 patients treated with NATESTO, the most common adverse events reported were local nasal reactions at the site of gel application. The most frequently observed were rhinorrhea, epistaxis and nasal discomfort which were mild and transient in the majority of cases.

The adverse drug reactions observed in at least 2% of patients are listed below in Table 1, shown by system organ class and in order of decreased frequency. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. NATESTO was evaluated in a multicenter, open-label clinical study that included 90-Day Treatment period and two, open-label safety extension periods of 90 and 180 days, respectively.

A total of 306 hypogonadal men with morning testosterone concentrations ≤ 300 ng/dL received NATESTO (see Clinical Studies). 90-Day Treatment Period Table 1 summarizes the most common (experienced by ≥2% of patients in any treatment group) Adverse Drug Reactions during the 90-day Treatment Period.

Table 1:

Summary of Adverse Drug Reactions (≥2% of Patients in Any Treatment Group) – Treatment Period. 6% each). 6% each). 1%). 9%). 5%). Less Common Clinical Trial Adverse Drug Reactions (<1%) Adverse Drug Reactions occurring in less than 1% of patients are presented in Table 2 below.

NATESTO® Product Monograph Page 11 of 39 Table 2:

Clinical Trial Adverse Drug Reactions (<1%) Grouped by System Organ Class System Organ Class Preferred Term Endocrine Disorders Endocrine Disorder, Hyperthyroidism Eye Disorders Dry Eye, Eye Pruritus, Glaucoma Gastrointestinal Disorders Dyspepsia, Gastroesophageal Reflux Disease, Retching, Vomiting General Disorders and Administration Site Conditions Pyrexia, Chills, Fatigue, Nodule, Oedema Peripheral, Immune System Disorders Hypersensitivity Infections and Infestations Rhinitis, Ear Infection, Nasal Vistibulitis, Pharyngitis Injury, Poisoning and Procedural Complications Excoriation, Sensation of a Foreign Body Investigations Blood Creatine Phosphokinase Increased, Blood Luteinising Hormone Decreased, Weight Increased, Blood Follicle Stimulating Hormone Decreased, Blood Glucose Increased, Blood Prolactin Decreased, Blood Thyroid Stimulating Hormone Increased, Electrocardiogram QT Prolonged, Haematocrit Increased, Neutrophil Count Increased, Oestradiol Increased, QRS Axis Abnormal Metabolism and Nutrition Disorders Decreased Appetite, Hypercholesterolaemia, Hyperlipidaemia, Hypertriglyceridaemia Musculoskeletal and Connective Tissue Disorders Myalgia, Arthralgia, Pain In Extremity Nervous System Disorders Headache, Anosmia, Burning Sensation, Depressed Level Of Consciousness, Migraine, Paraesthesia Psychiatric Disorders Anger, Abnormal Dreams Renal and Urinary Disorders Hematuria, Nocturia, Urinary Retention Reproductive System and Breast Disorders Prostatomegaly, Ejaculation Disorder, Erectile Dysfunction, Testicular Atrophy Respiratory, Thoracic and Mediastinal Disorders Increased Viscosity Of Nasal Secretion, Nasal: Obstruction, Discharge Discolouration, Oedema, Septum Deviation, Septum Ulceration, Ulcer, […]