TRIPTODUR
Generic: TRIPTORELIN
Basic Information
Manufacturer
Azurity Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
f41380e7-b830-432d-a5f5-a872932f107e
Indications & Usage
1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.
( 1 )
TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [ see Warnings and Precautions ( 5.1 ) ] Psychiatric Events [ see Warnings and Precautions ( 5.2 ) ] Convulsions [ see Warnings and Precautions ( 5.3 ) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.4 ) ] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 ) ] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months.
The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian.
Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial.
Table 1: Adverse Reactions1 Occurring in ≥ 2 Patients Treated with TRIPTODUR in an Open-Label Single-Arm Trial Adverse Reactions Number of Patients Reporting Event (%) (Total N=44) Infections & Infestations Bronchitis 2 (4.5) Gastroenteritis 3 (6.8) Influenza 2 (4.5) Nasopharyngitis 6 (13.6) Otitis externa 2 (4.5) Pharyngitis 2 (4.5) Sinusitis 2 (4.5) Upper respiratory tract infection 4 (9.1) Nervous System Disorders Headache 6 (13.6) Reproductive System & Breast Disorders Menstrual (Vaginal bleeding) 2 3 (7.7) Respiratory, Thoracic & Mediastinal Disorder Cough 3 (6.8) Vascular Disorders Hot flush 2 (4.5) 1 Injection site reactions are presented separately 2 Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44.
Other Selected Adverse Reactions: Injection Site Reactions Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).
Psychiatric Disorders Anxiety (2.3%) and mood altered (2.3%) 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of triptorelin or GnRH agonists.
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.
Hypersensitivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.
Cardiovascular: Hypertension.
Psychiatric: Emotional lability, such as crying, irritability, impatience, anger, and aggression .
Depression, including rare reports of suicidal ideation and attempt.
Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.
Nervous System: Convulsions , pseudotumor cerebri (idiopathic intracranial hypertension) Vision Disorders: Visual impairment, visual disturbance Skin Reactions: erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc.
at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months.
The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian.
Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial.
Table 1: Adverse Reactions1 Occurring in ≥ 2 Patients Treated with TRIPTODUR in an Open-Label Single-Arm Trial Adverse Reactions Number of Patients Reporting Event (%) (Total N=44) Infections & Infestations Bronchitis 2 (4.5) Gastroenteritis 3 (6.8) Influenza 2 (4.5) Nasopharyngitis 6 (13.6) Otitis externa 2 (4.5) Pharyngitis 2 (4.5) Sinusitis 2 (4.5) Upper respiratory tract infection 4 (9.1) Nervous System Disorders Headache 6 (13.6) Reproductive System & Breast Disorders Menstrual (Vaginal bleeding) 2 3 (7.7) Respiratory, Thoracic & Mediastinal Disorder Cough 3 (6.8) Vascular Disorders Hot flush 2 (4.5) 1 Injection site reactions are presented separately 2 Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44.
Other Selected Adverse Reactions: Injection Site Reactions Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).
Psychiatric Disorders Anxiety (2.3%) and mood altered (2.3%) 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of triptorelin or GnRH agonists.
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.
Hypersensitivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.
Cardiovascular: Hypertension.
Psychiatric: Emotional lability, such as crying, irritability, impatience, anger, and aggression .
Depression, including rare reports of suicidal ideation and attempt.
Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.
Nervous System: Convulsions , pseudotumor cerebri (idiopathic intracranial hypertension) Vision Disorders: Visual impairment, visual disturbance Skin Reactions: erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis