Fensolvi
Generic: LEUPROLIDE ACETATE
Basic Information
Manufacturer
TOLMAR Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
dfb6e01c-f138-471d-bf5b-2be38247e3f0
Indications & Usage
1 INDICATIONS AND USAGE FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial rise in gonadotropin 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 )] .
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥5%) were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough, and hot flush.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tolmar Pharmaceuticals, Inc.
at 1-844-4TOLMAR (1-844-486-5627) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical studies 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.
FENSOLVI was evaluated in an uncontrolled, open-label, single-arm clinical trial in which 64 pediatric patients with CPP received at least one dose of FENSOLVI.
The age ranged from 4 to 9 years at start of treatment; 62 patients were female and 2 were male; 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; 2% Native Hawaiian or Other Pacific Islander.
56% of the subjects self-identified as Hispanic or Latino ethnicity.
Adverse reactions that occurred in ≥ 5% of patients are shown in Table 2.
Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial Adverse Reactions % of Patients (N=64) Injection site pain 31 Nasopharyngitis 22 Pyrexia 17 Headache 16 Cough 13 Abdominal pain 9 Injection site erythema 9 Nausea 8 Constipation 6 Vomiting 6 Upper respiratory tract infection 6 Bronchospasm 6 Productive cough 6 Hot flush 5 Other Adverse Reactions: Psychiatric Emotional disorder (2%) and irritability (2%) 6.2 Postmarketing Experience The following adverse reactions have been identifed during postapproval use of leuprolide acetate or FENSOLVI.
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.
Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions.
General : chest pain, weight increase, weight decrease, decreased appetite, fatigue.
Laboratory Abnormalities: decreased WBC.
Metabolic : diabetes mellitus.
Musculoskeletal and Connective Tissue : arthralgia, epiphysiolysis, muscle spasms, myalgia.
Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial 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.
Skin and Subcutaneous Tissue : injection site reactions including induration and abscess, flushing, hyperhidrosis.
Reproductive System: vaginal bleeding, breast enlargement.
Vascular : hypertension, hypotension.
Respiratory: dyspnea.
Psychiatric Events [see Warnings and Precautions ( 5.2 )] .
Convulsions [see Warnings and Precautions ( 5.3 )] .
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥5%) were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough, and hot flush.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tolmar Pharmaceuticals, Inc.
at 1-844-4TOLMAR (1-844-486-5627) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical studies 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.
FENSOLVI was evaluated in an uncontrolled, open-label, single-arm clinical trial in which 64 pediatric patients with CPP received at least one dose of FENSOLVI.
The age ranged from 4 to 9 years at start of treatment; 62 patients were female and 2 were male; 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; 2% Native Hawaiian or Other Pacific Islander.
56% of the subjects self-identified as Hispanic or Latino ethnicity.
Adverse reactions that occurred in ≥ 5% of patients are shown in Table 2.
Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial Adverse Reactions % of Patients (N=64) Injection site pain 31 Nasopharyngitis 22 Pyrexia 17 Headache 16 Cough 13 Abdominal pain 9 Injection site erythema 9 Nausea 8 Constipation 6 Vomiting 6 Upper respiratory tract infection 6 Bronchospasm 6 Productive cough 6 Hot flush 5 Other Adverse Reactions: Psychiatric Emotional disorder (2%) and irritability (2%) 6.2 Postmarketing Experience The following adverse reactions have been identifed during postapproval use of leuprolide acetate or FENSOLVI.
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.
Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions.
General : chest pain, weight increase, weight decrease, decreased appetite, fatigue.
Laboratory Abnormalities: decreased WBC.
Metabolic : diabetes mellitus.
Musculoskeletal and Connective Tissue : arthralgia, epiphysiolysis, muscle spasms, myalgia.
Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial 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.
Skin and Subcutaneous Tissue : injection site reactions including induration and abscess, flushing, hyperhidrosis.
Reproductive System: vaginal bleeding, breast enlargement.
Vascular : hypertension, hypotension.
Respiratory: dyspnea.