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warnings and cautions
5 WARNINGS AND PRECAUTIONS Initial Rise of Gonadotropins and Sex Steroid Levels: During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty including vaginal bleeding may be observed during the first weeks of therapy or after subsequent doses. Instruct patients and caregivers to notify the physician if these symptoms continue beyond the second month after FENSOLVI administration. ( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. ( 5.2 ) Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.3 ) Severe Cutaneous Adverse Reactions (SCARs): Have been reported in patients receiving GnRH agonists, including leuprolide products. Interrupt FENSOLVI if signs and symptoms of SCARs develop. Permanently discontinue FENSOLVI if a SCAR is confirmed ( 5.4 ). Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including leuprolide acetate. Monitor patients for headache, papilledema, and blurred vision. ( 5.5 ) 5.1 Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug [see Clinical Pharmacology ( 12.2 )] . Therefore, an increase in clinical signs and symptoms of puberty including vaginal bleeding may be observed during the first weeks of therapy or after subsequent doses [see Adverse Reactions (6) ] . Instruct patients and caregivers to notify the physician if these symptoms continue beyond the second month after FENSOLVI administration. 5.2 Psychiatric Events Psychiatric events have been reported in patients taking GnRH agonists, including leuprolide acetate. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with FENSOLVI [see Adverse Reactions (6.1 , 6.2) ] . 5.3 Convulsions Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above [see Adverse Reactions (6.2) ] . 5.4 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) have been reported in patients receiving GnRH agonists, including leuprolide products [ see Adverse Reactions ( 6.2 )]. These reactions include Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts. Monitor patients for signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash or lymphadenopathy. Advise patients and caregivers of the signs and symptoms of SCARs. If a SCAR is suspected, interrupt FENSOLVI. Consult a healthcare provider with expertise in the diagnosis and management of SCARs. If a diagnosis of SCARs is confirmed, permanently discontinue FENSOLVI. 5.5 Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists, including leuprolide acetate. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea [see Adverse Reactions ( 6.2 ) ] .
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 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 )] 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 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 1. Table 1: 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 identified during post-approval use of FENSOLVI 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. 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, 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. Reproductive System: vaginal bleeding, breast enlargement. Vascular : hypertension, hypotension. Respiratory: dyspnea.