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The efficacy and safety
of TRIPTODUR were
demonstrated in a multicenter
phase 3 study1,2
aMeasurement of serum LH, FSH, estradiol (girls), and testosterone (boys) levels collected at screening and at Months 1 (Day 29), 2 (Day 57), 3 (Day 85), 6 (Day 169), 9 (Day 253), and 12 (Day 337).1,2 LH and FSH were assessed both before and 30 minutes after stimulation with commercial leuprolide acetate 20 μg/kg subcutaneous injectable solution 1 mg/0.2 mL.1,2
bTransabdominal ultrasound was performed in girls; bone age was assessed by x-ray of the left hand and wrist. Collected during screening period, Month 6, and Month 12.2 Presence of unstable intracranial tumors at screening was excluded by MRI or CT scans of the brain, unless they had been performed within 3 months prior to treatment initiation.
93% of children
suppression with TRIPTODUR at
Month 6 (primary endpoint)1
LH suppression to prepubertal
levels as early as Month 11
98% of children achieved LH suppression with TRIPTODUR at Month 121
Three patients presented with nonsuppressed LH levels at Month 6.2
Note: 95% of children (n/N=42/44) achieved prepubertal LH levelsa at Months 2, 3, and 9.
aSerum LH ≤5 IU/L thirty minutes after GnRH-agonist stimulation.
bResults are from intent-to-treat (ITT) population.
effective suppression of
stimulated LH throughout the study3
Mean LH remained
suppressed to prepubertal
levels (≤5 IU/L) at all time
points post-initiation of
Please go to section labeled "LH suppression to prepubertal levels" for more information about treatment nonresponders.
of sex steroids2
Suppression was achieved
from Week 4 through Week 482
TRIPTODUR arrested or reversed
progression of clinical signs of puberty1,2
77% of girls
(n/N=30/39) exhibited regression of uterine
length at Month 121
100% of boys
(n/N=5/5) showed absence of progression
of testicular volume at Month 121
aResults are from ITT population.
bMonth 6 data: 64% (n/N=28/44).
cMonth 6 data: 91% (n/N=40/44).
*Tanner stage refers to a scale used to measure the onset and progression of pubertal changes as determined by the physical development of secondary sex characteristics.4
BA, bone age; BMI, body mass index; CA, chronological age; CPP, central precocious puberty; CT, computerized tomography; FSH, follicle-stimulating hormone; GnRH, gonadotropin-releasing hormone; IM, intramuscular; ITT, intent-to-treat; LH, luteinizing hormone; MRI, magnetic resonance imaging.
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
IMPORTANT SAFETY INFORMATION
TRIPTODUR is contraindicated in:
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, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.
Psychiatric Events - Psychiatric events have been reported in patients taking GnRH agonists. 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 TRIPTODUR.
Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. 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.
Pseudotumor Cerebri (idiopathic intracranial hypertension) - has been reported in pediatric patients receiving GnRH agonists, including triptorelin. 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.
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).
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
The Important Safety Information does not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.