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98% of patients achieved LH suppression with TRIPTODUR by Month 122

LH Suppression to Prepubertal Levels2

Percentage of Treatment-Naive Patients Achieving Prepubertal
Luteinizing Hormone (LH)a (GnRH-Stimulated LH ≤5 IU/L)2,b

Month 1

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n/N=42/44

Month 6

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n/N=41/44
(primary endpoint)

Month 12

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n/N=43/44

Note: 95% of children (n/N=42/44) achieved prepubertal LH levelsa at Months 2, 3, and 9.

aSerum LH ≤5 IU/L 30 minutes after GnRHa stimulation.

bResults are from intent-to-treat (ITT) population.

Three patients presented with nonsuppressed LH levels at Month 6.4

  • Two of the nonresponders showed prepubertal levels at Month 12. One had a borderline LH value of 5.1 IU/L at Month 6, but a suppressed testosterone level of 2 ng/dL. The other encountered a technical problem with the first injection, which is likely to have played a significant role regarding this treatment failure.
  • The third nonresponder was a 9-year-old overweight boy with a body mass index of 23.1 kg/m2, who may have required a higher drug dose for adequate hormonal suppression or who may represent one of the rare children with CPP who do not achieve suppression with GnRHAs.

Study Design for TRIPTODUR Twice-Yearly Administration

The efficacy and safety of TRIPTODUR were demonstrated in an international, single-arm, open-label, multicenter phase 3 study over 1 year2,4

The study was an open-label, noncomparative, multicenter phase 3 trial on the efficacy and safety of triptorelin 22.5 mg 6-month formulation in patients with CPP. The study was conducted in 44 patients (n=39 girls; n=5 boys) with CPP aged 2 to 9 years who were naive to previous GnRHa treatment.2,4 TRIPTODUR was initiated no more than 18 months after onset of the first signs of puberty.4 Eighteen medical centers in the United States, Chile, and Mexico participated in the study.4

Measurements Taken:

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). 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.2,4

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. 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.4
CT=computerized tomography; FSH=follicle-stimulating hormone; IM=intramuscular; MRI=magnetic resonance imaging.

IMPORTANT SAFETY INFORMATION FOR TRIPTODUR

Indication:

TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Important Safety Information

Contraindications

TRIPTODUR is contraindicated in:

  • Individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
  • Women who are or may become pregnant. Expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to the fetus.

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.

Adverse Reactions

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.

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Important Safety Information

Contraindications

  • History of serious hypersensitivity reactions to pegylated L-asparaginase
  • History of serious thrombosis during L-asparaginase therapy
  • History of serious pancreatitis during previous L-asparaginase treatment
  • History of serious hemorrhagic events during previous L-asparaginase therapy
  • Severe hepatic impairment

WARNINGS and PRECAUTIONS

Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedicate patients 30-60 minutes prior to administration of ASPARLAS. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.

Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis. If pancreatitis is confirmed, do not resume ASPARLAS.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.

Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity: Hepatotoxicity and abnormal liver function, including elevations of transaminase, bilirubin (direct and indirect), reduced serum albumin, and plasma fibrinogen can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment that include ASPARLAS through 6 weeks after the last dose of ASPARLAS. In the event of serious liver toxicity, discontinue treatment with ASPARLAS and provide supportive care.

ADVERSE REACTIONS

The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial are elevated transaminases (52%), increased bilirubin (20%), pancreatitis (18%) and abnormal clotting studies (14%). There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst). Not all grade 1 and 2 adverse reactions were collected prospectively.

References

1. Data on file. Azurity Pharmaceuticals, Inc. 2. Triptodur [package insert]. Woburn, MA: Azurity Pharmaceuticals Inc; 2022. 3. Eugster EA. Treatment of central precocious puberty. J Endocr Soc. 2019;3(5):965-972. 4. Klein K, Yang J, Aisenberg J, et al. Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty. J Pediatr Endocrinol Metab. 2016;29(11):1241-1248. 5. Emmanuel M, Bokor BR. Tanner stages. [Updated December 11, 2022]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2023. https://www.ncbi.nlm.nih.gov/books/NBK470280. Accessed April 25, 2023. 6. Carel JC, Eugster EA, Rogol A, et al. Consensus statement of the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123(4):e752-e762. 7. Supprelin [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; 2022.