CPP untreated

If CPP is left untreated

Central precocious puberty can have an impact on growth, development, and the psychosocial well-being of the child.

For untreated children, the long-term outcomes may include short stature, body disproportion, and obesity.

The association between early puberty and negative behavioral outcomes may be due to. [1]

  • Lack of developmental readiness (i.e., children are not prepared for the sudden emotional and increased drive in adolescence)
  • Psychological distress caused by developing earlier than their peers

Therefore, early diagnosis and adequate treatment are important to ensure that these children experience normal physical and psychological development.[2]

Treatment continues for a finite time until the child reaches the age when puberty onset would occur naturally.[3][4]

References
  1. Galván, A. 2017. Puberty. In: The Neuroscience of Adolescence (Cambridge Fundamentals of Neuroscience in Psychology). 1st ed. Cambridge: Cambridge University Press; 2017:21-49.
  2. Kaplowitz P, Bloch C. Evaluation and referral of children with signs of early puberty. Pediatrics. 2016;137(1):e20153732. doi:10.1542/peds. 2015-3732.
  3. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
  4. Klein K, Soliman AM, Bonafede M, et al. Health Care Utilization and Economic Burden in Patients with Central Precocious Puberty: An Assessment of the Commercially Insured and Medicaid Populations. J Manag Care Spec Pharm. 2019;25(7):836-846. doi:10.18553/jmcp.2019.25.7.836

IMPORTANT SAFETY INFORMATION

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FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

Convulsions have been observed in patients treated with GnRH agonists 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 such as bupropion and SSRIs.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) has been reported in pediatric patients treated with GnRH agonists.  Patients should be monitored for headache, papilledema and blurred vision.

The most common adverse events seen with FENSOLVI 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. 

Please see Full Prescribing Information for FENSOLVI for additional important safety information. 

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.