Epidemiology

Epidemiology

Incidence

Based on an 8-year of age definition for precocity used by most clinicians, epidemiology studies have shown that the overall incidence of sexual precocity is estimated to be 1:5000 to 1:10,000 children.[1]

The condition of precocious puberty is far more common in girls than in boys with a female-to-male ratio of approximately 10:1.[2]

Factors

A number of factors appear to be related to early puberty.[3]

Ethnicity

It is unclear why, but on average, black girls with precocious puberty seem to start puberty about a year earlier than white girls.

Genetics

Occasionally, precocious puberty can be triggered by genetic mutations that affect the release of sex hormones. Most often these children have a parent or sibling with similar genetic abnormalities.

International adoption

The reason here is also unclear, but children who are adopted from other countries outside the United States are 10 to 20 times more likely to develop precocious puberty.

Obesity

There is an association between obesity in young girls and an increased risk of precocious puberty, though this may not be a direct link. However, obesity does not seem to be associated with early puberty in boys.

References
  1. Carel JC, Eugster EA, Rogol A, Ghizzoni L, Palmert MR, Antoniazzi F,et al.; ESPE-LWPES GnRH Analogs Consensus Conference Group. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123(4):e752–62.
  2. Tirumuru SS, Arya P, Latthe P, Kirk J. Understanding precocious puberty in girls. Obstet Gynaecol. 2012;14(2):121-129. Doi: 10.1111/j.1744-4667.2012.00094.x.
  3. WebMD. Causes and consequences of early puberty. https://www.webmd.com/children/causes-symptoms?print=true. Accessed October 9, 2019.

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.