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Premature sexual development

Premature sexual development

Premature sexual development may be classified as one of the following:[1]

  • Central precocious puberty (CPP) = true gonadotropin (GnRH)-dependent with activation of the HPG axis. This form of precocious puberty is associated with early maturation of the HPG axis, resulting in early pulsatile secretion of GnRH and subsequent sex hormone production from the ovaries or testes. CPP represents 80% of cases of early puberty.
  • Peripheral precocious puberty (PPP) = pseudo- or gonadotropin (GnRH)- independent without involvement of the HPG axis. Production of gonadal hormones is autonomous and independent of the activation of hypothalamic–pituitary function. PPP represents 20% of cases of early puberty.
References
  1. Haqq D, Boston B, LaFranchi S. Precocious puberty. Vol 5. In: Sciarra JJ, ed. Gynecology and Obstetrics. Philadelphia: Lippincott Williams & Wilkins; 2004.
  2. Partsch C-J. Sippell WG. Pathogenesis and epidemiology of precocious puberty. Effects of exogenous oestrogens. Hum Reproduct. 2001;7(3):292-302.


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.