FDA approves 2 new strengths of leuprolide acetate for treatment of children with central precocious puberty

August 19, 2011

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty (CPP).

CPP is a condition that causes children to enter puberty too soon, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females, and can potentially lead to a diminished adult height. By definition, CPP appears in girls under 8 years of age and boys under 9 years of age. Treatment with Lupron Depot-PED helps to arrest pubertal development until a more appropriate time.

"The approval of 2 new 3-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with CPP and may reduce the number of injections per year from 12 to 4," said Eugene Sun, MD, vice president, Global Pharmaceutical Development, Abbott.

Patients with central precocious puberty who have been prescribed Lupron Depot-PED receive an injection that is administered in the physician’s office. The 3 current strengths of Lupron Depot-PED are given to patients once a month. Now, patients who are prescribed the newly approved formulation may receive their treatments every 3 months.

Lupron Depot-PED works by suppressing the level of hormones that cause puberty. This decrease in the production of certain hormones delays premature puberty until a more appropriate time in the child's life. During puberty, the brain produces a hormone called gonadotropin-releasing hormone (GnRH). Through a complex process, GnRH causes increases in other hormones such as luteinizing hormone (LH) and follicle stimulating hormone (FSH). It is these hormones that cause the ovaries to produce estrogen and the testicles to produce testosterone.

Abbott's submission to FDA was supported by new data from a 24-week, open-label study involving 84 patients with central precocious puberty. Patients received a total of 2 injections, 12 weeks apart, and were followed for nearly 6 months to evaluate hormone suppression and safety. Overall, hormone suppression with the new 3-month depot formulation in both strengths was sustained in patients throughout the treatment period. In patients who had not been previously treated for CPP, the onset of hormone suppression was consistent with that resulting from other currently available Lupron Depot-PED formulations.

The most common side effects from this study were injection-site pain, weight gain, headache, altered mood, and injection-site swelling. The 3-month formulation is expected to become available later this month.

Central precocious puberty occurs in 1 child of every 5,000 to 10,000 children and is more common in girls.

Lupron Depot-PED 7.5-mg, 11.25-mg, and 1- mg strengths for 1-month administration for treatment of children with CPP are also available.

Children should not receive any formulation of Lupron Depot-PED if they have experienced any type of allergic reaction to Lupron Depot-PED or similar drugs. Females who are or may become pregnant should not receive any formulation of Lupron Depot-PED. During the first weeks of Lupron Depot-PED treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. The doctor should be notified if signs/symptoms of puberty continue beyond the second month of treatment.

Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in patients who are taking medications that have been associated with convulsions. Convulsions also have been reported in patients without any of these conditions.

The initial response to Lupron Depot-PED should be monitored, as should the continued response during treatment, as clinically needed. For children receiving a 1-month injection, response is assessed 1 to 2 months after the initial injection. For children receiving a 3-month injection, response is assessed 2 to 3 months after the initial injection and month 6. Height and bone age should be checked every 6 to 12 months in children using Lupron Depot-PED.

It is important that children keep their medical appointments and follow the prescribed injection schedule. Pubertal development could begin again if injections are missed.

The most common side effects for any GnRH agonist, including Lupron Depot-PED, are injection-site reactions/pain, including abscess, general pain, headache, fluctuating emotions, and hot flushes/sweating.

The most frequent adverse reactions in Lupron Depot-PED studies were pain; acne; injection-site reactions, including pain, swelling and abscess; rash, including a painful rash with fever, blisters/sores, and facial swelling; vaginitis/vaginal bleeding/vaginal discharge; increased weight; and altered mood.

Lupron Depot-PED is not for children under the age of 2 years.