Effectively treat Central

Precocious Puberty with the

only PBS-listed treatment.
1,2

Maintained LH suppression for up to 36 months of additional treatment beyond 6 months3

Lucrin (leuprorelin acetate) Depot

Paediatric 30 mg Pre-filled Dual Chamber
Syringe (PDS) Injection 3 months2
Sustained LH suppression
100% of subjects (n=38) maintained LH < 4 IU/L at their final visit over 42 months
(6 months pivotal trial plus 36 months extension)3

Suppressed clinical sexual characteristics of puberty at 6 months3

Pubic hair suppressed in 94% of girls and 80% of boys
Breast development in 84% of girls (regression or no change in pubertal stage)

Favourable safety profile

With no new or unexpected safety concerns identified over 42 months
(6 months pivotal trial plus 36 months extension)3,4

Updated PBS initiation criteria

The patient must be aged 10 years or younger (girls) or 11 years or younger (boys)
AND patient must have had onset of signs or symptoms of central precocious puberty prior
to the age of 8 years (girls) or 9 years (boys).1
Initiation*

Telephone Authority required

Call 1800 888 333
Max no. of repeats: 1

Continuation*

Authority required
(Streamlined 4871)
Max no. of repeats: 1

*Lucrin Depot Paediatric must be initiated by a paediatric endocrinologist or an endocrinologist specialising in paediatrics and may be
continued in consultation with these specialists.

PBS Information: Authority Required. Treatment of Central Precocious Puberty (CPP) by or

in conjunction with a paediatric endocrinologist or an endocrinologist specialising in paediatrics.
Refer to PBS Schedule for full information.

Please review Product Information before prescribing.

To have a copy of the Product Information sent to you telephone: 1800 043 460.
MINIMUM PRODUCT INFORMATION Lucrin Depot Paediatric 30 mg Prelled Dual-Chamber Syringe (PDS) Injection 3-Month (Sterile leuprorelin acetate for Suspension). INDICATIONS
Treatment of children with central precocious puberty (CPP). CONTRAINDICATIONS Hypersensitivity to GnRH, GnRH agonists, any of the excipients in Lucrin Depot Paediatric 30 mg, pregnancy and
nursing mothers (although not expected to be relevant to the indication). PRECAUTIONS Initial rise in clinical signs and symptoms of puberty, pituitary apoplexy, convulsions, emotional lability and
tearfulness, potential atrophy of reproductive organs and suppression of reproductive performance (reversible after a long treatment-free period) in females. No safety or efcacy data in paediatric
patients < 2 years. Noncompliance with treatment regimen or inadequate dosing may result in lack of control of pubertal process with gonadotropins and/or sex steroids increasing above
prepubertal levels. Prior to treatment, CPP should be clinically diagnosed by: - Measurement of blood concentrations of LH and sex steroids - Assessment of bone age vs. chronological age
Baseline evaluations should include - Height and weight measurements - Diagnostic imaging of brain - Pelvic/testicular/adrenal ultrasound - Human chorionic gonadotropin levels - Adrenal
steroid measurements Response to treatment should be monitored with a GnRH stimulation test, basal LH or serum concentration of sex steroid levels at months 2-3, month 6 and further as
clinically appropriate. Height and bone age should be assessed every 6-12 months. ADVERSE EFFECTS Injection site reactions/pain, general pain, headache, emotional lability, hot ushes/
sweating, initial increase in clinical signs/symptoms of puberty (are effect), decreased appetite, obesity, dizziness, tearfulness, cough, hyperhidrosis, pallor, see full PI. DOSAGE AND METHOD
OF USE Must only be prescribed after initial assessment by a paediatric endocrinologist, and with the ongoing supervision of such a specialist. Intramuscular injection. Vary site of administration.
30mg injection 3 monthly. Hormonal and clinical parameters to be monitored during treatment, e.g. at month 2-3, month 6 and further as clinically appropriate, to ensure adequate
suppression. (See full PI for dosing guidelines). DATE OF PREPARATION January 2015, based on Product Information last updated 12th December 2014. Version 02. References:
1. Department of Health, Pharceutical Benets Scheme, available from www.pbs.gov.au, accessed December 2015. 2. LUCRIN Approved Product Information. December 2014.
3. Lee PA, et al. J Clin Endocrinol Metab 2014, 99: 3153-3159 4. Lee PA, et al. J Clin Endocrinol Metab 2012, 97: 1572-1580. AbbVie is a registered trademark of AbbVie Inc.
AbbVie Pty Ltd, ABN 48 156 384 262, Level 7, 241 ORiordan Street, Mascot 2020. Medical Information phone: 1800 043 460 www.abbvie.com.au AU-LUC-2014-49(a) January 2016