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Uninterrupted LH suppression through month 12 after the first month of hormone therapy1

*Study Design

A multicenter, open-label study evaluating the effectiveness and safety of a 50-mg histrelin subcutaneous implant in children with central precocious puberty (CPP). The initial duration of treatment was 12 months (plus a 1-month follow-up period), with the possibility of rolling over into multiple 12-month extension phases. Efficacy assessments included endpoints that measured the suppression of gonadotropins (LH and FSH) and gonadal sex steroids (estrogen in girls and testosterone in boys) on treatment as well as bone age advancement and linear growth.1,2

SUPPRELIN® Long-Acting maintained suppression in treatment-naïve patients and pre-treated patients through month 12 (n=36)1,2

Once-Yearly Dosing

Learn how SUPPRELIN® LA delivers a full year of medication in a single implant.1

Billing and Coding

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FSH=follicle-stimulating hormone.
GnRHa=gonadotropin-releasing hormone agonist.
LH=luteinizing hormone.

Consistent histrelin acetate release for a full year in most subjects1

*Study Design

Pharmacokinetics of histrelin after implantation of SUPPRELIN® LA was evaluated in a total of 47 children with central precocious puberty (CPP) (11 patients in Study 1 and 36 patients in Study 2) at 4 weeks after implant insertion and throughout the treatment period.1

There was no apparent pharmacokinetic difference between treatment-naïve patients and pre-treated patients1

  • Median peak serum histrelin concentration over the study period was 0.43 ng/mL, which is expected to maintain gonadotropins at prepubertal levels
  • Median serum histrelin concentrations remained above the limit of quantification for the treatment period

Patient Profiles

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Resources

Discover important information you can share with parents and caregivers about CPP and treatment with SUPPRELIN® LA.

FSH=follicle-stimulating hormone.
GnRHa=gonadotropin-releasing hormone agonist.
LH=luteinizing hormone.
INDICATION
  • SUPPRELIN® LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP)
  • Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment
  • Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia
IMPORTANT SAFETY INFORMATION about SUPPRELIN® LA
  • SUPPRELIN® LA is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs and in females who are or may become pregnant while receiving the drug. SUPPRELIN® LA is pregnancy Category X. SUPPRELIN® LA may cause fetal harm or spontaneous abortion when administered to pregnant patients. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus
  • SUPPRELIN® LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment, with worsening or onset of new symptoms during this period. Within 4 weeks of therapy, gonadal steroid suppression occurs and manifestations of puberty decrease
  • Implant insertion and removal is a surgical procedure and should utilize aseptic technique. Careful adherence to the recommended insertion and removal procedures is recommended to avoid potential complications. Proper surgical technique is critical in minimizing adverse events related to the insertion and the removal of the histrelin implant. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used including ultrasound, CT, or MRI (this implant is not radiopaque). In some cases the implant broke during removal and multiple pieces were recovered. Rare events of spontaneous extrusion have been observed in clinical trials. During SUPPRELIN® LA treatment, patients should be evaluated for evidence of clinical and biochemical suppression of CPP manifestation
  • LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months. Every 6-12 months, height and bone age should be assessed
  • In clinical trials, the most common adverse reactions involved the implant site and included discomfort, bruising, soreness, pain, tingling, itching, erythema, and implant area protrusion and swelling
  • Seizures (Nervous system disorders) have been identified during post-approval use of SUPPRELIN® LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
  • The safety and effectiveness in pediatric patients under the age of 2 years has not been established. The use of SUPPRELIN® LA in children under 2 years is not recommended

Please see full Prescribing Information for SUPPRELIN® LA.

More Safety Info
 
INDICATION
  • SUPPRELIN® LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP)
  • Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment
  • Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia
IMPORTANT SAFETY INFORMATION about SUPPRELIN® LA
  • SUPPRELIN® LA is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs and in females who are or may become pregnant while receiving the drug. SUPPRELIN® LA is pregnancy Category X. SUPPRELIN® LA may cause fetal harm or spontaneous abortion when administered to pregnant patients. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus
  • SUPPRELIN® LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment, with worsening or onset of new symptoms during this period. Within 4 weeks of therapy, gonadal steroid suppression occurs and manifestations of puberty decrease
  • Implant insertion and removal is a surgical procedure and should utilize aseptic technique. Careful adherence to the recommended insertion and removal procedures is recommended to avoid potential complications. Proper surgical technique is critical in minimizing adverse events related to the insertion and the removal of the histrelin implant. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used including ultrasound, CT, or MRI (this implant is not radiopaque). In some cases the implant broke during removal and multiple pieces were recovered. Rare events of spontaneous extrusion have been observed in clinical trials. During SUPPRELIN® LA treatment, patients should be evaluated for evidence of clinical and biochemical suppression of CPP manifestation
  • LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months. Every 6-12 months, height and bone age should be assessed
  • In clinical trials, the most common adverse reactions involved the implant site and included discomfort, bruising, soreness, pain, tingling, itching, erythema, and implant area protrusion and swelling
  • Seizures (Nervous system disorders) have been identified during post-approval use of SUPPRELIN® LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
  • The safety and effectiveness in pediatric patients under the age of 2 years has not been established. The use of SUPPRELIN® LA in children under 2 years is not recommended

Please see full Prescribing Information for SUPPRELIN® LA.

References

1.
SUPPRELIN® LA [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; 2013.
2.
Eugster EA, Clarke W, Kletter GB, et al. Efficacy and safety of histrelin subdermal implant in children with central precocious puberty: a multicenter trial. J Clin Endocrinol Metab. 2007;92(5):1697-1704.

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Rx Only

SUPPRELIN® is a registered trademark of Endo International plc or one of its affiliates.

© 2015 Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA 19355

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INDICATION
INDICATION & IMPORTANT SAFETY INFO
INDICATION
  • SUPPRELIN® LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP)
  • Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment
  • Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia
IMPORTANT SAFETY INFORMATION about SUPPRELIN® LA
  • SUPPRELIN® LA is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs and in females who are or may become pregnant while receiving the drug. SUPPRELIN® LA is pregnancy Category X. SUPPRELIN® LA may cause fetal harm or spontaneous abortion when administered to pregnant patients. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus
  • SUPPRELIN® LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment, with worsening of symptoms or onset of new symptoms during this period. Within 4 weeks of therapy, gonadal steroid suppression occurs and manifestations of puberty decrease
  • Implant insertion and removal is a surgical procedure and should utilize aseptic technique. Careful adherence to the recommended insertion and removal procedures is recommended to avoid potential complications. Proper surgical technique is critical in minimizing adverse events related to the insertion and the removal of the histrelin implant. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used including ultrasound, CT, or MRI (this implant is not radiopaque). In some cases the implant broke during removal and multiple pieces were recovered. Rare events of spontaneous extrusion have been observed in clinical trials. During SUPPRELIN® LA treatment, patients should be evaluated for evidence of clinical and biochemical suppression of CPP manifestation
  • LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months. Every 6-12 months, height and bone age should be assessed
  • In clinical trials, the most common adverse reactions involved the implant site and included discomfort, bruising, soreness, pain, tingling, itching, erythema, and implant area protrusion and swelling
  • Seizures (Nervous system disorders) have been identified during post-approval use of SUPPRELIN® LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
  • The safety and effectiveness in pediatric patients under the age of 2 years has not been established. The use of SUPPRELIN® LA in children under 2 years is not recommended

Please see full Prescribing Information for SUPPRELIN® LA.