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Consistent LH suppression through 5 years2

Treatment-naïve and pre-treated subjects.
Baseline to 12 months: P<0.0001; baseline to 24 months: P<0.0001; baseline to 36 months: P<0.01; baseline to 48 months: P<0.05; baseline to 60 months: P<0.05.
  • Discontinuation of SUPPRELIN® LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males)1
*Study Design

A long-term extension of a Phase 3, prospective, open-label study evaluating the effectiveness and safety of a 50-mg histrelin subcutaneous implant in children with central precocious puberty (CPP). Patients deemed clinically appropriate for continued treatment were eligible to enter the study extension; the previous implant was removed after 12 months and a new implant inserted, for up to 72 months. Of 36 children (33 girls, 3 boys) enrolled in the initial trial, 11 received a fifth implant and completed 60 months of therapy; 2 children received a sixth implant and completed 72 months of therapy. The primary endpoint was LH suppression as measured in response to GnRHa stimulation.2

Uninterrupted control after the first month of therapy1

  • In an open-label extension study through 5 years, SUPPRELIN® LA maintained significant LH suppression in all patients at 60 months of therapy, following once-yearly insertion and removal (P<0.05, n=8)2
  • SUPPRELIN® LA minimized the potential for interruptions in LH suppression during each 12-month dosing interval1,2
  • In a Phase 3 study, 97% (31/32) of parents of eligible children opted to continue with SUPPRELIN® LA treatment when subsequent treatment was recommended by the prescribing healthcare professional3

Implant

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Insertion & Removal

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GnRHa=gonadotropin-releasing hormone agonist.
LH=luteinizing hormone.

Estradiol suppression through 5 years2

Treatment-naïve and pre-treated subjects.
  • Discontinuation of SUPPRELIN® LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males)1
*Study Design

A long-term extension of a Phase 3, prospective, open-label study evaluating the effectiveness and safety of a 50-mg histrelin subcutaneous implant in children with central precocious puberty (CPP). Patients deemed clinically appropriate for continued treatment were eligible to enter the study extension; the previous implant was removed after 12 months and a new implant inserted, for up to 72 months. Of 36 children (33 girls, 3 boys) enrolled in the initial trial, 11 received a fifth implant and completed 60 months of therapy; 2 children received a sixth implant and completed 72 months of therapy. The primary endpoint was LH suppression as measured in response to GnRHa stimulation.2

Control after the first month of therapy1

  • Estradiol suppression was present in all 33 girls (100%) through month 9 and 97% at month 121
  • Mean estradiol levels remained suppressed through the fifth year of therapy following annual insertion and removal of SUPPRELIN® LA (n=7)2

The SUPPRELIN® LA Implantation Kit

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Billing and Coding

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GnRHa=gonadotropin-releasing hormone agonist.

Sustained decrease in bone age to chronological age ratio through 5 years2

Baseline to 12 months: P<0.0001; baseline to 24 months: P<0.0001; baseline to 36 months: P<0.0001; baseline to 48 months: P<0.001; baseline to 60 months: P<0.01.
  • Discontinuation of SUPPRELIN® LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males)1
*Study Design

A long-term extension of a Phase 3, prospective, open-label study evaluating the effectiveness and safety of a 50-mg histrelin subcutaneous implant in children with central precocious puberty (CPP). Patients deemed clinically appropriate for continued treatment were eligible to enter the study extension; the previous implant was removed after 12 months and a new implant inserted, for up to 72 months. Of 36 children (33 girls, 3 boys) enrolled in the initial trial, 11 received a fifth implant and completed 60 months of therapy; 2 children received a sixth implant and completed 72 months of therapy. The primary endpoint was LH suppression as measured in response to GnRHa stimulation.2

SUPPRELIN® Long-Acting significantly reduced the mean BA to CA ratio through the fifth year of therapy (P<0.01, n=7)2

Resources

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

Get SUPPRELIN® LA

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BA=bone age.
CA=chronological age.
GnRHa=gonadotropin-releasing hormone agonist.
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.
Silverman LA, Neely EK, Kletter GB, et al. Long-term continuous suppression with once-yearly histrelin subcutaneous implants for the treatment of central precocious puberty: a final report of a phase 3 multicenter trial. J Clin Endocrinol Metab. 2015;100(6):2354-2363.
3.
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.
4.
Data on file, DOF-SP-22. Endo Pharmaceuticals Inc; 2015.

Intended for U.S. Residents Only

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.