Full Prescribing Information|Medication Guide

A full year of consistent medication delivered in a single, small, flexible implant1

Consistently delivers ~65 mcg of histrelin acetate every day for 1 full year.1

Minimally invasive procedures1:

  • Insertion and removal are minimally invasive surgical procedures that may be performed under local anesthetic using aseptic technique
  • The method of anesthesia used (ie, local, conscious sedation, general) is at the discretion of the healthcare professional
  • For more information on the suggested insertion and removal procedure, please see the full Prescribing Information
Polaroid 1

The SUPPRELIN® LA Implantation Kit1

SUPPRELIN® LA is supplied in a corrugated shipping carton that contains 2 inner cartons: a small one for the vial containing the SUPPRELIN® LA implant, which is shipped with a cold pack inside a polystyrene cooler that must be refrigerated upon arrival, and a larger one comprising the Implantation Kit, which must not be refrigerated, for use during insertion or removal of SUPPRELIN® LA. The SUPPRELIN® LA Implantation Kit includes all the necessary components for the insertion and removal of the implant (sterile gloves not included).

Implantation Kit

The Implantation Kit is to be stored at room temperature and should NOT be refrigerated.

Components

  • 1 #15 disposable scalpel
  • 1 syringe with 18-gauge needle
  • 1 25-gauge, 1.5” needle
  • 1 SS mosquito clamp
  • 4 packages gauze sponges
  • 2 packages alcohol swabs
  • 1 fenestrated drape
  • 1 non-fenestrated drape
  • 1 package skin antiseptic swab
  • 1 package surgical closure strips
  • 1 package coated absorbable suture
  • 1 package cohesive bandage
  • 1 vial local anesthetic (manufacturer may vary)
  • 1 implant insertion tool
  • 1 benzoin tincture antiseptic
  • Prescribing Information, including Medication Guide*

Item not shown.

The SUPPRELIN® LA implant contains 50 mg of histrelin acetate. The SUPPRELIN® LA implant carton contains a cold pack for refrigerated shipment and a small carton containing an amber plastic pouch. Inside the pouch is a glass vial with a Teflon-coated stopper and an aluminum seal, containing the implant in 2 mL of sterile 1.8% sodium chloride solution. (Note: The 3.5-mL vial is not completely filled with saline.) Upon receipt, refrigerate the small carton containing the amber plastic pouch and glass vial (with the implant inside) until the day of insertion. The implant vial should not be opened until just before the time of insertion.1

Download full instructions for implanting and removing the SUPPRELIN® LA implant
See suggested billing and coding for SUPPRELIN® LA†

Coding is part of the clinical decision. Please use codes that most accurately reflect the procedures performed. Suggestions by Endo do not guarantee reimbursement or take the place of professional coding advice.

 
See More
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 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. Confirm that the entire implant has been removed. Monitor luteinizing hormone, follicle stimulating hormone or testosterone for suppression of CPP. 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.

  • Psychiatric events have been reported in patients taking GnRH agonists, including SUPPRELIN® LA. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including SUPPRELIN® LA, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Monitor for development or worsening of psychiatric symptoms during treatment with SUPPRELIN® LA.

  • Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN® LA. Reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

  • Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.

  • 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.

  • The safety and effectiveness in pediatric patients under the age of 2 years have not been established. The use of SUPPRELIN® LA in children under 2 years is not recommended.

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.

Please see the full Prescribing Information.

See More
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 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. Confirm that the entire implant has been removed. Monitor luteinizing hormone, follicle stimulating hormone or testosterone for suppression of CPP. 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.

  • Psychiatric events have been reported in patients taking GnRH agonists, including SUPPRELIN® LA. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including SUPPRELIN® LA, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Monitor for development or worsening of psychiatric symptoms during treatment with SUPPRELIN® LA.

  • Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN® LA. Reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

  • Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.

  • 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.

  • The safety and effectiveness in pediatric patients under the age of 2 years have not been established. The use of SUPPRELIN® LA in children under 2 years is not recommended.

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.

Please see the full Prescribing Information.

Reference: 1. SUPPRELIN® LA [package insert]. Endo USA, Inc.

Intended for U.S. Healthcare Professionals Only

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