supprelinla.com SUPPRELIN? LA (histrelin acetate) | HCP Website

supprelinla.com
Title: SUPPRELIN? LA (histrelin acetate) | HCP Website
Keywords: supprelin la, histrelin acetate, supprelin la implant, central precocious puberty, treatment for central precocious puberty
Description: HCPs can learn about SUPPRELIN? LA (histrelin acetate) 47 safety and side effects, features and risks, including full prescribing information
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Alexa Rank: 7329884
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supprelinla.com Traffic & Earnings

Purchase/Sale Value: $2,324
Daily Revenue: $6
Monthly Revenue $191
Yearly Revenue: $2,324
Daily Unique Visitors 586
Monthly Unique Visitors: 17,580
Yearly Unique Visitors: 213,890

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central precocious puberty 5 0.94%
treatment for central precocious puberty 1 0.29%

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SUPPRELIN? LA (histrelin acetate) | HCP Website We're sorry but our site requires JavaScript. Full Prescribing Information Full Important Safety Information FOR CAREGIVERS FOR CAREGIVERS FOR HEALTHCARE PROFESSIONALS Home Clinical Data 1-Year Data 5-Year Data Safety Once-Yearly Dosing Once-Yearly Dosing Patient Profiles Procedure Get SUPPRELIN? LA Resources Print Email SUPPRELIN? Long-Actinga€”The only once-yearly treatment for central precocious puberty (CPP)1 Uninterrupted medication delivery for a full year1 Once-Yearly Dosing Hypothetical patient. Get to know your SUPPRELIN? LA patient See how treatment with SUPPRELIN? LA might fit into your patientsa€? lifestyles1 Meet Kayla & Justin Hypothetical patient. Get SUPPRELIN? LA The SUPPRELIN? LA Support Center may help your patients get started on therapy Discover the Support Center Justin is a hypothetical patient. 5-Year Data Review long-term results for SUPPRELIN? LA. Resources Discover important information you can share with parents and caregivers about CPP and treatment with SUPPRELIN? LA. 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. Reference 1. SUPPRELIN? LA [package insert]. Malvern, PA: Endo Pharmaceuticals Inc; 2013. TOP Intended for U.S. Residents Only Home Full Prescribing Information Contact Us Site Map Corporate Home 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 Privacy/Legal SP-04001/October 2015 www.supprelinla.com 1-800-462-ENDO (3636) INDICATION SUPPRELIN? LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP) 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. If you would like to email a link to this page of the website, provide your name and email address, as well as the recipients’ email address(es), in the form fields below: * = Required Fields *Sender's Name: *Sender's Email Address: *Recipients' Email Address(es): Subject line: Information that may be of interest to you Endo Pharmaceuticals Inc is committed to respecting the privacy of its website visitors. No personal information (including email addresses) about you or the recipient will be collected from this email notification feature offered by Endo Pharmaceuticals. For more information about how Endo Pharmaceuticals protects personal information about you, please read our Privacy Policy at www.endo.com/privacy-legal. Cancel You are now leaving the SUPPRELIN? LA website. Endo Pharmaceuticals is not responsible for the content of linked sites. 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