{
 "query": "histrelin",
 "ingredient": "histrelin",
 "slug": "histrelin",
 "rxcui": "50975",
 "brands": [
  "Supprelin"
 ],
 "names": [
  "histrelin",
  "histrelin acetate"
 ],
 "classes": [
  {
   "id": "L02AE",
   "name": "Gonadotropin releasing hormone analogues"
  }
 ],
 "alternatives": [
  "buserelin",
  "goserelin",
  "leuprolide",
  "triptorelin"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "(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. SUPPRELIN LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puber...",
  "contraindications": "is contraindicated in: Patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs Pregnancy [see Use in Specific Populations ( 8.1 )] . History of hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH analogs ( 4 ). Pregnancy ( 4 ).",
  "warnings_and_cautions": "Initial Agnostic Action: Initial transient increases of estradiol and/or testosterone may cause a temporary worsening of symptoms ( 5.1 ). Implant Breakage: Have been observed during implant removal. Monitor luteinizing hormone, follicle stimulating hormone or testosterone for suppression of CPP ( 5.2 , 5.6 ) Psychiatric Events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. ( 5.3 ) Convulsions: Have been observed in patients receiving GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.4 ) Severe Cutaneous Adverse Reactions: Have been reported in patients receiving GnRH agonists. Interrupt SUPPRELIN LA if signs or symptoms of severe cutaneous adverse reactions develop. Permanently discontinue SUPPRELIN LA if a severe cutaneous adverse reaction is confirmed. ( 5.5 ) Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in ...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described here and elsewhere in the label: Initial Agonist Action [see Warnings and Precautions ( 5.1 )] Implant Breakage [see Warnings and Precautions ( 5.2 )] Psychiatric Events [see Warnings and Precautions ( 5.3 )] Convulsions [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is implant site reaction (51.1%), including complications related to the insertion or removal of the implant ( 6 ). Adverse events related to suppression of endogenous sex steroid secretion may occur ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Adverse Reaction Profile The most common adverse reactions with SUPPRELIN LA involved the implant site. Local reactions after implant insertion include bruising, pain, soreness, erythema and swelling. During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.5 ) 09/2025",
  "information_for_patients": "Advise the patient to read the FDA-Approved patient labeling ( Medication Guide ). Initial Agonistic Action Patients should be advised that a transient worsening of symptoms of puberty or onset of new symptoms may occur initially. However, within 4 weeks of histrelin therapy, complete suppression of gonadal steroids occurs and manifestations of puberty decrease [ see Warnings and Precautions ( 5.1 )]. Post-insertion Care Patients should be instructed to refrain from getting the inserted arm wet for 24 hours and from strenuous exertion of the inserted arm for 7 days after implant insertion to allow the incision to fully close. The adhesive elastic bandage can be removed at that time. The patient should not remove the surgical strips; rather, the strips should be allowed to fall off on their own after several days. Psychiatric Adverse Events Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression, have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with SUPPRELIN LA [ ...",
  "spl_medguide": "Medication Guide SUPPRELIN \u00ae LA [Suh-Preh-Lin El-Ay] (histrelin acetate) subcutaneous implant What is the most important information I should know about SUPPRELIN LA? In the first week of treatment, SUPPRELIN LA can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. Within 4 weeks of treatment, you should see signs in your child that puberty is stopping. Some people who had SUPPRELIN LA placed in their arm have had the implant come through the skin (extrusion). Call your child\u2019s doctor right away if the SUPPRELIN LA implant comes through the skin. Some people taking GnRH agonists like SUPPRELIN LA have had new or worsening mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying irritability restlessness (impatience) anger acting aggressive Call your child\u2019s doctor right away if your child has any new or worsening mental symptoms or problems while taking SUPPRELIN LA . Some people taking GnRH agonists like SUPPRELIN LA have had seizures. The risk of seizures may be higher in people who: have a history of seizures ...",
  "clinical_studies": "The efficacy of SUPPRELIN LA in children with CPP has been evaluated in two single-arm, open label studies. Study 1 was conducted in 11 pretreated female patients, 3.7 to 11.0 years of age. Study 2 was conducted in 36 patients (33 females and 3 males), 4.5 to 11.6 years of age. Sixteen pretreated and 20 treatment-na\u00efve patients were enrolled in Study 2. Baseline patient characteristics were typical of patients with CPP. Efficacy assessments were similar in both studies and included endpoints that measured the suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment. Other assessments were clinical (evidence of stabilization or regression of signs of puberty) or gonadal steroid-dependent (bone age, linear growth). In Study 2, the primary measure of efficacy was LH suppression. In Study 2, suppression of LH was induced in all treatment na\u00efve subjects and maintained in all pretreated subjects at Month 1 after implantation and continued through Month 12 (suppression was defined as a peak LH < 4 mIU/mL following stimulation with the GnRH analog leuprolide acetate)....",
  "brand_name": "SUPPRELIN LA",
  "manufacturer": "Endo USA, Inc.",
  "application_number": "NDA022058",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20250925",
  "set_id": "d8fb000e-3cc9-4803-b71d-2cc597661977",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 672,
  "serious": 191,
  "death": 28,
  "hospitalization": 63,
  "primary_suspect": 672,
  "top_reactions": [
   [
    "Drug Ineffective",
    100
   ],
   [
    "Incorrect Product Administration Duration",
    68
   ],
   [
    "Incorrect Drug Administration Duration",
    64
   ],
   [
    "Procedural Complication",
    53
   ],
   [
    "Device Breakage",
    51
   ],
   [
    "Rash",
    42
   ],
   [
    "Off Label Use",
    41
   ],
   [
    "Headache",
    30
   ],
   [
    "Implant Site Rash",
    25
   ],
   [
    "Weight Increased",
    23
   ],
   [
    "Device Expulsion",
    22
   ],
   [
    "Rash Pruritic",
    21
   ],
   [
    "Device Dislocation",
    19
   ],
   [
    "Death",
    18
   ],
   [
    "Implant Site Infection",
    17
   ]
  ],
  "by_year": {
   "2019": 51,
   "2020": 47,
   "2021": 32,
   "2022": 46,
   "2023": 30,
   "2024": 46,
   "2025": 28,
   "2026": 12
  },
  "by_year_primary": {
   "2019": 51,
   "2020": 47,
   "2021": 32,
   "2022": 46,
   "2023": 30,
   "2024": 46,
   "2025": 28,
   "2026": 12
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 3,
  "nda": 3,
  "anda": 0,
  "first_approval": "19911224",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 5,
  "sponsors": [
   "ENDO OPERATIONS",
   "SHIRE"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1991"
 },
 "trials": {
  "total": 15,
  "completed": 7,
  "terminated": 3,
  "with_results": 2,
  "industry": 7,
  "phase3": 7,
  "results_share": 0.2857142857142857,
  "terminated_share": 0.2
 },
 "pubmed": {
  "rct": 0,
  "meta": 0,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 28348.7,
  "records": 250,
  "by_name": [
   [
    "Supprelin",
    28348.7
   ]
  ],
  "names_checked": [
   "histrelin",
   "Supprelin"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 0,
   "letter": "F",
   "why": [
    "0 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "5 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $28,349 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are incorrect product administration duration, incorrect drug administration duration, procedural complication. How would we recognize and handle those?",
  "Why this one over buserelin, goserelin, leuprolide? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}