Histrelin dosage in published studies and labels

These are the doses used for Histrelin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Histrelin has an FDA-approved human dosage for children with central precocious puberty. SUPPRELIN LA is one 50 mg histrelin acetate implant placed under the skin of the inner upper arm every 12 months; it releases about 65 mcg a day. VANTAS, a once-yearly histrelin implant used in advanced prostate cancer, has no current listing on DailyMed, so prostate-cancer use is covered here only by trial reports.

FDA Approved
Dosage evidence summary for Histrelin
Human dosing establishedYes
Studied dose rangeOne 50 mg implant every 12 months (SUPPRELIN LA, central precocious puberty)
RouteSubcutaneous implant
FrequencyOne implant every 12 months
Duration studiedContinued until the appropriate age for puberty; a new implant may be placed when the old one is removed
Evidence levelFDA Approved
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Histrelin, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — SUPPRELIN LA, central precocious pubertyFDA-approved label · FDA prescribing informationChildren with central precocious pubertyOne implant containing 50 mg histrelin acetate, releasing about 65 mcg a daySubcutaneous implant in the inner upper armEvery 12 monthsRemoved after 12 months; another implant may be inserted to continue. Stopping is considered at about 11 years for girls and 12 years for boysSuppression of LH, FSH and sex steroidsSUPPRELIN LA (histrelin acetate) subcutaneous implant — FDA prescribing information (Endo), DailyMed
Phase 3 long-term extension (Silverman et al., 2015)Clinical trial · Phase 3 open-label studyChildren with central precocious puberty (n=36; 20 treatment-naive, 16 previously treated)One 12-month histrelin implant, replaced by a new implant at removalSubcutaneous implantYearlyUp to 6 years of treatment and up to 1 year of follow-upHormonal suppression maintained; predicted adult height in girls rose from 151.9 cm to 166.5 cm at month 60 (n=6)Silverman LA 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.
Prostate cancer — open-label extension of a pivotal study (Shore et al., 2012)Clinical trial · Open-label extension studyMen with advanced prostate cancer who had responded to 52 weeks of the histrelin implant (n=104)One histrelin implant placed each year; the strength is not stated in the indexed abstractSubcutaneous implantYearlyOver 70% received three consecutive implants; the longest single treatment period was over 4 yearsSerum testosterone stayed below 50 ng/dL in all patients; hot flashes in 64.4%Shore N, Cookson MS, Gittelman MC. Long-term efficacy and tolerability of once-yearly histrelin acetate subcutaneous implant in patients with advanced prostate cancer. BJU Int. 2012.

Where sources disagree

  • The implant is not a dose that can be divided or repeated more often. It releases histrelin continuously for 12 months, and the label sets a single regimen: one implant a year.
  • The SUPPRELIN LA label warns of an initial rise in gonadotropins and sex steroids in the first weeks, implant breakage, psychiatric events, convulsions, severe skin reactions and pseudotumor cerebri. It calls for LH, FSH and estradiol or testosterone checks 1 month after insertion and every 6 months after that.
  • VANTAS, the once-yearly histrelin implant for advanced prostate cancer named in Djavan et al. (Can J Urol, 2010), has no DailyMed listing today. The prostate-cancer row above comes from a trial report, not a current US label.