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.
| Human dosing established | Yes |
|---|---|
| Studied dose range | One 50 mg implant every 12 months (SUPPRELIN LA, central precocious puberty) |
| Route | Subcutaneous implant |
| Frequency | One implant every 12 months |
| Duration studied | Continued until the appropriate age for puberty; a new implant may be placed when the old one is removed |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — SUPPRELIN LA, central precocious pubertyFDA-approved label · FDA prescribing information | Children with central precocious puberty | One implant containing 50 mg histrelin acetate, releasing about 65 mcg a day | Subcutaneous implant in the inner upper arm | Every 12 months | Removed after 12 months; another implant may be inserted to continue. Stopping is considered at about 11 years for girls and 12 years for boys | Suppression of LH, FSH and sex steroids | SUPPRELIN 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 study | Children with central precocious puberty (n=36; 20 treatment-naive, 16 previously treated) | One 12-month histrelin implant, replaced by a new implant at removal | Subcutaneous implant | Yearly | Up to 6 years of treatment and up to 1 year of follow-up | Hormonal 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 study | Men 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 abstract | Subcutaneous implant | Yearly | Over 70% received three consecutive implants; the longest single treatment period was over 4 years | Serum 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.