Peptide LibraryLeuprolide dosage in published studies and labels
These are the doses used for Leuprolide 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
Leuprolide has FDA-approved human dosages that depend on the product, strength and indication. For advanced prostate cancer, LUPRON DEPOT (intramuscular) and ELIGARD (subcutaneous) give 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months or 45 mg every 6 months; CAMCEVI is 42 mg every 6 months, CAMCEVI ETM 21 mg every 3 months, and the daily injection is 1 mg. For endometriosis and fibroids, LUPRON DEPOT is 3.75 mg monthly or 11.25 mg every 3 months. For central precocious puberty, LUPRON DEPOT-PED is 7.5–15 mg monthly by weight, 11.25 or 30 mg every 3 months, or 45 mg every 6 months, and FENSOLVI is 45 mg every 6 months.
FDA Approved
| Human dosing established | Yes |
|---|---|
| Route | Intramuscular · Subcutaneous |
| Frequency | Daily, monthly, every 3, 4 or 6 months, by product |
| Duration studied | Long-term for prostate cancer; up to 6 months per course for endometriosis; up to 3 months for fibroids; until the age of puberty for central precocious puberty |
| Titration | LUPRON DEPOT-PED monthly doses are chosen by body weight and raised to the next strength if suppression is not adequate. |
| 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 — LUPRON DEPOT, advanced prostate cancerFDA-approved label · FDA prescribing information | Men with advanced prostate cancer | 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks or 45 mg every 24 weeks | Intramuscular | Every 4, 12, 16 or 24 weeks by strength | Long-term | Treatment of advanced prostate cancer | LUPRON DEPOT 7.5 mg, 22.5 mg, 30 mg and 45 mg (leuprolide acetate for depot suspension) — FDA prescribing information (AbbVie), DailyMed |
| FDA label — ELIGARD, advanced prostate cancerFDA-approved label · FDA prescribing information | Men with advanced prostate cancer | 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months or 45 mg every 6 months | Subcutaneous | Every 1, 3, 4 or 6 months by strength | Long-term | Treatment of advanced prostate cancer | ELIGARD (leuprolide acetate) for injectable suspension — FDA prescribing information (Tolmar), DailyMed |
| FDA label — CAMCEVI, advanced prostate cancerFDA-approved label · FDA prescribing information | Adults with advanced prostate cancer | 42 mg | Subcutaneous (prefilled syringe) | Once every 6 months | Long-term | Treatment of advanced prostate cancer | CAMCEVI (leuprolide) injectable emulsion — FDA prescribing information (Accord BioPharma), DailyMed |
| FDA label — CAMCEVI ETM, advanced prostate cancerFDA-approved label · FDA prescribing information | Adults with advanced prostate cancer | 21 mg | Subcutaneous (prefilled syringe) | Once every 3 months | Long-term | Treatment of advanced prostate cancer | CAMCEVI ETM (leuprolide) injectable emulsion — FDA prescribing information (Foresee), DailyMed |
| FDA label — leuprolide acetate injection (daily)FDA-approved label · FDA prescribing information | Men with advanced prostatic cancer (palliative treatment) | 1 mg (0.2 mL) | Subcutaneous | Once daily | Long-term | Palliative treatment of advanced prostatic cancer | Leuprolide acetate injection 1 mg/0.2 mL (Endo) — FDA prescribing information, DailyMed |
| FDA label — LUPRON DEPOT 3.75 mg, endometriosis and fibroidsFDA-approved label · FDA prescribing information | Women with endometriosis; women with anemia caused by uterine fibroids, before surgery, with iron therapy | 3.75 mg, alone or with norethindrone acetate 5 mg daily as add-back therapy (endometriosis) | Intramuscular | Once a month | Up to six injections for endometriosis; up to three months for fibroids. Total therapy with add-back should not exceed 12 months | Pain relief and reduction of endometriotic lesions; preoperative improvement of anemia | LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) — FDA prescribing information (AbbVie), DailyMed |
| FDA label — LUPRON DEPOT 11.25 mg, endometriosis and fibroidsFDA-approved label · FDA prescribing information | Women with endometriosis; women with anemia caused by uterine fibroids, before surgery, with iron therapy | 11.25 mg, alone or with norethindrone acetate 5 mg daily as add-back therapy (endometriosis) | Intramuscular | Once every 3 months | Up to two injections (6 months) for endometriosis; one injection for fibroids | Pain relief and reduction of endometriotic lesions; preoperative improvement of anemia | LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension) — FDA prescribing information (AbbVie), DailyMed |
| FDA label — LUPRON DEPOT-PED, central precocious pubertyFDA-approved label · FDA prescribing information | Children with central precocious puberty | 1-month: 7.5 mg (25 kg or less), 11.25 mg (over 25 kg up to 37.5 kg) or 15 mg (over 37.5 kg). 3-month: 11.25 mg or 30 mg. 6-month: 45 mg | Intramuscular | Every month, every 12 weeks or every 24 weeks by formulation | Stopped at the appropriate age for the onset of puberty | Suppression of pituitary gonadotropins and sex steroids | LUPRON DEPOT-PED (leuprolide acetate for depot suspension) — FDA prescribing information (AbbVie), DailyMed |
| FDA label — FENSOLVI, central precocious pubertyFDA-approved label · FDA prescribing information | Children aged 2 and over with central precocious puberty | 45 mg | Subcutaneous | Once every 6 months | Stopped at the appropriate age for the onset of puberty | Suppression of pituitary gonadotropins and sex steroids | FENSOLVI (leuprolide acetate) for injectable suspension — FDA prescribing information (Tolmar), DailyMed |
Where sources disagree
- Depot strengths are not interchangeable. The LUPRON DEPOT labels say the strengths have different release characteristics, are not additive, and that a fractional dose or a combination of doses must not be used; a 3-month 11.25 mg depot is not three 3.75 mg monthly doses.
- The same strength can mean a different product and route: 7.5–45 mg LUPRON DEPOT is intramuscular, while ELIGARD and VABRINTY (Uronova; same four strengths and schedules), FENSOLVI and CAMCEVI are subcutaneous. LUTRATE DEPOT is a further 22.5 mg 3-month product for advanced prostate cancer.
- The prostate cancer labels warn of tumor flare in the first weeks of treatment (bone pain, urinary obstruction, spinal cord compression), and of hyperglycemia, diabetes and other metabolic changes with GnRH agonists. ELIGARD and CAMCEVI also warn of increased cardiovascular risk. The pediatric label warns of pseudotumor cerebri.
- Older DailyMed listings for VIADUR (Bayer, 2007) and the TAP LUPRON daily injection (2008) have not been updated since; the daily 1 mg injection is now listed by other labellers, including the Endo product cited here.