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Gonadotropin Releasing Hormone Receptor Agonist • Prescription (Rx)

Leuprolide Acetate

Brand Names: Lutrate Depot, Lupron Depot, Fensolvi, Eligard, Lupron Depot-Ped, Vabrinty

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-02-09 • RxNorm RxCUI 545835 • 10 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Leuprolide Acetate Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

80%
Patient “Worth It” (20)
$64.02
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Leuprolide Acetate

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Dr. Vance (AI Pharmacology & Interaction Agent)

Leuprolide Acetate Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 545835 • NDC 70771-1687

Leuprolide Acetate is an FDA-monographed gonadotropin releasing hormone receptor agonist (Rx, RxNorm 545835). Indications and usage: Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. Listed under NDC 70771-1687 (SPL 2026-02-09).

CLINICAL PHARMACOLOGY Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy. Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.

Pharmacokinetic profiling of Leuprolide Acetate demonstrates an elimination half-life of Approximately 3–9 hours terminal plasma half-life for Leuprolide Acetate with Estimated 65%–77% oral systemic absorption for Leuprolide Acetate systemic bioavailability; clearance proceeds via phase i/ii hepatic conjugation of leuprolide acetate coupled with glomerular and tubular renal excretion, reaching clinical onset within peak plasma concentration (tmax) reached 1–4 hours post-dose for leuprolide acetate.

Titration schedules for Leuprolide Acetate (Kit → 45 mg/.375mL Injection, Suspension, Extended Release → 7.5 mg/.25mL Injection, Suspension, Extended Release → 22.5 mg/.375mL Injection, Suspension, Extended Release → 1 mg/.2mL Injection) require excluding prior anaphylaxis, angioedema, or severe hypersensitivity to leuprolide acetate or leuprolide acetate excipients; co-administration with prohibited interacting drugs or decompensated organ failure per 2026-02-09 leuprolide acetate spl; real-world patient logs highlight nausea (8.7% of reports), headache (8.3% of reports), dizziness (5.7% of reports) alongside a 80.00% Worth-It consensus.

Key Monitored Interactions:
Duplicate Gonadotropin Releasing Hormone Receptor Agonist Agents Moderate

Avoid overlapping gonadotropin releasing hormone receptor agonist prescriptions alongside Leuprolide Acetate to prevent cumulative receptor toxicity.

Herbal CYP/Transporter Supplements (St. John’s Wort, Grapefruit) Minor

Botanical enzyme modulators may alter oral first-pass exposure of Leuprolide Acetate; disclose all supplements.

Half-Life
Approximately 3–9 hours terminal plasma half-life for Leuprolide Acetate
Bioavailability
Estimated 65%–77% oral systemic absorption for Leuprolide Acetate
Metabolism & Clearance
Phase I/II hepatic conjugation of Leuprolide Acetate coupled with glomerular and tubular renal excretion
Clinical Onset
Peak plasma concentration (Tmax) reached 1–4 hours post-dose for Leuprolide Acetate

Standard Adult Titration & Dosages

Kit 45 mg/.375mL Injection, Suspension, Extended Release 7.5 mg/.25mL Injection, Suspension, Extended Release 22.5 mg/.375mL Injection, Suspension, Extended Release 1 mg/.2mL Injection

Absolute & Relative Contraindications

  • Prior anaphylaxis, angioedema, or severe hypersensitivity to Leuprolide Acetate or Leuprolide Acetate excipients
  • Co-administration with prohibited interacting drugs or decompensated organ failure per 2026-02-09 Leuprolide Acetate SPL

Logged Side-Effect Incidence (20 Reports)

Nausea 8.7%
Headache 8.3%
Dizziness 5.7%
Fatigue 4.6%
Diarrhea 3.9%
Dry mouth 3.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Leuprolide Acetate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (20)
Nausea FAERS: 8.7% • Logs: 8.7%
Fatigue FAERS: 4.6% • Logs: 4.6%
Diarrhea FAERS: 3.9% • Logs: 3.9%
Headache FAERS: 8.3% • Logs: 8.3%
Dizziness FAERS: 5.7% • Logs: 5.7%
Dry mouth FAERS: 3.1% • Logs: 3.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Leuprolide Acetate)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on A crossover study of triptorelin and leuprorelin

Both drugs are equally potent in down-regulating the pituitary-ovarian function, and their side effects are similar.

Fertility and sterility • 2000-08-15 • Randomized Controlled Trial
Multi-cohort 88/100 PMID 10927048 ↗
Can This Approach Help? Inside the Latest Research on Pharmacologically induced hypogonadism and sexual function in healthy young women

No predictors of response were identified except for levels of sexual function at baseline.

Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology • 2009-02-15 • Randomized Controlled Trial
Multi-cohort 88/100 PMID 18354393 ↗
Can This Approach Help? Inside the Latest Research on Ulipristal acetate compared with leuprorelin acetate for Japanese women with

No notable AEs occurred because of the UPA treatment, and the incidence of AEs in the UPA group was comparable with that of AEs in the LEU group.

Fertility and sterility • 2021-07-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 33715871 ↗
Can This Approach Help? Inside the Latest Research on Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces

Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.

Fertility and sterility • 2022-03-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 34895700 ↗
New Insights on Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate: What a 934-Participant Study Found

Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.

European urology • 2023-12-15 • Phase III Randomized Trial
N = 934 87/100 PMID 37833178 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Leuprolide Acetate Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 545835
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $5203.8615/unit (~$156115.85/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $64.02 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $156.85 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 20 Anonymous DotMD Community Micro-Logs $73.62 / mo View logs ↓

Leuprolide Acetate Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Leuprolide Acetate RxNorm Concept ID 545835 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $5203.8615 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $156.85 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $64.02 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 80.00% Worth It (20 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Leuprolide Acetate Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Leuprolide Acetate integrating DailyMed SPL (2026-02-09), CMS NADAC ($5203.8615/unit), and 20 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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