pharmacopeia
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/api/v1/drug/leuprolide

Mechanism of action

Sourced from openFDA

Leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist, acts as an inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis.

Gonadotropin Releasing Hormone ReceptorHormone Receptor

Indications

Sourced from openFDA
  • VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.ICD-10: C61

Contraindications

Sourced from openFDA
  • Hypersensitivity VABRINTY is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.contraindicated

Dosage & administration

Sourced from openFDA

VABRINTY is administered subcutaneously based on the following recommended dose and schedule: 7.5 mg subcutaneously every month ( 2.1 ) 22.5 mg subcutaneously every 3 months ( 2.1 ) 30 mg subcutaneously every 4 months ( 2.1 ) 45 mg subcutaneously every 6 months ( 2.1 ) See Full Prescribing Information for preparation and administration instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dosage VABRINTY is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). VABRINTY must be administered by a healthcare provider. The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation. Table 1. VABRINTY Recommended Dosing Dosage 7.5 mg 22.5 mg 30 mg 45 mg Recommended dose 1 injection every month 1 injection every 3 months 1 injection every 4 months 1 injection every 6 months As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injections were administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband). In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of metastatic castration-resistant prostate cancer. 2.2 Preparation Instructions Use aseptic technique throughout the procedure.

Warnings & precautions

Sourced from openFDA

Tumor Flare: Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate. ( 5.1 , 5.7 ) Hyperglycemia and diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. ( 5.2 ) Cardiovascular diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. ( 5.3 ) Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits. ( 5.4 ) Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice. (5.5) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis, occurred in patients treated with VABRINTY. Interrupt VABRINTY if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed. ( 5.6 ) Embryo-Fetal Toxicity: May cause fetal harm.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Flare [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Diabetes [see Warnings and Precautions ( 5.2 )] Cardiovascular Disease [see Warnings and Precautions ( 5.3 )] Effect on QT/QTc Interval [see Warnings and Precautions ( 5.4 )] Convulsions [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5. 6 )] Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. ( 6.1 ) As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Uronova Pharmaceuticals, Inc. at 877-712-4575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of all VABRINTY formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of VABRINTY 7.5 mg was evaluated in 8 surgically castrated males (Table 4). VABRINTY, like other GnRH analogs, caused a transient increase in serum testosterone concentrations during the first one to two weeks of treatment.

Use in specific populations

Sourced from openFDA

Females and males of reproductive potential: VABRINTY may impair fertility. ( 8.3 ) Pediatric: Safety and effectiveness in pediatric patients have not been established. ( 8.4 ) Geriatric: This label reflects clinical trials for VABRINTY in prostate cancer where the majority of subjects were at least 65 years of age ( 8.5 ). 8.1 Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, VABRINTY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. Expected hormonal changes that occur with VABRINTY treatment increase the risk for pregnancy loss. In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus (see Data) . Data Animal Data In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug.

Approval history

Sourced from openFDA
  • Jan 26, 1989NDANDA019732Abbvie Endocrine Inc
  • Oct 22, 1990NDANDA020011Abbvie Endocrine Inc
  • Apr 16, 1993NDANDA020263Abbvie Endocrine Inc
  • Dec 22, 1995NDANDA020517Abbvie Endocrine Inc
  • Mar 7, 1997NDANDA020708Abbvie Endocrine Inc
  • Jan 23, 2002NDANDA021343Tolmar
  • Jul 24, 2002NDANDA021379Tolmar
  • Feb 13, 2003NDANDA021488Tolmar

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
77,569 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hot Flush9,55712%
  2. 2Intercepted Product Preparation Error9,05812%
  3. 3Death8,36611%
  4. 4Syringe Issue7,88410%
  5. 5Device Leakage6,1237.9%
  6. 6Wrong Technique In Product Usage Process5,3366.9%
  7. 7Fatigue5,1286.6%
  8. 8Injection Site Pain4,8696.3%
  9. 9Prostatic Specific Antigen Increased2,4303.1%
  10. 10Asthenia2,3973.1%
  11. 11Drug Ineffective2,3613.0%
  12. 12Off Label Use2,3423.0%
  13. 13Fall1,9902.6%
  14. 14Arthralgia1,9632.5%
  15. 15Pain1,9492.5%

Literature

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Recent PubMed references pinned to Leuprolide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 508 ClinicalTrials.gov registrations naming Leuprolide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Leuprolide work?
Leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist, acts as an inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis.
What is Leuprolide used for?
According to FDA labeling, Leuprolide carries indications including: VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Leuprolide?
Leuprolide is classified as Gonadotropin releasing hormone analogues, Gonadotropin Releasing Hormone Receptor Agonist, Gonadotropin Releasing Hormone Receptor Agonists, Hormone Receptor Modulators, Decreased Follicle Stimulating Hormone Secretion, Decreased GnRH Secretion, Decreased Luteinizing Hormone Secretion, Decreased Ovarian Estrogen Secretion, Decreased Testosterone Secretion.
What are the brand names for Leuprolide?
Leuprolide is marketed under brand names including Camcevi, Eligard, Fensolvi, Lupron, Lutrate, Vabrinty.
What are the contraindications for Leuprolide?
Leuprolide labeling lists contraindications including: Hypersensitivity VABRINTY is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.. Always consult the full prescribing information and a clinician.
Note. Data for leuprolide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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