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Lupron (Leuprolide Acetate) - Summary

 
 



LUPRON SUMMARY

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone.

LUPRON INJECTION (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer.

INDICATIONS AND USAGE

LUPRON INJECTION is indicated in the treatment of children with central precocious puberty. Children should be selected using the following criteria:

  1. Clinical diagnosis of CPP (idiopathic or neurogenic) with onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males.
  2. Clinical diagnosis should be confirmed prior to initiation of therapy:
      Confirmation of diagnosis by a pubertal response to a GnRH stimulation test. The sensitivity and methodology of this assay must be understood.
    • Bone age advanced 1 year beyond the chronological age.
  3. Baseline evaluation should also include:
      Height and weight measurements.
    • Sex steroid levels.
    • Adrenal steroid level to exclude congenital adrenal hyperplasia.
    • Beta human chorionic gonadotropin level to rule out a chorionic gonadotropin secreting tumor.
    • Pelvic/adrenal/testicular ultrasound to rule out a steroid secreting tumor.
    • Computerized tomography of the head to rule out intracranial tumor.

See all Lupron indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lupron (Leuprolide)

Chronic inflammation may be linked to aggressive prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2014.04.18]
The presence of chronic inflammation in benign prostate tissue was associated with high-grade, or aggressive, prostate cancer, and this association was found even in those with low...

Quarter of Prostate Cancer Patients May Abandon 'Watchful Waiting' Approach
Source: MedicineNet Cancer Specialty [2014.04.18]
Title: Quarter of Prostate Cancer Patients May Abandon 'Watchful Waiting' Approach
Category: Health News
Created: 4/17/2014 12:35:00 PM
Last Editorial Review: 4/18/2014 12:00:00 AM

Per Lesion Ultrasound in Prostate Cancer Active Surveillance
Source: Medscape Radiology Headlines [2014.04.17]
For prostate cancer patients followed with active surveillance, the addition of monitoring with per lesion transrectal ultrasound could help identify patients who need intervention.
Medscape Medical News

Radical treatment for advanced prostate cancer may herald major survival advantage over conventional treatment
Source: Endocrinology News From Medical News Today [2014.04.15]
Controversial new research may overturn the standard treatment of men with advanced prostate cancer.

Longest Prostate Cancer Active Surveillance Study Promising
Source: Medscape Urology Headlines [2014.04.14]
The longest follow-up to date of active surveillance shows that it is a safe and feasible approach for as long as 20 years after diagnosis.
Medscape Medical News

more news >>

Published Studies Related to Lupron (Leuprolide)

A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. [2011.09]
PURPOSE: We investigated the efficacy and safety of degarelix treatment and the effects of switching from leuprolide to degarelix in an ongoing extension study with a median 27.5-month followup of a pivotal 1-year prostate cancer trial... CONCLUSIONS: Data support the statistically significant prostate specific antigen progression-free survival benefit for degarelix over leuprolide seen during year 1 and the use of degarelix as first line androgen deprivation therapy as an alternative to a gonadotropin-releasing hormone agonist. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A randomized trial of microdose leuprolide acetate protocol versus luteal phase ganirelix protocol in predicted poor responders. [2011.06.30]
We performed a randomized trial to compare IVF outcomes in 54 poor responder patients undergoing a microdose leuprolide acetate (LA) protocol or a GnRH antagonist protocol incorporating a luteal phase E(2) patch and GnRH antagonist in the preceding menstrual cycle.

Hot flushes in prostatic cancer patients during androgen-deprivation therapy with monthly dose of degarelix or leuprolide. [2011.06]
The aim of the study was to compare the onset, incidence and frequency/intensity of hot flushes during androgen-deprivation therapy with a gonadotropin-releasing hormone antagonist (GnRH) blocker versus an agonist using data from a randomized Phase 3 clinical trial...

Randomized trial of leuprolide versus continuous oral contraceptives in the treatment of endometriosis-associated pelvic pain. [2011.04]
OBJECTIVE: To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain...

Effects of metformin and leuprolide acetate on insulin resistance and testosterone levels in nondiabetic postmenopausal women: a randomized, placebo-controlled trial. [2010.11]
OBJECTIVE: To determine whether insulin sensitizers lower androgen levels and whether androgen suppression improves insulin resistance in nondiabetic postmenopausal women... They confirm that treatment of insulin resistance decreases T production in this population and demonstrate that pharmacologic lowering of T does not affect insulin resistance.

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Clinical Trials Related to Lupron (Leuprolide)

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases [Recruiting]
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.

Pilot Study of Lupron to Improve Immune Function After Allogeneic Bone Marrow Transplantation [Recruiting]
Background:

- One way to treat certain cancers of the blood and immune system is to give a patient

stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patient's. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications.

- Researchers are studying the use of drugs that lower hormone levels and may allow the

immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug lupron, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells.

Objectives:

- To determine whether lupron improves immune system function after bone marrow

transplantation from a donor with similarities in their immune cells (matched to each other).

- To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug FLT in

imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor.

Eligibility:

- People between 15 (or as young as 9 in those who have gone through puberty) and 40

years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, or high-risk myelodysplastic syndrome. They must also be eligible for a bone marrow transplant.

- Genetically similar donors for the patients who are eligible for a transplant.

Design:

- People taking part in the study will be screened with a physical examination, medical

history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first.

- Donors will provide bone marrow for transplant according to standard bone marrow

transplant (BMT) procedures.

- All women and half of the men will receive regular lupron doses 2 weeks before BMT to

suppress hormone function.

- All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy

before the bone marrow transplant (depending on age). Recipients will also receive other drugs to prevent transplant rejection and other complications of transplantation.

- Recipients will be monitored in the hospital for 4 weeks after transplant with blood

tests and other studies.

- Some recipients will have an imaging study with FLT during the protocol. These imaging

studies will take place before the transplant, on days 5 and 28 after transplant, and at a later time to be determined by the study researchers.

- Following discharge, participants will be monitored closely for up to 6 months, with

regular but less frequent followup visits for at least 5 years. Study-related medications, including vaccinations for the new immune system, will be provided by the National Institutes of Health during the hospital stay and after discharge.

Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot � (Leuprorelin Acetate - Abbot) [Recruiting]
The primary objective of this study is to examine, in healthy subjects, the comparative pharmacodynamics of Lorelin Depot (leuprorelin), manufactured by the Chemical Pharmaceutical Laboratory Bergamo Ltda with the product Lupron Depot (leuprorelin), manufactured by Abbott Laboratories Ltd, through the strength of biological markers follicle stimulating hormone (FSH), luteinizing hormone (LH) and total testosterone, associated with the activity of the substance.

Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.

Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation [Recruiting]
The purpose of this study is to help determine if palifermin and/or leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant.

The investigators want to see if palifermin and/or leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC) [Recruiting]
There is no effective standard treatment for fibrolamellar liver cancer that cannot be removed by surgery. The investigators want to find out what effects, good and/or bad, 3 drugs called letrozole, leuprolide and everolimus will have on cancer. All of these drugs are FDA approved for the treatment of different cancers. Letrozole and leuprolide stop the body from producing estrogen, a normal hormone produced by the body. Too much estrogen may help fibrolamellar liver cancer grow. Everolimus is a drug that may block other chemicals in the body that can help cancer grow. The combination of letrozole and leuprolide plus everolimus may work well together.

more trials >>

Reports of Suspected Lupron (Leuprolide) Side Effects

Headache (21)Fatigue (14)Hot Flush (12)Pain (9)Night Sweats (8)Abortion Spontaneous (8)Back Pain (8)Dyspnoea (8)Arthralgia (8)Bone Pain (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Lupron has an overall score of 5. The effectiveness score is 8 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
 

Lupron review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   uterine fibroids/heavy bleeding
Dosage & duration:   one injection once a month (dosage frequency: once a month) for the period of 6 months
Other conditions:   anemia
Other drugs taken:   iron
  
Reported Results
Benefits:   The drug stopped my menstrual periods and put me into artificial menopause. The hope was that it would trigger my body to go into menpause and stop the heavy bleeding associated with my fibroids. Unfortunately, my period came back approximately 2 months after the last injection
Side effects:   Hot flashes, night sweats and vaginal dryness.
Comments:   I was injected once a month subcutaneously in my abdomen just below the belly button.

 

Lupron review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Endometriosis
Dosage & duration:   1 syringe (dosage frequency: once a month) for the period of 3 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The Lupron suppressed the growth of the Endometriosis on my urethas.
Side effects:   I experienced memory loss.
Comments:   Received one shot during each visit once a month. Then after the third shot started having severe memory loss. Could not remember where I was driving to while in my car, could not remember where I lived etc.

See all Lupron reviews / ratings >>

Page last updated: 2014-04-18

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