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Treatment Name: Leuprolide ace­tate (Lupron Depot®, Eligard®)

Leuprolide ace­tate (Lupron Depot®, Eligard®) is a Treatment Regimen for Prostate Cancer

How does leuprolide acetate (Lupron Depot®, Eligard®) work?
Leuprolide is designed to slow the growth of prostate cancer cells and decreases the size of prostate tumors.

Inside prostate cancer cells, androgens bind to androgen receptors and cause the cancer cell to grow and divide.

Androgen production is increased when certain hormones that are made in your brain (such as gonadotropin-releasing hormone, or GnRH) tells your body to produce more. Leuprolide works over time by lowering the amounts of GnRH, which in turn decreases androgen production. With lowered levels of androgen hormone in the body,  the androgen-dependent prostate cancers lack the necessary stimulation for continued growth.

Goals of therapy:
When the prostate cancer is metastatic, leuprolide is not commonly given with the goal of cure but is given to decrease symptoms and extend life. This is done by reducing testosterone to castrate levels. If the disease is not metastatic it may be given after surgery and with radiation therapy with the goal of cure.

Schedule

  • Leuprolide acetate injection every one month, three months, four months, or six months
    • Your doctor will help determine the ideal frequency for injections
    • Because leuprolide is available in multiple formulations, check with the product labeling to determine whether intramuscular (I.M.) or subcutaneous (SubQ) is recommended before administration
  • An anti-androgen, such as bicalutamide, is often prescribed prior to starting leuprolide. See our ChemoExperts tip below for more information

Leuprolide is usually given in an outpatient infusion center or doctor’s office. If the prostate cancer is metastatic, therapy with leuprolide is typically continued until the drug no longer works or unacceptable toxicity is experienced. If the disease is not metastatic, it can be given for either 6 months or 2 years.

Click here for common starting doses of leuprolide (Lupron®, Eligard®).

Side Effects

In clinical studies, the most commonly reported side effects of leuprolide (Lupron Depot®, Eligard®) are shown here. Side effects sometimes have percentage ranges [example: 45– 79%] because they differed between clinical studies:

  • Hot flashes (45 - 79%)
  • Pain (12 - 27%)
  • Injection-site pain, mostly mild (8 - 22%)
  • Mild shrinking of testicles (2 - 21%)
  • Back pain (5 - 16%)
  • Joint pain (9 - 15%)
  • Fatigue (6 - 14%)
  • Weakness (12%)
  • Flu-like symptoms (12%)
  • Constipation (10 - 12%)
  • Headache (7 - 10%)
  • Rash (6 - 10%)
  • Insomnia (9%)
  • Cough (7%)
  • Blood in the urine (7%)
  • Sore throat (7%)
  • Burning during urination (6%)
  • High blood pressure (6%)
  • Anemia [low red blood cells] (5%)
  • Muscle pain (5%)
  • Waking at night to urinate (5%)
  • Sinus infection (5%)
  • Urinary tract infection (5%)
  • Dizziness (3 - 5%)
  • Nausea (4%)
  • Mild swelling of breast tissue (1 - 4%)
  • Decreased sex drive (1 - 2%)

On average, 1 - 3% of patients discontinue leuprolide due to unacceptable side effects.

Note: Both the dose and frequency (how often you receive it) of leuprolide injections can change the severity and frequency of expected side effects.

Side effect videos Side Effect Videos
PainPainConstipationConstipationBleedingBleedingFatigue Fatigue AnemiaAnemiaNausea and VomitingNausea and Vomiting

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment then and periodically during treatment. Labs often include: Comprehensive Metabolic Panel (CMP), prostate specific antigen (PSA), serum testosterone levels, plus any others your doctor may order.

For most patients, testosterone levels initially increase above the baseline level, then begin to decrease and fall to castrate levels (=serum testosterone level less than 50 ng/dL, or less than 20 ng/dL depending upon reference) within four weeks of starting treatment.

How often is imaging needed?
Imaging may be checked before treatment and periodically during treatment at the discretion of your doctor. Imaging may include: computerized tomography (CT) scans and positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results your doctor may advise to continue this treatment as planned, delay treatment, or switch therapy. Serum testosterone levels are often obtained periodically throughout treatment to determine if leuprolide is still working.

ChemoExperts Tips

  • After starting leuprolide, you can experience a temporary surge of testosterone, which can lead to an increase in symptoms of prostate cancer. This is known as “tumor flare”. To prevent this from happening, your doctor may prescribe an anti-androgen medication such as bicalutamide (Casodex®) one to four weeks before leuprolide to block leuprolide’s effect of the increased testosterone levels in the blood. Oral anti-androgen medications are often only needed for the first few weeks of treatment with leuprolide because the testosterone levels decrease shortly thereafter with continued leuprolide therapy
  • Tumor flare from leuprolide acetate (Lupron®) can be especially dangerous if there is cancer around the spine. Talk to your doctor about the best way to time each medication to prevent this problem.
  • Leuprolide can be injected intramuscularly into the buttocks, thigh, or shoulder and subcutaneously into the upper or mid-abdomen. Your injection site may change periodically. The injection site depends upon which formulation you are using, therefore the package insert should also be referenced to determine the appropriate injection site and method before adminstration
  • Prolonged leuprolide therapy (> 6 months) can cause a decrease in the strength of the bones which can lead to bone fractures. Calcium + Vitamin D can be taken to help maintain bone strength. In some cases, medications such as zoledronic acid (Reclast®, Zometa®), denosumab (Prolia®), or alendronate (Fosamax®) may also need to be given to increase the strength of the bones
  • If you experience any injection-site reaction, it is typically mild and will subside in a few days. If the reaction does not go away after a few days, contact your doctor
  • Normal function of the pituitary gland usually returns within 3 months after stopping treatment with leuprolide
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for prostate cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications.

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Leuprolide ace­tate (Lupron Depot®, Eligard®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Leuprolide ace­tate (Lupron Depot®, Eligard®). Depending upon your income, they may be able to help cover the cost of:

  • Leuprolide Acetate

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Leuprolide ace­tate (Lupron Depot®, Eligard®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Leuprolide ace­tate (Lupron Depot®, Eligard®)

Individual Drug Label Information

Leuprolide Acetate (Lupron®, Eligard®)

  • Is a subcutaneous (SubQ) or intramuscular (I.M.) injection available in 7.5 mg once monthly, 22.5 mg every 3 months, 30 mg every 4 months, and 45 mg every 6 months
  • May interact with medications known to interfere with heart rhythm. Ask your pharmacist to double check to see if you are taking any of these types of interacting medicines
  • Use of leuprolide may cause fetal harm when administered to a pregnant woman. Use is contraindicated during pregnancy
General side effects from leuprolide (Lupron Depot®, Eligard®) 
  • Many patients experience periodic hot flashes, or flushing while receiving leuprolide
  • May cause an increase in blood sugar. Patients with diabetes should monitor blood sugar closely after starting therapy
  • Fatigue, weakness, or flu-like symptoms
  • Increase in blood pressure (hypertension)
  • Constipation
  • Joint or muscle pain
  • Decreased bone density
  • Pain and skin irritation or rash at the injection-site may occur and is usually mild
  • Cardiovascular disease, such as heart attack or stroke have been reported in men
  • When used in men, shrinking of the testicles and decreased sex drive (libido) can occur
  • Changes in urination and painful urination may occur. If you notice blood in the urine, contact your doctor
  • You may experience a drop in the amount of red blood cells in your blood, although it is usually only a mild decrease
  • In rare cases, swelling of breast tissue can occur
  • Click on the leuprolide acetate (Lupron Depot®, Eligard®) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1) Sharifi R, Bruskewitz RC, Gittleman MC, et al. Leuprolide Acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996;18:647-657.

2) Chu FM, Jayson M, Dineen MK, et al. A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. J Urol. 2002;168:1199-1203.

3) Sharifi R, Knoll LD, Smith J, et al. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998;51:271-276.

4) Sartor O, Dineen MK, Perez-Marreno R, et al. An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer. Urology. 2003;62:319-323.

5) Spitz A, Young JM, Larsen L, et al. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012;15:93-99.

6) Crawford ED, Sartor O, Chu F, et al. A 12-month clinical study of LA-2585 (45.0 mg): a new 6-month subcutaneous delivery system for leuprolide acetate for the treatment of prostate cancer. J Urol. 2006;175:533-536.

Created: February 24, 2017 Updated: February 25, 2017

What is Prostate Cancer?

A disease of the cells found in the prostate gland in men.  Prostate cancer is a common condition caused by abnormal growth and rate changes in the prostate gland cells that form tumors.  The stage of prostate cancer can vary at diagnosis and throughout treatment.  The staging includes both the TNM + Grade, which is based on exam of tissue removed by surgery, and clinical staging: Stage I, IIa, IIb, III, IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What are Androgens?

Androgens are steroids made naturally in a male's body in the testes and adrenal glands, but can also be made by prostate tumors.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common starting doses of leuprolide (Lupron®, Eligard®)

  • Leuprolide 7.5 mg injection every month
  • Leuprolide 22.5 mg injection every three months
  • Leuprolide 30 mg injection every four months
  • Leuprolide 45 mg injection every six months

Check with the product labeling to determine whether. intramuscular (I.M.) or subcutaneous (SubQ) is recommended before administration

Clinical Studies

If you are interested in reading the clinical trials results, please click on reference below:

1) Sharifi R, Bruskewitz RC, Gittleman MC, et al. Leuprolide Acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996;18:647-657.

2) Chu FM, Jayson M, Dineen MK, et al. A clinical study of 22.5 mg. La-2550: A new subcutaneous depot delivery system for leuprolide acetate for the treatment of prostate cancer. J Urol. 2002;168:1199-1203.

3) Sharifi R, Knoll LD, Smith J, et al. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998;51:271-276.

4) Sartor O, Dineen MK, Perez-Marreno R, et al. An eight-month clinical study of LA-2575 30.0 mg: a new 4-month, subcutaneous delivery system for leuprolide acetate in the treatment of prostate cancer. Urology. 2003;62:319-323.

5) Spitz A, Young JM, Larsen L, et al. Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. Prostate Cancer Prostatic Dis. 2012;15:93-99.

6) Crawford ED, Sartor O, Chu F, et al. A 12-month clinical study of LA-2585 (45.0 mg): a new 6-month subcutaneous delivery system for leuprolide acetate for the treatment of prostate cancer. J Urol. 2006;175:533-536.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is "prostate specific antigen (PSA)"?

PSA is an enzyme that is produced by cells of the prostate. PSA is normally found in small amounts in the blood but may be elevated in patients with prostate cancer or other conditions of the prostate such as prostatitis (inflammation of the prostate) and benign prostatic hyperplasia (BPH). An elevated level of PSA in the blood does not diagnose prostate cancer, but may be used to help monitor response to treatment or to monitor for disease relapse.

What does "metastatic" mean?

Metastatic disease is when cancer cells have spread from their primary (original) location to other parts of the body and started more tumor(s).