What is ELIGARD®​ and how does it work?

ELIGARD is a proven LHRH agonist that works by lowering your testosterone3

What is an LHRH agonist?

Luteinizing hormone-releasing hormone (LHRH) agonists are drugs that work by stopping testosterone production in the testicles.4ELIGARD is a proven LHRH agonist with a unique formulation for consistent drug delivery. You can choose from several dosing options—including receiving 1 injection every 6-months (only twice a year).5,3

ELIGARD works by lowering your testosterone (T) levels.

Prostate cancer cells need hormones called androgens to replicate. In men, the main androgen is testosterone. The goal of hormone therapy is to keep your body from making testosterone, which can slow down tumor growth, at least for a period of time.4

How it works

1. Testosterone “stimulates” cancer cells

Most of the body’s testosterone is made by the testicles. Testosterone stimulates the growth of prostate cancer cells.

2. ELIGARD targets the source of testosterone production

ELIGARD suppresses testosterone produced by the testicles. This has the effect of inhibiting the growth of the tumor, which relies on testosterone to grow.

3. Testosterone hormone levels fall

Within 3 weeks, ELIGARD causes male hormone levels including testosterone to fall. This can slow down tumor growth, at least for a period of time.4

4. A temporary rise in testosterone levels is common

Rise in testosterone
The first injection of ELIGARD makes testosterone levels rise for a short period of time. This rise is called a “flare" and is common. Your response to ELIGARD should be monitored by your doctor to evaluate if the product is working for you.

Consistent drug release

ELIGARD uses an advanced, extended-release delivery technology. It is designed to deliver a continuous dose of medicine to your body until your next ELIGARD injection — no matter which dose your doctor prescribes.5

Consistent drug release

Flexible dosing options to meet your needs

There are 4 dosing options for ELIGARD.3​ You and your doctor can choose the dosing option that works best for you. Injections are administered in your doctor’s office, clinic, or hospital.

12 injections per year

1 Injection every month

4 injections per year

1 Injection every 3 months

3 injections per year

1 Injection every 4 months

2 injections per year

1 Injection every 6 months

Ask your doctor if a 6-month dosing option (2 injections a year) is right for you.

ELIGARD side effects3

Many men experience side effects during hormonal therapies. The most common side effects of ELIGARD®​ are:

  • Hot flashes
  • Fatigue (tiredness)
  • Dizziness

Common side effects related to ELIGARD injection are:

  • Burning and stinging
  • Pain,
  • Bruising
  • Redness

You may experience other side effects and should always tell your doctor about how you are feeling when receiving ELIGARD.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Additional side effects have been reported with ELIGARD. Please see additional Important Safety Information for ELIGARD.

Important Safety Information

ELIGARD®​ is used for the palliative treatment of advanced prostate cancer. ELIGARD is a prescription medication that must be administered by a health care professional.

  • ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any similar drugs.
  • ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., bone pain, urinary symptoms, or nerve problems such as numbness, during this period. If your cancer has spread to the urinary tract or spine, urinary blockage or pressure on the spine that can lead to paralysis may occur. Your doctor will discuss with you the benefits and risks of taking ELIGARD.
  • Increased risk of heart attack, sudden death due to heart problems and stroke have also been reported in men taking ELIGARD. ELIGARD may also affect electrical activity in the heart that can cause an irregular heartbeat. Your doctor will monitor you for heart conditions.
  • Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD. Your doctor will monitor blood sugar levels.
  • Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.
  • ELIGARD may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss.
  • ELIGARD may impair fertility in males of reproductive potential.

The most common injection site reactions are transient burning and stinging, pain, bruising, and redness. The most common side effects include hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, decreased erections and enlargement of breasts. Other side effects, including thinning of bones that may lead to fracture, and rare but serious problems with the pituitary gland in the brain, have been reported with ELIGARD.

These are not all the possible side effects of ELIGARD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information​ for additional Important Safety Information.

References
  1. Key Statistics for Prostate Cancer. American Cancer Society Website. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed July 2020.
  2. Risk Factors for Prostate Cancer. Cancer Treatment Centers of America Website. https://www.cancercenter.com/cancer-types/prostate-cancer/risk-factors. Accessed July 2020.
  3. ELIGARD®​ (leuprolide acetate) for injectable suspension, 7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing information. Fort Collins, CO: Tolmar Therapeutics, Inc.; 2019.
  4. https://www.nccn.org/patients/guidelines/prostate/index.html. Accessed January 2020
  5. Sartor O. Eur Urol 2006
  6. Prettyman, Urologic Nursing​ 2019

©2020 Tolmar Pharmaceuticals, Inc. All rights reserved. Tolmar, ELIGARD, Tolmar TotalSolutions and their associated logos are trademarks of the Tolmar group. Third party trademarks, product names, and copyrights belong to their respective owners.

Important Safety Information

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ELIGARD®​ is used for the palliative treatment of advanced prostate cancer. ELIGARD is a prescription medication that must be administered by a health care professional.

  • ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any similar drugs.

ELIGARD®​ is used for the palliative treatment of advanced prostate cancer. ELIGARD is a prescription medication that must be administered by a health care professional.