Tolmar Affirms Full Supply of Eligard® (Leuprolide Acetate) for Injectable Suspension for the Palliative Management of Advanced Prostate Cancer

Company increases manufacturing capacity of U.S.-made drug to ensure uninterrupted supply for patients undergoing treatment amid industry shortage

BUFFALO GROVE, Ill., Aug. 10, 2020 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today affirmed the full availability of ELIGARD® (leuprolide acetate) for injectable suspension in all doses for patients undergoing palliative treatment for advanced prostate cancer. The company confirmed the complete inventory of product supply and also announced a production increase in response to reports of a shortage in the United States for a different leuprolide acetate injection product used in the palliative treatment for advanced prostate cancer. Tolmar has a demonstrated record of providing consistent supply of ELIGARD in the U.S. and globally across approximately 89 countries, with no shortages to date.

On July 24, 2020 and re-verified on August 3, 2020, the U.S. Food and Drug Administration (FDA) listed the Lupron Depot, 3 months, 22.5 mg PDS Kit and 6 months, 45 mg PDS Kit as not available and on backorder in its database of Current and Resolved Drug Shortages and Discontinuations Reported to FDA. The listing indicates the estimated duration of this shortage is currently unknown.

"Tolmar is pleased to step up production in our state-of-the-art cGMP facilities to help ensure that advanced prostate cancer patients across the U.S. won't miss a single injection in their treatment plan," said Anil D'Souza, Chief Executive Officer, Tolmar. "ELIGARD has always been manufactured to the highest quality standards in our Northern Colorado plants, and we are able to fill any short or long-term gaps in the supply of this drug for those who need it."

ELIGARD® (leuprolide acetate) for injectable suspension, an FDA-approved palliative treatment for advanced prostate cancer, is given by subcutaneous injection. It is a form of androgen deprivation therapy, which is the standard of care for the treatment of advanced prostate cancer. A luteinizing hormone-releasing hormone (LHRH) agonist, ELIGARD reduces circulating testosterone to castration levels to inhibit the growth of cancer cells. It may be administered monthly or in three, four or six-month controlled-release doses. All doses are in inventory.

"During the global COVID-19 pandemic, cancer patients, providers and others in the urology and uro-oncology community should not have an added concern about the supply of a vital medication," continued Mr. D'Souza. "Tolmar has a full inventory of API and the other components of ELIGARD, and the capacity to manufacture sufficient supply of the drug for those who need it at this time."

For more information about product availability or any questions about reported leuprolide acetate product shortages in the U.S. market, please contact Tolmar at 1-877-ELIGARD (1-877-354-4273).

About Tolmar and ELIGARD

Tolmar is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing and commercialization of specialty pharmaceuticals. The Company's lead product, ELIGARD®, is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.

"Tolmar" refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. ELIGARD was developed and is manufactured by Tolmar Inc. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while TOLMAR Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For more information about the company, please visit www.TOLMAR.com. Information about ELIGARD is available at www.eligard.com.

IMPORTANT SAFETY INFORMATION

ELIGARD (leuprolide acetate for injectable suspension) is a medicine for the treatment of advanced prostate cancer. It works by reducing the amount of testosterone in the blood. It is not a cure.

ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any medicines that reduce testosterone the same way. ELIGARD should not be used by women who are pregnant or may become pregnant. ELIGARD can cause pregnancy loss or harm to an unborn baby if used in pregnant women.

Severe and possibly life-threatening reactions called anaphylaxis have occurred in people receiving 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.

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.

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.

Please see Full Prescribing Information for additional important safety information.

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SOURCE Tolmar Pharmaceuticals, Inc.

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