Leuprolide Acetate 22.5mg Injection

Product Information

What is Leuprolide Acetate 22.5 mg Injection?

Leuprolide Acetate 22.5 mg is a three-month depot injection used primarily in the treatment of advanced prostate cancer as part of androgen deprivation therapy (ADT). It is the generic equivalent of Lupron Depot 22.5 mg (USA) and corresponds to Prostap 3 DCS in the UK. One injection suppresses testosterone production for a full 12 weeks, making it one of the most widely used long-acting GnRH agonists in oncology practice.

The 22.5 mg strength is specifically indicated for prostate cancer and differs from the 11.25 mg formulation, which is used for endometriosis and fibroids. Both strengths contain leuprolide acetate as the active ingredient and work through the same mechanism — sustained suppression of the hypothalamic-pituitary-gonadal axis.

Uses of Leuprolide Acetate 22.5 mg Injection

The primary use of Leuprolide 22.5 mg is advanced prostate cancer. It is prescribed as part of androgen deprivation therapy to reduce testosterone to castrate levels, slowing tumour growth and managing disease progression. It is used in localised high-risk disease, locally advanced prostate cancer, and metastatic prostate cancer — often alongside an antiandrogen such as bicalutamide or enzalutamide.

In addition to prostate cancer, Leuprolide 22.5 mg is used in premenopausal women with hormone receptor-positive breast cancer to suppress oestrogen, and in some cases for endometriosis and central precocious puberty where the higher strength is clinically appropriate.

How Does Leuprolide Acetate 22.5 mg Work?

Leuprolide acetate is a synthetic analogue of GnRH (gonadotropin-releasing hormone). After the initial injection, there is a brief stimulatory effect on LH and FSH — causing a temporary testosterone flare in men. This is followed by sustained downregulation of GnRH receptors in the pituitary gland, leading to a significant and maintained reduction in testosterone to castrate levels (below 50 ng/dL) within two to four weeks. This level of testosterone suppression is the goal of androgen deprivation therapy in prostate cancer treatment.

Benefits of Treatment

The 3-month depot formulation reduces clinic visits to four per year while maintaining consistent testosterone suppression. Clinical trials confirm that Leuprolide 22.5 mg achieves and maintains castrate testosterone levels comparable to surgical castration. It is well-tolerated with a predictable side effect profile, and its generic availability makes it a cost-effective option for long-term androgen deprivation therapy in prostate cancer patients.

Frequently Asked Questions

What is Leuprolide Acetate 22.5 mg used for?

Leuprolide Acetate 22.5 mg is used primarily to treat advanced prostate cancer through androgen deprivation therapy. It reduces testosterone to castrate levels, slowing tumour growth. It is also used in premenopausal women with hormone receptor-positive breast cancer and in select cases of endometriosis or central precocious puberty.

Is Leuprolide Acetate 22.5 mg generic for Lupron Depot?

Yes. Leuprolide Acetate 22.5 mg is the generic equivalent of Lupron Depot 22.5 mg, manufactured by AbbVie in the USA. In the UK, the corresponding branded product is Prostap 3 DCS by Takeda. Eligard 22.5 mg (subcutaneous formulation) is a commonly prescribed alternative in both the USA and EU.

How often is the injection given?

Once every 12 weeks (three months). It is administered by a healthcare professional as an intramuscular depot injection. The extended-release microsphere formulation ensures sustained testosterone suppression throughout the full dosing interval.

What is the difference between Leuprolide 11.25 mg and 22.5 mg?

Both are three-month depot formulations of leuprolide acetate. The 11.25 mg dose is indicated for endometriosis, uterine fibroids, and IVF protocols. The 22.5 mg dose is used for prostate cancer androgen deprivation therapy and, in some protocols, hormone receptor-positive breast cancer. The higher dose is not used interchangeably with the lower dose.

What is androgen deprivation therapy (ADT)?

Androgen deprivation therapy reduces male hormone (testosterone) levels to slow or stop the growth of prostate cancer cells. Leuprolide 22.5 mg achieves this through chemical means — referred to as medical castration — without the need for surgical intervention. It is used across all stages of hormone-sensitive prostate cancer.

What is the difference between Lupron Depot and Eligard?

Both contain leuprolide acetate 22.5 mg and are given every three months. The main difference is the delivery system and route: Lupron Depot uses a microsphere suspension given intramuscularly, while Eligard uses the Atrigel polymer system and is given subcutaneously. Clinical outcomes are comparable; choice depends on prescriber preference and patient comfort.

Is it the same as Prostap 3 DCS in the UK?

Prostap 3 DCS contains leuprorelin acetate — the international non-proprietary name for leuprolide acetate — and is the UK’s primary branded equivalent for the 3-month prostate cancer indication. It is manufactured by Takeda and licensed for advanced prostate cancer treatment in the United Kingdom.

What are the common side effects?

Common side effects include hot flushes, night sweats, fatigue, reduced libido, and erectile dysfunction. With long-term use, bone density loss (osteoporosis), weight gain, and mood changes may occur. Men on long-term ADT are often monitored with DEXA scans and may be prescribed bone-protective agents such as bisphosphonates.

How does Leuprolide compare to Goserelin (Zoladex) for prostate cancer?

Both are GnRH agonists with comparable testosterone suppression and clinical outcomes in prostate cancer. Goserelin (Zoladex) is given as a subcutaneous implant — available in 1-month and 3-month formulations. Leuprolide is administered intramuscularly. Choice is based on prescriber preference, local formulary, and patient suitability.

What is the dose when used with enzalutamide or bicalutamide?

Leuprolide 22.5 mg every 12 weeks is used as the backbone ADT agent alongside oral antiandrogens such as bicalutamide, enzalutamide, or apalutamide in combination hormonal blockade regimens. The combination is standard practice in high-risk localised and metastatic hormone-sensitive prostate cancer.

Medical Disclaimer

This content is for general reference only and does not constitute medical advice. Leuprolide Acetate is a prescription-only medicine. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.

Reviewed by a Licensed Pharmacist | Content reviewed: 2025