Leuprolide Acetate 11.25 mg Injection

Product Information

What is Leuprolide Acetate 11.25 mg Injection?

Leuprolide Acetate 11.25 mg is a three-month depot injection used to manage hormone-sensitive conditions including endometriosis, uterine fibroids, and prostate cancer. It is the generic equivalent of Lupron Depot (USA) and is marketed as Prostap SR in the UK. Each injection provides continuous hormone suppression for approximately 12 weeks.

Leuprolide Acetate is a synthetic GnRH agonist. Given as a single depot injection, it gradually suppresses the body’s production of oestrogen and testosterone. This makes it effective for conditions driven by sex hormones — including endometriosis pain, fibroid growth, and androgen-sensitive prostate cancer. The 11.25 mg strength is the standard three-month formulation and is FDA-approved in the United States.

Uses of Leuprolide Acetate Injection

Leuprolide 11.25 mg is used across several clinical settings. In women, it reduces endometriosis-related pelvic pain and lesion size, and shrinks uterine fibroids before surgery. In men with prostate cancer, it is a core part of androgen deprivation therapy (ADT). It is also used in children with central precocious puberty and in certain IVF protocols to regulate ovulation timing.

How Does Leuprolide Acetate Work?

After injection, leuprolide causes a brief surge in LH and FSH, followed by sustained suppression of both hormones. This significantly reduces oestrogen in women and testosterone in men. By removing the hormonal stimulus, oestrogen-driven conditions stop progressing and androgen-sensitive prostate tumours are deprived of the signals needed to grow.

Benefits of Treatment

The three-month depot format means only four injections per year. Clinical studies support its effectiveness in reducing endometriosis pain, fibroid volume, and PSA levels in prostate cancer. It has decades of clinical use behind it, a well-understood safety profile, and is available as a cost-effective generic in most markets.

Frequently Asked Questions

What is Leuprolide Acetate used for?

Leuprolide is used to treat endometriosis, uterine fibroids, prostate cancer, and central precocious puberty. It is also used in some IVF protocols. It works by suppressing oestrogen or testosterone production depending on the patient’s condition.

Is Leuprolide Acetate generic for Lupron Depot?

Yes. Leuprolide Acetate 11.25 mg is the generic equivalent of Lupron Depot 11.25 mg by AbbVie (USA). In the UK, the equivalent branded product is Prostap SR 11.25 mg by Takeda. Both contain the same active ingredient and follow the same three-month dosing schedule.

How often is the injection given?

One injection every 12 weeks (three months). It is administered by a healthcare professional as a subcutaneous or intramuscular depot injection, reducing clinic visits compared to monthly alternatives.

Can Leuprolide shrink uterine fibroids?

Yes. By lowering oestrogen levels, Leuprolide reduces fibroid volume and heavy bleeding. It is typically prescribed for three to six months as a pre-surgical measure to make removal easier, rather than as a long-term standalone treatment.

Is Leuprolide used in IVF treatment?

Yes, in certain IVF long protocols, Leuprolide suppresses natural hormone activity to allow controlled ovarian stimulation. The dose and timing used in IVF differ from the depot regimens used for endometriosis or prostate cancer.

Is it the same as Prostap SR in the UK?

Yes. Prostap SR 11.25 mg (Takeda, UK) contains leuprorelin acetate — the INN name for leuprolide acetate — at the same strength and for the same indications. It is the closest UK branded equivalent to Lupron Depot.

What are the common side effects?

Common side effects include hot flushes, night sweats, reduced libido, mood changes, and injection site reactions. In men, it may cause erectile dysfunction and bone density loss over time. In women, symptoms can resemble menopause. Most effects resolve after treatment ends.

How does Leuprolide compare to Goserelin (Zoladex)?

Both are GnRH agonists with similar mechanisms and outcomes. Goserelin (Zoladex) is more commonly used in the UK; Leuprolide is more common in the USA. Choice depends on local prescribing preference, formulation convenience, and patient tolerability.

How does Leuprolide compare to Triptorelin?

Triptorelin (Decapeptyl, Diphereline) has comparable efficacy and is available in 1-month and 3-month depot forms. Leuprolide has more published data in prostate cancer and endometriosis; Triptorelin is more widely used across parts of Europe.

What is the dose for prostate cancer?

Leuprolide 11.25 mg is given once every 12 weeks as part of androgen deprivation therapy. It is used alone or combined with an antiandrogen such as bicalutamide for complete androgen blockade.

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: July 2026