FDA approved VABRINTY (leuprolide acetate) for Advanced Prostate CancerFDA approved Vabrinty for advanced prostate cancer with flexible dosing.

FDA From the archive Source published December 14, 2004 Summary added May 12, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider VABRINTY as a GnRH agonist option for advanced prostate cancer with flexible subcutaneous dosing intervals.

The FDA has approved VABRINTY (leuprolide acetate) for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin-releasing hormone (GnRH) agonist that provides continuous release of leuprolide acetate over one, three, four, or six months depending on the dose. The approval offers clinicians a flexible dosing option for patients with advanced prostate cancer, allowing for less frequent injections. VABRINTY must be administered by a healthcare provider via subcutaneous injection. The recommended doses are 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months, and 45 mg every 6 months. In clinical trials, injections were given in the upper or mid-abdominal area. Treatment is usually continued upon development of metastatic castration-resistant prostate cancer.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

VABRINTY is a gonadotropin releasing hormone (GnRH) agonist. It acts by suppressing pituitary gonadotropin secretion, leading to reduced testosterone levels.

Indication & Patient Population

VABRINTY is indicated for the treatment of advanced prostate cancer.

Dosing & Administration

VABRINTY is administered subcutaneously by a healthcare provider. The recommended doses are: 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months, and 45 mg every 6 months. The injection site should vary periodically and be in an area with sufficient soft or loose subcutaneous tissue. In clinical trials, injections were given in the upper or mid-abdominal area. Avoid areas with brawny or fibrous tissue or locations that could be rubbed or compressed. The product must be mixed as described and administered within 30 minutes of mixing.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

VABRINTY provides a GnRH agonist option for advanced prostate cancer with flexible dosing intervals. In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of metastatic castration-resistant prostate cancer.

The FDA has approved a new drug called Vabrinty (leuprolide acetate) for the treatment of advanced prostate cancer. Vabrinty is a hormone therapy that lowers certain hormones that can help cancer grow. It is given as a shot under the skin by a healthcare provider. Depending on the dose, shots can be given every 1, 3, 4, or 6 months. This flexibility allows doctors to choose a schedule that works best for each patient.

Vabrinty is for men with advanced prostate cancer. The approval is based on studies showing it works well to control the cancer. The most common side effects include hot flashes, tiredness, and injection site reactions. Like other similar drugs, Vabrinty may cause a temporary increase in certain symptoms at the start of treatment.

This approval means there is another option for treating advanced prostate cancer. It does not mean that Vabrinty is right for everyone. Patients should talk to their doctor about whether this drug is a good choice for their specific situation. The doctor can explain the benefits and risks and help decide on the best treatment plan.

What this means for you:

Vabrinty offers flexible dosing for advanced prostate cancer, but talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedDec 2004

View Original Abstract ↓

1 INDICATIONS AND USAGE VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )

FDA approved VABRINTY (leuprolide acetate) for Advanced Prostate CancerFDA approved Vabrinty for advanced prostate cancer with flexible dosing.

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FDA approved VABRINTY (leuprolide acetate) for Advanced Prostate CancerFDA approved Vabrinty for advanced prostate cancer with flexible dosing.

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