Skip to Content

Xyosted FDA Approval History

Reviewed by J.Stewart B.Pharm. Last updated on Oct 9, 2018.

FDA Approved: Yes (First approved September 28, 2018)
Brand name: Xyosted
Generic name: testosterone enanthate
Dosage form: Subcutaneous Injection
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male

Xyosted (testosterone enanthate) is a self-administered, subcutaneous injection formulation of the androgen testosterone for the treatment of male hypogonadism, also known as testosterone deficiency or Low T.

Warning: Blood Pressure Increases
  • Xyosted can increase your blood pressure, which can increase your risk of having a heart attack or stroke, and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke, or if you have other risk factors.
  • If your blood pressure increases while you are on Xyosted, blood pressure medicines may need to be started. If you are already taking blood pressure medicines, new blood pressure medicines may need to be added, or your current blood pressure medicines may need to be changed to control your blood pressure.
  • If your blood pressure cannot be controlled, Xyosted may need to be stopped.
  • Your healthcare provider will monitor your blood pressure while you are being treated with Xyosted.

What is Xyosted?

  • Xyosted is a prescription medicine that contains testosterone.
  • Xyosted is a controlled substance (CIII).
  • Xyosted is not intended for use by women.

Do not take Xyosted if:

  • you are a male who has breast cancer.
  • you have or might have prostate cancer.
  • you are a woman who is pregnant. Xyosted may harm your unborn baby.
  • you are allergic to Xyosted or to any ingredients in Xyosted including testosterone or sesame oil.
  • have low testosterone without certain medical conditions.

Before you use Xyosted
Tell your healthcare provider about all your medical conditions, including, if you:

  • have high blood pressure or heart problems.
  • have high red blood cell count (hematocrit) or high hemoglobin laboratory value.
  • have urinary problems due to an enlarged prostate.
  • have kidney or liver problems.
  • have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder.
  • have problems breathing while you sleep (sleep apnea).

How should I use Xyosted?

  • See the detailed Instructions for Use leaflet that comes with your prescription for information about how to use Xyosted.
  • Xyosted is for subcutaneous injection in the abdominal region only.
  • You should not inject Xyosted until you have been trained on the proper way to use it.

Common Side Effects

The most common side effects of Xyosted include:

  • red blood cell count increase
  • prostatic specific antigen (PSA) increase (a test used to screen for prostate cancer)
  • high blood pressure
  • injection site reactions including bruising, bleeding, redness, and hardness
  • headache.

Development Timeline for Xyosted

Oct  1, 2018ApprovalFDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
Apr  5, 2018Antares Pharma Provides Xyosted Regulatory Update
Oct 20, 2017Antares Pharma Receives Complete Response Letter From the FDA for Xyosted
Feb 27, 2017Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot® Testosterone
Dec 21, 2016Antares Pharma Announces Submission of New Drug Application for Quickshot Testosterone

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.