What is the most important safety information I should know about XYOSTED?
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 for heart attack or stroke. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED.
What is XYOSTED?
XYOSTED is a prescription medicine that contains testosterone. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions.
It is not known if XYOSTED is safe and effective to treat men who have low testosterone due to aging.
It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Improper use of XYOSTED may effect bone growth in children.
XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your XYOSTED in a safe place to protect it. Never give your XYOSTED to anyone else. Selling or giving away this medicine may harm others and it is against the law.
XYOSTED is not meant for use by women.
Do not use XYOSTED if you:
What should I tell my healthcare provider before using XYOSTED?
Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you any of the following: high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Using XYOSTED with other medicines can affect each other. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Know the medicines you take. Ask your pharmacist for a list of all your medicines if you are not sure. Show your list to your healthcare provider and pharmacist when you get a new medicine.
How should I use XYOSTED?
What are the possible side effects of XYOSTED?
XYOSTED can cause serious side effects including:
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of XYOSTED include: red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache.
Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XYOSTED. For more information, ask your healthcare provider or pharmacist.
For more information, go to www.XYOSTED.com or call 1-844-XYOSTED (1-844-996-7833).
To report side effects to the FDA visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information, including Boxed Warning, and Medication Guide.
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