Testosterone Injection

Important Warning

Testosterone undecanoate injection (Aveed) may cause serious breathing problems and allergic reactions, during or immediately after the injection. The injection should be given by a doctor or nurse in a healthcare setting where these problems or reactions can be treated. You will need to remain in the healthcare setting for at least 30 minutes after you receive your injection. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after your injection: tightening of your throat, difficulty breathing, difficulty swallowing, shortness of breath, cough or urge to cough, chest pain, dizziness, fainting, sweating, rash, hives, or itching.

A program has been set up to limit the use of testosterone undecanoate injection (Aveed) and to inform people about the increased risk of breathing problems and allergic reactions while receiving this medication. The program also makes sure that everyone who received this medication understands the risks and benefits from this medication and receives the medication in a setting where they can be monitored for serious reactions.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with testosterone undecanoate injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.