(testosterone undecanoate) Injection
SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
- Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose [see WARNINGS AND PRECAUTIONS].
- Following each injection of Aveed, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis [see WARNINGS AND PRECAUTIONS].
- Because of the risks of serious POME reactions and anaphylaxis, Aveed is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Aveed REMS Program [see WARNINGS AND PRECAUTIONS].
Aveed (testosterone undecanoate) injection contains testosterone undecanoate (17β-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoate.
Testosterone undecanoate is a white to off-white crystalline substance. The empirical formula of testosterone undecanoate is C30H48O3 and a molecular weight of 456.7. The structural formula is:
Figure 2: Testosterone Undecanoate
Aveed is a clear, yellowish, sterile oily solution containing testosterone undecanoate, a testosterone ester, for intramuscular injection. Each single use vial contains 3 mL of 250 mg/mL testosterone undecanoate solution in a mixture of 1500 mg of benzyl benzoate and 885 mg of refined castor oil.
Last reviewed on RxList: 7/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Aveed Information
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