testosterone undecanoate (Aveed)

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GENERIC NAME: testosterone undecanoate

BRAND NAME: Aveed

DRUG CLASS AND MECHANISM: Testosterone undecanoate is a long-acting man-made version of testosterone, the natural male sexual hormone. Testosterone is responsible for the normal growth and development of male sex organs and characteristics. It includes growth and development of male organs of penis, testicles, prostate, body hair, vocal cord thickening, and muscle and fat distribution. The FDA approved testosterone undecanoate in March 2014.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Injection: 250 mg/ml

STORAGE: Testosterone undecanoate is stored between 15 C to 30 C (59 F to 86 F), in original cartons until use.

PRESCRIBED FOR: Testosterone undecanoate is prescribed for adult males with deficiency or absence of testosterone due to primary hypogonadism or hypogonadotropic hypogonadism.

DOSING: Males over 18 years of age: The recommended dose of testosterone undecanoate is 750 mg (3 ml) intramuscularly; followed by 750 mg (3 ml) intramuscularly after 4 weeks, then 750 mg (3 ml) intramuscularly every 10 weeks thereafter.

Safe and effective use of testosterone undecanoate is not determined for males under 18 years of age.

DRUG INTERACTIONS: Testosterone should be used cautiously with warfarin (Coumadin) because testosterone can reduce breakdown of warfarin, leading to increased warfarin blood levels and bleeding risk.

Testosterone can decrease in blood glucose, therefore insulin requirements may change in diabetic patients.

PREGNANCY: Testosterone undecanoate is not recommended for pregnant women or in women who may become pregnant. Testosterone undecanoate causes fetal harm; therefore, it must be avoided.

NURSING MOTHERS: Although it is not known whether testosterone undecanoate enters breast milk, it is not recommended for nursing mothers due to high risks of infant harm and serious adverse events.

SIDE EFFECTS: Side effects of testosterone undecanoate are acne, injection site pain, increased prostate specific antigen (PSA), hypogonadism, increased estradiol, fatigue, insomnia, and aggression.

Special Warning: Aveed may cause a serious lung problem called pulmonary oil microembolism (POME ) as well as a serious allergic reaction after receiving the injection.

REFERENCE:

FDA Prescribing Information.


Medically Reviewed by a Doctor on 6/24/2014



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