Generic Name and Formulations:
Testosterone undecanoate 250mg/mL; soln for IM inj; contains castor oil, benzyl benzoate.
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Not established in men with age-related hypogonadism.
Prior to treatment, confirm diagnosis by ensuring serum testosterone has been measured in the AM on at least 2 separate days and that these concentrations are below normal range. Give by deep IM inj into gluteal muscle. ≥18yrs: 3mL (750mg) once at initiation, followed by 3mL (750mg) at 4 weeks, then 3mL (750mg) every 10 weeks thereafter.
<18yrs: not established.
Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.
Not for use in women. Risk of serious pulmonary oil microembolism reactions and anaphylaxis; observe for 30mins after each inj. Avoid intravascular inj. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Elderly.
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. May alter serum lipids; adjust dose of lipid-lowering drugs or discontinue testosterone. May affect thyroid levels.
Acne, inj site pain, hypogonadism, fatigue, irritability, insomnia, mood swings, increased PSA, estradiol, or hemoglobin; edema, gynecomastia, possible azoospermia (w. large doses).
Available only through the Aveed REMS program. For more information call (855) 755-0494 or visit www.AveedREMS.com.
Single-use vial (3mL)—1
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