Indications for AVEED:
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations of Use:
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. Nursing mothers.
Serious pulmonary oil microembolism (POME) reactions and anaphylaxis.
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