Aveed

— THERAPEUTIC CATEGORIES —
  • Hypogonadism

Aveed Generic Name & Formulations

General Description

Testosterone undecanoate 250mg/mL; soln for IM inj; contains castor oil, benzyl benzoate.

Pharmacological Class

Androgen.

How Supplied

Single-use vial (3mL)—1

Manufacturer

Aveed Indications

Indications

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.

Aveed Dosage and Administration

Adult

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.

Children

<18yrs: not established.

Aveed Contraindications

Contraindications

Male breast or prostate cancer. Pregnancy. Nursing mothers.

Aveed Boxed Warnings

Boxed Warning

Serious pulmonary oil microembolism (POME) reactions and anaphylaxis.

Aveed Warnings/Precautions

Warnings/Precautions

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.

REMS

YES

Aveed Pharmacokinetics

See Literature

Aveed Interactions

Interactions

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.

Aveed Adverse Reactions

Adverse Reactions

Acne, inj site pain, hypogonadism, fatigue, irritability, insomnia, mood swings, increased PSA, estradiol, or hemoglobin; edema, gynecomastia, possible azoospermia (w. large doses).

Aveed Clinical Trials

See Literature

Aveed Note

Notes

Available only through the Aveed REMS program. For more information call (855) 755-0494 or visit www.AveedREMS.com.

Aveed Patient Counseling

See Literature

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