Test Undecanoate (Inj)
Testosterone Undecanoate Injection (Aveed in US, Nebido outside US)
Ultra-long-acting injectable testosterone in castor oil. Dosed every 10-14 weeks after loading. Carries an FDA boxed warning for pulmonary oil microembolism (POME) and anaphylaxis. REMS-restricted to certified healthcare settings with 30-minute post-injection observation.
At a glance
- Half-life
- ~82 days Mean terminal t½ ~82 days IM (Aveed label, NDA 022219). Steady state reached after ~3 doses. Castor oil vehicle drives the slow release, NOT just the ester.
- Routes
- IM
- Vial sizes
- 750 mg · 1000 mg
- Evidence base
- 3 studies 3 human
Mechanism
11-carbon ester dissolved in refined castor oil (NOT sesame oil) for slow lymphatic absorption from the IM depot. The combination of long ester chain and castor oil vehicle gives the longest depot duration of any approved T ester (~70-90 day terminal t½). Once absorbed, lymphatic transport bypasses first-pass metabolism, then esterases release free testosterone systemically.
Dosing
Any amounts shown here are reported from published studies only. 3 of 3 catalogued studies involved human subjects. COMPOUND does not publish its own dosing guidance.
Published evidence
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Human RCT 2023
Cardiovascular Safety of Testosterone-Replacement Therapy
TRAVERSE class CV safety data applies; AF/PE signals extend to undecanoate use.
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Human RCT 2008
Long acting testosterone undecanoate therapy in men with hypogonadism (Aveed pivotal trial)
Pivotal Phase 3 supporting Aveed approval: 84% of men maintained T in normal range with 10-week dosing after 6-week loading.
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Human observational 2020
Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis
POME spontaneous reporting rate <0.1% per injection across 633 case safety reports. Quantifies BBW risk in real-world use.
Reported side effects
- Pulmonary oil microembolism (POME)
- Rare Serious · FDA BOXED WARNING. Cough, dyspnea, chest pain, syncope during or immediately after injection. Postmarketing rate <0.1%/injection but clinically significant. Drives REMS observation requirement (30 min post-injection).
- Anaphylaxis
- Rare Serious · FDA BOXED WARNING. Reported even after initial uneventful injections. Drives REMS observation requirement.
- Polycythemia / hematocrit elevation
- Very common Moderate · Occurs but somewhat less peak-driven than weekly esters due to flat PK.
- Acne / oily skin
- Common Mild
- Injection site pain
- Common Mild · Large volume (3-4 mL of viscous castor oil) injection.
- Estradiol elevation / gynecomastia
- Common Mild
- HPTA suppression / fertility loss
- Very common Moderate · Universal. HCG add-on protocol harder to time given 10-week injection cadence.
- Hepatic dysfunction
- Rare Moderate · Minor LFT elevations, generally clinically insignificant.
Interactions
-
Anastrozole Synergy
AI for E2 management. Less commonly needed than with weekly esters due to flatter PK.
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HCG Synergy
HPTA preservation adjunct possible but adherence is harder when primary T is q10wk.
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Self injection Contraindicated
Aveed REMS program prohibits home self-administration. Must be injected by certified healthcare provider with 30-min observation post-injection due to POME and anaphylaxis BBW.
Reconstitution and storage
Not applicable: single-dose 3 mL vial of castor oil solution (250 mg/mL). Slow injection (60-90 sec) into gluteal muscle is critical for POME risk reduction.
Room temperature 20-25°C, protect from light.
Open the reconstitution calculator for Test Undecanoate (Inj)