Enel Health®Atlas
Sign in
Enel Health®Atlas
Browse libraries

Not medical advice. The Atlas is not a substitute for a clinician who can examine you.

Aveed (Testosterone Undecanoate Injection)

Endo, the long-acting injectable with a REMS

Evidence grade 4 of 5, Strong. Read how the Atlas grades evidence.

The written rationale for this grade is still being prepared.

FDA
FDA Approved (Aveed 2014, REMS)

Reference only. Not medical advice.

What can go wrong

POME and anaphylaxis (rare, serious) drive the REMS. Cannot be self-administered at home. Long action means a problem (e.g., rising hematocrit) cannot be quickly reversed.

This is something to take to a clinician. The Atlas can tell you what is known about aveed (testosterone undecanoate injection) in general. It cannot tell you what is happening in your body, and the difference matters most for exactly the symptoms that bring people to this page.

Aveed (testosterone undecanoate injection; Endo Pharmaceuticals, FDA-approved 2014) is a long-acting depot dosed roughly every 10 weeks after loading. Its convenience (very infrequent injections) is offset by a REMS (Risk Evaluation and Mitigation Strategy): because of rare but serious pulmonary oil microembolism (POME) and anaphylaxis reactions, it must be administered in a certified healthcare setting with 30 minutes of observation. The large oil-depot volume is the reason for the POME risk.

Injected only every 10 weeks, but under a safety program.

What people take it for

What it is taken for. Approval, where it exists, covers only some of these.

  • Very-low-frequency injectable TRT (clinic-administered)

Safety in detail

Restricted-distribution REMS program: risk of serious pulmonary oil microembolism (POME) and anaphylaxis; must be given in a certified setting with 30-minute post-injection observation.

What it does to fertility

Suppresses spermatogenesis; not fertility-preserving.

What has to be monitored

The bloodwork this needs, and the reason it belongs with a clinician rather than a website.

  • Total testosterone (trough at ~10 weeks)
  • Hematocrit
  • PSA (over 40)

What people get wrong

  • Often saidLong-acting means lower risk

    ActuallyThe opposite trade-off applies: infrequent dosing is convenient, but the large oil depot carries POME/anaphylaxis risk and any adverse effect persists for weeks.

Who profits, and who pushes back

Nobody is named here yet, because we have not done that work on this entry. Read that as unfinished. Somebody almost certainly sells this, and somebody almost certainly disputes it. Assume both until we have checked.

At a glance

Active
Testosterone undecanoate (injectable)
Frequency
~every 10 weeks (after loading)
REMS
POME / anaphylaxis; 30-min observation
Approved
2014

What this entry does not yet cover

What follows is unfinished work on our side, not a finding about Aveed (Testosterone Undecanoate Injection). A short entry is not a safe entry.

  • Timeline. We have not built the dated record of research and regulatory events.
  • Cost and market. We have not documented what it sells for or who sells it.
  • Supply chain. We have not mapped where it is made.
  • Who uses it. We have not documented the user groups.
  • What could change. No forward-looking summary yet.
  • How it compares. We have not set it against the alternatives.
  • Children and teenagers. We have not checked what is known about younger people.
  • Where we land. We have not taken a position on this yet.

Sources

No sources recorded for this entry yet. Nothing on this page can be checked against a citation until that changes, so treat it as a summary awaiting its evidence.