Sources of injectable Testosterone Undecanoate (Aveed or Nebido) in the U.S? Compounders?

[AndrewP]

Is injectable testosterone undecanoate available in the U.S (aka not clinic-only Aveed)? If so, who can make it?

It vaguely appears that Empower may be able to make a mixed-ester combination? Beyond that, I see no way to procure this in the US. Does anyone have an ideas?

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[FunkOdyssey]

I see no way to procure this in the US. Does anyone have an ideas?

UGL

 

[Nelson Vergel]

The company that makes Aveed (Nebido outside the US) requires doctors to be registered with them for doctors to prescribe it.

This requirement exists because of the REMS (Risk Evaluation and Mitigation Strategy) program mandated by the FDA for Aveed.

The core concern: Pulmonary Oil Microembolism (POME)

Aveed's formulation—testosterone undecanoate in castor oil—carries a specific risk of POME, a rare but serious reaction that can occur during or immediately after injection. Symptoms include coughing, shortness of breath, chest tightness, dizziness, and fainting. There's also a risk of anaphylaxis.

What the REMS requires:

1. Healthcare setting certification — Aveed can only be administered in a certified healthcare setting (not at home), where staff are trained to recognize and manage POME and anaphylactic reactions
2. Prescriber enrollment — Doctors must register with the Aveed REMS program, confirming they understand the risks and will only prescribe it for administration in appropriate settings
3. Post-injection observation — Patients must be monitored for 30 minutes after each injection

Why this differs from other testosterone formulations:

Testosterone cypionate and enanthate don't carry the same POME risk profile, so they don't require REMS programs. Patients can self-inject at home.

The practical impact:

This is a significant barrier to Aveed adoption in the US despite its convenient dosing schedule (every 10 weeks after loading). Many physicians find the registration and monitoring requirements burdensome, and patients dislike mandatory office visits for every injection. It's one reason Aveed hasn't captured more market share despite offering a genuinely useful longer-acting option.

Outside the US, Nebido faces fewer restrictions in most countries, though administration protocols vary by region.

 

[Nelson Vergel]

Why can compounding pharmacies not make it in the US?

The short answer: testosterone undecanoate is not on the FDA's list of bulk drug substances that compounding pharmacies can use.

How compounding regulation works:

Under the Drug Quality and Security Act (2013), compounding pharmacies operate under two frameworks:

• 503A pharmacies (traditional compounding) can compound medications for individual patients with prescriptions, but only using bulk substances on the FDA's approved list or that are components of FDA-approved drugs
• 503B outsourcing facilities face similar restrictions and must also follow cGMP standards

The problem with testosterone undecanoate:

1. Not in an approved reference product for compounding — While Aveed is FDA-approved, its formulation (in castor oil with specific excipients) is protected. Compounders can't simply replicate it.
2. Not on the 503A/503B bulk substances list — The FDA maintains lists of substances that can be used for compounding. Testosterone cypionate and enanthate are available as bulk substances; testosterone undecanoate is not.
3. The REMS complication — Even if a compounder could source testosterone undecanoate, the FDA would likely argue that compounding it circumvents the safety controls built into the REMS program.

The practical reality:

Endo Pharmaceuticals (Aveed's manufacturer) has market exclusivity effectively protected by this regulatory structure. There's been no significant push to add testosterone undecanoate to the bulk compounding list, partly because the existing cypionate and enanthate options serve most clinical needs, and the patient advocacy energy hasn't coalesced around this particular issue.

It's a regulatory gap that benefits the branded manufacturer while limiting patient options.