Why can’t I inject AVEED at home?

Because the label does not allow the setting, not merely the technique. AVEED is available only through a restricted programme under a Risk Evaluation and Mitigation Strategy, and the programme’s requirements fall on the clinic: prescribers must be certified, healthcare settings must be certified, and settings must “have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis.” After each injection the patient is observed for 30 minutes. A 750 mg depot of castor-oil solution carries a risk of pulmonary oil microembolism and of anaphylaxis that can appear after any dose including the first, and the 30-minute window exists because those reactions are treatable if someone is there.

Are JATENZO, KYZATREX and TLANDO interchangeable?

No, and two of the three labels say so in as many words: “KYZATREX® is not substitutable with other oral testosterone undecanoate products” and “TLANDO is not substitutable with other oral testosterone undecanoate products.” The numbers make the point on their own. JATENZO starts at 237 mg twice daily and titrates between 158 mg and 396 mg twice daily. KYZATREX starts at 200 mg twice daily and titrates between 100 mg once daily and 400 mg twice daily. TLANDO is a fixed 225 mg twice daily with no titration scheme at all — the label instead directs continuing or discontinuing based on the level. Three products, three dose scales, three different blood-draw times.

Is oral testosterone undecanoate the same drug as the injection?

Same molecule, almost nothing else in common. The injection is 750 mg of ester in castor oil given into muscle roughly every ten weeks with an observation requirement; the capsules are a few hundred milligrams taken twice a day with food and absorbed largely through the lymphatics, which is why food is part of the instruction rather than a comfort measure. The oral products have no REMS and no boxed warning for POME. If you are reading about “testosterone undecanoate” without knowing whether the writer means AVEED or a capsule, almost none of what you read will apply to you.

Pulmonary oil microembolism — oil from the injection reaching the pulmonary circulation. The label describes it as “cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope”, reported during or immediately after intramuscular testosterone undecanoate. Most episodes last a few minutes and settle with supportive measures; some have lasted several hours and required emergency care or hospitalisation. The technique in the label — deep gluteal placement, aspirating for several seconds to confirm no blood, injecting over 60 to 90 seconds — is aimed at reducing the chance of intravascular injection, which is the mechanism.

Prescription only

Testosterone Undecanoate

Sold as Aveed, Jatenzo, Kyzatrex, Tlando.

What the label states

The injection’s label opens with a boxed warning, so this page does too. “Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.” It continues: “Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis.” And: “Because of the risks of serious POME reactions and anaphylaxis, AVEED is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program.” Only then the dose: “The recommended dose of AVEED is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.” The oral capsules are different medicines with different numbers — JATENZO starts at “237 mg taken orally twice daily”, KYZATREX at “200 mg orally twice daily”, TLANDO at “225 mg (taken as two 112.5 mg capsules), orally twice daily” — and both KYZATREX and TLANDO state they are “not substitutable with other oral testosterone undecanoate products.”

Quoted from the approved product label. Clinics commonly prescribe differently — more frequent, smaller injections of the same weekly total are routine — and where this site describes that, it is named as practice rather than as labelling.

Route: Intramuscular only, deep in the gluteal muscle, in a healthcare setting with 30 minutes of observation afterwards (AVEED) — or oral, twice daily with food (JATENZO, KYZATREX, TLANDO).
Vehicle: AVEED is an oily solution: each 3 mL single-use vial contains 1500 mg of benzyl benzoate and 885 mg of refined castor oil. The three oral products are liquid-filled capsules and have no injectable vehicle at all.
Usual barrel: 3 mL luer-lock
Strengths covered: No strength page yet

Which syringe, and why

A 3 mL luer-lock, and the label describes the procedure rather than leaving it to inference: “attach an 18-gauge needle and draw 3 mL of air into the syringe… Withdraw 3 mL (750 mg) of AVEED solution from the vial… Replace the syringe needle used to draw up the solution from the vial with a new intramuscular needle and inject.” Three millilitres is the reason the 1 mL barrel that suits cypionate and enanthate is the wrong instrument here — the dose physically does not fit — and castor oil with benzyl benzoate is more viscous than sesame or cottonseed oil, which is why an 18-gauge is named for the draw. The injection itself is slow and deliberate: the label directs aspirating for several seconds to confirm no blood appears, then depressing the plunger “slowly (over 60 to 90 seconds)… at a constant rate”. None of this is a home procedure, and the oral capsules involve no syringe whatsoever.

Administration

1
This injection is given in a healthcare setting, under a REMS
The AVEED REMS Program requires that prescribers be certified, that healthcare settings be certified, and that settings “have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis.” After every injection the patient stays 30 minutes. That is a labelled requirement on the clinic, not a cautious suggestion, and it is why AVEED is not dispensed for self-administration.
2
Confirm the diagnosis first
Every testosterone undecanoate label, injection and oral alike, requires serum testosterone measured in the morning on at least two separate days with both results below the normal range before therapy begins.
3
Identify the site precisely
The label names it: “The site for injection for AVEED is the gluteus medius muscle site located in the upper outer quadrant of the buttock. Care must be taken to avoid the needle hitting the superior gluteal arteries and sciatic nerve.” Sites alternate left and right between injections.
4
Aspirate before injecting
Intravascular injection is the mechanism behind POME, so the label builds a check into the procedure: pull back and aspirate for several seconds; if any blood appears, withdraw, discard the syringe and prepare another dose.
5
Inject over 60 to 90 seconds
Not a push. The label specifies depressing the plunger slowly over 60 to 90 seconds at a constant rate, with the needle held at 90° and deeply embedded, then applying gentle pressure with a sterile pad on withdrawal.
6
Observe for 30 minutes
The boxed warning, the dosage section, the warnings section and the patient counselling section all repeat it. POME and anaphylaxis can follow any injection, including the first, after years of uneventful doses.
7
For the oral capsules: take them with food, and do not swap brands
All three oral products are taken twice daily with food, and food matters — undecanoate is absorbed through the lymphatics with dietary fat. The monitoring blood draw differs by brand: JATENZO measures 6 hours after the morning dose, KYZATREX 3 to 5 hours, TLANDO 8 to 9 hours. A level drawn on the wrong schedule is not interpretable.

Storage

—AVEED: “Store at controlled room temperature 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP controlled room temperature] in its original carton until the date indicated.”
—AVEED is a single-use vial. The label directs inspecting each vial before use, using only vials free from particles, and discarding the unused portion — there is no second 750 mg dose in a 3 mL vial.
—The oral capsules are stored per their own cartons. This page does not restate them, because three brands with three different capsule strengths do not share one storage statement.
—No testosterone undecanoate product is refrigerated.

Monitoring

Marker	When	Why
Immediate post-injection observation	30 minutes after every AVEED injection, in the healthcare setting	The only monitoring on this page measured in minutes. POME presents as urge to cough, dyspnoea, throat tightening, chest pain, dizziness or syncope, usually within moments of the injection; most episodes resolve with supportive measures but some have required emergency care or admission.
Total testosterone	AVEED: as directed. Oral: 6 hours after the morning dose (JATENZO), 3–5 hours (KYZATREX), 8–9 hours (TLANDO)	The oral labels do not just suggest a level, they tie the dose to it. JATENZO titrates between 158 mg and 396 mg twice daily against a 425–970 ng/dL window; KYZATREX between 100 mg and 400 mg twice daily against 460–971 ng/dL; TLANDO does not titrate at all and instead directs discontinuing if the level falls outside 300–1080 ng/dL. The draw time is part of the specification.
Haematocrit	Baseline and periodically	Erythrocytosis is the commonest clinically significant adverse effect of testosterone therapy at any route, and may require a dose reduction, a longer interval or phlebotomy.
Blood pressure	Periodically	Oral testosterone undecanoate products carry blood pressure warnings of their own; testosterone products generally are not recommended in uncontrolled hypertension.
PSA and prostate symptoms	Baseline and periodically in men over 40	Common to every testosterone product. The Endocrine Society guideline sets out which men warrant closer prostate surveillance before therapy starts.

Frequently asked questions

Why can’t I inject AVEED at home?: Because the label does not allow the setting, not merely the technique. AVEED is available only through a restricted programme under a Risk Evaluation and Mitigation Strategy, and the programme’s requirements fall on the clinic: prescribers must be certified, healthcare settings must be certified, and settings must “have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis.” After each injection the patient is observed for 30 minutes. A 750 mg depot of castor-oil solution carries a risk of pulmonary oil microembolism and of anaphylaxis that can appear after any dose including the first, and the 30-minute window exists because those reactions are treatable if someone is there.
How often is AVEED injected?: Five times a year after the first month. The label states: “The recommended dose of AVEED is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.” It also notes that dosage titration is not necessary — unlike every other testosterone product on this site, there is no dose to adjust, only the interval the label sets.
Are JATENZO, KYZATREX and TLANDO interchangeable?: No, and two of the three labels say so in as many words: “KYZATREX® is not substitutable with other oral testosterone undecanoate products” and “TLANDO is not substitutable with other oral testosterone undecanoate products.” The numbers make the point on their own. JATENZO starts at 237 mg twice daily and titrates between 158 mg and 396 mg twice daily. KYZATREX starts at 200 mg twice daily and titrates between 100 mg once daily and 400 mg twice daily. TLANDO is a fixed 225 mg twice daily with no titration scheme at all — the label instead directs continuing or discontinuing based on the level. Three products, three dose scales, three different blood-draw times.
Is oral testosterone undecanoate the same drug as the injection?: Same molecule, almost nothing else in common. The injection is 750 mg of ester in castor oil given into muscle roughly every ten weeks with an observation requirement; the capsules are a few hundred milligrams taken twice a day with food and absorbed largely through the lymphatics, which is why food is part of the instruction rather than a comfort measure. The oral products have no REMS and no boxed warning for POME. If you are reading about “testosterone undecanoate” without knowing whether the writer means AVEED or a capsule, almost none of what you read will apply to you.
What is POME?: Pulmonary oil microembolism — oil from the injection reaching the pulmonary circulation. The label describes it as “cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope”, reported during or immediately after intramuscular testosterone undecanoate. Most episodes last a few minutes and settle with supportive measures; some have lasted several hours and required emergency care or hospitalisation. The technique in the label — deep gluteal placement, aspirating for several seconds to confirm no blood, injecting over 60 to 90 seconds — is aimed at reducing the chance of intravascular injection, which is the mechanism.

Sources

Educational reference, not medical advice. Dose, route and whether this compound is appropriate at all are decisions for your clinician.