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Generic Name
Undecanoate
Brand Names
Aveed, Jatenzo, Kyzatrex, Tlando
FDA approval date: March 05, 2014
Classification: Androgen
Form: Injection, Capsule
What is Aveed (Undecanoate)?
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism : testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone , luteinizing hormone ) above the normal range. Hypogonadotropic hypogonadism : gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME and anaphylaxis. Limitations of Use Safety and efficacy of AVEED in men with “age-related hypogonadism” have not been established. Safety and efficacy of AVEED in males less than 18 years old have not been established [see Use in Specific Populations.
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Brand Information
Aveed (testosterone undecanoate)
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
- 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
- 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
- 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
1INDICATIONS AND USAGE
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME and anaphylaxis.
Limitations of Use
- Safety and efficacy of AVEED in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
- Safety and efficacy of AVEED in males less than 18 years old have not been established
2
Warnings and Precautions, Venous Thromboembolism (5.4) 07/2025
Warnings and Precautions, Blood Pressure Increases (5.6) 07/2025
Warnings and Precautions, Cardiovascular Risk (5.6) Removed 07/2025
3DOSAGE AND ADMINISTRATION
Prior to initiating AVEED, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range.
3.1Dosage
AVEED is for intramuscular use only. Dosage titration is not necessary.
Inject AVEED deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection
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.
3.2Preparation Instructions
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Carefully remove the gray plastic cap from the top of the vial by lifting it up from the edges with your fingers or by pushing the bottom edge of the cap upward using the top of your thumb. Remove only the gray plastic cap while leaving the aluminum metal ring and crimp seal around the gray rubber stopper in place. To facilitate the removal of medication from the vial, attach an 18-gauge needle and draw 3 mL of air into the syringe. Hold the needle at a 45° angle to the stopper with the bevel in the up orientation. Inject through the gray rubber stopper into the vial to create positive pressure within the vial chamber.
Withdraw 3 mL (750 mg) of AVEED solution from the vial. Expel excess air bubbles from the syringe. Replace the syringe needle used to draw up the solution from the vial with a new intramuscular needle and inject. Discard any unused portion in the vial.
3.3Administration Instructions
The site for injection for AVEED is the
Figure 1: Identifying the Injection Site
Following antiseptic skin preparation, enter the muscle and maintain the syringe at a 90° angle with the needle in its deeply imbedded position. Grasp the barrel of the syringe firmly with one hand. With the other hand, pull back on the plunger and aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, immediately withdraw and discard the syringe and prepare another dose.
If no blood is aspirated, reinforce the current needle position to avoid any movement of the needle and slowly (over 60 to 90 seconds) depress the plunger carefully and at a constant rate, until all the medication has been delivered. Be sure to depress the plunger completely with sufficient controlled force. Withdraw the needle.
Immediately upon removal of the needle from the muscle, apply gentle pressure with a sterile pad to the injection site. If there is bleeding at the site of injection, apply a bandage.
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
4DOSAGE FORMS AND STRENGTHS
750 mg/3 mL (250 mg/mL) testosterone undecanoate sterile injectable solution is provided in an amber glass, single use vial with silver-colored crimp seal and gray plastic cap.
5CONTRAINDICATIONS
AVEED should not be used in any of the following patients:
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman
- Men with known hypersensitivity to AVEED or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate).
6OVERDOSAGE
There have been no reports of overdosage in the AVEED clinical trials. There is 1 report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident.
Treatment of overdosage would consist of discontinuation of AVEED together with appropriate symptomatic and supportive care.
7DESCRIPTION
AVEED (testosterone undecanoate) injection contains testosterone undecanoate (17β-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone. Testosterone is formed by cleavage of the ester side chain of testosterone undecanoate.
Testosterone undecanoate is a white to off-white crystalline substance. The empirical formula of testosterone undecanoate is C
Figure 2: Testosterone Undecanoate
C
AVEED is a clear, yellowish, sterile oily solution containing testosterone undecanoate, a testosterone ester, for intramuscular injection. Each single use vial contains 3 mL of 250 mg/mL testosterone undecanoate solution in a mixture of 1500 mg of benzyl benzoate and 885 mg of refined castor oil.
8HOW SUPPLIED/STORAGE AND HANDLING
AVEED, NDC 67979-511-43: 750 mg/3 mL (250 mg/mL) testosterone undecanoate sterile injectable solution is provided in an amber glass vial with silver-colored crimp seal and gray plastic cap. Each vial is individually packaged in a carton box.
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.
Before use, each vial should be visually inspected. Only vials free from particles should be used.
Single Use Vial. Discard unused portion.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the
Advise patients of the following:
9.1Risks of Serious Pulmonary Oil Microembolism (POME) and Anaphylaxis
- Serious POME reactions, involving cough, urge to cough, shortness of breath, sweating, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate. The majority of these events lasted a few minutes and resolved with supportive measures; however, some lasted up to several hours and some required emergency care and/or hospitalization.
- Episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular testosterone undecanoate.
- Both serious POME reactions and anaphylaxis can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
- Advise the patient to read the AVEED REMS information sheet titled
- Instruct patients to remain at the healthcare setting for 30 minutes after each AVEED injection.
9.2Men with Known or Suspected Carcinoma of the Prostate or Breast
Men with known or suspected prostate or breast cancer should not use AVEED
9.3Potential Adverse Reactions to Androgens
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
- Changes in urinary habits, such as increased urination at night, trouble starting the urine stream, passing urine many times during the day, having an urge to go the bathroom right away, having a urine accident, or being unable to pass urine or weak urine flow
- Breathing disturbances, including those associated with sleep or excessive daytime sleepiness
- Too frequent or persistent erections of the penis
- Nausea, vomiting, changes in skin color, or ankle swelling
- Venous thromboembolism, the signs and symptoms of which may include lower limb pain, edema, or erythema; dyspnea; or chest pain.
- Increased blood pressure that can increase cardiovascular risk over time
9.4Patients Should Be Advised of the Following Instructions for Use
- Read the Medication Guide before starting AVEED therapy and reread the Guide before each injection.
- Adhere to all recommended monitoring.
- Report any changes in their state of health, such as signs and symptoms of venous thromboembolism, changes in urinary habits, breathing, sleep, and mood.
- Be aware of the importance of monitoring BP periodically while on AVEED. If BP increases while on AVEED, antihypertensive medications may need to be started, added, or adjusted, or AVEED may need to be discontinued.