Aveed testosterone undecanoate 250 mg/mL Injection — NDC 67979-511-43 (Billing 67979-0511-43)

1 INDICATIONS 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 [see Use in Specific Populations ( 8.4 )]. Aveed (testosterone undecanoate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) ( 1 ) Hypogonadotropic hypogonadism (congenital or acquired) ( 1 ) 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 pulmonary oil microembolism and anaphylaxis ( 1 ).

Limitations of Use Safety and efficacy of Aveed in men with “age-related hypogonadism” have not been established ( 1 ). Safety and efficacy of Aveed in males less than 18 years old have not been established ( 1 , 8.4 ).

2 DOSAGE 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. Prior to initiating Aveed, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). For intramuscular use only ( 2.1 ).

Three (3) mL (750 mg) is to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter ( 2.1 ). 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 ( 2.3 ). Inject Aveed deeply into the gluteal muscle following the usual precautions for intramuscular administration of oily solutions ( 2.3 ).

2.1Dosage 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 [see Dosage and Administration ( 2.3 )] .

Intravascular injection of AVEED may lead to POME [see Warnings and Precautions ( 5.1 )]. 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.

2.2Preparation 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.

2.3Administration Instructions 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. Between consecutive injections, alternate the injection site between left and right buttock.

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 pati… [Excerpted — this section continues on DailyMed.]

3 DOSAGE 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. 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 ( 3 ).

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide ). Advise patients of the following:

17.1Risks 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 "What You Need to Know About AVEED ® Treatment: A Patient Guide" . Instruct patients to remain at the healthcare setting for 30 minutes after each AVEED injection.

17.2Men with Known or Suspected Carcinoma of the Prostate or Breast Men with known or suspected prostate or breast cancer should not use AVEED [see Contraindications ( 4 )] .

17.3Potential 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

17.4Patients 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. Manufactured for: Endo USA Malvern, PA 19355 © 2025 Endo, Inc. or one of its affiliates.

Revised: 07/2025

MEDICATION GUIDE AVEED ® (Uh-Veed) (testosterone undecanoate) injection Read this Medication Guide before you receive AVEED and before each injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about AVEED? AVEED may cause serious side effects, including: A serious lung problem. AVEED can cause a serious lung problem called a pulmonary oil microembolism (POME) reaction.

POME is caused by tiny droplets of oil that have traveled to the lungs. Symptoms of a POME reaction may include: o cough or urge to cough o difficulty breathing o sweating o tightening of your throat o chest pain o dizziness o fainting Serious allergic reactions (anaphylaxis). AVEED can cause a serious allergic reaction right after receiving the injection.

Some of these allergic reactions may be life threatening. These reactions can happen after you receive your first dose of AVEED or may happen after receiving more than 1 dose. You may need emergency treatment in a hospital , especially if these symptoms get worse over the 24 hours after your AVEED injection.

These side effects may happen during or right after each injection. To be sure that you are not having one of these reactions: o You need to stay in the doctor’s office, clinic, or hospital for 30 minutes after having your AVEED injection so that your doctor can watch you for symptoms of POME or a serious allergic reaction. o You can only get AVEED at your doctor’s office, clinic, or hospital. AVEED is only available through a restricted program called the AVEED Risk Evaluation and Mitigation Strategy (REMS) Program.

For more information about the AVEED REMS Program go to www.AveedREMS.com or call 1-855-755-0494. What is AVEED? AVEED is a prescription medicine that contains testosterone.

AVEED is used to treat adult males who have low or no testosterone due to certain medical conditions. AVEED is only for adult males who need testosterone replacement therapy and when the benefit of receiving AVEED is more than the risk of POME and anaphylaxis. Your healthcare provider will test your blood before you start and while you are taking AVEED.

It is not known if AVEED is safe or effective to treat men who have low testosterone due to aging. It is not known if AVEED is safe and effective for use in children younger than 18 years old. Improper use of AVEED may affect bone growth in children.

AVEED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. AVEED is not meant for use in women. Who should not receive AVEED?

Do not receive AVEED if you: have breast cancer have or might have prostate cancer are pregnant. AVEED may harm your unborn baby. are allergic to AVEED or to any of the ingredients in AVEED. See the end of this leaflet for a complete list of ingredients in AVEED.

Talk to your doctor before receiving this medicine if you have any of the above conditions. What should I tell my doctor before receiving AVEED? Before receiving AVEED, tell your doctor if you: have breast cancer have or might have prostate cancer have urinary problems due to an enlarged prostate have high blood pressure or are being treated for high blood pressure have heart problems have liver or kidney problems have problems breathing while you sleep (sleep apnea) have any other medical conditions Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Receiving AVEED with certain other medicines can affect each other. Especially tell your doctor if you take: insulin medicines that decrease blood clotting corticosteroids Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take.

Keep a list of your medicines and show them to your doctor and pharmacist when you get a new m… [Excerpted — this section continues on DailyMed.]