Treat Hypogonadism with 5 Shots a Year After the First Month of Therapy

Testosterone undecanoate, the active ingredient in AVEED ® , is long acting due to its structure and formulation 2

The active ingredient in AVEED ® has long-term kinetics because it is a depot that has a longer aliphatic side chain than other testosterone esters. 2

Writing a Prescription for AVEED ®

Inject 750 mg IM on day 1, followed by a 2nd injection 4 weeks later. Subsequent injections are given every 10 weeks thereafter. 1

Inject 750 mg IM every 10 weeks. 1

In-office storage

• No refrigeration required 1
• 60-month shelf life 3

Always Administered by a Healthcare Professional

Because AVEED ® is administered in-office, you can:

• Closely monitor treatment progress
• Track patient adherence
• Avoid the risk of secondary exposure to testosterone (transference)

In-office administration procedures 1

1. Location
AVEED ® should be injected deeply into the gluteus medius muscle, avoiding the superior gluteal arteries and sciatic nerve. Intravascular injection may lead to pulmonary microembolism of the .

2. Inject
Deliver the full dose using steady pressure over a period of 60 to .

3. Monitor
Patient should remain on-site for after each injection to allow for early recognition and management of a potential anaphylactic reaction or an injection-based pulmonary oil

You should test the patient's blood before and while the patient receives AVEED ® . 1

Please print the full Prescribing Information, including Boxed Warning and Medication Guide.

Proper Injection Technique for AVEED ® Intramuscular Injection 1

1. 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. 2. 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. 3. 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. 4. 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. 5. Following each injection of AVEED ® , observe patients in the healthcare setting for in order to provide appropriate medical treatment in the event of serious or anaphylaxis.

Among 3,556 patients in worldwide clinical trials 1 * :

• 9 POME events occurred in 8 patients
• 2 events of anaphylaxis occurred

*Patients treated with intramuscular testosterone undecanoate.

In an 84-week clinical study using a dose of in men, the most commonly reported adverse were acne, injection site pain, prostatic specific increased, estradiol increased, hypogonadism, fatigue, irritability, hemoglobin increased, insomnia, and mood swings.

AVEED ® is available only through a restricted program called the AVEED ® REMS Program because of the risk of serious POME and anaphylaxis.

Notable requirements of the AVEED ® REMS Program include the following:

• Healthcare providers who prescribe AVEED ® must be certified with the REMS Program before ordering or dispensing AVEED ® .
• Healthcare settings must be certified with the REMS Program and have healthcare providers who are certified before ordering or dispensing AVEED ® . Healthcare settings must have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis.

Further information is available at www.AveedREMS.com or call 1-855-755-0494.

Learn how you can become a prescriber through the AVEED ® REMS † Program.

Read an overview of the injection procedure and other important facts about administering AVEED ® .

† Risk Evaluation and Mitigation Strategy.

Intended for U.S. Residents Only

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INDICATIONS AND IMPORTANT SAFETY INFORMATION about AVEED ®

AVEED ® (testosterone undecanoate) 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 (LHRH) deficiency or 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 pulmonary oil microembolism and anaphylaxis.

• 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.

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.

• 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).

WARNINGS AND PRECAUTIONS

• Serious Pulmonary Oil Microembolism (POME) Reactions and Anaphylaxis
  Serious POME reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate 1000 mg . 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. To minimize the risk of intravascular injection of AVEED ® , care should be taken to inject the preparation deeply into the gluteal muscle, being sure to follow the recommended procedure for intramuscular administration. In addition to serious POME reactions, 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. Patients with suspected hypersensitivity reactions to AVEED ® should not be re-treated with AVEED ® . 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 and anaphylaxis.
• AVEED ® Risk Evaluation and Mitigation Strategy (REMS) Program
  AVEED ® is available only through a restricted program called the AVEED ® REMS Program because of the risk of serious POME and anaphylaxis. Notable requirements of the AVEED ® REMS Program include the following:
  • Healthcare providers who prescribe AVEED ® must be certified with the REMS Program before ordering or dispensing AVEED ® .
  • Healthcare settings must be certified with the REMS Program and have healthcare providers who are certified before ordering or dispensing AVEED ® . Healthcare settings must have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis.

  Further information is available at www.AveedREMS.com or call .

  AVEED ® was evaluated in an 84-week clinical study using a dose regimen of at initiation, at , and every thereafter in 153 hypogonadal men. The most commonly reported adverse reactions (≥2%) were: acne, injection site pain, prostate specific antigen increased, hypogonadism, estradiol increased, fatigue, irritability, hemoglobin increased, insomnia, and mood swings.

  In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Adverse reactions leading to discontinuation included: hematocrit increased, estradiol increased, prostatic specific antigen increased, prostate cancer, mood swings, prostatic dysplasia, acne, and deep vein thrombosis.

  • Postmarketing ExperiencePulmonary Oil Microembolism (POME) and Anaphylaxis Serious pulmonary oil microembolism (POME) reactions, involving cough, urge to cough, dyspnea, hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been reported to occur during or immediately after the injection of intramuscular testosterone undecanoate in use outside the United States. In addition to serious POME reactions, episodes of anaphylaxis, including life-threatening reactions, have also been reported to occur following the injection of intramuscular testosterone undecanoate in post-approval use outside of the United States.
  • Insulin - Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
  • Oral Anticoagulants - Changes in anticoagulant activity may be seen with androgens, therefore, more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
  • Corticosteroids - The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease.

  USE IN SPECIFIC POPULATIONS

  • Geriatric Use - There have not been sufficient numbers of geriatric patients in controlled clinical studies with AVEED ® to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There are insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.
  • Infertility - Spermatogenesis may be suppressed and reduced fertility is observed in some men taking testosterone replacement therapy.

  DRUG ABUSE AND DEPENDENCE

  AVEED ® contains testosterone undecanoate, a Schedule III controlled substance in the Controlled Substances Act.

  • Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders.
  • Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression.
  • The following adverse reactions have been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemia, testicular atrophy, subfertility, and infertility.
  • The following adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male pattern baldness, and menstrual irregularities.
  • The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
  • Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications have not been documented.

  Please see full Prescribing Information, including Boxed Warning and Medication Guide.

  Intended for U.S. Residents Only