AVEED® (testosterone undecanoate) injection is a prescription medicine that contains testosterone, a controlled substance (CIII). AVEED® is used to treat adult males who have low or no testosterone due to certain medical conditions.
\nAVEED® is only for adult males who need testosterone replacement therapy and when the benefit of receiving AVEED® is more than the risk of pulmonary oil microembolism (POME) and anaphylaxis.
\nIt is not known if AVEED® is safe or effective to treat men who have low testosterone due to aging.
\nIt 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.
\nDo not receive AVEED® if you:
\nhave breast cancer, have or might have prostate cancer, are allergic to AVEED® or to any of the ingredients in AVEED® (testosterone undecanoate, castor oil, benzyl benzoate).
\nare a woman, or are pregnant. AVEED® may harm your unborn baby.
\nAVEED® may cause serious side effects, including:
\nA serious lung problem. AVEED® can cause a serious lung problem called POME. POME is caused by tiny droplets of oil that have traveled to the lungs. Symptoms of a POME reaction may include:
\nSerious 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.
\nYou may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after your AVEED® injection.
\nThese side effects may happen during or right after each injection. To be sure that you are not having one of these reactions:
\nBefore 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 heart problems, have liver or kidney problems, have problems breathing while you sleep (sleep apnea), or have any other medical conditions.
\nTell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
\nReceiving AVEED® with certain other medicines can affect each other. Especially tell your doctor if you take insulin, medicines that decrease blood clotting, or corticosteroids. Ask your doctor or pharmacist for a list of these medicines, if you are unsure.
\n\nAVEED® can cause serious side effects, including:
\nCall your doctor right away if you have any of the serious side effects listed above.
\nThe most common side effects of AVEED® include acne, pain at the injection site, increased prostate specific antigen (a test used to screen for prostate cancer), increased estradiol level, low testosterone level, feeling tired, irritability, increased red blood cell count, difficulty sleeping, or mood swings.
\nOther side effects include more erections than are normal for you or erections that last for a long time.
\nDrug abuse is the intentional use of a drug for its rewarding mental and physical effects. Physical dependence is characterized by withdrawal symptoms after abruptly stopping the drug or significantly reducing the dose. Serious side effects relating to the heart and blood vessels, for instance, heart attack and congestive heart failure, and mental status, including major depression, paranoia, delusions, hallucinations, hostility, and aggression, are associated with abuse of testosterone and anabolic androgenic steroids.
\nSide effects associated with abuse or misuse by men include mini-stroke, convulsions, mild mania (elation and hyperactivity), irritability, abnormal blood lipids, decrease in size or function of testicles, decreased or absence of fertility; by women include unwanted hair growth, development of male characteristics, voice deepening, clitoris enlargement, decrease in size or function of breasts, male pattern baldness, menstrual irregularities; by male and female adolescents include halting of growth and early puberty.
\nTell your doctor if you have any side effect that bothers you or that does not go away.
\nThese are not all the possible side effects with AVEED®. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.
\nGeriatric Patients: 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
\nPlease see full Prescribing Information, including Boxed Warning and patient Medication Guide.
\n\nAVEED® (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
\nPrimary 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
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.
\n Limitations of use:\nSafety 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
\nSerious 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.
CONTRAINDICATIONS
\nMen 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
\n\n\nSerious 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
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.
\nBoth 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®.
\nFollowing 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.
\nAVEED® is available only through a restricted program called the AVEED® REMS Program because of the risk of serious POME and anaphylaxis.
\nNotable requirements of the AVEED® REMS Program include the following:
\nFurther information is available at www.AveedREMS.com or call
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer - Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens.
Polycythemia - Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
Venous Thromboembolism (VTE) - There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as AVEED®. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with AVEED® and initiate appropriate workup and management.
Cardiovascular Risk - Some postmarketing studies have shown an increased risk of major adverse cardiovascular events (MACE) with use of testosterone replacement therapy. Patients should be informed of this possible risk when deciding to use or to continue to use AVEED®.
Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations - Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If testosterone abuse is suspected, check serum testosterone concentrations to ensure that they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
Use in Women - Due to lack of controlled evaluations in women and potential virilizing effects, AVEED® is not indicated for use in women.
Potential for Adverse Effects on Spermatogenesis - With large doses of exogenous androgens, including AVEED®, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Hepatic Adverse Effects - Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. AVEED® is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue AVEED® while the cause is evaluated.
Edema - Androgens, including AVEED®, may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia - Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism.
Sleep Apnea - The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
Lipids - Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy.
Hypercalcemia - Androgens, including AVEED®, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Decreased Thyroxine-binding Globulin - Androgens, including AVEED®, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Laboratory Monitoring - Monitor prostatic specific antigen (PSA), hemoglobin, hematocrit, and lipid concentrations at the start of treatment and periodically thereafter.
ADVERSE REACTIONS
\nAVEED® was evaluated in an 84-week clinical study using a dose regimen of
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.
\nPulmonary Oil Microembolism (POME) and Anaphylaxis
\nSerious 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 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.
\nDRUG INTERACTIONS
\nInsulin - 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
\nGeriatric 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
\nAVEED® contains testosterone undecanoate, a Schedule III controlled substance in the Controlled Substances Act.
\nAbuse 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.
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