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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. Following each injection of testosterone undecanoate, 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 [see Warnings and Precautions (5.1)].
Because of the risks of serious POME reactions and anaphylaxis, testosterone undecanoate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program [see Warnings and Precautions (5.2)].
Testosterone undecanoate injection contains testosterone undecanoate (17I?-undecanoyloxy-4-androsten-3-one) which is an ester of the androgen, testosterone.
Testosterone undecanoate injection is a clear, yellowish, sterile oily solution containing testosterone undecanoate, a testosterone ester, for intramuscular injection.
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.
Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. Testosterone undecanoate 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
The site for injection for testosterone undecanoate is the gluteus medius muscle site located in the upper outer quadrant of the buttock. Following antiseptic skin preparation, enter the muscle and maintain the syringe at a 90A° angle with the needle in its deeply imbedded position. 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. Immediately upon removal of the needle from the muscle, apply gentle pressure with a sterile pad to the injection site. Following each injection of testosterone undecanoate, 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 (5.1).
Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.3)].
Men with known hypersensitivity to testosterone undecanoate or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate). 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 (4 mL).
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.
Following each injection of testosterone undecanoate, 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. Testosterone undecanoate is available only through a restricted program called the AVEED REMS Program because of the risk of serious POME and anaphylaxis.
Healthcare providers who prescribe testosterone undecanoate must be certified with the REMS Program before ordering or dispensing testosterone undecanoate.
Healthcare settings must be certified with the REMS Program and have healthcare providers who are certified before ordering or dispensing testosterone undecanoate. Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of testosterone. Due to lack of controlled evaluations in women and potential virilizing effects, testosterone undecanoate is not indicated for use in women. With large doses of exogenous androgens, including testosterone undecanoate, 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. Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism [see Adverse Reactions (6.1)].
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. Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Androgens, including testosterone undecanoate, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria).
Androgens, including testosterone undecanoate, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Testosterone undecanoate was evaluated in an 84-week clinical study using a dose regimen of 750 mg (3 mL) at initiation, at 4 weeks, and every 10 weeks thereafter in 153 hypogonadal men. Table 1 presents adverse reactions reported by a‰?1% of patients in the 84-week clinical study.
In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. A total of 725 hypogonadal men received intramuscular testosterone undecanoate in a total of 7 controlled clinical trials. Adverse events attributable to pulmonary oil microembolism and anaphylaxis were reported in a small number of patients in controlled clinical trials. During a review that involved adjudication of all cases meeting specific criteria, 9 POME events in 8 patients and 2 events of anaphylaxis among 3,556 patients treated with intramuscular testosterone undecanoate in 18 clinical trials were judged to have occurred.


The following adverse reactions have been identified during post-approval use of testosterone undecanoate. 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 1000 mg (4 mL) in post-approval 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. Both serious POME reactions and anaphylaxis have been reported to occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
The following treatment emergent adverse events or adverse reactions have been identified during post-marketing clinical trials and during post-approval use outside the United States of intramuscular testosterone undecanoate.
Cardiac Disorders: angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia. General Disorders and Administrative Site Conditions: chest pain, edema peripheral, injection site discomfort, injection site hematoma, injection site irritation, injection site pain, injection site reaction, malaise, paresthesia, procedural pain.
Immune System Disorders: anaphylactic reaction, anaphylactic shock, asthma, dermatitis allergic, hypersensitivity, leukocytoclastic vasculitis. Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood glucose increased, blood pressure increased, blood prolactin increased, blood testosterone decreased, blood testosterone increased, blood triglycerides increased, gamma-glutamyltransferase increased, hematocrit increased, intraocular pressure increased, liver function test abnormal, prostate examination abnormal, prostatic specific antigen increased, transaminases increased. Metabolism and Nutrition Disorders: diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia.
Musculoskeletal and Connective Tissue Disorders: musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus.
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps): prostate cancer, prostatic intraepithelial neoplasia.
Nervous System Disorders: cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack.
Psychiatric Disorders: aggression, anxiety, depression, insomnia, irritability, Korsakoffa€™s psychosis non-alcoholic, male orgasmic disorder, nervousness, restlessness, sleep disorder. Renal and Urinary Disorders: calculus urinary, dysuria, hematuria, nephrolithiasis, pollakiuria, renal colic, renal pain, urinary tract disorder. Reproductive System and Breast Disorders: benign prostatic hyperplasia, breast induration, breast pain, erectile dysfunction, gynecomastia, libido decreased, libido increased, prostate induration, prostatitis, spermatocele, testicular pain. Respiratory, Thoracic and Mediastinal Disorders: asthma, chronic obstructive pulmonary disease, cough, dysphonia, dyspnea, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary microemboli, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome, snoring. Skin and Subcutaneous Tissue Disorders: acne, alopecia, angioedema, angioneurotic edema, dermatitis allergic, erythema, hyperhidrosis, pruritus, rash. Vascular Disorders: cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, hot flush, hypertension, syncope, thromboembolism, thrombosis, venous insufficiency.
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. 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. 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.
Testosterone undecanoate is contraindicated in pregnant women or in women who may become pregnant. Although it is not known how much testosterone transfers into human milk, testosterone undecanoate is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Safety and effectiveness of testosterone undecanoate in pediatric patients less than 18 years old have not been established. There have not been sufficient numbers of geriatric patients in controlled clinical studies with testosterone undecanoate to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH [see Warnings and Precautions (5.3)]. Testosterone undecanoate is a Schedule III controlled substance in the Controlled Substances Act. Although drug dependence has not been documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence has been observed in some individuals abusing high doses of anabolic steroids. Treatment of overdosage would consist of discontinuation of testosterone undecanoate together with appropriate symptomatic and supportive care. Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Following intramuscular injection of 750 mg of testosterone undecanoate, serum testosterone concentrations reach a maximum after a median of 7 days (range 4 a€“ 42 days) then slowly decline (Figure 2). Circulating testosterone is chiefly bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free), and the rest is loosely bound to albumin and other proteins.
Testosterone undecanoate is metabolized to testosterone via ester cleavage of the undecanoate group. DHT concentrations increased in parallel with testosterone concentrations during testosterone undecanoate treatment. There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
Analysis of serum testosterone concentrations from 117 hypogonadal men in the 84-week clinical study of testosterone undecanoate indicated that serum testosterone concentrations achieved were inversely correlated with the patienta€™s body weight. We are a serious supplier of sex enhancement, mainly specializes in manufacturing and exporting various high quality Medicines and health care powders.


These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose [see Warnings and Precautions (5.1)]. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Intravascular injection of testosterone undecanoate may lead to pulmonary oil microembolism [see Warnings and Precautions (5.1)].
Draw 3 mL of air into the syringe and inject into the vial to create positive pressure within the vial chamber. Care must be taken to avoid the needle hitting the superior gluteal arteries and sciatic nerve.
Patients with suspected hypersensitivity reactions to testosterone undecanoate should not be re-treated with testosterone undecanoate. Healthcare settings must have on-site access to equipment and personnel trained to manage serious POME and anaphylaxis. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [See Contraindications (4)].
It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 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. In these clinical trials, the dose and dose frequency of intramuscular testosterone undecanoate varied from 750 mg to 1000 mg, and from every 9 weeks to every 14 weeks. In the 84-week clinical trial of testosterone undecanoate, 1 patient experienced a mild coughing fit lasting 10 minutes after his third injection, which was retrospectively attributed to POME. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. Of the153 patients enrolled in the pivotal clinical study utilizing testosterone undecanoate, 26 (17.0%) were over 65 years of age. Primary hypogonadism is caused by defects of the gonads, such as Klinefeltera€™s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). Cleavage of the undecanoic acid side chain of testosterone undecanoate by tissue esterases releases testosterone.
Steady state serum testosterone concentration was achieved with the 3rd injection of testosterone undecanoate at 14 weeks. Intramuscular injection of 750 mg of testosterone undecanoate generates mean steady state serum total testosterone concentrations in the normal range for 10 weeks. About 90% of a testosterone dose given intramuscularly is excreted in the urine as glucuronic and sulfuric acid-conjugates of testosterone or as metabolites. Replace the syringe needle used to draw up the solution from the vial with a new intramuscular needle and inject. Between consecutive injections, alternate the injection site between left and right buttock.
With the other hand, pull back on the plunger and aspirate for several seconds to ensure that no blood appears.
If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level.
Long-term therapy with intramuscular testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. In another clinical trial of intramuscular testosterone undecanoate (1000 mg), a hypogonadal male patient experienced the urge to cough and respiratory distress at 1 minute after his tenth injection, which was also retrospectively attributed to POME.
Exposure of a fetus to androgens, such as testosterone, may result in varying degrees of virilization. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. Testosterone undecanoate was nearly undetectable 42 days following injection of testosterone undecanoate.
If any blood is drawn into the syringe, immediately withdraw and discard the syringe and prepare another dose.
In addition to those adverse reactions noted in Table 1, the following adverse events were reported by at least 3% of patients in these trials, irrespective of the investigatora€™s assessment of relationship to study medication: sinusitis, prostatitis, arthralgia, nasopharyngitis, upper respiratory tract infection, bronchitis, back pain, hypertension, diarrhea and headache. If this drug is used in pregnancy or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus. If these occur, promptly discontinue testosterone undecanoate while the cause is evaluated.



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