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Aveed testosterone undecanoate injection contains testosterone undecanoate 17beta;-undecanoyloxyandrostenone 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 30 H 48 O 3 and a molecular weight of The structural formula is:. Aveed is a clear, yellowish, sterile oily solution containing testosterone undecanoate, a testosterone ester, for intramuscular injection. Aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
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. Prior to initiating Aveed, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
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 Administration Instructions ].
The recommended dose of Aveed is 3 mL mg injected intramuscularly, followed by 3 mL mg injected after 4 weeks, then 3 mL mg injected every 10 weeks thereafter. 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, you can draw 3 mL of air into the syringe and inject it through the gray rubber stopper into the vial to create positive pressure within the vial chamber.
Withdraw 3 mL 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.
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. Identifying the Injection Site. 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. 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. Each vial is individually packaged in a carton box. Before use, each vial should be visually inspected. Only vials free from particles should be used. Endo Pharmaceuticals Solutions Inc. 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.
Aveed was evaluated in an week clinical study using a dose regimen of mg 3 mL at initiation, at 4 weeks, and every 10 weeks thereafter in hypogonadal men.
In the week clinical trial, 7 patients 4. Adverse reactions leading to discontinuation included: During the week clinical trial, the average serum PSA increased from 1.
Fourteen 14 patients A total of hypogonadal men received intramuscular testosterone undecanoate in a total of 7 controlled clinical trials. In these clinical trials, the dose and dose frequency of intramuscular testosterone undecanoate varied from mg to mg, and from every 9 weeks to every 14 weeks.
Several of these clinical trials incorporated additional doses upon initiation of therapy eg, loading doses. Adverse events attributable to pulmonary oil microembolism and anaphylaxis were reported in a small number of patients in controlled clinical trials.
In the week clinical trial of Aveed, 1 patient experienced a mild coughing fit lasting 10 minutes after his third injection, which was retrospectively attributed to POME. In another clinical trial of intramuscular testosterone undecanoate 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.
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, 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 Aveed. 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.
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 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 of intramuscular testosterone undecanoate. In most cases, the dose being used was mg. Blood and Lymphatic System Disorders: Ear and Labyrinth Disorders: General Disorders and Administrative Site Conditions: Metabolism and Nutrition Disorders: Musculoskeletal and Connective Tissue Disorders: Neoplasms Benign, Malignant and Unspecified including cysts and polyps: Renal and Urinary Disorders: Reproductive System and Breast Disorders: Respiratory, Thoracic and Mediastinal Disorders: Skin and Subcutaneous Tissue Disorders: 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.
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.
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids AAS , and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
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 also been reported in men: The following additional adverse reactions have been reported in women: The following adverse reactions have been reported in male and female adolescents: Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:. Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia , insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. 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 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. 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.
Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at an increased risk for prostate cancer. 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. 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. Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men.