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AVEED(testosterone undecanoate)injection, for intramuscular use CIII
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AVEED® safely and effectively. See full prescribing information for AVEED®.
AVEED® (testosterone undecanoate) injection, for intramuscular use
CIII
Initial U.S. Approval: 1953
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
See full prescribing information for complete boxed warning
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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. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose (5.1).
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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 (5.1).
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Aveed is available only through a restricted program called the Aveed REMS Program (5.2).
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 6/2014
INDICATIONS AND USAGE
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:
o Primary hypogonadism (congenital or acquired) (1)
o 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:
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Safety and efficacy of Aveed in males less than 18 years old have not been established (1, 8.4).
DOSAGE AND ADMINISTRATION
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For intramuscular use only (2.1).
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3 mL (750 mg) is to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter (2.1).
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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).
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Inject Aveed deeply into the gluteal muscle following the usual precautions for intramuscular administration of oily solutions (2.3).
DOSAGE FORMS AND STRENGTHS
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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).
CONTRAINDICATIONS
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Men with carcinoma of the breast or known or suspected carcinoma of the prostate (4, 5.3).
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Pregnant or breastfeeding women. Testosterone may cause fetal harm (4, 8.1, 8.3).
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Known hypersensitivity to Aveed or its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate) (4).
WARNINGS AND PRECAUTIONS
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Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH (5.3).
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Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. eva luate patients with signs or symptoms consistent with DVT or PE. (5.5)
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Exogenous administration of androgens may lead to azoospermia (5.7).
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Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.9).
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Sleep apnea may occur in those with risk factors (5.11).
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Monitor prostatic specific antigen (PSA), hemoglobin, hematocrit, and lipid concentrations periodically (5.3, 5.4, 5.12).
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥2%) are acne, injection site pain, prostatic specific antigen (PSA) increased, estradiol increased, hypogonadism, fatigue, irritability, hemoglobin increased, insomnia, and mood swings (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Androgens may decrease blood glucose, and therefore may decrease insulin requirements in diabetic patients (7.1).
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Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time is recommended in patients taking warfarin (7.2).
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Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease (7.3).
USE IN SPECIFIC POPULATIONS
Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer (8.5).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 09/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
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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. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose [seeWarnings and Precautions (5.1)].
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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 [see Warnings and Precautions (5.1)].
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Because of the risks of serious POME reactions and anaphylaxis, Aveed is available only through a restricted program under a Risk eva luation and Mitigation Strategy (REMS) called the Aveed REMS Program [see Warnings and Precautions (5.2)].
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.
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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.
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Hypogonadotropic hypogonadism (congenital or acquired): idiopathic 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 pulmonary oil microembolism and anaphylaxis.
Limitations of use:
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Safety and efficacy of Aveed in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
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 pulmonary oil microembolism [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.
2.2 Preparation Instructions
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Remove the plastic cap from the vial. Do not remove the aluminum ring or crimp seal. To facilitate the removal of medication from the vial, you can draw 3 mL of air into the syringe and inject 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.
2.3 Administration 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 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).
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.
4 CONTRAINDICATIONS
Aveed should not be used in any of the following patients:
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Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.3)].
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Women who are or may become pregnant, or who are breastfeeding. Testosterone can cause fetal harm when administered to a pregnant woman. Aveed may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization [see Use in Specific Populations (8.1, 8.3)].
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Men with known hypersensitivity to Aveed or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate).
5 WARNINGS AND PRECAUTIONS
5.1 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 (4 mL). 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 [see Dosage and Administration (2.2, 2.3) and Adverse Reactions (6.2)].
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.
5.2 Aveed Risk eva luation 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:
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Healthcare providers who prescribe Aveed must be certified with the REMS Program before ordering or dispensing Aveed.
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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.
5.3 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. eva luate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4)].
5.4 Polycythemia
Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of testosterone.
Check hematocrit prior to initiating testosterone treatment. &n |
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