Adult Dosing

Male hypogonadism

• 50-400 mg IM q2-4 wks (testosterone enanthate, testosterone cypionate)

CA breast, palliative management in postmenopausal women

• 200-400 mg IM q2-4 wks (testosterone enanthate)

Primary hypogonadism, Hypogonadotropic hypogonadism (congenital or acquired) (testosterone undecanoate)

• 3 ml (750 mg) IM followed by 3 mL (750 mg) injected after 4 weeks, then 3 ml (750 mg) injected every 100 weeks thereafter

Pediatric Dosing

• Safety and effectiveness in pediatric patients < 12 years have not been established

Delayed puberty

• 50-200 mg IM q2-4 wks for up to 6 months (testosterone enanthate)

Note:

• Androgen therapy should be used cautiously in pediatric patients and by specialists aware of adverse effects on bone maturation
• Monitoring of skeletal maturation must be done every six months by hand and wrist X-ray

[Outline]

• Adult Dosing
• Pediatric Dosing

• Hypogonadism in androgen-deficient men (testosterone cypionate and testosterone enanthate)
• Delayed puberty in men (testosterone enanthate)
• Androgen-responsive breast cancer in postmenopausal women (testosterone enanthate)
• Primary hypogonadism (congenital or acquired)(testosterone undecanoate)
• Hypogonadotropic hypogonadism (congenital or acquired) (testosterone undecanoate)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to sesame oil
• Prostate CA
• CA breast; male patients
• Severe renal impairment
• Severe hepatic impairment
• Severe cardiac disease
• Female patients who are or may become pregnant

testosterone undecanoate

• Serious serious pulmonary oil microembolism (POME) reactions, involving urge to cough, dyspnea, throat tightening, chest, pain, dizziness, and syncope; and episodes of anaphylaxis, including life threatening reactions, may occur during or immediately after initiation of testosterone undecanoate injection
• Closely monitor 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, therapy is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AVEED REMS Program

Renal Dose Adjustment

• Mild/Moderate impairment: Use with caution; dose adjustments not defined
• Severe impairment: Contraindicated

Hepatic Dose Adjustment

• Mild/Moderate impairment: Use with caution; dose adjustments not defined
• Severe impairment: Contraindicated

See Supplemental Patient Information

• Testosterone cypionate is not bioquivalent to testosterone proprionate
• Prolonged use of high doses can cause serious hepatic adverse effects including peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice. If cholestatic jaundice develops, discontinue therapy
• Evaluate geriatric patients for presence of prostate cancer prior to starting therapy; geriatric patients are at an increased risk of development of prostatic hypertrophy and prostatic CA
• Androgen therapy may cause hypercalcemia by stimulating osteolysis especially in breast cancer and immobilized patients
• Women should be observed for signs of virilization
• Gynecomastia may occur
• Monitor CrCl, Hgb, HCT periodically if long term treatment; LFTs, PSA and Lipid panel periodically
• Use cautiously in healthy males with delayed puberty. In children, androgen therapy may accelerate bone maturation without producing compensatory linear growth. Monitor hand/wrist x-rays q6 months in prepubertal males
• Monitor periodic urine and serum Ca levels in women with disseminated CA breast
• Exogenous administration of androgens may lead to azoospermia

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• CV disease
• Hx of MI
• Hx of CAD
• CHF
• Edema
• Diabetes mellitus
• Chronic Pulmonary disease
• Obese patients
• Hyperlipidemia
• BPH
• Hx of sleep apnea
• Geriatric population (increased risk of prostate CA)

Supplemental Patient Information

• Should instruct patients to report any of the following side effects of androgens: Too frequent or persistent erections of the penis, any nausea, vomiting, jaundice, or ankle swelling

Pregnancy Category:X

Breastfeeding: Unsafe.

• REPRODUCTIVE: Menstrual irregularities, amenorrhea, gynecomastia, oligospermia
• GU: Erectile dysfunction, priapism, prostatic enlargement, virilization
• ENDO: Inhibition of gonadotropin secretiont, clitoral enlargement, hirsutism
• EENT: Deepening of voice
• CV: Edema, hypertension, tachycardia
• GI: Nausea, vomiting, diarrhea, abdominal pain
• HEP: Cholestatic jaundice, drug-induced hepatitis, elevated LFTs, hepatocellular neoplasms, peliosis hepatitis
• HEMA: Polycythemia, suppression of clotting factors II, V, VII, and X
• CNS: Change in libido, headache, insomnia, anxiety, depression
• NEURO: Paresthesia
• METABOLIC: Hypercholesterolemia, hypercalcemia, hyperkalemia, hyperphosphatemia
• DERM: Male pattern baldness, acne
• MUSC: Myalgias
• LOCAL: Pain at injection site
• MISC: Bleeding (if concomitant anticoagulant therapy)

• Androgen; binds to androgen receptors. Responsible for the normal growth and development of male sex organs. Produces multiple anabolic and androgenic effects
• Metabolized by liver
• Renally excreted: 90% (as metabolites), feces: 6%
• Half-life: 10-100 mins

US Trade Name(s)

• Aveed
• Delatestryl
• Depo-Testosterone

US Availability

testosterone cypionate (generic)

• INJ: 100 mg/mL (10 mL vial)
• INJ: 200 mg/mL (1, 10 mL vial)

Aveed (testosterone undecanoate)

• INJ: 250 mg/mL

Delatestryl (testosterone enanthate)

• INJ: 200 mg/mL (5 mL)

Depo-Testosterone (testosterone cypionate)

• INJ: 100 mg/mL (10 mL vial)
• INJ: 200 mg/mL (1, 10 mL vial)

Canadian Trade Name(s)

• Delatestryl
• Depo-Testosterone

Canadian Availability

testosterone enanthate (generic)

• INJ: 200 mg/mL

testosterone cypionate (generic)

• INJ: 100 mg/mL (2 mL amp)

testosterone propionate (generic)

• INJ: 100 mg/mL

Delatestryl (testosterone enanthate)

• INJ: 200 mg/mL (5 mL)

Depo-Testosterone (testosterone cypionate)

• INJ: 100 mg/mL (10 mL vial)

UK Trade Name(s)

• Nebido
• Sustanon 100
• Sustanon 250
• Virormone

UK Availability

testosterone enantate (generic)

• INJ: 250 mg/mL (1 mL amp)

Nebido (testosterone undecanoate)

• INJ: 250 mg/mL (4 mL amp)

Sustanon 100

• INJ: 100 mg [testosterone propionate 20 mg+testosterone phenylpropionate 40 mg+testosterone isocaproate 40 mg (1 mL amp)

Sustanon 250

• INJ: 250 mg [testosterone propionate 30 mg+testosterone phenylpropionate 60 mg+testosterone isocaproate 60 mg+testosterone decanoate 100 mg (1 mL amp)

Virormone (testosterone propionate)

• INJ: 50 mg/mL (2 mL amp)

Australian Trade Name(s)

• Sustanon
• Primteston depot
• Reandron

Australian Availability

Sustanon

• INJ: 100 mg [testosterone propionate 20 mg+testosterone phenylpropionate 40 mg+testosterone isocaproate 40 mg (1 mL amp)
• INJ: 250 mg [testosterone propionate 30 mg+testosterone phenylpropionate 60 mg+testosterone isocaproate 60 mg+testosterone decanoate 100 mg (1 mL amp)

Primteston depot (testosterone enanthate)

• INJ: 250 mg/mL (1 mL prefilled syringe)

Reandron (testosterone undecanoate)

• INJ: 1000 mg/4 mL

[Outline]

Endocrine/Metabolic

Sex Hormones

Androgens & Anabolic Steroids

Urologic

Sex Hormones

Androgens & Anabolic Steroids

Pricing data from www.DrugStore.com in U.S.A.

• Depo-Testosterone 100 MG/ML OIL [Vial] (PFIZER U.S.)
  10 ml = $78.74
  30 ml = $207.86
• Depo-Testosterone 200 MG/ML OIL [Vial] (PFIZER U.S.)
  10 ml = $132.29
  20 ml = $258.28
• Depo-Testosterone 200 MG/ML OIL [Vial] (PFIZER U.S.)
  1 ml = $27.99
  3 ml = $79.97
• Delatestryl 200 MG/ML OIL [Vial] (ENDO PHARMACEUTICALS)
  5 ml = $93.98
  15 ml = $262.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.