DEPO-TESTOSTERONE ® (DEEP-o tess-TOSS-ter-own)Drug Fact Sheet for Professionals
Therigy, Apr 16, 2008
Cross-referenced Guide to Primary and Secondary Literature March 2008 – (033108DFSHPDEP) A Part of the Therigy Drug Reference Series for Healthcare Professionals
The following drug fact sheet provides a concise reference to the Pharmacia & Upjohn product Depo-Testosterone® (pronounced DEEP-o tess-TOSS-ter-own) (Generic Name: testosterone cypionate), principally used in the treatment of replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, primary hypogonadism, hypogonadotropic hypogonadism. The publication summarizes clinically important information relevant for discussions with patients and other healthcare professionals on the packaging, administration, dosage, storage, handling, and other specific information such as patient assistance programs available for this drug. The publication is beneficial in preparing for discussions with patients, caregivers and colleagues or for use in professional training programs and is intended for use by healthcare professionals. It is a part of a series of drug references and not intended to for sale or distribution except as a part of that series. The publication is reviewed and updated annually unless otherwise necessary.
testosterone cypionate (injectable) (tess TOSS ter own)
DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.·Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.·Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Male hypogonadism is a condition in which the body doesn't produce enough of the sex hormone testosterone. As many as 5 million men in the United Sates may not produce enough testosterone — the hormone that plays a key role in masculine growth and development during puberty.
During fetal development, low testosterone can cause incomplete formation of sex organs. Low testosterone levels before puberty can permanently affect growth and development. After puberty, the development of hypogonadism is more likely to cause temporary problems that may improve with treatment. Some types of hypogonadism can be treated with testosterone replacement therapy.
Hypogonadism can occur during fetal development, puberty or adulthood. Depending on when it develops, the signs and symptoms differ.
Fetal development: If the body doesn't produce enough testosterone during fetal development, growth of external sex organs may be impaired. Depending at when it develops, and how much testosterone is present, a child that is genetically male may be born with: Female genitals / Ambiguous genitals (genitals that are neither clearly male or female) /Underdeveloped male genitals
Puberty: During puberty, male hypogonadism may slow growth and affect development. It can cause: Decreased development of muscle mass / Lack of deepening of the voice / Impaired growth of body hair / Impaired growth of the penis and testicles /Excessive growth of the arms and legs in relation to the trunk of the body / Development of breast tissue (gynecomastia)
Adulthood:In adult males, hypogonadism may alter certain masculine physical characteristics and impair normal reproductive function. Signs and symptoms may include: Erectile dysfunction /Infertility /Decrease in beard and body hair growth /Increase in body fat /Decrease in size or firmness of testicles /Decrease in muscle mass /Development of breast tissue (gynecomastia) /Loss of bone mass (osteoporosis )
Place of Service
Physician (Clinic)/ Home
male hypogonadism: 50-400 mg IM q2-4wk
breast CA, advanced: 200-400 mg IM q2-4wk
male hypogonadism: 40-50 mg/m2 IM q month
Info: for initiation of pubertal growth
male hypogonadism: 100 mg/m2 IM q month
Info: for terminal growth phase
male hypogonadism: 100 mg/m2 IM q2wk
Info: for maintenance virilizing dose
male hypogonadism: 40-50 mg/m2 IM q month
Info: for delayed puberty; treat for 6 months
injection site reaction
Side Effects3 Continued
elevated liver transaminases
Known hypersensitivity to the drug
Males with carcinoma of the breast
Males with known or suspected carcinoma of the prostate gland
Women who are or who may become pregnant
Patients with serious cardiac, hepatic or renal disease
Pregnancy Category X
Vials should be stored at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Protect from light.
Vials should be shipped at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Protect from light.
In 10 mL vials.In cottonseed oil 736 mg with benzyl benzoate 0.1 mL and benzyl alcohol 9.45 mg.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.