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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

ABSTRACT
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.
Drug Name:DEPO-TESTOSTERONE® 
(DEEP-o  tess-TOSS-ter-own)
 
Manufacturer Contact:Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporationhttp://www.PFIZER.com  
Generic Name:testosterone cypionate (injectable) (tess TOSS ter own)
Indication1: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.
Other Brands:NONE
Disease Overview3: 
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 )
MEDICATION INFORMATION
Place of ServicePhysician (Clinic)/ Home
Administration Route1IM
Dose3

Adult

  • male hypogonadism: 50-400 mg IM q2-4wk
  • breast CA, advanced: 200-400 mg IM q2-4wk

Pediatric

  • 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
Side Effects3                                                             
Serious Reactions
  • cholestatic jaundice
  • peliosis hepatitis
  • hepatocellular CA
  • leukopenia

Common Reactions

  • injection site reaction
  • acne
  • hirsuitism
  • urticaria
  • myalgias
  • nausea
  • abdominal pain
  • diarrhea
  • flushing
  • edema
  •  HTN
  • tachycardia
  • insomnia
  • anxiety
Side Effects3 Continued
  • headache
  • elevated liver transaminases
  • electrolyte disorders
  • hyperlipidemia
  • priapism
  • polycythemia
Contraindications
  • 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 Category1Pregnancy Category X
Storage3Vials should be stored at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Protect from light.
Shipping InformationVials should be shipped at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Protect from light.
Patient Assistance Program3Pfizer Pfriends  866-906-2800 http://www.pfizerhelpfulanswers.com/PfizerPfriends.aspx
Manufacturer PackagingDosage Strength, FormMisc.

 Depo-Testosterone (testosterone cypionate) cypionate 200 mg/ml

1 mL vials NDC 0009-0417-01

10 mL vials NDC 0009-0417-02

 1 mL vials & 10 mL vials In cottonseed oil 560 mg with benzyl benzoate 0.2 mL and benzyl alcohol 9.45 mg.

 Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.

Testosterone cypionate is not for IV use. 

 Depo-Testosterone (testosterone cypionate) cypionate 100 mg/ml

10 mL vials NDC 0009-0347-02

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.
REFERENCES
1.     DepoTestosterone Package Insert. Pfizer Pharmaceuticals.
2.     Webmd [Internet database] http://www.webmd.com/
3.     Epocrates [Internet database] https://online.epocrates.com/


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Drug Fact Sheets for Clinicians