Testosterone Cypionate Injection

Overview

Testosterone is the primary androgen hormone found in the body. Testosterone is synthesized by cells in the testis and adrenal cortex and is responsible for sexual maturation at all stages of development throughout life. Androgens stimulate the development of the prostate, seminal vesicle, penis, and scrotum. During puberty, androgens produce an abrupt growth of muscle, cause a redistribution of body fat, a deepening of the voice, and stimulate the growth of body and facial hair. Androgens are also responsible for the maintenance of spermatogenesis.

In addition to sexual maturation in males, testosterone also assists in other functions within the body: 

  • Bone: Testosterone indirectly impacts the development and maintenance of bone growth by its conversion to estradiol via the aromatase enzyme. Estradiol minimizes the breakdown of bone by inhibiting the resorption of bone by osteoclasts. Additionally, testosterone is converted into dihydrotestosterone (DHT) by the enzyme 5-alpha reductase. DHT encourages bone osteoblasts and the building of bone.1
  • Blood: Testosterone enhances the production of red blood cells in males. The process is not yet fully understood and is undergoing research.2
  • Brain: Testosterone levels in the body have been shown to have an influence on cognitive abilities in males. Research indicates there is a correlation between low testosterone levels in men with memory impairment as well as impaired verbal and visual performance.3
  • Mood: Though also poorly understood, researchers have observed an association between hypogonadism in men and depressive moods. Studies show an improvement in moods after treatment with testosterone.4
  • Skeletal muscle: Testosterone has a hypertrophic and hyperplastic effect on skeletal muscle. Testosterone supplementation has been shown to assist in reversing muscle loss in men in response to aging.5

Testosterone levels in men have been found to decline with age. When endogenous androgens are unavailable, testosterone replacement therapy may be necessary for normal male growth and development.

Testosterone in an injectable form requires the addition of one or multiple esters to control its solubility in the bloodstream. The smaller the carbon chain, the more soluble the medication and the shorter the half-life of the medication in the body. Conversely, the longer the carbon chain (as in the case of the cypionate ester), the less soluble and the longer the half-life of the drug. The half-life of testosterone cypionate when injected intramuscularly is approximately eight days.6 For replacement in the hypogonadal male, 50-400 mg of testosterone cypionate can be administered intramuscularly every two to four weeks.6

Indications

Testosterone is indicated in men for the treatment of conditions associated with a deficiency or absence of endogenous testosterone.

How Supplied

Commercially-Available Testosterone Options

Testosterone was first approved for use in the U.S. in 1939. The first injectable testosterone was approved by the FDA in the 1950’s. Today it is available commercially for men as a transdermal patch, gel, topical solution, nasal gel, buccal system, and intramuscular injection to treat hypogonadism and delayed puberty.6-15

Compounded Testosterone Options

While testosterone is commercially available in injectable form, the strength or formulation may need to be tailored to a specific patient’s needs. For example, compounded testosterone cypionate injection may be an option for men that are intolerant to cottonseed oil or in those that would benefit from a unique strength as determined by a prescriber. Common formulations prepared at Galleria Medical Pharmacy include but are not limited to:

Testosterone Cypionate 50mg/mL in Grapeseed Oil 5mL Multiple Dose Vial

Testosterone Cypionate 100mg/mL in Grapeseed Oil 5mL Multiple Dose Vial

Testosterone Cypionate 150mg/mL in Grapeseed Oil 5mL Multiple Dose Vial

Testosterone Cypionate 200mg/mL in Grapeseed Oil 5mL Multiple Dose Vial

Storage

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain. Please note that warming the vial should help redissolve any crystals that may have formed during storage temperatures lower than recommended.

Reference

  1. Mohamad, N. V., Soelaiman, I. N., , Chin, K. Y., “A concise review of testosterone and bone health”, Clinical interventions in aging, vol. 11, pp. 1317–1324. September 2016. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5036835/
  2. Coviello, A. D., Kaplan, B., Lakshman, K. M., Chen, T., Singh, A. B., Bhasin, S., “Effects of graded doses of testosterone on erythropoiesis in healthy young and older men”, The Journal of clinical endocrinology and metabolism, vol.93 issue 3, pp. 914–919. March 2008. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2266950/
  3. Resnick, S.M., Matsumoto, A.M., Stephens-Shields, A.J., Ellenberg, S.S., Gill, T.M., Shumaker, S.A., Pleasants, D.D., Barrett-Connor, E., Bhasin, S., Cauley, J.A., Cella, D., Crandall, J.P., Cunningham, G.R., Ensrud, K.E., Farrar, J.T., Lewis, C.E., Molitch, M.E., Pahor, M., Swerdloff, R.S., Cifelli, D., Anton, S., Basaria, S., Diem, S.J., Wang, C., Hou, X., Snyder, P.J., “Testosterone Treatment and Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment”, Journal of the American Medical Association. Vol.317 issue 7, pp.717–727. 2017. Available: https://jamanetwork.com/journals/jama/fullarticle/2603930
  4. Spitzer, M., Basaria, S., Travison, T. G., Davda, M. N., DeRogatis, L., Bhasin, S., “The effect of testosterone on mood and well-being in men with erectile dysfunction in a randomized, placebo-controlled trial”. Andrology, vol.1 issue 3, pp.475–482. March 2013. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630276/
  5. Atkinson, R.A., Srinivas-Shankar U., Roberts, S.A., Connolly, M.J., Adams, J.E., Oldham, J.A., Wu, F.C., Seynnes, O.R., Stewart, C.E., Maganaris, C.N., Narici, M.V., “Effects of Testosterone on Skeletal Muscle Architecture in Intermediate-Frail and Frail Elderly Men”, The Journals of Gerontology: Series A, Vol. 65A, issue 11, pp.1215–1219. November 2010. Available: https://academic.oup.com/biomedgerontology/article/65A/11/1215/596059
  6. DEPO-TESTOSTERONE (testosterone cypionate) injection, package insert. New York, NY: Pharmacia & Upjohn Co.; 2006 Sept.
  7. Androderm® (testosterone transdermal system) package insert. Corona, CA: Watson Pharma, Inc.; 1999 Jan.
  8. Androgel (testosterone gel) package insert. Marietta, GA: Solvay Pharmaceuticals, Inc.; 2012 Sept.
  9. Fortesta (testosterone) gel, package insert. Chadds Ford, PA: Endo Pharmaceuticals Inc.; 2010 Dec.
  10. Testosterone gel package insert. Malvern, PA: Auxilium Pharmaceuticals, Inc.; 2010 Apr.
  11. Axiron (testosterone) topical solution, package insert. Indianapolis, IN: Lilly USA, LLC; 2011 Dec.
  12. Natesto (testosterone) nasal gel package insert. Durants, Christ Church Barbados: Trimel BioPharma SRL; 2014 May.
  13. Striant (testosterone buccal system) package insert. Livingston, NJ: Columbia Laboratories, Inc.; 2014 Mar.
  14. DELATESTRYL (Testosterone Enanthate Injection, USP) package insert. Lexington, MA: Indevus Pharmaceuticals, Inc.; 2007 July.
  15. Aveed (testosterone undecanoate Injection) package insert. Malvern, PA: Endo Pharmaceuticals Solutions Inc.; 2014 Mar.

Compounding Pharmacy Statement

Testosterone cypionate injection is compounded with drug components whose suppliers are registered with the FDA. While Galleria Medical Pharmacy adheres to USP <797> guidelines and applicable state and federal regulations to meet the required quality standards, the statements made regarding compounded testosterone cypionate injection have not been evaluated by the FDA for safety or clinical effectiveness. As such, this preparation is not intended to diagnose, treat, cure, or prevent any disease. For inquiries concerning this preparation, please contact (504) 267-9876.