Testosterone for Injection Medication Monograph

Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at 888-689-2271

Información por escrito acerca de esta receta se le a presentado a usted. Favor de leer esta información antes de tomar el medicamento. Si usted tiene preguntas tocante esta receta, un farmacéutico estará presente durante horas de negocio para contestar sus preguntas

Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at:

Quejas sobre la practica de farmacia pueden ser reportadas al Concilio Farmacia del Estado de Tejas:

William P. Hobby Building Ste. 3-600, 333 Guadalupe Street, Box 21

Austin, Texas 78701-3942 Tel: (512) 305-8000 www.tsbp.state.tx.us

Testosterone is both a medication and steroid naturally found in the body. It is used to treat male hypogonadism. It is a controlled substance because it can be abused to increase athletic ability. It is mainly produced by the testes in males. Due to feedback on the body, testosterone injections can cause the body to stop making its own testosterone, therefore therapy should be monitored closely by a physician

Indications: Testosterone is used to treat male hypogonadism

Renal Dosing: There are no dosage adjustments provided in the manufacturer’s labeling (not studied)

Severe renal impairment: Use is contraindicated

Hepatic Impairment: There are no dosage adjustments provided in the manufacturer’s labeling (not studied)

Severe hepatic impairment: Use is contraindicated

Contraindications: breast cancer (males); prostate cancer (known or suspected); pregnant women or women who may be pregnant; breast-feeding women; hypersensitivity to testosterone; serious cardiac, hepatic, or renal disease

Warnings/Precautions:

Breast cancer: Long term use (>10 years) of parenteral testosterone for male hypogonadism may increase the risk of breast cancer in males (Medras 2006)

Cardiovascular events: Available studies are inconclusive regarding the risk of developing major adverse cardiovascular events (MACE) such as nonfatal MI, stroke, or cardiovascular death following testosterone use. According to the FDA, prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions (eg, disorders of the testicles, pituitary gland, brain) and confirmed by laboratory tests (FDA Drug Safety Communication 2015). The Endocrine Society suggests it may be prudent to avoid testosterone therapy in men who have experienced a cardiovascular event (eg, MI, stroke, acute coronary syndrome) in the past six months (The Endocrine Society 2014). Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy for cardiovascular events

Dyslipidemia: May alter serum lipid profile; use caution with history of MI or coronary artery disease

Gynecomastia: May cause gynecomastia, which may persist in patients treated for hypogonadism

Hepatic effects: Prolonged use of androgens has been associated with serious hepatic effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, jaundice). Prolonged use of intramuscular testosterone enanthate has been associated with multiple hepatic adenomas. Discontinue therapy if signs or symptoms of hepatic dysfunction develop

Hypercalcemia: May cause hypercalcemia in patients with prolonged immobilization or cancer

Oligospermia: Large doses may suppress spermatogenesis; oligospermia may occur. Discontinue therapy if this occurs, if restarted, a lower dose should be used

Polycythemia: May increase hematocrit requiring dose adjustment or discontinuation. Withhold initial treatment in patients with hematocrit >50%. Discontinue therapy if hematocrit exceeds 54%; may reinitiate at lower dose

Priapism: Priapism or excessive sexual stimulation may occur; discontinue therapy if this occurs

Prostate cancer: May increase the risk of prostate cancer. Withhold therapy pending urological evaluation in patients with palpable prostate nodule or induration, PSA >4 ng/mL, or PSA >3 ng/mL in men at high risk of prostate cancer

Venous thromboembolism: Venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported. Evaluate patients with symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those with acute shortness of breath for PE. Discontinue therapy if suspected

Drug Interactions: : Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Androgens may increase the serum concentration of cyclosporine (Systemic). Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Substrate of CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP3A4 (minor)

Please speak with your doctor or pharmacist about other possible drug interactions as this list is not all-inclusive

Adverse Reactions: Acne, enlarged breasts, increase in blood pressure, impaired fertility, skin irritation where injected, increased prostate size (BPH), mood disturbances

Storage: Room temperature. Do not refrigerate or freeze

Patient Education:

What should I tell my doctor about before taking this medication?

Prostate problems or problems with urinating, prostate or breast cancer, liver problems, kidney problems, high cholesterol, history of or current heart problems, history of blood clots, fertility problems, other medications you take including those that are over-the-counter

When and how do I take this medication?

Testosterone is usually injected weekly, biweekly, or multiple times per week without regards to time of day. The dosing schedule can vary greatly between patients and route of administration

Testosterone can be self-injected into several sites, both intramuscularly and subcutaneously with equal efficacy. Intramuscularly, testosterone is most commonly injected into the gluteus medius muscle of the buttox or the vastus lateralis muscle in the thigh. Subcutaneously, testosterone is injected into the abdomen area. The site of injection should be alternated each dose so you do not inject into the same area each time

Rotate the vial in your hands to warm the testosterone vial before injecting. This will make the liquid easier and more comfortable to inject

What side effects should I call my doctor about right away?

Signs of an allergic reaction like rash, hives, or itching; signs of high blood pressure like severe headache, passing out, or dizziness; trouble passing urine passing urine more often, or a weak stream of urine; mood changes or depression; signs of a blood clot such as pain, swelling, warmth, or numbness in your arm or leg, confusion, extreme headache, weakness on one side; change in shape or size of testicles

I usually use a different sized needle and/or syringe. Is the one that was sent ok to use?

After much testing and discussion with both doctors and patients, we have standardized our needles. Since our formulation is in grapeseed oil, the viscosity is such that a single smaller needle can be used to withdraw testosterone from the vial and inject comfortably into the body. We stock a limited inventory of needle sizes. You may purchase additional sizes at your local pharmacy should you desire