Understanding Compounded Medications

Compounded testosterone is prescribed under federal law but is not FDA-approved, meaning it does not undergo the same regulatory review for safety, efficacy, or manufacturing quality. Your Good Medics provider may recommend a specific compounded testosterone formulation based on your health evaluation and treatment needs.

Warning: Risks Associated with Testosterone Therapy

Testosterone therapy carries potential risks, particularly for individuals with pre-existing medical conditions. It is important to discuss all potential benefits and risks with your healthcare provider before starting treatment.

Testosterone therapy may increase the risk of:

• Cardiovascular events, including heart attack and stroke
• Prostate growth, which may worsen symptoms of benign prostatic hyperplasia (BPH)
• Increased red blood cell production, which can raise the risk of blood clots
• Liver toxicity in some formulations
• Worsening of sleep apnea in predisposed individuals

What is Testosterone Used For?

Testosterone replacement therapy (TRT) is prescribed for individuals with clinically diagnosed testosterone deficiency (hypogonadism), characterized by low testosterone levels and associated symptoms, including:

• Fatigue
• Reduced muscle mass and strength
• Decreased libido
• Erectile dysfunction
• Brain fog and difficulty concentrating
• Mood disturbances, such as depression or irritability

TRT aims to restore testosterone levels to a normal range and alleviate these symptoms.

Limitations of Use

• Testosterone should not be used in men with normal testosterone levels.
• TRT is not a treatment for infertility and may reduce sperm production.
• Testosterone should not be used to enhance athletic performance or muscle building in healthy individuals.

Who Should Not Use Testosterone?

Do not take testosterone if you:

• Have or are suspected of having prostate cancer or breast cancer
• Have untreated severe sleep apnea
• Have severe heart, kidney, or liver disease
• Have an elevated hematocrit (high red blood cell count)
• Have uncontrolled high blood pressure
• Are allergic to testosterone or any of its components

How to Take Testosterone Injections

Testosterone injections are administered as an intramuscular (IM) injection, typically in the thigh, glute, or deltoid muscle, depending on your provider’s recommendations. Injections are usually given once weekly or biweekly, depending on the formulation and dosing schedule prescribed.

Your healthcare provider will guide you on self-injection techniques or schedule clinic visits for administration.

What to Discuss with Your Provider Before Taking Testosterone

Before beginning TRT, inform your healthcare provider of all medications, supplements, and pre-existing conditions.

Medication Interactions:

• Blood thinners (anticoagulants) such as warfarin may have increased effects with testosterone therapy, leading to a higher risk of bleeding.
• Insulin or diabetes medications may require dosage adjustments due to testosterone’s potential impact on blood sugar levels.
• Corticosteroids and other hormone treatments may interact with testosterone, increasing fluid retention.

Medical Conditions to Disclose

Before starting TRT, tell your provider if you have or have had:

• Heart disease or history of heart attack or stroke
• Prostate issues, including benign prostatic hyperplasia (BPH) or prostate cancer
• Kidney or liver disease
• Diabetes
• High red blood cell count (polycythemia)
• Sleep apnea
• Uncontrolled high blood pressure
• Fertility concerns

Pregnancy and Breastfeeding

Testosterone therapy is not for use in women and should never be used by pregnant or breastfeeding individuals due to potential risks to the baby. Women exposed to testosterone may experience virilization effects, including deepened voice, body hair growth, and changes in menstrual cycles.

Serious Side Effects

If you experience a medical emergency, call 911 immediately.

Serious side effects of TRT include:

• Heart attack or stroke (Symptoms: chest pain, shortness of breath, sudden weakness or numbness, slurred speech)
• Blood clots (Symptoms: leg swelling, pain, redness, difficulty breathing)
• Prostate enlargement or prostate cancer progression (Symptoms: difficulty urinating, weak urine flow, frequent nighttime urination)
• Severe mood changes (Symptoms: depression, aggression, suicidal thoughts)
• Liver toxicity (Symptoms: dark urine, yellowing of the skin or eyes, persistent nausea)
• High red blood cell levels (polycythemia), increasing the risk of stroke or clot formation
• Severe allergic reactions (Symptoms: swelling of the face, difficulty breathing, rash, dizziness)

Common Side Effects

Some side effects are mild but should still be monitored:

• Acne or oily skin
• Increased body hair growth
• Water retention and swelling
• Breast tenderness or enlargement (gynecomastia)
• Increased red blood cell count
• Injection site reactions (pain, redness, swelling)
• Changes in mood, including increased aggression or irritability

Monitoring During Testosterone Therapy

Regular follow-ups with your healthcare provider are essential while on TRT. Monitoring typically includes:

• Testosterone levels to ensure optimal dosing
• Hematocrit and hemoglobin levels to monitor for increased red blood cell count
• Liver function tests to assess liver health
• PSA (Prostate-Specific Antigen) levels to check for prostate changes
• Blood pressure and cardiovascular health assessments

Reporting Side Effects

If you experience side effects, report them to your healthcare provider or the FDA MedWatch program at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

This document is not exhaustive. For complete safety information, refer to the official prescribing information or consult your healthcare provider.