Important Safety Information — Compounded Testosterone

What is this?

This Important Safety Information summarizes key warnings, precautions, contraindications, and possible side effects for compounded testosterone, a prescription medication used in certain patients when a licensed healthcare provider determines that testosterone therapy is medically appropriate.

This page does not include all possible information about compounded testosterone. Always follow your prescription label, pharmacy instructions, and the instructions provided by your ATHS healthcare provider.

Compounded testosterone is not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are dispensed. Compounded medications may be prescribed when a licensed healthcare provider determines that a compounded preparation is medically appropriate for a specific patient.

Testosterone is a Schedule III controlled substance. Use only as prescribed.

Safety and effectiveness of testosterone therapy have not been established for men with age-related hypogonadism, sometimes referred to as late-onset hypogonadism. Your provider will determine whether testosterone therapy is medically appropriate based on your symptoms, medical history, physical risk factors, and laboratory results.

Important Warnings and Precautions

Compounded testosterone may cause or worsen serious medical problems, including:

• Increased blood pressure, which may require monitoring and treatment and may increase cardiovascular risk over time.
• Blood clots, including deep vein thrombosis and pulmonary embolism.
• Fluid retention or edema, which may be serious in patients with heart, kidney, or liver disease.
• Increased red blood cell count, also called polycythemia.
• Worsening of enlarged prostate symptoms or urinary obstruction.
• Growth or worsening of known or suspected prostate cancer.
• Suppression of sperm production, which may reduce fertility.
• Gynecomastia, or breast tissue enlargement.
• Hypercalcemia, especially in immobilized patients.
• Allergic or hypersensitivity reactions, including reactions to testosterone, carrier oils, preservatives, or other ingredients in the compounded medication.
• Serious psychiatric, cardiovascular, liver, reproductive, and withdrawal-related risks when testosterone is abused, misused, or taken at doses higher than prescribed.

Seek emergency medical care if you experience chest pain, sudden shortness of breath, symptoms of stroke, swelling or pain in one leg, sudden vision changes, severe allergic reaction, or a prolonged erection lasting more than four hours.

Who Should Not Use Compounded Testosterone?

Do not use compounded testosterone if you:

• Are allergic to testosterone or any ingredient in the compounded medication.
• Are a male with breast cancer.
• Have known or suspected prostate cancer.
• Are pregnant or may become pregnant.
• Have serious heart disease.
• Have serious liver disease.
• Have serious kidney disease.
• Have been told by a healthcare provider that testosterone therapy is unsafe for you.
• Are seeking testosterone for bodybuilding, athletic enhancement, or non-medical performance purposes.

Testosterone may cause fetal harm and should not be used during pregnancy.

Before Using Compounded Testosterone, Tell Your Provider If You:

Tell your ATHS provider about your full medical history, especially if you have or have ever had:

• Heart disease, heart attack, stroke, chest pain, heart failure, or abnormal heart rhythm.
• High blood pressure.
• Blood clots, clotting disorders, or a family history of blood clots.
• Prostate enlargement, elevated PSA, prostate cancer, or urinary problems.
• Breast cancer.
• Liver disease.
• Kidney disease.
• Sleep apnea.
• Diabetes.
• High hematocrit, high hemoglobin, or polycythemia.
• High calcium levels or prolonged immobilization.
• Fertility concerns or plans to have children.
• Depression, anxiety, bipolar disorder, aggression, mania, psychosis, or other psychiatric conditions.
• Vision problems, including central serous chorioretinopathy.
• Any history of allergic reaction to testosterone, hormone therapy, injections, oils, preservatives, or compounded medications.

Also tell your provider about all prescription medications, over-the-counter medications, supplements, hormones, peptides, anabolic steroids, fertility medications, and performance-enhancing substances you use or have recently used.

Compounded Formulation and Allergy Information

Compounded injectable testosterone may be prepared in a carrier oil, which may include cottonseed oil, sesame oil, grapeseed oil, MCT oil, or another vehicle selected by the dispensing pharmacy. Some preparations may contain benzyl alcohol, benzyl benzoate, or other inactive ingredients.

Tell your provider and pharmacist if you have allergies or sensitivities to seeds, nuts, oils, preservatives, benzyl alcohol, benzyl benzoate, or any prior reaction to an oil-based injection. Severe hypersensitivity reactions, including anaphylactoid reactions, have been reported with testosterone products.

If your compounded medication contains benzyl alcohol, tell your provider if you are pregnant, may become pregnant, or are breastfeeding. Benzyl alcohol can cross the placenta.

Drug Interactions

Compounded testosterone may interact with other medications.

Tell your provider if you take:

• Blood thinners or oral anticoagulants.
• Insulin or diabetes medications.
• Corticosteroids.
• Medications that affect blood pressure.
• Other hormone therapies.
• Anabolic steroids.
• Fertility medications such as hCG, clomiphene, or enclomiphene.
• Supplements marketed for testosterone, libido, muscle growth, or performance.

Testosterone may increase sensitivity to oral anticoagulants. Patients using anticoagulants may require closer monitoring of prothrombin time or INR and possible anticoagulant dose adjustment by their healthcare provider.

In patients with diabetes, testosterone may affect blood glucose and could change insulin or diabetes medication requirements.

Monitoring During Treatment

Your provider may require periodic lab testing and follow-up visits while you are using compounded testosterone.

Monitoring may include:

• Total testosterone.
• Free testosterone.
• Hemoglobin and hematocrit.
• PSA, when clinically appropriate.
• Liver-related labs, when clinically appropriate.
• Lipids, including HDL cholesterol, when clinically appropriate.
• Blood pressure.
• Estradiol, when clinically appropriate.
• Other labs based on your medical history and treatment plan.

Do not skip recommended lab testing. Testosterone therapy can create risks that may not be obvious without blood work.

Possible Side Effects

Possible side effects of testosterone therapy include:

• Acne or oily skin.
• Increased body or facial hair.
• Male-pattern hair loss.
• Breast tenderness or enlargement.
• Changes in libido.
• Mood changes, irritability, anxiety, or depression.
• Headache.
• Nausea.
• Fluid retention or swelling.
• Increased blood pressure.
• Increased red blood cell count.
• Reduced sperm production.
• Testicular shrinkage.
• Infertility or reduced fertility.
• Worsening sleep apnea.
• Decreases in HDL cholesterol and other lipid changes.
• Changes in liver function tests.
• Rare liver-related complications, especially with prolonged high-dose androgen use.
• Injection-site pain, irritation, swelling, or inflammation, if using an injectable formulation.

Serious side effects may include:

• Blood clots.
• Pulmonary embolism.
• Severe allergic reaction.
• Severe psychiatric symptoms.
• Priapism, or an erection lasting more than four hours.
• Significant prostate or urinary symptoms.
• Polycythemia.
• Edema or fluid retention, especially in patients with heart, kidney, or liver disease.
• Hypercalcemia in immobilized patients.

Contact your provider if side effects are persistent, worsening, or concerning.

Blood Clot Warning

Blood clots have been reported in patients using testosterone products. Symptoms of a blood clot may include:

• Pain, swelling, warmth, or redness in one leg.
• Sudden shortness of breath.
• Chest pain.
• Rapid heartbeat.
• Coughing blood.
• Sudden dizziness or fainting.

Seek emergency medical attention if these symptoms occur.

Cardiovascular and Blood Pressure Warning

Testosterone may increase blood pressure, which can increase cardiovascular risk over time. Your provider may monitor your blood pressure before and during treatment, especially if you have high blood pressure, heart disease, a history of heart attack or stroke, or other
cardiovascular risk factors.

Tell your provider if you have chest pain, shortness of breath, fainting, swelling, rapid weight gain, worsening exercise tolerance, or any new or worsening cardiovascular symptoms.

Seek emergency medical attention if you experience chest pain, sudden shortness of breath, sudden weakness, trouble speaking, sudden vision changes, severe headache, fainting, or symptoms of a heart attack or stroke.

Edema and Fluid Retention Warning

Testosterone may cause retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing heart, kidney, or liver disease.

Tell your provider if you develop swelling of the ankles, feet, or legs; sudden weight gain; shortness of breath; or worsening heart failure symptoms.

Hypercalcemia Warning

Hypercalcemia may occur in immobilized patients using testosterone. Tell your provider if you are immobilized due to surgery, hospitalization, fracture, serious illness, or prolonged bed rest.

Symptoms of high calcium may include nausea, vomiting, constipation, increased thirst, frequent urination, confusion, weakness, or abnormal heart rhythm. If hypercalcemia occurs, testosterone therapy may need to be discontinued.

Prostate and Urinary Warning

Testosterone should not be used in men with known or suspected prostate cancer. Testosterone may also worsen symptoms of benign prostatic hypertrophy, including urinary obstruction.

Tell your provider if you experience:

• Difficulty urinating.
• Weak urine stream.
• Frequent nighttime urination.
• New or worsening urinary urgency.
• Blood in urine.
• Pelvic pain.
• Elevated PSA.
• History of prostate cancer or suspected prostate cancer.

Older patients treated with testosterone may have an increased risk of developing prostate enlargement and prostate cancer, although conclusive evidence is lacking.

Fertility Warning

Testosterone therapy can suppress the body’s natural testosterone production and may reduce sperm production. This may reduce fertility and may contribute to infertility in some patients.

Tell your provider before starting treatment if you are trying to conceive, plan to have children, or want to preserve fertility.

Hepatic Warning

Serious hepatic complications, including hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis, have been associated principally with prolonged use of high-dose 17-alpha alkyl androgens. Testosterone cypionate is not a 17-alpha alkyl androgen, but liver-related lab changes and rare hepatic complications have been reported with androgen therapy.

Tell your provider if you experience yellowing of the skin or eyes, dark urine, persistent nausea or vomiting, unusual fatigue, abdominal pain, or other symptoms suggestive of liver problems.

Administration and Route of Use

Use compounded testosterone exactly as prescribed. Do not change your dose, frequency, or route of administration unless instructed by your healthcare provider.

If you are prescribed injectable testosterone, follow all instructions provided by your healthcare provider and pharmacy, including instructions for injection technique, storage, handling, and disposal of needles and syringes.

Abuse, Misuse, Dependence, and Withdrawal

Use compounded testosterone only as prescribed.

Testosterone abuse can occur when testosterone is used at higher doses than prescribed, used without medical need, combined with anabolic steroids, or used for bodybuilding or athletic performance enhancement.

Abuse of testosterone and anabolic androgenic steroids has been associated with serious adverse reactions, including cardiac arrest, heart attack, stroke, heart failure, liver injury, depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, aggression, testicular atrophy, subfertility, infertility, and withdrawal symptoms.

Withdrawal symptoms after abrupt discontinuation or significant dose reduction may include depressed mood, major depression, fatigue, craving, restlessness, irritability, loss of appetite, insomnia, decreased libido, and hypogonadotropic hypogonadism.

Do not increase your dose, change your schedule, combine testosterone with anabolic steroids, or continue treatment against medical advice.

While Using Compounded Testosterone

Tell your provider immediately if you:

• Start any new medication or supplement.
• Are diagnosed with a new medical condition.
• Experience chest pain, shortness of breath, fainting, or stroke-like symptoms.
• Develop leg swelling, redness, warmth, or pain.
• Notice mood changes, aggression, depression, mania, hallucinations, paranoia, or suicidal thoughts.
• Develop breast swelling or tenderness.
• Have persistent or frequent erections.
• Develop worsening urinary symptoms.
• Experience severe acne, swelling, rapid weight gain, or fluid retention.
• Become immobilized due to surgery, hospitalization, injury, or serious illness.
• Are planning surgery or a major medical procedure.
• Are trying to conceive.

Pregnancy, Breastfeeding, and Use in Women

Testosterone should not be used during pregnancy. Testosterone may harm an unborn baby and may cause virilization of a female fetus.

Testosterone is not recommended for use while breastfeeding.

This Important Safety Information is intended for the compounded testosterone product described by ATHS. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication.

Pediatric Use

Testosterone therapy may accelerate bone maturation in children and adolescents and may compromise adult height. Safety and effectiveness in pediatric patients have not been established for the indications for which ATHS prescribes compounded testosterone.

ATHS does not prescribe compounded testosterone to patients under 18 years of age.

Missed Dose

If you miss a dose, follow the instructions on your prescription label or contact your healthcare provider or pharmacy.

Do not take extra testosterone to make up for a missed dose. Do not change your dosing schedule without medical direction.

Overdose

In case of overdose or accidental exposure, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Storage

Follow the storage instructions provided by your pharmacy.

Unless your prescription label or pharmacy instructions state otherwise, store medication at controlled room temperature, generally 20°C to 25°C / 68°F to 77°F, away from excessive heat, moisture, and direct light.

In general:

• Store medication at the temperature listed on the prescription label.
• Keep away from excessive heat, moisture, and direct light.
• Keep out of reach of children and pets.
• Do not use medication that appears contaminated, discolored, damaged, crystallized, or otherwise unusual.
• If using injectable medication, use only as instructed and dispose of needles and syringes in an appropriate sharps container.

Medication Disposal

Do not flush unused medication down the toilet or pour it into a sink or drain unless specifically instructed.

If no take-back option is available, follow local disposal guidance or ask your pharmacist for instructions.

For injectable supplies, place needles and syringes in an approved sharps container. Do not place loose needles directly into household trash.

Reporting Side Effects

Tell your healthcare provider if you experience side effects or symptoms that concern you.

You may report suspected adverse reactions or product quality concerns to the FDA through MedWatch
at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Telemedicine Disclosure

This prescription may be issued through telemedicine after review by a licensed healthcare provider. If you experience concerning symptoms, contact your ATHS provider or seek emergency medical care.

Withholding or providing inaccurate information about your symptoms, medical history, medications, substance use, allergies, prior reactions, or lab results may result in serious harm.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions,
warnings, or precautions associated with compounded testosterone. This page does not provide medical advice,
diagnosis, or treatment.

Compounded testosterone is prescribed only when a licensed healthcare provider determines that it is medically appropriate. Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality before dispensing.

For questions about your medication, prescription, dosing, side effects, or treatment plan, contact your healthcare provider or pharmacist.