Depo-Testosterone

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Testosterone falls into category X. It has been shown that women taking testosterone during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Testosterone should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if testosterone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using testosterone.

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

• Virilization has been reported in children who were secondarily exposed to testosterone gel.
• Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
• Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

You should not receive testosterone if you are allergic to it, or if you have:

• prostate cancer;

• male breast cancer;

• a serious heart condition;

• severe liver disease;

• severe kidney disease; or

• if you are pregnant or may become pregnant.

To make sure testosterone is safe for you, tell your doctor if you have:

• diabetes;

• enlarged prostate;

• heart disease or coronary artery disease;

• a history of heart attack, stroke, or blood clot;

• high cholesterol or triglycerides (a type of fat in the blood);

• breast cancer (in men, or in women who have hypercalcemia);

• liver or kidney disease;

• if you are bedridden or otherwise debilitated; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

This medicine can harm an unborn baby or cause birth defects. Do not use testosterone if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are receiving testosterone.

It is not known whether testosterone injection passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Testosterone is injected into a muscle. Testosterone injection is usually given every 2 to 4 weeks.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Testosterone injections should be given only by a healthcare professional.

The length of treatment with testosterone injection will depend on the condition being treated.

Testosterone will not enhance athletic performance and should not be used for that purpose.

While receiving testosterone, you will need frequent blood tests.

Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

Call your doctor for instructions if you miss an appointment for your testosterone injection.

Testosterone injection is used for the treatment of men whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.

Testosterone injection is also used in women with breast cancer that has spread to other parts of the body (metastatic).

Testosterone injection is also used to stimulate delayed puberty in male teenagers.

This medicine is to be given only by or under the direct supervision of your doctor. The Aveed® brand is only available under a restricted distribution program called the Aveed® REMS program.

• If you have an allergy to testosterone or any other part of Depo-Testosterone (testosterone cypionate injection).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are male and have breast or prostate cancer.
• If you have any of these health problems: Heart disease, kidney disease, or liver disease.
• If you are a woman. This medicine is not approved for use in women. If you are a woman using this medicine, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

This is not a list of all drugs or health problems that interact with Depo-Testosterone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

1. Known hypersensitivity to the drug
2. Males with carcinoma of the breast
3. Males with known or suspected carcinoma of the prostate gland
4. Women who are or who may become pregnant
5. Patients with serious cardiac, hepatic or renal disease

There have been no reports of acute overdosage with the androgens.

NDC 0009-0085-10

Depo®-
Testosterone

Testosterone
Cypionate
Injection, USP
CIII

10 mL vial
Multi-dose vial

100 mg
per mL

One 10 mL Vial
Multiple-Dose

For Intramuscular Use Only

Rx ONLY

NOVAPLUS®