Pronunciation:

tes-TOS-ter-one

Brand Names:

• Aveed
• Delatestryl
• Depo-Testosterone
• Testone CIK
• Testopel Pellets
• Testro AQ
• Xyosted

Dosage Forms:

• Implant
• Solution
• Oil

Warnings:

Testosterone undecanoate is available only through a restricted program called the Aveed(R) REMS Program due to the risk of serious pulmonary oil microembolism (POME) reactions (urge to cough, dyspnea, throat tightening, chest pain, dizziness, syncope) and potentially life-threatening anaphylaxis. These reactions have occurred during or immediately after administration and may occur at any time during the course of therapy, including after the first dose. Monitor patients in a healthcare setting for 30 minutes after each injection .

Warning: Blood Pressure IncreasesTestosterone enanthate can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.Before initiating testosterone enanthate, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of testosterone enanthate outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.Due to this risk, use testosterone enanthate only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Androgen

Uses of This Medicine:

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. Xyosted™ is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Depo®-Testosterone in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Aveed® or Xyosted™ in the pediatric population. Safety and efficacy have not been established.

Although Delatestryl® may be used for short periods of time in certain male teenagers to treat delayed puberty. X-ray exams of the hands and wrists of male teenagers should be made every 6 months while receiving this medicine.

Older adults—

Appropriate studies on the relationship of age to the effects of testosterone injection have not been performed in the geriatric population. However, elderly patients are more likely to have heart or prostate problems (including enlarged prostate), which may require caution in patients receiving this medicine.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dicumarol
• Levoketoconazole
• Methotrexate
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to benzyl benzoate, refined castor oil, or sesame oil or
• Breast cancer (in males) or
• Hypogonadism, age-related or
• Prostate cancer, known or suspected—Aveed®, Delatestryl®, or Xyosted™ should not be used in patients with these conditions.

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Coronary artery disease or
• Diabetes or
• Drug abuse or dependence, or history of or
• Enlarged prostate or
• Heart attack, or history of or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Liver problems or
• Problems in passing urine or
• Sleep apnea (breathing problem)—Use with caution. May make these conditions worse.

• Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases (blood clots).

• Heart disease (eg, congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

• Heart disease, severe or
• Kidney disease, severe or
• Liver disease, severe—Depo®-Testosterone should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into your muscle (usually in the buttocks). Xyosted™injection is given as a shot under your skin in the stomach area. You or your caregiver may be trained to prepare and inject Xyosted™ injection at home. Be sure that you understand how to use the medicine.

If you use Xyosted™ injection at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Check the liquid in the Xyosted™ autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

Use a new needle each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form (solution):
  • For low testosterone levels:
    • Adults—At first, 75 milligrams (mg) injected under the skin once a week. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine should not be used by women who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause a serious lung problem called pulmonary oil microembolism (POME). Tell your doctor right away if you have a cough or urge to cough, dizziness, fainting, trouble breathing, sweating, tightening of your throat, or chest pain.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

This medicine may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, sharp pains in the chest, or trouble breathing.

This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. Talk with your doctor before you use this medicine if you plan to have children.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

Depo®-Testosterone contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Check with your doctor if you are concerned.

This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Back pain

bladder pain

bleeding from the gums or nose

bloody or cloudy urine

bluish lips or skin

changes in mood

chills

difficult, burning, or painful urination

dizziness

eye pain

fever

frequent urge to urinate

groin pain

headache

irritability

lower back or side pain

muscle aches

pain or burning with urination

ringing in the ears

stomach pain

swelling of the arm or leg

Incidence not known

Arm, back, or jaw pain

black, tarry stools

chest pain or discomfort

confusion

cough or urge to cough

decrease in amount of urine

difficulty with breathing

difficulty with swallowing

fainting

fast, pounding, or irregular heartbeat or pulse

inability to move the arms, legs, or facial muscles

nausea

noisy, rattling breathing

pain in the chest, groin, or legs, especially the calves

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe, sudden headache

skin rash, hives, itching

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sweating

swelling of the fingers, hands, feet, or lower legs

tightening of your throat

unusual bleeding or bruising

unusual tiredness or weakness

vision changes

vomiting

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acne or pimples

Less common

Attack, assault, or force

difficulty in moving

joint pain

muscle pain or stiffness

not able to ejaculate semen

pain or redness at the injection site

trouble sleeping

weight gain

Incidence not known

Continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

hair loss or thinning of the hair

hearing loss

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

loss in sexual ability, desire, drive, or performance

more erections than usual or erections that last a long time

swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.