Testro AQ (Intramuscular, Subcutaneous)

Testosterone injection is used to treat men whose bodies do not produce enough natural testosterone, a condition known as hypogonadism. Testosterone is a male hormone that helps with the growth and development of male sex organs and the 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 help male teenagers who have delayed puberty.

This medicine should only be given by or under the direct supervision of your doctor. The Aveed® brand is only available through a restricted distribution program called the Aveed® REMS program. Xyosted™ is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure 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 show 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 recklessly. 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 in 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 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.

In deciding to use a medicine, it's important to consider the risks of taking it against the benefits it may provide. This is a choice you and your doctor will make together. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research on the effects of Depo®-Testosterone in children younger than 12 years has not been conducted. Its safety and effectiveness are not established.

Research on the effects of Aveed® or Xyosted™ in children has not been conducted. Its safety and effectiveness are not established.

Delatestryl® may be used for short periods in certain teenage boys to treat delayed puberty. X-ray exams of the hands and wrists should be done every 6 months for these boys while using this medicine.

Geriatric

Research on the effects of testosterone injection in elderly patients has not been conducted. However, older patients are more likely to have heart or prostate issues (including enlarged prostate), which may require caution when taking this medicine.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. It's important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on 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 necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed, your doctor may adjust the dose or frequency for one or both.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor about any other medical problems, especially:

• Allergy to benzyl benzoate, refined castor oil, or sesame oil, or
• Breast cancer (in males), or
• Age-related hypogonadism, or
• Known or suspected prostate cancer—Aveed®, Delatestryl®, or Xyosted™ should not be used in these cases.

• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), or
• Coronary artery disease, or
• Diabetes, or
• History of drug abuse or dependence, or
• Enlarged prostate, or
• History of heart attack, 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
• Urination issues, or
• Sleep apnea (breathing problem)—Use with caution. This may worsen these conditions.

• Blood disorder (e.g., polycythemia)—May increase risk for blood clots.

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

• Severe heart disease, or
• Severe kidney disease, or
• Severe liver disease—Depo®-Testosterone should not be used in these cases.

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.

In the U.S.

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

Available Dosage Forms:

• Implant
• Solution
• Oil

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

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.

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