Delatestryl

Testosterone injection is used to treat men who do not produce enough natural testosterone, a condition called hypogonadism. Testosterone is a hormone that helps develop male sex organs and maintain male characteristics.

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

Testosterone injection is also used to help male teenagers who are experiencing delayed puberty.

This medicine should only be given by or under the direct supervision of your doctor.

When deciding to use this medicine, your doctor will weigh the risks against the benefits. You and your doctor will make this decision together. The following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

Appropriate studies on how age affects the use of testosterone injection have not been done in older adults. However, elderly patients may be more likely to have heart or prostate issues (including enlarged prostate), which may require caution when using 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 at all, while in other cases, two different medicines may be used together even if an interaction could occur. In such cases, your doctor may adjust the dose, or other precautions may be needed. It is especially important that your healthcare professional knows if you are taking any of the following medicines while receiving this medicine. The following interactions are significant but not necessarily all-inclusive.

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

• 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 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 medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, particularly:

• Allergy to benzyl benzoate, refined castor oil, or sesame oil or
• Breast cancer (in males) or
• Hypogonadism, age-related or
• Known or suspected prostate cancer - Delatestryl® should not be used in these patients.
• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism) or
• Coronary artery disease or
• Diabetes or
• Drug abuse or dependence, or a history of it 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
• Issues with urination or
• Sleep apnea (breathing problem)—Use with caution. This may worsen these conditions.
• Blood disorder (e.g., polycythemia)—May increase the risk of thromboembolic diseases (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 issues.
• Severe heart disease or
• Severe kidney disease or
• Severe liver disease—Depo®-Testosterone should not be used in these patients.

It is very important that your doctor check 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 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.

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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 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.

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).

Dosing

The dose of this medicine will be different for different patients.

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.