Testone CIK

In the U.S.

• Aveed
• Delatestryl
• Depo-Testosterone
• Testone CIK
• Testro AQ

Available Dosage Forms:

• Suspension
• Oil
• Solution
• Injectable

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

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.

This section provides information on the proper use of a number of products that contain testosterone. It may not be specific to Testone CIK. Please read with care.

A nurse or other trained health professional will give you this medicine in the hospital or a clinic. This medicine is given as a shot into your muscle (usually in the buttocks). This medicine needs to be given on a fixed schedule. Make sure you keep all of your appointments.

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

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.

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. Anaphylaxis 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, shortness of breath, 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.

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. .

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:

• Abdominal or stomach pain
• arm, back, or jaw pain
• black, tarry stools
• bleeding from the gums or nose
• blood in the urine or stools
• chest pain or discomfort
• confusion
• cough or urge to cough
• decrease in amount of urine
• difficulty with breathing
• difficulty with swallowing
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• frequent urination
• headache
• 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
• ringing in the ears
• 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:

• Acne or pimples

• Attack, assault, or force
• changes in mood
• irritability
• not able to ejaculate semen
• pain or redness at the injection site
• trouble sleeping
• weight gain

• 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.