Pronunciation:

tes-TOS-ter-one SIP-ee-oh-nate

Brand Names:

• Azmiro
• Depo-Testosterone
• Testone CIK

Dosage Forms:

• Oil

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Testosterone

Uses of This Medicine:

Testosterone cypionate injection is use to treat males 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. This medicine is not for use in female patients.

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

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 testosterone cypionate injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of testosterone cypionate 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
• Apixaban
• Azathioprine
• Bupropion
• Dabigatran Etexilate
• Dicumarol
• Edoxaban
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Rivaroxaban
• 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:

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Enlarged prostate or
• Heart attack, or history of or
• Heart or blood vessel disease or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Liver disease or
• Sleep apnea or
• Stroke, history of—Use with caution. May make these conditions worse.

• Breast cancer or
• Prostate cancer, known or suspected—Should not be used in patients with these conditions.

• 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.

• Lung disease, chronic or
• Obesity—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle (usually in the buttock).

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

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 female patients, especially if pregnant or breastfeeding. Testosterone may cause birth defects if a pregnant person 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 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 increase the risk of prostate cancer, especially in older males. 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 (eg, deep vein thrombosis, pulmonary embolism). Tell your doctor right away if you have anxiety, chest pain, coughing, dizziness or lightheadedness, fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, or trouble breathing.

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 males make and affect the 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 edema (fluid and sodium retention). Check with your doctor right away if you have a decrease in amount of urine, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain.

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.

Hypercalcemia (high calcium in the blood) may occur in patients taking this medicine. Check with your doctor right away if you have stomach pain, confusion, constipation, depression, dry mouth, increased urination, loss of appetite, metallic taste, or muscle weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.

This medicine may increased risk of bone growth problems in children. Your doctor will check your child's bone growth every 6 months.

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:

Incidence not known

Acne

anxiety

bleeding gums or nose

bluish lips or skin

chest pain, discomfort, or tightness

chills

clay-colored stools

confusion

constipation

cough

dark urine

decrease in amount of urine

diarrhea

difficulty in speaking

difficulty swallowing

discouragement

dizziness or lightheadedness

double vision

dry mouth

enlargement of penis or testes

eye pain

fast heartbeat

feeling sad or empty

fever

growth of pubic hair

headache

hives, itching, skin rash

inability to move the arms, legs, or facial muscles

inability to speak

increased urination

irritability

lack or slowing of normal growth in children

loss of appetite

loss of interest or pleasure

metallic taste

muscle weakness

nausea

pain, redness, or swelling in the arm or leg

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

painful or prolonged erection of the penis

penile pain during erection

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

rapid increase in height

ringing in the ears

slow speech

stomach pain

sweating

swelling

swelling of the breasts or breast soreness

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

thirst

tiredness

trouble breathing

trouble concentrating

trouble sleeping

unpleasant breath odor

unusual tiredness or weakness

vomiting

vomiting of blood

weight gain or loss

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

inability to speak

seizures

severe or sudden headache

slurred speech

temporary blindness

weakness in the arm or leg on one side of the body, sudden and severe

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:

Incidence not known

Decreased or increased interest in sexual intercourse

inability to have or keep an erection

increased or loss in sexual ability, desire, drive, or performance

pain and swelling at the injection site

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.