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Testosterone (Intramuscular route)

Brand Names:

  • Aveed

Dosage Forms:

  • Solution

Warnings:

Intramuscular route(Solution)

Serious pulmonary oil microembolism (POME) reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Following each injection of testosterone undecanoate, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis. Testosterone undecanoate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Aveed(TM) REMS Program .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Testosterone

Uses of This Medicine:

Testosterone injection is used for the treatment of 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 only available under a restricted distribution program called Aveed™ REMS program.

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 injection in the pediatric population. Safety and efficacy have not been established.

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.

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
  • 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 or refined castor oil or
  • Breast cancer (males) or
  • Prostate cancer, known or suspected—Should not be used in patients with these conditions.
  • Blood disorder (eg, polycythemia)—May increase risk for thromboembolic diseases.
  • Diabetes or
  • Drug abuse or dependence, or history of or
  • Enlarged prostate or
  • Hypercalcemia (high calcium in the blood) or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Liver problems or
  • Problems in passing urine or
  • Sleep apnea (breathing problem)—Use with caution. May make these conditions worse.
  • Heart disease or
  • Kidney disease or
  • Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

Proper Use of This Medicine:

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 or pharmacist 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 women. 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.

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.

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
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
chest tightness or heaviness
cough or urge to cough
decrease in the amount of urine
difficulty breathing
difficulty swallowing
difficulty urinating
dizziness
eye pain
fainting
fast, pounding, or irregular heartbeat or pulse
feeling need to urinate often
frequent urination
headache
nausea
noisy, rattling breathing
pain in the chest, groin, or legs, especially the calves
pain or discomfort in arms, jaw, back, or neck
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
sudden, unexplained shortness of breath
sweating
swelling of the fingers, hands, feet, or lower legs
tightening of your throat
tiredness
troubled breathing at rest
unusual bleeding or bruising
unusual tiredness or weakness
vision changes
vomiting
weakness
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
changes in mood
irritability
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
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.


Last Updated: 4/4/2014

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