Pronunciation:

tes-TOS-ter-one un-dek-a-NOE-ate

Brand Names:

• Jatenzo
• Tlando
• Andriol

Dosage Forms:

• Capsule, Liquid Filled

Warnings:

Warning: Blood Pressure IncreasesTestosterone undecanoate can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. Before initiating testosterone undecanoate, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of testosterone undecanoate outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use testosterone undecanoate only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies .

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Testosterone

Uses of This Medicine:

Testosterone 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. This medicine is not for use in women.

This medicine is available only with your doctor's prescription.

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 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 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 taking 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
• Bupropion
• Dabigatran Etexilate
• Dicumarol
• Edoxaban
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Levoketoconazole
• 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 disorder (eg, polycythemia)—May increase risk for thromboembolic diseases (blood clots).

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Diabetes or
• Drug abuse or dependence, or history of 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
• Hypertension (high blood pressure) or
• Liver disease or
• Sleep apnea (breathing problem) or
• Stroke, history of—Use with caution. May make these conditions worse.

• Breast cancer (in males) or
• Hypogonadism, age-related 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:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

Take this medicine with food.

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 low testosterone levels:
  • For oral dosage form (Jatenzo® capsules):
    • Adults—Dose is based on the testosterone concentration level in your blood and must be determined by your doctor. At first, the dose is 237 milligrams (mg) taken 2 times a day, in the morning and in the evening. Your doctor may adjust your dose as needed. However, the dose is not more than 396 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (Tlando® capsules):
    • Adults—Dose is based on the testosterone concentration level in your blood and must be determined by your doctor. The usual dose is 225 milligrams (mg) 2 times a day, in the morning and in the evening.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

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, especially those 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 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.

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 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. Also tell your 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.

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.

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.

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.

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.

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 immediately if any of the following side effects occur:

Less common

Bleeding from the gums or nose

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

bone or muscle pain

discouragement

dizziness

enlarged prostate

eye pain

feeling sad or empty

headache

irritability

lack of appetite

loss of interest or pleasure

nervousness

painful or difficult urination

pounding in the ears

ringing in the ears

slow or fast heartbeat

stomach pain

tingling of the hands or feet

trouble concentrating

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

Rare

Changes in behavior

thoughts of killing oneself

Incidence not known

Chest pain or discomfort

confusion

difficulty breathing

difficulty in speaking

double vision

inability to move the arms, legs, or facial muscles

inability to speak

nausea

pain in the chest, groin, or legs, especially the calves

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

severe, sudden headache

slow or slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sweating

vision changes

vomiting

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:

Less common

Belching

bloated, full feeling

diarrhea

excess air or gas in the stomach

heartburn

indigestion

runny or stuffy nose

sore throat

stomach discomfort or upset

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.