Jatenzo

Jatenzo is a prescription medicine that contains testosterone. Jatenzo is used to treat adult men who have low or no testosterone due to certain medical conditions.

Jatenzo belongs to a class of drugs known as androgens. These work by increasing the body's natural supply of hormone.

This medication comes in capsule form and is taken twice daily with food.

Common side effects of Jatenzo include thickening of the blood, diarrhea and indigestion.

Jatenzo is a prescription medicine used to treat hypogonadism, a condition associated with deficiency or absence of natural testosterone, in men.

It is not known if Jatenzo is safe or effective in children younger than 18 years old. Improper use of Jatenzo may affect bone growth in children. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Jatenzo is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Jatenzo in a safe place to protect it. Never give your Jatenzo to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law. 

Jatenzo is not meant for use by women.

Serious side effects have been reported with Jatenzo. See the "Jatenzo Precautions" section for more information.

Common side effects of Jatenzo include the following:

• increased red blood cell count
• diarrhea
• heart burn
• burping
• foot, leg and ankle swelling
• nausea
• enlarged prostate gland
• high blood pressure
• headache

This is not a complete list of Jatenzo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your doctor about your medications before, during, and after treatment with Jatenzo. Especially tell your doctor if you take:

• insulin
• medicines that decrease blood clotting (blood thinners) such as warfarin, Dabigatran, eliquis, others
• corticosteroids (such as prenisone, prednisolone, betamethasone, others)
• drugs that increase blood pressure (Effexor, Prozac, sudafed, others)

This is not a complete list of Jatenzo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Jatenzo including the following:

• Jatenzo can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on Jatenzo, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure.

If your blood pressure cannot be controlled, Jatenzo may need to be stopped.

Your healthcare provider will monitor your blood pressure while you are being treated with Jatenzo.

• Increase in red blood cell count (hematocrit) or hemoglobin. Jatenzo increases red blood cell counts in some patients. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks.

You may need to stop Jatenzo if your red blood cell count increases.

Your healthcare provider should check your red blood cell count and hemoglobin while you use Jatenzo.

• If you already have an enlarged prostate, your signs and symptoms may worsen while using Jatenzo. These may include:

• increased urination at night
• trouble starting your urine stream
• urinating many times during the day
• urge to go to the bathroom right away
• a urine accident
• inability to pass urine or weak urine flow

• Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Jatenzo.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with Jatenzo.
• In large doses Jatenzo may lower your sperm count.
• Liver problems. Symptoms of liver problems may include:
  • nausea or vomiting
  • yellowing of your skin or whites of your eyes
  • dark urine
  • pain on the right side of your stomach area (abdominal pain)
• Swelling of your ankles, feet, or body (edema), with or without heart failure.
• Enlarged or painful breasts.
• Breathing problems while you sleep (sleep apnea).
• Changes in mood. Talk to your healthcare provider if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.

Do not take Jatenzo if

• you have or have had breast cancer
• you have or are suspected of having prostate cancer
• you are pregnant
• you are allergic to any of its ingredients
• your hypogonadism is not caused by a genetic or structural problem
• you are under 18 or over 65 years of age

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jatenzo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Jatenzo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Jatenzo or to any of its ingredients
• are pregnant 
• are insulin-dependent diabetic
• have high or low blood pressure
• have a history of blood clots
• have a history of abuse or dependence
• take other steroid products
• have or suspect you have prostate cancer
• have breast cancer

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

Jatenzo is not indicated for use in women. That said, this medication is not to be taken during pregnancy. 

In animal studies, pregnant animals given Jatenzo had babies born with problems and miscarraiges. No well-controlled studies have been done in humans. 

Tell your doctor if are breastfeeding or plan to breastfeed. 

Jatenzo is not indicated for use in women.

• Take Jatenzo exactly as your healthcare provider tells you take it.
• Take Jatenzo by mouth two times daily. Take 1 time in the morning and take 1 time in the evening.
• Take Jatenzo with food.
• Your healthcare provider may change your Jatenzo dose. Do not change your Jatenzo dose without talking to your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have 
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended starting dose of Jatenzo for the treatment of hypogonadism is 237 mg orally once in the morning and once in the evening with food. Dose can be adjusted to a minimum of 158 mg twice daily and a maximum of 396 mg twice daily based on serum testosterone drawn 6 hours after morning dose at least 7 days after starting treatment or following dose adjustment and periodically thereafter. 

If you take too much Jatenzo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep this and all medicines out of the reach of children.
• Store Jatenzo at room temperature.

JATENZO 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 JATENZO, 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 JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
• Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.