Xyosted

Xyosted is a prescription medication used to treat low testosterone levels in men with no or low testosterone.

Xyosted belongs to a group of drugs called androgen analogs. These work by supplying the body with the necessary androgen.

This medication is available in an injectable form to be given subcutaneously once a week.

Common side effects of Xyosted include red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache.

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

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

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

Serious side effects have been reported with Xyosted. See the “Xyosted Precautions” section.

Common side effects of Xyosted include the following:

• Red blood cell increase,
• Prostatic specific antigen (PSA) increase (a blood test for prostate cancer),
• Increased blood pressure
• Injection site reactions including bruising, bleeding, redness and headache.

Other side effects include more erections than are normal for you or erections that last a long time.

This is not a complete list of Xyosted side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do 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 medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Insulin such as insulin lispro (Humalog), insulin aspart (Novolog), and insulin detemir (Levemir)
• Blood thinners such as warfarin
• Corticosteroids (steroids) such as prednisone(Deltasone), triamcinolone (Kenalog and others), and methylprednisolone (Medrol) 
• Medications that can cause increase in blood pressure such as pseudoephedrine (Sudafed)

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

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

• Increase in blood pressure. Xyosted 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 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.
• Increase in red blood cell count, hematocrit or hemoglobin. High red blood cell counts increase the risk of clots, strokes, and heart attacks. You may need to stop Xyosted if your red blood cell count increases. Your healthcare provider should check your red blood cell count, hematocrit and hemoglobin while you use Xyosted. 
• Cardiovascular Risk. Possible increase risk of heart attack, death, or stroke.
• If you already have an enlarged prostate, your signs and symptoms may get worse while using Xyosted. This can include: increased nighttime urination, trouble starting urination, more frequent urination, feeling an urge to urinate, having a urine accident, and being unable 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 Xyosted.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg 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. 
• In large doses Xyosted 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 or pain on the right side of your stomach area (abdominal pain).
• Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
• Enlarged or painful breasts.
• Problems breathing while you sleep (sleep apnea).
• Change in mood. Talk to your healthcare provide if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts. 

Call your healthcare provider right away if you have any of the serious side effects listed above.

Do not take Xyosted if you:

• are a man who has breast cancer.

• have or might have prostate cancer.

• are a woman who is pregnant. Xyosted may harm your unborn baby.

• are allergic to Xyosted or to any ingredients in Xyosted including testosterone or sesame oil.

• have low testosterone without certain medical conditions. For example, do not take Xyosted if you have low testosterone due to 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 Xyosted, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Xyosted or to any of its ingredients

• have high blood pressure or heart problems.

• have high red blood cell count (hematocrit) or high hemoglobin laboratory value.

• have urinary problems due to an enlarged prostate.

• have kidney or liver problems.

• have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder.

• have problems breathing while you sleep (sleep apnea)

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

Xyosted is not indicated for use in women.

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

Xyosted is contraindicated in pregnant women. Based on studies done in pregnant animals, women taking Xyosted during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Xyosted is not indicated for use in women.

Because of the possibility for adverse reactions in nursing infants from Xyosted, it should not be used in women that are breastfeeding.

See the detailed Instructions for Use for information about how to use Xyosted.

Use Xyosted exactly as your healthcare provider tells you to take it.

Your healthcare provider will show you or your caregiver how to inject Xyosted. You should not inject Xyosted until you have been trained on the proper way to use it.

• Xyosted comes in subcutaneous injection form and is taken once every week.
• This medication is to be given directly into the fatty tissue on either left or right side of the abdomen.
• Take with or without food.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xyosted at the same time.

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

The recommended starting dose for testosterone replacement in low testosterone level men is 75 mg once weekly injected subcutaneously into the abdomen. Dose is adjusted after six weeks of initial dosing based on testosterone concentration in the body.

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

Do not refrigerate or freeze. Use at room temperature.

Store at controlled room temperature, 68°F to 77°F (20°C to 25°C). Protect from light (keep in carton until time of use).

Keep Xyosted and all medicines out of the reach of children.

Xyosted can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease. Before initiating Xyosted, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbation of pre-existing hypertension in patients on Xyosted. Re-evaluate whether the benefits of Xyosted outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment. Due to this risk, use Xyosted only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.