Certain health conditions can make it difficult for some men to have normal levels of testosterone. Low testosterone levels, also known as hypogonadism, can affect a person’s life, can cause different symptoms at different ages, and can be caused by certain health conditions.
Xyosted was approved in 2018 and is the first weekly auto-injector drug for testosterone replacement therapy. An auto-injector helps to make injecting the medicine easier.
How Does It Work?
Testosterone affects many parts of the body and can affect your sex drive (libido), bone and muscle growth, facial hair, and sperm production. Low testosterone can cause many symptoms, which are listed below.
- Tiredness
- Change in sex life
- Trouble thinking
- Changes in mood, including depression
- Low muscle or bone mass
- More body fat
- Hair thinning
- Trouble sleeping
Xyosted contains testosterone, which helps increase low testosterone levels in people with hypogonadism. Xyosted is used in adult males to treat low testosterone levels caused by certain health conditions, which are listed below
- Issues with the testes
- Issues with the hypothalamus or pituitary glands, which are glands in your brain that are responsible for producing hormones
- Changes in hormone levels including follicle-stimulating hormone (FSH), luteinizing hormone (LH), gonadotropin, and luteinizing hormone-releasing hormone (LHRH)
- Chemotherapy
- Radiation
- Trauma
How Do I Use It?
Xyosted is injected into the stomach once a week. It is usually started at a dose of 75 milligrams. Your health care provider may change your dose, depending on your testosterone levels after using Xyosted. Xyosted also comes in a 50-milligram and 100-milligram doses. To ensure that you are injecting Xyosted properly, follow the “Instructions For Use” that comes with your prescription.
How Was It Studied?
One clinical study was done to look at the safety and efficacy of Xyosted. The study looked at men diagnosed with hypogonadism to see what percentage of them would achieve a normal testosterone level at week 12 while using Xyosted. People would receive 75 milligrams once weekly, and dosage adjustments were made if needed. The study included people who were 18 years of age or older, with the average age being 53 years old. About 89% of people in the study were White Americans, 7% of people were Black Americans, and 3% of people were Asian Americans, including 5% of people who identified as Hispanic or Latino.
What Benefits Were Seen?
About 93% of people in the study achieved a testosterone level that was within a normal range, which showed that Xyosted helped increase and maintain testosterone levels in people with low levels.
How Long Does It Take to Work?
It may take a few weeks for Xyosted to increase your testosterone levels to a normal range. Your health care provider will monitor your testosterone levels while you’re using Xyosted to see if any dose adjustments need to be made.
How Can I Manage Side Effects?
The most common side effects seen with Xyosted are listed below.
- Changes in blood tests
- High blood pressure
- Bruising where you get the shot
- Headache
Xyosted can cause changes in certain blood tests, including an increase in your hematocrit and prostate-specific antigen (PSA). Hematocrit is a test that measures the number of red blood cells in your blood. PSA is a protein that is made by your prostate and is a test used to screen for prostate cancer. Your health care provider will likely monitor your blood levels.
Xyosted can also cause high blood pressure, but there are things you can do to help. This includes exercising regularly and following the DASH diet which includes fruits, vegetables, and low-fat or nonfat dairy products. It also limits alcohol, smoking, trans and saturated fats, and sodium. Call your health care provider if you notice your blood pressure increasing, and go to the emergency room if the top number (systolic) of your blood pressure is over 180 mm Hg or if the bottom number (diastolic) of your blood pressure is over 120 mm Hg.
Because Xyosted is injected in the stomach, you may have bruising where the needle goes in. Changing where you get the shot each time you inject Xyosted can help lessen this. Only use the left side or the right side of your stomach to inject Xyosted. It is important not to inject the medicine into areas where the skin is tender, bruised, red, scaly, or hard and not to inject within 2 inches of the belly button.
If you get headaches while using Xyosted, taking over-the-counter medicines such as Tylenol or ibuprofen may help. Tell your health care provider if you have headaches that do not go away or get worse.
What Type of Drug Interactions Can Happen?
If you are using insulin for your diabetes while using Xyosted, you may get low blood sugar. Keep a record of your blood sugar at home to show your health care provider. Your health care provider may lower your insulin dose if your blood sugar readings are low. Talk to your health care provider about how to recognize low blood sugar and what to do if you experience it. Symptoms of low blood sugar can include the following listed below.
- Headache
- Crankiness or anxiety
- Hunger
- Dizziness or confusion
- Blurry vision
- Slurred speech
- Sweating
- Feeling jittery or shaky
- Fast heartbeat
- Seizures
If you are taking a blood thinner, which is a medicine used to help treat or prevent blood clots, your health care provider may monitor you more often. If you are taking warfarin, your health care provider may monitor your international normalized ratio (INR) to see how long it takes for your blood to clot.
Taking a corticosteroid, which is a medicine used for certain inflammatory conditions, with Xyosted could cause your body to hold more fluid (edema). Symptoms may include shortness of breath and swelling in your arms and legs. Your health care provider may monitor you while taking these two medicines, especially if you have heart, kidney, or liver disease.
A side effect of Xyosted is an increase in your blood pressure. Taking medicines that can increase your blood pressure while using Xyosted can increase your blood pressure even more. These medicines may include cough and cold medicines that contain decongestants, nonsteroidal anti-inflammatory drugs (NSAIDs), medicines for migraines, or weight loss medicines.
What Are Other Unique Considerations to Be Aware Of?
Xyosted is a Schedule III controlled substance that could lead to abuse and misuse, which is when the medicine is used too much or in the wrong way, or dependence, when your body starts to rely on the medicine. Keep Xyosted in a safe place. Do not sell or give Xyosted away, as this may harm others and is against the law.
Xyosted is for males 18 years of age or older. The safety and efficacy of Xyosted has not been established in men less than 18 years old. Xyosted is not for use in women.
Is There a Cost Savings Program?
There is a copay card available from the drugmaker that may allow you to pay as little as $15 per prescription. Whether you are eligible depends on the type of insurance that you have. You can find out more at www.xyosted.com/hcp/savings-and-support or by calling 866-255-8984.
