Prader-Willi syndrome is a condition that affects your ability to feel full after eating. It can also cause anxiety and constant thoughts about food, or the constant urge to eat, known as hyperphagia (excessive hunger). If hyperphagia is not controlled, it can lead to weight gain and obesity. Vykat XR (diazoxide choline) is a medicine used to manage these symptoms in children and adults with Prader-Willi syndrome
How Does It Work for Excessive Hunger?
Prader-Willi syndrome is a rare condition usually caused by genetic changes in your DNA. It can also occur after a head or brain injury. The condition affects the part of the brain known as a hypothalamus, which tells you that you are full when you eat enough food. One of the challenges of Prader-Willi syndrome is that people often do not have the feeling of being full after eating and may have nonstop hunger and weight gain. Children with Prader-Willi syndrome may always seek out more food, eat big portions, or try to store or hide food to eat later. Some children may even eat food that is still frozen or that is in the garbage. This food seeking and excessive hunger often sets in during early childhood. If these symptoms are not controlled, they can lead to weight gain and obesity.
Vykat XR may help to lower the urge to eat. The medicine works on certain hormones and parts of your brain that affect appetite.
How Do I Take Vykat XR?
Vykat XR is a tablet that should be taken once daily by mouth. Tablets can be taken with or without food, but must be taken whole and not split, chewed, or crushed.
When you first start taking Vykat XR, your health care provider will likely start you on the lowest dose of Vykat XR and increase your dose every two weeks until you have reached a maintenance dose. A maintenance dose is the dose that you stay on and take every day to help manage your symptoms. This slow increase in your dose is called titration. If you miss a week or more of taking Vykat XR, your health care provider may have you restart the medicine at a lower dose and then slowly increase it back up to your maintenance dose.
How Was It Studied?
One clinical study was conducted to see if Vykat XR was safe and effective for reducing excessive hunger in children and adults with Prader-Willi syndrome. Each person in the study took Vykat XR. These people took the medicine for an average of 3.3 years. Then, as part of the study, some people were switched to placebo. They did not know if they were taking medicine or the placebo. The study looked at whether the people who switched to the placebo had a change in their symptoms over 16 weeks. People enrolled in the study were 4 years old or older with Prader-Willi syndrome and excessive hunger and had already been taking Vykart XR for an average of 3.3 years (range: 2.5 to 4.5 years). The people in the study were between 7 and 29 years old, with an average age of 15. About three-quarters (72%) were under the age of 17 when the study started. Most (86%) people were White. About 7% were Black or African American, and 8% were multiple races. Over half (56%) of people were female and less than half (44%) were male.
At the start of the study, people either continued taking Vykat XR or were switched to placebo. After 16 weeks, feelings of hunger and behaviors around food were compared in both groups using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score. The HQ-CT score measures food-seeking behaviors and has a maximum score of 36. At the start of the study, people had an average HQ-CT score of 8.5 while taking Vykat XR.
What Benefits Were Seen in Studies?
The study found that based on their HQ-CT score, people who were switched to the placebo had worsening feelings of hunger compared to people who continued on Vykat XR after 16 weeks. In people who continued taking Vykat XR, the HQ-CT score increased by an average of 2.6. In people who switched to the placebo, the score increased by an average of 7.6. This means that everyone experienced an increase in hunger-related behaviors, but people who switched to the placebo had their scores increase by almost three times more than the people who kept taking Vykat XR.
Your results may differ from what was seen in clinical studies.
How Can I Tell If It Is Working?
Vykat XR lowers the feeling of excessive hunger by working on hormones in the brain. Your health care provider will slowly increase your dose of Vykat XR every two weeks when you first start taking the medicine, which means you may not experience the full effects of the medicine right away.
If Vykat XR is working for you, you may experience fewer urges to eat and also spend less time focused on food. Talk to your health care provider if your feelings of hunger or urges to eat stay the same after starting the medicine. Your health care provider may stop the medicine.
What Are the Common Side Effects and How Can I Manage Them?
The most common side effects seen with Vykat XR are excessive hair growth (hypertrichosis), fluid retention (edema), high blood sugar levels, and skin rash.
Excessive hair growth can be managed with shaving, waxing, tweezing, threading, laser hair removal, electrolysis, or creams that contain depilatories. If excessive hair growth becomes unmanageable using these methods, talk to your health care provider.
A skin rash can be managed by using mild, gentle cleansers instead of scented soaps, taking oatmeal baths, taking allergy medicines like Benadryl, or using anti-inflammatory over-the-counter creams like hydrocortisone to soothe itching and inflammation. If your rash worsens or does not go away while taking Vykat XR, contact your health care provider.
Talk to your health care provider if you have fluid retention (edema) or signs of fluid retention such as trouble breathing and swelling of your ankles, legs, feet, or other areas. Your health care provider may temporarily stop Vykat XR, reduce the dose, or prescribe other medicines such as diuretics (water pills) to help manage the excess fluid.
Vykat XR also can cause high blood sugar levels, and in serious cases, can lead to diabetic ketoacidosis. Before you start Vykat XR and while taking the medicine, your health care provider will test your blood sugar levels and may start you on medicine to control your blood sugar. Your health care provider may also monitor your blood sugar levels regularly during the first few weeks that you are taking Vykat XR or ask you to monitor them at home. You may be at higher risk for having high blood sugar levels if you use growth hormones or steroids or if you already had high blood sugar before starting Vykat XR. Depending on your blood sugar levels while taking Vykat XR, your health care provider may stop or lower the dose of Vykat XR. You should watch for signs of high blood sugar while taking Vykat XR and call your health care provider if any of these occur: feeling really thirsty, needing to urinate often, having larger amounts of urine, feeling more hungry than usual, or unintended weight loss.
When blood sugar levels get very high, this can lead to a serious condition called diabetic ketoacidosis. This is when your body does not have enough insulin, and this causes harmful substances called ketones to build up in the body. Call a health care provider right away if you experience nausea or vomiting, stomach-area pain, feeling very tired, woozy, or confused, trouble breathing, your breath smelling fruity or sweet, or very high blood sugar levels (over 300 mg/dL).
What Type of Drug Interactions Can Happen?
Many other medicines can increase or decrease the levels of Vykat XR in your blood. This can increase your risk of side effects or make Vykat XR less effective. Vykat XR may also change the levels of other medicines in the body. If you are taking any of these other medicines, your health care provider may make changes to your doses or medicines. Your pharmacist or health care provider can tell you if any of the medicines you are taking will affect Vykat XR.
Medicines known as diuretics (water pills) can cause high blood sugar levels and high uric acid levels (hyperuricemia) in the blood when they are taken with Vykat XR. Your health care provider will have you watch for symptoms of high blood sugar and high uric acid levels. Your dose of Vykat XR may need to be lowered when you are taking water pills.
Check with your health care provider before starting or stopping any medicines while taking Vykat XR.
This is not a complete list of interactions. Tell your pharmacist or health care provider about all the prescription and over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you take or have recently taken. This will help them determine if there are any interactions with Vykat XR or if you need a dosage adjustment.
Is There Any Cost Assistance Available?
There is financial support available for people with insurance that can reduce your prescription cost to as little as $0 per month. There is also a program that offers prescriptions at zero cost to people who meet certain criteria. You can find out more by visiting www.vykatxr.com/patient-support-overview or by calling 833-765-3661.