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Prescribing Information

VYKAT XR can help manage hyperphagia in PWS

Most people with PWS will experience hyperphagia, but it looks different for everyone. Hyperphagia doesn’t mean being overweight or obese, but these can be signs.

Get to know the different sides of hyperphagia

Hyperphagia is known as extreme hunger, constant thoughts about food, and a constant urge to eat that cannot be satisfied with food.

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Hyperphagia can start as early as age 4 and often continues throughout life for people living with PWS.

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Hyperphagia can also mean food-related anxiety or constantly thinking and talking about food, but may not always mean overeating.

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People with PWS and hyperphagia aren’t always obese or overweight.

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A change in routine, even due to seasonal changes, can affect people with PWS who have hyperphagia.

The early signs of hyperphagia may be hard to recognize.

Environmental controls and other routines may make symptoms even less obvious.

What are the signs of hyperphagia?

What are the signs of hyperphagia?

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Obsessive thoughts about food

  • Obsessively talks about food or asks for food
  • Gets upset when stopped from talking about food
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Greater urge to eat

  • Bargains and manipulates others to get food
  • Gets upset when denied food
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Behavioral problems related to food

  • Forages through trash for food
  • Sneaks food while family is asleep
  • Wakes up in the middle of the night to pursue and sneak food
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Rarely feels full

  • Eats excessively or to the point of dangerous stomach problems

Hyperphagia can change over time, from childhood to adulthood

Children with hyperphagia start to show a strong interest in food and can start to ask a lot of questions about food.

As hyperphagia continues, people living with it can feel hungry all the time and may start to ask about food a lot. When denied food, they can become upset.

As people with hyperphagia age, they could start to manipulate others for food and sneak or steal food.

Hyperphagia continues throughout life and people living with it need ongoing, constant supervision.

For someone as independent as 25-year-old Emma, PWS and hyperphagia often took away the thing that was most important to her. There was always a feeling that a situation could explode at any moment if her routines around meals or snacks were altered. After starting VYKAT XR, Emma can tolerate changes around her schedule, she sometimes feels full, and her independent spirit finally has room to grow.

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“When Emma turned about 5 and it still hadn’t really hit, we thought we dodged a bullet. By the time she turned 10, 11, Emma’s hyperphagia got a lot more serious.”

– Mark, Emma’s dad

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TAKING VYKAT XR

IMPORTANT SAFETY INFORMATION
What is VYKAT XR used for?

VYKAT XR is a prescription medicine used to treat extreme hunger, constant thoughts about food, and constant urge to eat that cannot be satisfied with food (hyperphagia) in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).

What is the most important information I should know about VYKAT XR?

VYKAT XR may cause serious side effects, including:

  • High blood sugar levels (hyperglycemia). Hyperglycemia is common during treatment with VYKAT XR and can also be severe. Hyperglycemia can lead to a condition called diabetic ketoacidosis (increased ketones in the blood) in some people who take VYKAT XR. Diabetic ketoacidosis is a serious condition that needs to be treated in a hospital and can be life-threatening.
    • Your healthcare provider will:
      • check your blood sugar levels before you start VYKAT XR, during treatment and more often during treatment if you have an increased chance of getting hyperglycemia.
      • check your HbA1c before and during treatment.
    • If you get hyperglycemia during treatment with VYKAT XR, your healthcare provider may give you medicines to treat hyperglycemia, change your dose if you already take hyperglycemia medications, or your doctor may change your dose of, temporarily stop, or permanently stop VYKAT XR.
  • Tell your healthcare provider if you get any of the following signs and symptoms:
    • hyperglycemia: feel very thirsty, need to urinate more often than usual, have higher amounts of urine than usual, feel more hungry than usual, or weight loss
    • diabetic ketoacidosis: nausea, vomiting, stomach-area (abdominal) pain, feel weak or very tired or trouble breathing
  • Too much fluid in your body or swelling (fluid overload). Swelling in the body from too much fluid is common during treatment with VYKAT XR and can also be severe. Your healthcare provider may decrease your dose or temporarily stop VYKAT XR if you get fluid overload. Tell your healthcare provider if you have trouble breathing or get any other signs or symptoms of fluid overload such as swelling of your legs, ankles, or feet, or unusual swelling anywhere in your body.
Who should NOT take VYKAT XR?

Do not take VYKAT XR if you are allergic to diazoxide, any ingredients in VYKAT XR or medicines called thiazides.

Before taking VYKAT XR, tell your healthcare provider about all of your medical conditions, including if you:

  • have diabetes or prediabetes
  • are sick
  • plan to have surgery
  • drink alcohol very often
  • are dehydrated or have lost a lot of body fluid
  • have heart problems or a history of swelling in your legs or other parts of your body that required medicine
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. VYKAT XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with VYKAT XR
  • are breastfeeding or plan to breastfeed. VYKAT XR passes into your breast milk, and it is not known if it can harm your baby. Tell your healthcare provider if you plan to breastfeed during treatment with VYKAT XR

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VYKAT XR with certain other medicines may affect the way VYKAT XR or the other medicine works and may increase your risk of side effects. Do not change your dose or stop any medicines you take, or start any new medicines, without talking to your healthcare provider first during treatment with VYKAT XR.

What are the possible side effects of VYKAT XR?

Increased hair growth all over the body, fluid overload or swelling, high blood sugar levels, and rash.

These are NOT all of the possible side effects of VYKAT XR.

Call your doctor for medical advice about side effects. You may report side effects to Soleno Therapeutics, Inc. at 1-833-765-3661 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For further information please read the Medication Guide and full Prescribing Information for VYKAT XR.