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Prescribing Information

Getting started with VYKAT XR

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VYKAT XR is taken once daily

Tablets are taken by mouth.

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It can be taken with or without food

Tablets must be stored in their original packaging and be taken whole. Do not chew, crush, or break. 

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Doses are based on weight

When starting VYKAT XR, your doctor will tell you how much to take and when.

getting-started

Ben

Dog lover and building block wizard taking VYKAT XR​

Everyone is different, so your doctor will work with you to find the appropriate dose

There are multiple dosage strengths and combinations of tablets you may need to take, and your doses may increase until you reach the dose that you will remain on until your doctor tells you otherwise.

It’s important to take VYKAT XR exactly as your doctor prescribes.

VYKAT XR tablets are available in the following strengths:

VYKAT XR
25 mg

25mg-tab

12.9 mm

VYKAT XR
75 mg

75mg-tab

8.6 mm

VYKAT XR
150 mg

150 Mg Tab

15.3 mm

Green pea

Pea

9 mm

Image for size reference

Get the details on taking VYKAT XR, along with help staying on track during treatment:

Food security, diet, and physical activity are still important when taking VYKAT XR

Even though it may be difficult, food security can help save a life

Food security starts by keeping food out of sight, but it doesn’t end there.

It can also mean:

scheduled-times

Setting scheduled times and expectations for snacks and meals.

communicating

Communicating any changes about when meals or snacks will happen.

plannig

Planning and discussing outings where there could be food or snacks.

All types of food security can help lessen anxiety and help your loved one focus on other daily activities.

getting-started-2

Trevin

Incredible brother and impressive bowler taking VYKAT XR​

Diet and exercise are important for people living with PWS because of their low muscle mass and rate of metabolism

VYKAT XR can be added to your existing diet and exercise plan to better help with managing hyperphagia

Talk to a doctor who can help provide specific guidance designed for you.

Fourteen-year-old Ellie’s family always lived in fear of the holidays because food is always at the center of celebrations. Since starting VYKAT XR, meltdowns resolve quicker, and Ellie can sometimes turn down treats at school. At special events like holidays, there are fewer difficult moments around food and more room for being together.

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“I’m super hopeful for Ellie’s future. I want her to live a full life of things she enjoys and loves and to leave this world better than she found it.”

– Gwyn, Ellie’s Mom

Work With Your Doctor

It’s important to take steps to work with your doctor during your treatment experience with VYKAT XR.

You can:

  • Request guidance for monitoring side effects like swelling and increased blood sugar from your doctor
  • Tell your doctor about side effects when they occur
  • Make sure to request scheduled, routine follow-up visits to assess your overall treatment journey

By taking these steps, you and your care team can address potential issues quickly and, ultimately, help keep you or your loved one healthy along the way.

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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.