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About ALKINDI SPRINKLE, the first and only low-dose hydrocortisone options for newborns and children

How ALKINDI SPRINKLE works

ALKINDI SPRINKLE is a drug that is approved to treat a disease called adrenal insufficiency (AI). AI occurs when the body fails to produce enough cortisol.

This is a problem because cortisol is the body’s main stress hormone, and it supports many different functions in the body. These include metabolism and healthy growth and development.

There are 3 organs in the body that work together to create and maintain a balance of hormones throughout the day.

Hypothalamus in brain graphic

Hypothalamus

A small area at the base of the brain

Pituitary gland in brain graphic

Pituitary Gland

A pea-sized gland at the base of the brain

Adrenal glands above kidneys graphic

Adrenal Glands

A pair of walnut-sized organs above the kidneys

Organ communication star icon

All of these organs communicate with each other to make sure the correct amount of important hormones, like cortisol, are made in the body

Based on where the problem is, AI can be diagnosed as:

  • Primary AI (problems with adrenal glands)
  • Central AI (problems with pituitary gland or hypothalamus)

AI is treated by giving patients a replacement for their missing cortisol, called hydrocortisone, which is the medicine in ALKINDI SPRINKLE.

ALKINDI SPRINKLE effectively managed the cortisol levels of newborns and children

ALKINDI SPRINKLE is the first and only FDA-approved, low-strength hydrocortisone granules designed just for kids.

It was shown to be safe and effective in clinical studies* with newborns and children under 6 years of age.

24 patients in a phase 3 study24Study 1

Single-dose study of 24 newborns and children

18 patients in extension studyStudy 218

Long-term study of 18 newborns and children

The 6 clinical studies* supported that ALKINDI SPRINKLE:
  • Bioequivalent results iconResulted in cortisol levels similar to those from adult-strength hydrocortisone therapy—in both tablet and intravenous forms—but now made appropriately for children
  • Increased cortisol iconIncreased cortisol in pediatric patients to levels similar to those seen in healthy children
  • No adrenal crises experienced safety iconWas well tolerated in all studies with no episodes of adrenal crisis or serious adverse reactions
    • Patients experienced minor, common side effects typical of taking hydrocortisone, including: bloating or swelling, changes in how the body reacts to blood sugar, raised blood pressure, behavior and mood changes, greater appetite, and weight gain
  • Gradual height and weight increases iconDid not result in any large declines or increases in growth for the patients who continued in a 2.5-year follow-up study
    • During the study, no trends were seen that might indicate over- or undertreatment

Know the potential side effects of ALKINDI SPRINKLE

Before taking ALKINDI SPRINKLE, you should review your child’s health history with your doctor and be aware of some side effects that are possible with hydrocortisone therapy.

What is the most important safety information I should know about ALKINDI SPRINKLE (hydrocortisone)?

Always give ALKINDI SPRINKLE exactly as your doctor has directed.

Adrenal crisis

Giving too low a dose or stopping medication can cause low levels of cortisol, which can result in serious illness or death. Treatment with intravenous hydrocortisone should be started immediately. When switching from another type of hydrocortisone to ALKINDI SPRINKLE, watch your child closely for any changes.

Taking too much ALKINDI SPRINKLE can increase risk of infections. All infections should be treated seriously. Tell your doctor if your child has any of these symptoms:

  • Fever
  • Cough
  • Flu-like symptoms
  • Stomach area pain
  • Diarrhea

Taking too much ALKINDI SPRINKLE for long periods of time can affect your child’s growth.

Taking too much ALKINDI SPRINKLE for long periods of time can cause Cushing’s syndrome. Tell your doctor if your child has any of these symptoms:

  • Weight gain
  • Slowed growth in height
  • High blood sugar
  • High blood pressure
  • Swelling
  • Bruising easily
  • Muscle weakness
  • Red, round face
  • Feeling depressed
  • Mood swings

Hydrocortisone can affect your child’s bone growth and strength.

Steroids can change your child’s behavior or mood. Tell your doctor if your child has periods of extreme happiness, extreme excitement, loss of contact with reality, or depression.

Tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE.

ALKINDI SPRINKLE can affect your child's stomach or intestine. Tell your doctor if your child has gastrointestinal illnesses such as stomach or intestinal ulcers, infections, or has had gastrointestinal surgery.

Your child should not take ALKINDI SPRINKLE if they are:

  • Allergic to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE
  • Having difficulties swallowing food or cannot be fed by mouth
  • Being fed through a nasogastric tube since ALKINDI SPRINKLE granules may block the tube

What should I tell my child’s doctor before administering ALKINDI SPRINKLE?

  • If your child is ill or has an infection since there may be a need to temporarily increase the dose of ALKINDI SPRINKLE
  • If your child is having an operation, let the medical team know your child is taking ALKINDI SPRINKLE before the operation
  • If your child is taking prescription medicines, over-the-counter medicines, vitamins, or herbal supplements since these may affect how ALKINDI SPRINKLE works

What are the most common side effects of ALKINDI SPRINKLE?

  • Bloating or swelling
  • Changes in how the body reacts to blood sugar
  • Raised blood pressure
  • Behavior and mood changes
  • Greater appetite
  • Weight gain
Side effects flag with star icon

This is not a complete list of all the possible side effects. Tell your doctor if your child has any side effects that are bothersome or do not go away.

Sprinkles on spoon iconRead about
kid-friendly dosing

*The ALKINDI SPRINKLE clinical trials were open-label, meaning all participants were given ALKINDI SPRINKLE; none were given a placebo.

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This site is for US audiences only. © 2021 Eton Pharmaceuticals. All rights reserved. Eton, ALKINDI SPRINKLE, and Eton Cares are trademarks of Eton Pharmaceuticals. All other trademarks are property of their respective owners. WS-ALK-001-rev3-04/21