About ALKINDI SPRINKLE, the first and only low-dose hydrocortisone option 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
A small area at the base of the brain
Pituitary Gland
A pea-sized gland at the base of the brain
Adrenal Glands
A pair of walnut-sized organs above the kidneys
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 what's causing it, the two types of AI are:
- 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 manages 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.
Single-dose study of 24 newborns and children
Long-term study of 18 newborns and children
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- 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
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- 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.
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
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.
Read aboutkid-friendly dosing
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*The ALKINDI SPRINKLE clinical trials were open-label, meaning all participants were given ALKINDI SPRINKLE; none were given a placebo.
USE
ALKINDI SPRINKLE is a prescription medicine used in children from birth to less than 17 years old as replacement therapy when the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
Always give ALKINDI SPRINKLE exactly as your doctor has directed.
Do not take ALKINDI SPRINKLE if you are allergic to hydrocortisone or any of its other ingredients.
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. If your child doesn’t get the entire dose of ALKINDI SPRINKLE because of vomiting or spitting some granules out, contact your doctor to see if another dose is needed.
Infections: all infections should be treated seriously, and stress dosing of hydrocortisone should be started early. Taking ALKINDI SPRINKLE should not stop your child from being vaccinated but let your healthcare provider know prior to vaccination.
Growth Retardation: the long-term use of corticosteroids in high doses may cause growth retardation in children.
Decrease in Bone Density: corticosteroids can affect your child’s bone growth and strength.
Cushing’s Syndrome Due to High Doses of Corticosteroids: treatment with high doses of corticosteroids can cause Cushing’s Syndrome. Treatment should be limited to the smallest dose required, and your child’s growth and development monitored appropriately.
Changes in Vision: tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE.
Psychiatric Changes: corticosteroids can change your child’s behavior or mood. Tell your doctor if your child has periods of extreme happiness, extreme sadness, hallucinations, or depression.
Gastrointestinal Reactions: tell the doctor if your child has stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of ulcers or tears in the stomach or intestines. Taking anti-inflammatory nonsteroidal drugs, like ibuprofen, naproxen, or aspirin, can increase the risk of ulcers or tears.
The most common side effects of ALKINDI SPRINKLE include retaining fluids, changes in glucose tolerance, high blood pressure, behavioral and mood changes, greater appetite, and weight gain.
Please visit ALKINDISPRINKLE.com/patient for more information
You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for more information.
USE INDICATION & IMPORTANT SAFETY INFORMATION
USE
ALKINDI SPRINKLE is a prescription medicine used in children from birth to less than 17 years old as replacement therapy when the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
Always give ALKINDI SPRINKLE exactly as your doctor has directed.
Do not take ALKINDI SPRINKLE if you are allergic to hydrocortisone or any of its other ingredients.
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. If your child doesn’t get the entire dose of ALKINDI SPRINKLE because of vomiting or spitting some granules out, contact your doctor to see if another dose is needed.
Infections: all infections should be treated seriously, and stress dosing of hydrocortisone should be started early. Taking ALKINDI SPRINKLE should not stop your child from being vaccinated but let your healthcare provider know prior to vaccination.
Growth Retardation: the long-term use of corticosteroids in high doses may cause growth retardation in children.
Decrease in Bone Density: corticosteroids can affect your child’s bone growth and strength.
Cushing’s Syndrome Due to High Doses of Corticosteroids: treatment with high doses of corticosteroids can cause Cushing’s Syndrome. Treatment should be limited to the smallest dose required, and your child’s growth and development monitored appropriately.
Changes in Vision: tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE.
Psychiatric Changes: corticosteroids can change your child’s behavior or mood. Tell your doctor if your child has periods of extreme happiness, extreme sadness, hallucinations, or depression.
Gastrointestinal Reactions: tell the doctor if your child has stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of ulcers or tears in the stomach or intestines. Taking anti-inflammatory nonsteroidal drugs, like ibuprofen, naproxen, or aspirin, can increase the risk of ulcers or tears.
The most common side effects of ALKINDI SPRINKLE include retaining fluids, changes in glucose tolerance, high blood pressure, behavioral and mood changes, greater appetite, and weight gain.
Please visit ALKINDISPRINKLE.com/patient for more information
You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for more information.
