Lower strengths.
Higher confidence.
Introducing ALKINDI SPRINKLE—the accurate, hassle-free hydrocortisone granules made for newborns and children with adrenal insufficiency
When your child's body is not creating enough cortisol, ALKINDI SPRINKLE is the new prescription medicine for adrenal insufficiency (AI) that:
- Provides more flexible, individualized dosing with 4 low-strength options as low as 0.5 mg
- Masks the bitter taste of hydrocortisone
- Removes the need for pill manipulation, like cutting, splitting, and dissolving
Announces the FDA approval of ALKINDI SPRINKLE for the treatment of AI in newborns and children under 17 years of age
Explains the key information on how to correctly use ALKINDI SPRINKLE
Describes information about ALKINDI SPRINKLE, like what it does, how to use it, and any potential side effects to be aware of
Get started today!
To enroll in the Eton Cares Program, use this ALKINDI SPRINKLE Patient Referral Form to talk to your doctor about whether ALKINDI SPRINKLE is right for you.
DownloadIFU=instructions for use.
USE
ALKINDI SPRINKLE is a prescription medicine used in children from birth to less than 17 years old as replacement therapy when part of the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
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.
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.
Your child should not take ALKINDI SPRINKLE if:
Allergic to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE.
Having difficulties swallowing food or is a premature baby who 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 healthcare provider 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 needs an operation. Let the anesthesiologist 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, these may affect how ALKINDI SPRINKLE works.
What are the possible side effects of ALKINDI SPRINKLE?
Like with all corticosteroids, ALKINDI SPRINKLE can cause reactions like swelling or shortness of breath. 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.
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.
Please visit ALKINDISPRINKLE.com/patient for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for more information.
USEINDICATION AND 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 part of the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
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.
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.
Your child should not take ALKINDI SPRINKLE if:
Allergic to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE.
Having difficulties swallowing food or is a premature baby who 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 healthcare provider 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 needs an operation. Let the anesthesiologist 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, these may affect how ALKINDI SPRINKLE works.
What are the possible side effects of ALKINDI SPRINKLE?
Like with all corticosteroids, ALKINDI SPRINKLE can cause reactions like swelling or shortness of breath. 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.
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.
Please visit ALKINDISPRINKLE.com/patient for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for more information.
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