ALKINDI SPRINKLE hydrocortisone oral granules for pediatric adrenal insufficiency

Accurate hydrocortisone dosing can provide safe and effective treatment in children with adrenal insufficiency

Dosing accuracy in children with adrenal insufficiency is essential. If a child gets too much (overdosing) or too little (underdosing) hydrocortisone, they may experience poor health outcomes that can last for a long time, even into their adult years.^2-5

Overdosing can lead to long-term health problems

If your child gets more hydrocortisone than prescribed, they are at risk for long-term health problems that could last into adulthood.⁶

Underdosing can lead to short-term health problems

If your child gets less hydrocortisone than prescribed, they could be in immediate danger.⁶

No representation is made for ALKINDI SPRINKLE in relation to these conditions.

Learn More About Accurate Dosing

ALKINDI SPRINKLE:

The only hydrocortisone treatment designed specifically for children with adrenal insufficiency

No pill splitting

No pill crushing

No compounding

Just sprinkles

Actual patients living with adrenal insufficiency.

ALKINDI SPRINKLE: Made with kids in mind

Accurately treat your child with the dose your doctor prescribed by following the Instructions for Use.

ALKINDI SPRINKLE is a granular version of hydrocortisone developed and approved for the treatment of adrenal insufficiency in newborns and children. The hydrocortisone oral granules are small enough to sprinkle onto soft food, like yogurt or applesauce, or directly into your child’s mouth. The capsules are designed to be opened and the medicine given on a full or empty stomach with a sip of fluids to ensure all granules are swallowed.

Always give ALKINDI SPRINKLE exactly as prescribed by your doctor.

See Why ALKINDI SPRINKLE Is Made for Kids

ALKINDI SPRINKLE helps provide kids with accurate hydrocortisone dosing

Learn more about accurate hydrocortisone treatment for children with adrenal insufficiency.

Learn More About ALKINDI SPRINKLE

USE 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 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.

Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement: Use of a greater than replacement dosage can suppress the immune system and increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections.

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.

Vaccination: Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.

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.

LAB-1466-v2