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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