USE AND IMPORTANT SAFETY INFORMATION FOR:

  • ALKINDI SPRINKLE® (hydrocortisone) oral granules and
  • KHINDIVI™ (hydrocortisone) 1 mg/mL oral solution

USE

ALKINDI SPRINKLE
ALKINDI SPRINKLE is a corticosteroid indicated for replacement therapy in pediatric patients with adrenocortical insufficiency.

KHINDIVI
KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.

Limitation of Use for KHINDIVI
KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing.

IMPORTANT SAFETY INFORMATION FOR ALKINDI SPRINKLE AND KHINDIVI

WHEN USING ALKINDI SPRINKLE OR KHINDIVI
Always give ALKINDI SPRINKLE or KHINDIVI exactly as your doctor has directed. Do not take ALKINDI SPRINKLE or KHINDIVI 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 or KHINDIVI, 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. When taking KHINDIVI during periods of stress, such as infections or after surgery, your doctor should switch to another oral hydrocortisone product and increase the dose.

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.
Contact your healthcare provider if any infections develop.

Growth Retardation: The long-term use of corticosteroids in high doses may cause growth retardation in children.

Decrease in Bone Mineral 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.

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.

Changes in Vision: Tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE or KHINDIVI.

Gastrointestinal Adverse 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.

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

ADDITIONAL IMPORTANT SAFETY INFORMATION FOR KHINDIVI

Systemic Adverse Reactions Due to Inactive Ingredients
Hyperosmolarity: KHINDIVI is not approved in children less than 5 years of age. The inactive ingredients in KHINDIVI can cause dangerous fluid imbalances.

Metabolic Acidosis and Other Adverse Reactions: Some ingredients in KHINDIVI may cause a buildup of acid in the body, low blood sugar, or injuries to the liver, kidneys, or brain that may increase the risk of adrenal crisis.

Laxative Effects Due to Inactive Ingredients: Some ingredients in KHINDIVI may cause stomach upset, resulting in vomiting and/or diarrhea and could increase the risk of adrenal crises in patients.

ADVERSE REACTIONS

The most common side effects of ALKINDI SPRINKLE or KHINDIVI include retaining fluids, changes in glucose tolerance, high blood pressure, behavioral and mood changes, greater appetite, and weight gain.

Additional side effects of KHINDIVI are reactions to inactive ingredients.

FOR ADDITIONAL INFORMATION ON ALKINDI SPRINKLE AND KHINDIVI
If you are being treated with ALKINDI SPRINKLE, please visit ALKINDISPRINKLE.com/patient for more information. If you are being treated with KHINDIVI, please visit KHINDIVI.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 on ALKINDI SPRINKLE and KHINDIVI.