For children aged 5 years and older with adrenal insufficiency
Depiction only. Not actual label.
New KHINDIVI oral liquid hydrocortisone helps make dosing easy so you can feel confident your loved one is getting the accurate dose they need every time.
*When entire dose is given as directed.
Call the Anovo® Specialty Pharmacy with questions about KHINDIVI at
KHINDIVI is comparable to ALKINDI SPRINKLE®1
KHINDIVI is a prescription medicine used in children 5 years of age and older as replacement therapy when the adrenal gland is not making enough cortisol.
Limitation of Use: KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing.
Always give KHINDIVI exactly as your doctor has directed.
Do not take 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 KHINDIVI, watch your child closely for any changes. During periods of stress such as infections or after surgery, your doctor should switch to another oral hydrocortisone product and increase the dose.
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 build-up 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.
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. Contact your health care 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 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 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.
The most common side effects of KHINDIVI 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 KHINDIVI-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.
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.
Reference: 1. Data on file. Eton Pharmaceuticals, Inc. Deer Park, IL.
KHINDIVI is a prescription medicine used in children 5 years of age and older as replacement therapy when the adrenal gland is not making enough cortisol.
Limitation of Use: KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing.
Always give KHINDIVI exactly as your doctor has directed.
Do not take 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 KHINDIVI, watch your child closely for any changes. During periods of stress such as infections or after surgery, your doctor should switch to another oral hydrocortisone product and increase the dose.
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 build-up 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.
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. Contact your health care 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 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 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.
The most common side effects of KHINDIVI 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 KHINDIVI-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.
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.
Reference: 1. Data on file. Eton Pharmaceuticals, Inc. Deer Park, IL.