Two options.
One standard:

INDICATION AND IMPORTANT SAFETY INFORMATION FOR:

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

INDICATION

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

Contraindication

Hypersensitivity to hydrocortisone or any of the ingredients in ALKINDI SPRINKLE or KHINDIVI.

WARNINGS AND PRECAUTIONS

Adrenal Crisis: Undertreatment or sudden discontinuation of therapy with ALKINDI SPRINKLE or KHINDIVI may lead to symptoms of adrenal insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stressor events, such as infections or surgery. Monitor patients closely when switching from other forms of hydrocortisone to ALKINDI SPRINKLE or KHINDIVI. Instruct patients and/or caregivers to contact their healthcare provider if the full dose of ALKINDI SPRINKLE is not administered, as a repeat dose may be required. Increase the dose of ALKINDI SPRINKLE during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations. During periods of stress (e.g., infections, surgery), KHINDIVI patients should be switched to another oral hydrocortisone product and increase the dose if oral medications are tolerated.

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. KHINDIVI patients should consider dosage reduction as needed.

Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE or KHINDIVI to achieve desired clinical response and monitor the patient’s growth.

Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing’s syndrome. Monitor patients for signs and symptoms of Cushing’s syndrome every 6 months; ALKINDI SPRINKLE-treated pediatric patients under 1 year of age may require more frequent monitoring.

Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption, which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE or KHINDIVI to achieve desired clinical response.

Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions, such as euphoria, mania, psychosis with hallucinations and delirium, or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.

Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances, and if they occur, refer them to an ophthalmologist.

Gastrointestinal Adverse Reactions: There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Concurrent administration of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDs for gastrointestinal adverse reactions.

Risk of Kaposi’s Sarcoma with Use of a Dosage Greater Than Replacement: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of ALKINDI SPRINKLE or KHINDIVI, they are at increased risk of developing Kaposi’s sarcoma.

Vaccination: Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated or 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 pediatric patients less than 5 years of age. The inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin undergo substantial systemic absorption, individually or in combination, resulting in increased plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age. Monitor pediatric patients using KHINDIVI for signs and symptoms consistent with hyperosmolarity.

Metabolic Acidosis and Other Adverse Reactions: The inactive ingredient polyethylene glycol 400 and propylene glycol that may result in metabolic acidosis, hypoglycemia, hepato-renal injury, and central nervous system toxicity (e.g., seizure and coma), may increase the risk of adrenal crisis. Monitor laboratory values and for physical signs and symptoms of these adverse reactions.

Laxative Effects Due to Inactive Ingredients: The inactive ingredients polyethylene glycol 400 and glycerin, whether alone or in combination, may cause gastrointestinal irritation resulting in vomiting and/or diarrhea. These gastrointestinal reactions may increase the risk of adrenal crisis. Monitor for signs or symptoms of gastrointestinal irritation and associated fluid and electrolyte abnormalities.

Adverse Reactions

ALKINDI SPRINKLE
Common adverse reactions for corticosteroids, like ALKINDI SPRINKLE, include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

KHINDIVI
The serious adverse reactions associated with KHINDIVI are adrenal crisis, systemic adverse reactions due to inactive ingredients, immunosuppression and increased risk of infection with dosage greater than replacement, Cushing’s syndrome, growth retardation, Kaposi’s sarcoma risk, psychiatric, ophthalmic and gastrointestinal adverse reactions.

To report a suspected adverse event related to ALKINDI SPRINKLE or KHINDIVI, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

Please see full Prescribing Information for more information on ALKINDI SPRINKLE and KHINDIVI.