ALKINDI SPRINKLE hydrocortisone oral granules

ALKINDI SPRINKLE is a treatment of pediatric-specific hydrocortisone oral granules that manages cortisol levels to help facilitate accurate and individualized dosing in infants, children, and adolescents (neonate to <17 years old) with adrenal insufficiency, including congentical adrenal hyperplasia (CAH).^1,2*

*The safety and effectiveness of ALKINDI SPRINKLE have not been established in patients over 17 years of age.¹

Avoid under- or overdosing in the treatment of adrenal insufficiency

Hydrocortisone has a narrow therapeutic dosing window.² Treating children outside this window can result in poor health outcomes beyond youth and into adulthood.^3-6

Learn More About Accurate Dosing

Dosing inaccuracy is possible with pill manipulation and compounded formulations at home and at the compounding pharmacy

There is a risk of under- or overdosing due to imprecise measurements in crushing or splitting tablets and the variability in physical dimensions of the resulting product.⁷

Guidelines exist for healthcare professionals; however, the methods caregivers use to manipulate tablets may vary depending on⁷:

Required dose
Type of product(s)
HCP advice
Home equipment

Compounding at the pharmacy

Issues with compounded hydrocortisone⁸:

21.4^%

21.4% of batches lacked uniformity of net mass or drug content*

3.6^%

3.6% completely failed to contain any trace of the labeled drug

*Evaluation of 56 batches containing 1125 capsules.

Accurate hydrocortisone dosing for your patients is possible with ALKINDI SPRINKLE*

ALKINDI SPRINKLE is available in 4 strengths within color-coded capsules for flexible, accurate dosing.

ALKINDI SPRINKLE can help provide accurate dosing tailored to the cortisol needs of your pediatric patients, with the lowest, most effective dose.

*When the entire dose is administered when and as directed.

Capsules shown are not actual size.

No pill splitting

No pill crushing

No compounding

Just sprinkles

See how ALKINDI SPRINKLE helps your pediatric patients keep their eyes on the future

Learn More About ALKINDI SPRINKLE

Prescribing ALKINDI SPRINKLE

All prescriptions for ALKINDI SPRINKLE need to be sent directly to Anovo^® Specialty Pharmacy using either of the methods below. Once ALKINDI SPRINKLE has been prescribed, your patients will have access to Eton Cares,* a comprehensive patient support program.

Via Fax

Complete the ALKINDI SPRINKLE Patient Referral Form, including prescription details and important information for the benefits investigation process
Send via fax (1-855-813-2039) to Anovo Specialty Pharmacy

Download Form

Via e-Script

Initiate e-Script from EMR system
Select “Anovo #5” for pharmacy

Anovo Specialty Pharmacy will follow up with a call to your office to obtain the patient information required for the benefits investigation process.

*Restrictions, limitations, and/or eligibility requirements apply.

Stay informed and up to date with ALKINDI SPRINKLE

INDICATION AND IMPORTANT SAFETY INFORMATION

Contraindication

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

Warnings and Precautions

Adrenal Crisis: Undertreatment or sudden discontinuation of therapy 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. 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 during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations.
Infections: Excessive doses may 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. Treat all infections seriously, and initiate stress dosing of steroids early.
Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE 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; pediatric patients under one 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 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.

Adverse Reactions

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

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

INDICATION

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

Please see full Prescribing Information for more information.

LAB-1465-v1

INDICATION AND IMPORTANT SAFETY INFORMATION

Contraindication

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

Warnings and Precautions

Adrenal Crisis: Undertreatment or sudden discontinuation of therapy 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. 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 during periods of stress. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations.
Infections: Excessive doses may 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. Treat all infections seriously, and initiate stress dosing of steroids early.
Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE 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; pediatric patients under one 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 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.

Adverse Reactions

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

INDICATION

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

Please see full Prescribing Information for more information.

LAB-1465-v1

References: 1. ALKINDI SPRINKLE. Package insert. Eton Pharmaceuticals, Inc; 2022. 2. Neumann U, Whitaker MJ, Wiegand S, et al. Absorption and tolerability of taste-masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency. Clin Endocrinol (Oxf). 2018;88(1):21-29. doi:10.1111/cen.13447 3. Han TS, Conway GS, Willis DS, et al. Relationship between final height and health outcomes in adults with congenital adrenal hyperplasia: United Kingdom congenital adrenal hyperplasia adult study executive (CaHASE). J Clin Endocrinol Metab. 2014;99:E1547‐E1555. doi:10.1210/jc.2014-1486 4. Oprea A, Bonnet NCG, Pollé O, Lysy PA. Novel insights into glucocorticoid replacement therapy for pediatric and adult adrenal insufficiency. Ther Adv Endocrinol Metab. 2019;10:2042018818821294. doi:10.1177/2042018818821294 5. Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(2):364-389. doi:10.1210/jc.2015-1710 6. Debono M, Newell Price J, Ross RJ. Novel strategies for hydrocortisone replacement. Best Pract Res Clin Endocrinol Metab. 2009;23(2):221-232. doi:10.1016/j.beem.2008.09.010 7. Watson C, Webb EA, Kerr S, Davies JH, Stirling H, Batchelor H. How close is the dose? Manipulation of 10 mg hydrocortisone tablets to provide appropriate doses to children. Int J Pharm. 2018;545(1-2):57-63. doi:10.1016/j.ijpharm.2018.04.054 8. Neumann U, Burau D, Spielmann S, et al. Quality of compounded hydrocortisone capsules used in the treatment of children. Eur J Endocrinol. 2017;177(2):239-242. doi:10.1530/EJE-17-0248

Accurate dosing helps your pediatric patients keep their eyes on the future

Avoid under- or overdosing in the treatment of adrenal insufficiency

Dosing inaccuracy is possible with pill manipulation and compounded formulations at home and at the compounding pharmacy

Compounding at the pharmacy

Accurate hydrocortisone dosing for your patients is possible with ALKINDI SPRINKLE*