Open capsule with sprinkles icon

ALKINDI SPRINKLE is the only precise, low-dose hydrocortisone granules that eliminate the uncertainty of pill splitting1,2

The recommended cortisol replacement therapy for adrenal insufficiency (AI) is hydrocortisone, but there has not been a licensed, low-dose formulation for children. This has forced physicians to rely on high-dosage adult tablets that are3-5:

  • Compounded by pharmacies
  • Manipulated by parents

Manipulations that require crushing or splitting a tablet or dispersion of insoluble tablets into a known volume of liquid for oral administration can lead to inaccuracies and may result in3,4,6,7:

Overdosing

EXCESS CORTISOL

  • Excessive weight gain
  • Short stature
  • Cushing's syndrome
  • Hypertension
  • Insulin resistance
  • Osteoporosis
  • Cardiovascular disease

Underdosing

DEFICIENT CORTISOL

  • Malaise/illness
  • Hypotension
  • Weight loss
  • Salt craving (primary AI)
  • Electrolyte disturbances
  • Virilization and rapid growth (CAH)
  • Adrenal crisis
Guidelines Recommendation

GUIDELINES RECOMMENDATION

Current glucocorticoid regimens place a higher value on the prevention of underdosage, but overtreatment also MUST be avoided.6

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Hydrocortisone has a NARROW THERAPEUTIC DOSING WINDOW as an AI replacement therapy. This may leave patients who were over- or undertreated as children with POOR HEALTH OUTCOMES lasting beyond the pediatric years into adulthood5

The wait is over—accurate and individualized dosing is finally available for your pediatric patients with AI1,2

ALKINDI SPRINKLE is an immediate-release formulation of hydrocortisone in multiparticulate granules that are designed to mask the drug’s bitter taste.1,5

The low-dose formulation of ALKINDI SPRINKLE allows for variable, multi-dose treatment regimens to match endogenous circadian rhythms in children. This provides more physiological cortisol levels than achieved by fixed-dose regimens.1,2,5,6

The granules are contained in capsules, which are designed to be opened and administered with a sip of fluids1,5,8:

  • As dry granules on spoon or directly in the mouth
  • By sprinkling on a small amount of soft food (such as yogurt or applesauce)
  • In both fasted and fed states

4 low strengths for accurate dosing1,2

ALKINDI SPRINKLE flexible dosing options for hydrocortisone

Capsules for opening

  • Known accuracy: no pill splitting, crushing, or compounding needed
  • Color coded for easy identification

With ALKINDI SPRINKLE, eliminate the IMPRECISE PROCESS OF PILL SPLITTING and reduce the risks associated with inaccurate dosing, like over- and undertreatment1,3,5

ALKINDI SPRINKLE is specifically formulated for your pediatric patients with taste-masked granules of hydrocortisone1,5

ALKINDI SPRINKLE granules are1,5,9:

  • Available in 4 flexible dosage strengths (0.5 mg, 1 mg, 2 mg, and 5 mg)
  • Taste-masked*
  • Significantly below the FDA’s granule size limit for choking, measuring ≤0.8 mm
  • Uniform in size and surface
  • Palatable according to parent and caregiver survey results in a phase 3, open-label study
  • Stored in capsules for opening
An open capsule, measuring ≤0.8 mm, pours out ALKINDI SPRINKLE granules. A zoomed-in diagram of the granule is shown, which reveals its layers, including the taste-masking coat, seal coat, hydrocortisone layer, and microcrystalline core
  • Taste-masking coat
  • Seal coat
  • Hydrocortisone layer
  • Microcrystalline core

The administration of ALKINDI SPRINKLE does not involve any pill manipulation1

ALKINDI SPRINKLE is for oral administration only and should be removed from the capsule carrier prior to use. The capsule can be a choking hazard for small children.1

Watch how easy ALKINDI SPRINKLE administration is at any age

Thumbnail for ALKINDI SPRINKLE administration video for babies that is predominantly purple in color and designed in a painterly style. Mother is partially seen in the bottom left of the screen. She is holding a baby in her arms who is wearing a purple headband and onesie.

Baby

Thumbnail for ALKINDI SPRINKLE administration video for young children that is predominantly yellow in color and designed in a painterly style. Young boy is seen sitting in a high chair being fed from a spoon by a person off camera. He is closing his eyes and wearing a yellow t-shirt.

Young Child

Thumbnail for ALKINDI SPRINKLE administration video for older children that uses predominantly cool colors and designed in a painterly style. Older girl is seen sitting pouring sprinkles from the ALKINDI SPRINKLE capsule directly into her mouth. She is wearing a green shirt with a purple hoodie on top.

Older Child

Number 1 icon
CHECK EXPIRATION AND PREPARE

Check the expiration date on the ALKINDI SPRINKLE bottle. DO NOT use after the expiration date on the bottle has passed.

Then, remove the prescribed dose of ALKINDI SPRINKLE capsules from the bottle.

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HOLD AND TAP

Hold capsule with the writing at the top. Tap the capsule to make sure the granules fall to the bottom.

Hand holding ALKINDI SPRINKLE capsule
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SQUEEZE

Gently squeeze the bottom of the capsule to loosen the top from the bottom.

Hand squeezing ALKINDI SPRINKLE capsule
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TWIST

Carefully twist off the top of the capsule.

2 hands twisting open ALKINDI SPRINKLE capsule
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GIVE ALKINDI SPRINKLE

ALKINDI SPRINKLE can be given either:

with food onto a spoon

Pour all granules onto a spoonful of cold or room temperature soft food (such as yogurt or applesauce), and give right away.

Hand pouring granules from ALKINDI SPRINKLE capsule onto spoon with food

Pour all granules directly onto a spoon, and place them into the child’s mouth.

Hand pouring granules from ALKINDI SPRINKLE capsule onto empty spoon

Pour all granules that make up the prescribed dose directly onto the child’s tongue.

Hand pouring granules from ALKINDI SPRINKLE capsule directly into child’s mouth
Number 1 icon
GIVE FLUIDS

After giving ALKINDI SPRINKLE, give a sip of fluids, such as water, milk, breast milk, or formula, right away to make sure all granules are swallowed.

Do not mix with liquid icon

DO NOT add ALKINDI SPRINKLE to liquid before administration, as this can result in less than the full dose being given and might dissolve the taste masking of the granules.1

Accurate dosing to match each patient’s individualized cortisol need6

Dose adjustment by weight or body surface area (BSA) may produce more physiological cortisol levels in AI patients than fixed-dose regimens.6

Only ALKINDI SPRINKLE can be precisely individualized to match a patient’s specific cortisol need by accurately titrating against unique clinical response with the lowest possible dose used.1

Recommended Replacement Dose4,6†

Stress dosing for pediatric AI patients

Adrenal crisis can be a significant cause of morbidity and mortality in patients with adrenal insufficiency. The Endocrine Society Guidelines recommend educating patient caregivers regarding symptom awareness, signs of emergent crisis, and the correct glucocorticoid replacement dose to use.6

The Endocrine Society Guidelines recommend these measures to educate patients and caregivers on adrenal crisis6:

Need to double or triple the routine oral glucocorticoid dose when a patient experiences:

  • Fever
  • Illness

Once the intercurrent illness episode is over, patients can return to their normal replacement dose of ALKINDI SPRINKLE.1,10

A glucocorticoid preparation injected intramuscularly or by IV may be needed in case of:

  • Severe illness
  • Severe trauma
  • Persistent vomiting
  • When fasting for a procedure (colonoscopy)
  • Prior and during surgical intervention
Increased sick day dose prescription icon

Ensure patients have an additional supply of hydrocortisone so they can increase their dose for all possible sick days.6

Medical facility icon

IMPORTANT: When parenteral hydrocortisone is required, the patient should be treated in a medical facility with the expertise and resources to treat emergencies.6

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Children with AI now have PRECISE CORTISOL REPLACEMENT OPTIONS to match their endogenous circadian rhythms2,5

CAH=congenital adrenal hyperplasia.

*When administered as directed.1

Dose should be individualized based on patient’s specific needs, weight, and/or BSA.6

Depending on the type of surgery, higher daily doses may be required (up to 10 times the normal daily dose).6,10

References:

  • ALKINDI SPRINKLE. Package insert. Eton Pharmaceuticals, Inc; 2021.
  • Whitaker MJ, Spielmann S, Digweed D, et al. Development and testing in healthy adults of oral hydrocortisone granules with taste masking for the treatment of neonates and infants with adrenal insufficiency. J Clin Endocrinol Metab. 2015;100(4):1681-1688. doi:10.1210/jc.2014-4060.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Data on file. Eton Pharmaceuticals, Inc. Deer Park, IL.
  • Center for Drug Evaluation and Research. Guidance for industry: size of beads in drug products labeled for sprinkle. Published May 2012. Accessed October 8, 2020. https://www.fda.gov/media/79676/download.
  • Miller WL, Flück CE. Adrenal cortex and its disorders. In: Sperling, MA, ed. Pediatric Endocrinology. 4th ed. Elsevier Saunders; 2014:471-532.

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This site is for US audiences only. © 2021 Eton Pharmaceuticals. All rights reserved. Eton, ALKINDI SPRINKLE, and Eton Cares are trademarks of Eton Pharmaceuticals. All other trademarks are property of their respective owners. WS-ALK-001-rev3-04/21