ALKINDI SPRINKLE is the only accurate low-dose hydrocortisone granules that eliminate the uncertainty of pill splitting1,2
Therapeutic challenges exist when treating adrenal insufficiency in pediatrics3
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:
No representations are made regarding an effect of ALKINDI SPRINKLE on these conditions.
GUIDELINES RECOMMENDATION
Current glucocorticoid regimens place a higher value on the prevention of underdosage, but overtreatment also MUST be avoided.6
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 when administered as directed.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 the granules 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) and administering within 5 minutes
- In both fasted and fed states
4 low strengths for accurate dosing1,2
Capsules for opening
- Known accuracy: no pill splitting, crushing, or compounding needed
- Color coded for easy identification
STORAGE AND HANDLING
With ALKINDI SPRINKLE, eliminate the PROCESS OF PILL SPLITTING, which can 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 hydrocortisone when administered as directed1,5
ALKINDI SPRINKLE granules are1,5,9:
- Available in 4 flexible dosage strengths (0.5 mg, 1 mg, 2 mg, and 5 mg)
- Taste-masked when administered as directed*
- 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
- 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 children of various ages take ALKINDI SPRINKLE
Baby [ | ]
Young Child [ | ]
Older Child [ | ]
Live Demonstration [ ]
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.
HOLD AND TAP
Hold capsule with the writing at the top. Tap the capsule to make sure the granules fall to the bottom.
SQUEEZE
Gently squeeze the bottom of the capsule to loosen the top from the bottom.
TWIST
Carefully twist off the top of the capsule.
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.
without food onto a spoon
Pour all granules directly onto a spoon, and place them into the child’s mouth.
directly into the child’s mouth
Pour all granules that make up the prescribed dose directly into the child’s mouth.
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 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 coating 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 specifically 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†
| Total Daily Dose | Dose Frequency | |
|---|---|---|
| Primary Adrenal Insufficiency | Starting dose: 8-10 mg/m2/day | Typically divided into 3-4 doses |
| Congenital Adrenal Hyperplasia | In
infancy: 25 mg/m2/day After first year of life: 10-15 mg/m2/day |
|
| Central Adrenal Insufficiency | 7-9 mg/m2/day | |
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:
Sick Day Rule 1Need 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
Sick Day Rule 2A 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‡
Ensure patients have an additional supply of hydrocortisone so they can increase their dose for all possible sick days.6
IMPORTANT: When parenteral hydrocortisone is required, the patient should be treated in a medical facility with the expertise and resources to treat emergencies.6
Children with AI now have ACCURATE CORTISOL REPLACEMENT OPTIONS to mimic their endogenous circadian rhythms2,5
READ ABOUTStay informed and up to date with ALKINDI SPRINKLE
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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.
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 http://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.
USE INDICATION & IMPORTANT SAFETY INFORMATION
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 http://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.
