Dosage Information

• Individualize the dose for each patient, using the lowest possible dosage.
• The recommended starting replacement dosage is 8 to 10 mg/m 2/day daily. Higher doses may be needed based on patient’s age and symptoms of the disease. Use of lower starting doses may be sufficient in patients with residual but decreased endogenous cortisol production.
• Round the dose to the nearest 0.5 mg or 1 mg. The contents of more than one capsule may be needed to supply the required dose.
• Divide the total daily dose in 3 doses and administer 3 times daily. Older pediatric patients may have their daily dose divided by 2 and administered twice daily.
• Monitor patients for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth and weight gain. Adjust doses accordingly.
• During episodes of acute febrile illness, gastroenteritis, surgery or major trauma, patients may need increased doses [see Warnings and Precautions ( 5.1)] .

Switching to ALKINDI SPRINKLE from Other Oral Hydrocortisone Formulations

When switching patients from other oral hydrocortisone formulations to ALKINDI SPRINKLE, use the same total daily hydrocortisone dosage. Closely monitor patients after switching to ALKINDI SPRINKLE for symptoms of adrenocortical insufficiency. If
symptoms of adrenal insufficiency occur after switching, increase the total daily dosage of ALKINDI SPRINKLE [see Warnings and Precautions (5.1)].

Administration Instructions

ALKINDI SPRINKLE are oral granules contained within capsules.
• Do not swallow the capsules. Do not chew or crush the granules.
• Do not use ALKINDI SPRINKLE granules in nasogastric or gastric tubes as they may
cause tube blockage.
• Open the capsule and administer the granules as follows:
o Hold the capsule so that the printed strength is at the top and tap to ensure all
the granules are in the lower half of the capsule.
o Squeeze the bottom of the capsule gently and twist off the top of the capsule.
o The granules may be administered by pouring the granules directly onto the
patient’s tongue, pouring the granules onto a spoon and placing in the patient’s
mouth, or sprinkling onto a spoonful of cold or room temperature soft food (such as
yogurt or fruit puree). The granules should be given and swallowed within 5 minutes
to avoid a bitter taste as the outer taste masking cover can dissolve.
o Tap the capsule to ensure all the granules are removed. Avoid wetting the capsule
on the tongue or soft food as this may result in granules remaining in the capsule.
o Immediately follow administration with ingestion of fluids such as water, milk, breast
milk or formula to ensure all granules are swallowed.
• Do not add the granules to liquid as this can result in reductions in the dose administered and
may result in a bitter taste.
• Instruct patients and/or caregivers to contact their healthcare provider if the full dose is not
administered (e.g., regurgitating, vomiting of granules). A repeat dose may be required to
avoid adrenal insufficiency [see Warnings and Precautions (5.1)].