Finally, low-dose options for adrenal insufficiency that are appropriate for kids
Treating children with adrenal insufficiency has historically been a challenge
Living with adrenal insufficiency (AI) can be difficult for you and your child, whether they are brand new to treatment or have tried treatments in the past that were hard to manage.
Until ALKINDI SPRINKLE, there wasn’t an FDA-approved, low-dose form of hydrocortisone for children. Instead, parents and caregivers had to use adult medication that was cut, split, or crushed to equal the dose prescribed by a doctor.
Hydrocortisone
A medicine used as a hormone replacement for people who do not have enough of the natural stress hormone, called cortisol.
These types of changes to the medication could introduce inaccuracies that can result in:
Overdosing
- Growth failure
- Abnormal weight gain
- Cushing’s syndrome
- High blood pressure
Too much medicine
Your child could have long-term problems
Underdosing
- Adrenal crisis
- Masculine features and
- rapid growth (CAH)
- Poor response to stress
- Weight loss
Too little medicine
Your child’s life could be in immediate danger
Growth failure
Too much hydrocortisone for long periods of time can affect the body’s growth permanently.
Cushing’s syndrome
A condition that occurs when the body experiences high levels of cortisol for a long time. Signs and symptoms include weight gain and a rounded face.
Adrenal Crisis
The most serious problem of adrenal insufficiency that happens when there is a severe lack of cortisol in the body. It can lead to life-threatening issues and can cause death if not treated right away.
CAH
Congenital adrenal hyperplasia (CAH): a type of adrenal insufficiency that happens when an enzyme in the body is missing, which is needed to make important hormones that help with stress, illness, and sexual development.
With ALKINDI SPRINKLE, your child now has a dependable hydrocortisone treatment that is precise and effective
Finally, you can treat your youngest adrenal insufficiency patients like kids
ALKINDI SPRINKLE is a granular version of hydrocortisone, meaning it's small enough to "sprinkle." The capsules are designed to be opened and the medicine given on full or empty stomachs with a sip of fluids.
Access granules by twisting open capsules
Pour on a spoon OR directly into child’s mouth
Sprinkle on a small amount of soft food (eg, yogurt or applesauce)
4 low strengths for accurate dosing
Capsules for opening
- No pill splitting, crushing, or dissolving into liquid needed
- Low-strength options to help prevent over- or underdosing
- Proven to mask the bitter taste of hydrocortisone
- Color-coded capsules are easy to identify
STORAGE AND HANDLINGALKINDI SPRINKLE granules are:
- Available in 4 flexible dosage strengths (0.5 mg, 1 mg, 2 mg, and 5 mg)
- Not bitter*
- Less than 0.8 mm in size, much smaller than the FDA-recommended size to prevent choking
- Similar in size and shape
- Pleasant taste according to parent and caregiver survey results
- Stored in easy-to-open capsules
Choose ALKINDI SPRINKLE and provide the exact dose your child needs while reducing the safety concerns and risks of over- and undertreatment that can occur from cutting and splitting adult-sized tablets
Administering ALKINDI SPRINKLE does not involve any pill alterations
ALKINDI SPRINKLE is for oral use only and should be removed from the capsule prior to taking. The capsule can be a choking hazard for small children.
Watch how easy it is to give ALKINDI SPRINKLE at any age
Baby
Young Child
Older Child
CHECK EXPIRATION AND PREPARE
Check the expiration date on the ALKINDI SPRINKLE bottle. DO NOT use after the expiration date listed on the bottle.
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 on 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 on a spoon
Pour all granules directly onto a spoon, and place them into your child’s mouth.
directly into your child’s mouth
Pour all granules that make up the prescribed dose directly onto your child’s tongue.
GIVE FLUIDS
After giving ALKINDI SPRINKLE, give your child 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, as this can result in less than the full dose being given and might make the medicine bitter.
ALKINDI SPRINKLE offers accurate dosing to match each child’s cortisol needs
Unlike previous adult-sized AI treatments, only ALKINDI SPRINKLE can be personalized to your child’s specific cortisol need with the lowest possible dose used. To reach your child’s total dose, your doctor will likely instruct you to give your child multiple smaller doses throughout the day at different times.
Your doctor may adjust your child’s dose by weight or body size throughout treatment to help better align with the appropriate cortisol levels for his or her age range.
During sick days, like times of higher stress or before surgery, you may need to give your child a higher dose of ALKINDI SPRINKLE. Your doctor can help you make the proper change.
Ensure your child has an extra supply of ALKINDI SPRINKLE so you have what you need if your doctor asks you to increase the dose for a sick day.
Read aboutpatient support
*When administered as directed.
USE
ALKINDI SPRINKLE is a prescription medicine used in children from birth to less than 17 years old as replacement therapy when the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
Always give ALKINDI SPRINKLE exactly as your doctor has directed.
Adrenal Crisis: giving too low a dose or stopping medication can cause low levels of cortisol, which can result in serious illness or death. Treatment with intravenous hydrocortisone should be started immediately. When switching from another type of hydrocortisone to ALKINDI SPRINKLE, watch your child closely for any changes.
Infections: all infections should be treated seriously, and stress dosing of hydrocortisone should be started early. Taking ALKINDI SPRINKLE should not stop your child from being vaccinated but let your healthcare provider know prior to vaccination.
Growth Retardation: the long-term use of corticosteroids in high doses may cause growth retardation in children.
Decrease in Bone Density: corticosteroids can affect your child's bone growth and strength.
Cushing's Syndrome Due to High Doses of Corticosteroids: treatment with high doses of corticosteroids can cause Cushing's Syndrome. Treatment should be limited to the smallest dose required, and your child's growth and development monitored appropriately.
Changes in Vision: tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE.
Psychiatric Changes: corticosteroids can change your child's behavior or mood. Tell your doctor if your child has periods of extreme happiness, extreme sadness, hallucinations, or depression.
Gastrointestinal Reactions: tell the doctor if your child has stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of ulcers or tears in the stomach or intestines. Taking anti-inflammatory nonsteroidal drugs, like ibuprofen, naproxen, or aspirin, can increase the risk of ulcers or tears.
The most common side effects of ALKINDI SPRINKLE include retaining fluids, changes in glucose tolerance, high blood pressure, behavioral and mood changes, greater appetite, and weight gain.
Please visit ALKINDISPRINKLE.com/patient for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for more information.
USEINDICATION & IMPORTANT SAFETY INFORMATION
USE
ALKINDI SPRINKLE is a prescription medicine used in children from birth to less than 17 years old as replacement therapy when the adrenal gland is not making enough cortisol.
IMPORTANT SAFETY INFORMATION
Always give ALKINDI SPRINKLE exactly as your doctor has directed.
Adrenal Crisis: giving too low a dose or stopping medication can cause low levels of cortisol, which can result in serious illness or death. Treatment with intravenous hydrocortisone should be started immediately. When switching from another type of hydrocortisone to ALKINDI SPRINKLE, watch your child closely for any changes.
Infections: all infections should be treated seriously, and stress dosing of hydrocortisone should be started early. Taking ALKINDI SPRINKLE should not stop your child from being vaccinated but let your healthcare provider know prior to vaccination.
Growth Retardation: the long-term use of corticosteroids in high doses may cause growth retardation in children.
Decrease in Bone Density: corticosteroids can affect your child's bone growth and strength.
Cushing's Syndrome Due to High Doses of Corticosteroids: treatment with high doses of corticosteroids can cause Cushing's Syndrome. Treatment should be limited to the smallest dose required, and your child's growth and development monitored appropriately.
Changes in Vision: tell your doctor if your child has blurred vision or other vision problems during treatment with ALKINDI SPRINKLE.
Psychiatric Changes: corticosteroids can change your child's behavior or mood. Tell your doctor if your child has periods of extreme happiness, extreme sadness, hallucinations, or depression.
Gastrointestinal Reactions: tell the doctor if your child has stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of ulcers or tears in the stomach or intestines. Taking anti-inflammatory nonsteroidal drugs, like ibuprofen, naproxen, or aspirin, can increase the risk of ulcers or tears.
The most common side effects of ALKINDI SPRINKLE include retaining fluids, changes in glucose tolerance, high blood pressure, behavioral and mood changes, greater appetite, and weight gain.
Please visit ALKINDISPRINKLE.com/patient for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call the FDA at 1-800-FDA-1088.
Please see full Prescribing Information for more information.
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