Ezallor Sprinkle Dosage

2.1 General Dosage and Administration Information

• Administer EZALLOR SPRINKLE orally as a single dose at any time of day, with or without food. Swallow capsules whole. Do not crush or chew. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating EZALLOR SPRINKLE, and adjust the dosage if necessary.
• If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose.

Recommended Dosage in Adult Patients

• The dosage range for EZALLOR SPRINKLE is 5 mg to 40 mg orally once daily.
• The recommended dose of EZALLOR SPRINKLE depends on a patient’s indication for usage, LDL-C, and individual risk for cardiovascular events.

Recommended Dosage in Pediatric Patients

Dosage in Pediatric Patients 8 Years of Age and Older with HeFH

The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older.

Dosage in Pediatric Patients 7 Years of Age and Older with HoFH

The recommended dosage is 20 mg orally once daily.

Dosing in Asian Patients

Initiate EZALLOR SPRINKLE at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of EZALLOR SPRINKLE when treating Asian patients not adequately controlled at doses up to 20 mg once daily.

Recommended Dosage in Patients with Renal Impairment

In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily.

There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

Dosage and Administration Modifications Due to Drug Interactions

EZALLOR SPRINKLE Dosage Modifications Due to Drug Interactions

Table 1 displays dosage modifications for EZALLOR SPRINKLE due to drug interactions.

Table 1: EZALLOR SPRINKLE Dosage Modifications Due to Drug Interactions

EZALLOR SPRINKLE Administration Modifications Due to Drug Interactions

When taking EZALLOR SPRINKLE with an aluminum and magnesium hydroxide combination antacid, administer EZALLOR SPRINKLE at least 2 hours before the antacid.

Preparation and Administration Instructions

EZALLOR SPRINKLE capsule should be swallowed whole. For patients unable to swallow an intact capsule, consider the following instructions based on the route of administration and refer to the accompanying Instructions for Use for complete administration instructions:

Oral Administration

• Carefully open the capsule and sprinkle the entire contents of the capsule onto at least one teaspoonful (5 mL) of room temperature applesauce or chocolate/vanilla flavored pudding.
• Stir the mixture for 10 to 15 seconds.
• Swallow the entire mixture within 60 minutes of mixing. Do not chew the mixture.
• Do not save the mixture for later use.
• Discard the unused portion immediately.

Nasogastric Tube (≥16 French) Administration

• Carefully open the capsule and empty the intact granules emptied into a 60 mL catheter tipped syringe barrel and add 40 mL of water. Do not use with liquids other than water.
• Replace the plunger and shake the syringe vigorously for 15 seconds. The granules in EZALLOR SPRINKLE capsule may start dissolving which is acceptable.
• Attach the syringe to a nasogastric tube (≥16-French) and deliver the contents of the syringe through the nasogastric tube into the stomach.
• Flush the nasogastric tube should with 20 mL of additional water after administering the mixture.
• Do not save the mixture for later use.
• Discard the unused portion immediately.