Miplyffa Dosage

Recommended Dosage

The recommended oral dosage of MIPLYFFA, in combination with miglustat, for patients with an actual body weight of:

• 8 kg to 15 kg, is 47 mg three times a day
• > 15 kg to 30 kg, is 62 mg three times a day
• > 30 kg to 55 kg, is 93 mg three times a day
• > 55 kg, is 124 mg three times a day

Administer MIPLYFFA with or without food.

Recommended Dosage in Patients with Renal Impairment

The recommended dosage of MIPLYFFA, in combination with miglustat, in patients with an eGFR ≥ 50 mL/minute is the same as the recommended dosage in patients with normal renal function.

For patients with an eGFR ≥ 15 to < 50 mL/minute, the recommended oral dosage of MIPLYFFA, in combination with miglustat, for patients with an actual body weight of :

• 8 kg to 15 kg, is 47 mg two times a day
• > 15 kg to 30 kg, is 62 mg two times a day
• > 30 kg to 55 kg, is 93 mg two times a day
• > 55 kg, is 124 mg two times a day

Administer MIPLYFFA with or without food.

Preparation and Administration Instructions

Swallow MIPLYFFA whole. However, for patients who have difficulty swallowing capsules, administer MIPLYFFA in one of two ways:

Oral Administration

1. Carefully open the capsule and sprinkle the entire contents into 15 mL of water or apple juice or 15 mL of soft food (e.g., applesauce, pudding, or yogurt).
2. Stir the mixture for 15 seconds.
3. Consume the entire mixture immediately.

Feeding Tube Administration (nasogastric or gastric tube)

1. Carefully open the capsule and sprinkle the entire contents into 20 mL of water. Do not add the capsule contents to other liquids besides water.
2. Stir the mixture for 15 seconds.
3. Administer the entire mixture immediately via feeding tube.
4. Flush the feeding tube with 5 mL of water after administration.

Do not save the mixture for later use.