Assessments Prior to First Dose of EMFLAZA

Administer all immunizations according to immunization guidelines prior to starting EMFLAZA. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting EMFLAZA [see Warnings and Precautions (5.8)].

Dosing Information

The recommended oral dosage of EMFLAZA is approximately 0.9 mg/kg/day once daily. If tablets are used, round up to the nearest possible dose. Any combination of the four EMFLAZA tablet strengths can be used to achieve this dose. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL).

Discontinuation

Dosage of EMFLAZA must be decreased gradually if the drug has been administered for more than a few days [see Warnings and Precautions (5.1)].

Important Preparation and Administration Instructions

EMFLAZA Tablets and Oral Suspension can be taken with or without food. Do not administer EMFLAZA with grapefruit juice [see Drug Interactions (7.1)]

EMFLAZA Tablets
EMFLAZA Tablets can be administered whole or crushed and taken immediately after mixing with applesauce.

EMFLAZA Oral Suspension
Shake EMFLAZA Oral Suspension well before administration.

Use only the oral dispenser provided with the product. After withdrawing the appropriate dose into the oral dispenser, slowly add the EMFLAZA Oral Suspension into 3 to 4 ounces of juice (except grapefruit juice) or milk and mix well. The dose should then be administered immediately.

Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.

Dosage Modification for Use with CYP3A4 Inhibitors and Inducers

CYP3A4 Inhibitors
Give one third of the recommended dosage when EMFLAZA is administered with moderate or strong CYP3A4 inhibitors. For example, a 36 mg per day dose would be reduced to a 12 mg per day dose when used with moderate or strong CYP3A4 inhibitors [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

CYP3A4 Inducers
Avoid use with moderate or strong CYP3A4 inducers with EMFLAZA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].