Testing Before Initiating and During Treatment with TEMBEXA

Perform hepatic laboratory testing in all patients before starting TEMBEXA and while receiving TEMBEXA, as clinically appropriate [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7)].

Perform pregnancy testing before initiation of TEMBEXA in individuals of childbearing potential to inform risk [see Warnings and Precautions (5.5) and Use in Specific Populations (8.3)].

Important Administration Instructions

Avoid direct contact with broken or crushed tablets or oral suspension. If contact with skin or mucous membranes occurs, wash thoroughly with soap and water, and rinse eyes thoroughly with water [see Warnings and Precautions (5.6)].

TEMBEXA Tablets

TEMBEXA tablets can be taken on an empty stomach or with a low-fat meal (approximately 400 calories, with approximately 25% of calories from fat) [see Clinical Pharmacology (12.3)]. Swallow TEMBEXA tablets whole. Do not crush or divide TEMBEXA tablets.

TEMBEXA Oral Suspension

Take TEMBEXA oral suspension on an empty stomach [see Clinical Pharmacology (12.3)]. Shake oral suspension before use. Use an appropriate oral dosing syringe to correctly measure the total prescribed dose [see Patient Counseling Information (17)]. Discard unused portion after completion of 2 prescribed doses.

For patients who cannot swallow, TEMBEXA oral suspension can be administered by enteral tube (naso-gastric or gastrostomy tubes) as follows:

•

Draw up prescribed dose with a calibrated catheter-tip syringe, and utilize this syringe to administer the dose via the enteral tube.

•

Refill the catheter-tip syringe with 3 mL of water, shake, and administer the contents via the enteral tube.

•

Flush with water before and after enteral administration.

Recommended Dosage

The recommended dosage of TEMBEXA in pediatric and adult patients is displayed in Table 1 [see Drug Interactions (7.1), Clinical Pharmacology (12.3) and Clinical Studies (14)].