Important Administration Instructions

Prior to oral administration, the supplied FIRVANQ powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [see Dosage and Administration (2.4)].

Adults

•

C. difficile‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.

•

Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

Pediatric Patients (less than 18 years of age)

For both C. difficile‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of FIRVANQ is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

Preparation and Storage of Solutions of FIRVANQ

Each FIRVANQ kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre‑measured Grape‑Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape‑Flavored Diluent provided in the kit. FIRVANQ is available in various strengths and volumes in the kit as shown in Table 1.

Steps for the Preparation of Solutions of FIRVANQ

1.

Hold the neck of the bottle containing the vancomycin hydrochloride USP powder for oral solution (see Table 1), and tap the bottom edges on a hard surface to loosen the powder.

2.

Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”).

3.

Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner.

4.

Carefully and slowly peel back the inner foil seal liner from the Powder Bottle.

5.

Shake the Grape‑Flavored Diluent (see Table 1) for a few seconds.

6.

Remove the cap from the diluent bottle.

7.

Carefully and slowly peel back the inner foil seal from the diluent bottle.

8.

Transfer approximately one-half the contents of Grape-Flavored Diluent into the Powder Bottle.

9.

Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle vertically for approximately 45 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle.

10.

Re-open the Powder Bottle and add the remaining Grape‑Flavored Diluent into the Powder Bottle.

11.

Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle for approximately 30 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle.

12.

Dispense the Powder Bottle containing reconstituted solution of FIRVANQ oral solution to the patient [see Patient Counseling Information (17)].

13.

Instruct the patient to shake the reconstituted solution of FIRVANQ well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters.

14.

Store the reconstituted solution of FIRVANQ at refrigerated conditions, 2°C to 8°C (36°F to 46°F) when not in use.

15.

Discard the reconstituted solution of FIRVANQ after 14 days, or if it appears hazy or contains particulates.