Qwo Injection Dosage

2.1 Dosage

QWO is injected subcutaneously at a dose of 0.84 mg per treatment area.

• A treatment area is defined as a single buttock receiving up to 12 injections, 0.3 mL each (up to a total of 3.6 mL), of QWO.
• A treatment visit may consist of up to 2 treatment areas.

Treatment should be repeated every 21 days for 3 treatment visits.

Reconstitution of Lyophilized Powder

Before reconstitution, remove the vials from the refrigerator and let stand at room temperature for at least 15 minutes. Inspect the vials containing QWO. The cake of lyophilized powder should be white in color and intact, showing no signs of erosion. The diluent should be a colorless solution, free of particulate matter.

After removal of the flip-off cap from the vial(s), using aseptic technique swab the rubber stopper and surrounding surface of the vial(s) containing QWO and diluent with sterile alcohol (no other antiseptics should be used).

Use only the supplied diluent for the reconstitution of QWO.

Using an appropriate sized syringe and needle (not supplied), withdraw the amount of supplied diluent based on the number of injection sites (see Table 1).

Inject the diluent slowly into the sides of the vial containing the lyophilized powder of QWO. Do not invert the vial or shake the solution. Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution.

The reconstituted QWO solution in the vial can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 8 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours prior to administration. If the reconstituted QWO solution in the vial is refrigerated, allow this solution to return to room temperature for approximately 15 minutes before use.

The reconstituted QWO solution should be clear, colorless and free of particulate matter. Inspect the solution visually for particulate matter or discoloration prior to administration. If the reconstituted QWO is not a clear, colorless solution essentially free of particulate matter, do not inject it.

Discard the syringe(s) and needle(s) used for reconstitution and the diluent vial(s).

After reconstitution, QWO solution in the vial should be used for only one injection session and for only one patient.

Administration

Preparation of Syringes for Injection

Using 1-mL syringes with removable needles (not supplied), draw up 0.9 mL of the reconstituted solution into each syringe. See Table 2 for the appropriate number of syringes needed based on the number of injection sites. After the syringes are prepared, pull the solution remaining in the needles into the barrels of the syringe and then replace the needle with a 30-gauge 1/2-inch needle. Administer reconstituted solution prepared in 1-mL syringes immediately. Do not store reconstituted solution in the 1-mL syringes.

Injection Technique

Mark the injection sites while the patient is standing. Inject QWO subcutaneously while the patient is in a prone position. Each injection of QWO should be administered as three 0.1-mL aliquots to positions A, B, and C (for a total injection volume of 0.3 mL) as shown in the following figure. The depth of the injection should be 0.5 inches (corresponding to the length of the needle) without downward pressure.

Needle Tip Position A: Position the needle at 90° angle perpendicular to the skin surface at the injection site and inject one 0.1-mL aliquot by gently pushing on the syringe plunger.

Needle Tip Position B: Withdraw the needle slightly (but not so much as to remove from the injection site) and reposition approximately 45° (but not more than 45°) and inject one 0.1-mL aliquot (towards head).

Needle Tip Position C: Withdraw the needle slightly (but not so much as to remove from the injection site) and reposition approximately 45° (but not more than 45°) and inject one 0.1-mL aliquot, (towards foot).

Withdraw needle from the skin completely and move to the next identified injection site. Each treatment area may receive up 12 injections. After treatment the patient should remain prone for at least 5 minutes.

Do not store, pool, or use any vials or syringes containing unused reconstituted solution after administration. Discard any unused portions.