Veopoz

Day 1 (Loading Dose):           

Administer a single 30 mg/kg dose by intravenous infusion after dilution [see Dosage and Administration (2.3)].

Day 8 and Thereafter (Maintenance Dosage):           

Inject 10 mg/kg as a subcutaneous injection once weekly starting on Day 8 [see Dosage and Administration (2.4)].

• The maintenance dosage may be increased to 12 mg/kg once weekly if there is inadequate clinical response after at least 3 weekly doses (i.e., starting from Week 4).
• The maximum maintenance dosage is 800 mg once weekly.
• Doses greater than 400 mg require 2 injections.

Preparation Instructions for Intravenous Infusion Loading Dose

1. Remove VEOPOZ vial(s) from refrigeration and allow the vial(s) to sit for at least 45 minutes at room temperature 20ºC to 25ºC (68ºF to 77ºF) before use.
2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VEOPOZ should be a clear to slightly opalescent, colorless to pale yellow solution that is free from visible particulates. Discard the vial(s) if the solution is cloudy, discolored or contains particulate matter.
3. Gently swirl the vial(s) in an upright position. Do not shake the vial(s) as this may result in foaming.
4. Use a 21G stainless steel needle with Luer-Lok to withdraw the calculated volume of VEOPOZ from the vial(s). Discard any unused VEOPOZ remaining in the vial(s).
5. Dilute VEOPOZ in an intravenous infusion bag of 25 mL to 250 mL of either 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 6.7 mg/mL to 20 mg/mL.
6. Mix the diluted solution by gentle inversion. Do not shake.

Administration Instructions for Intravenous Infusion Loading Dose

1. Infuse through an intravenous line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter.            
   • Infusion rate: infuse over a minimum of 1 hour; do not exceed maximum rate of 1000 mg/hour
   • Do not co-administer other medications through the same intravenous line
2. Observe the patient for 30 minutes following completion of the infusion [see Warnings and Precautions (5.3)].

Storage of Diluted Intravenous Solution

• Administer the diluted VEOPOZ solution immediately after preparation. If not used immediately, store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the end of the infusion or refrigerate at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to the end of infusion.
• If stored in the refrigerator, allow the diluted solution to come to room temperature prior to administration.
• Discard the unused VEOPOZ diluted solution after 8 hours if stored at room temperature or after 24 hours if refrigerated.
• Do not freeze the diluted solution.

Preparation Instructions for Subcutaneous Maintenance Dose

1. Remove VEOPOZ vial(s) from refrigeration and allow the vial(s) to sit for at least 45 minutes at room temperature 20ºC to 25ºC (68ºF to 77ºF) before use.
2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VEOPOZ should be a clear to slightly opalescent, colorless to pale yellow solution that is free from visible particulates. Discard the vial(s) if the solution is cloudy, discolored or contains particulate matter.
3. Gently swirl the vial(s) in an upright position. Do not shake the vial(s) as this may result in foaming.
4. Use a withdrawal needle (21G needle with Luer-Lok) to withdraw the calculated dose volume of VEOPOZ from the appropriate number of vial(s). Discard any unused VEOPOZ remaining in the vial(s).            
   • For patients receiving a dose greater than 400 mg, preparation of 2 separate injections will be required for subcutaneous administration of the total dose volume.
5. Change the needle on the syringe to an injection needle fulfilling the following criteria: 25G to 27G and 1/2 or 5/8-inch stainless steel needle with Luer-Lok.

Administration Instructions for Subcutaneous Maintenance Dose

1. Inject VEOPOZ into the abdomen, thigh, or upper arm. Rotate sites. Do not inject VEOPOZ into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact. When administering more than one injection, administer consecutively, each at different injection sites.
2. Observe the patient for 30 minutes following completion of the first subcutaneous injection [see Warnings and Precautions (5.3)].

Storage of Subcutaneous Injection

Administer the subcutaneous injection within 4 hours of preparation.

Risk Summary

Although there are no data on VEOPOZ use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, monoclonal antibodies can be actively transported across the placenta.

In an animal reproduction study in monkeys, pozelimab-bbfg did not adversely affect embryofetal or postnatal development when administered from pregnancy confirmation through parturition at doses that produced exposure up to 3.3 to 3.8 times the predicted clinical exposures (on an AUC basis; see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other outcome. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Risk Summary

There are no data on the presence of pozelimab-bbfg in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local gastrointestinal exposure and the extent of systemic exposure in the breastfed infant to pozelimab are unknown. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for VEOPOZ and any potential adverse effects on the breastfed infant from VEOPOZ or from the underlying maternal condition.