Veopoz

Pozelimab · Injection, Solution · Intravenous, Subcutaneous

Boxed warning. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update meningococcal vaccination (for serogroups A, C, W and Y, and serogroup B) at least 2 weeks prior to administering the first dose of VEOPOZ, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection. Follow the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. Patients receiving VEOPOZ are at increased risk for invasive disease caused by N. meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections…

Uses

1 INDICATIONS AND USAGE VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. VEOPOZ is a complement inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. ( 1 )

Dosage and administration

See the full prescribing information for meningococcal vaccine and prophylaxis recommendations prior to the first dose of VEOPOZ. ( 2.1 ) Recommended Dosage: Day 1 (loading dose): Administer a single 30 mg/kg dose by intravenous infusion after dilution. ( 2.2 ) Day 8 and thereafter (maintenance dosage): Inject 10 mg/kg as a subcutaneous injection once weekly starting on Day 8. 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. ( 2.2 ) See full prescribing information for instructions on preparation and administration. ( 2.2 , 2.3 , 2.4 ) 2.1 Recommended Vaccination and Prophylaxis for Meningococcal Infection Prior to First Dose of VEOPOZ Vaccinate patients for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current ACIP recommendations for patients receiving a complement inhibitor at least 2 weeks prior to administering the first dose of VEOPOZ [see Warnings and Precautions (5.1) ] . If urgent VEOPOZ therapy is indicated in a patient who is not up-to-date with vaccines for both MenACWY and MenB according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis. The efficacy, duration, and drug regimens for antibacterial drug prophylaxis have not been studied in patients receiving complement inhibitors, including VEOPOZ. 2.2 Recommended Dosage and Administration The recommended dosage of VEOPOZ is as follows: 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. 2.3 Intravenous Infusion Loading Dose: Preparation and Administration Instructions VEOPOZ for intravenous use must be prepared and administered by a healthcare provider. Preparation Instructions for Intravenous Infusion Loading Dose 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. 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. Gently swirl the vial(s) in an upright position. Do not shake the vial(s) as this may result in foaming. 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). 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. Mix the diluted solution by gentle inversion. Do not shake. Administration Instructions for Intravenous Infusion Loading Dose 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 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. 2.4 Subcutaneous Maintenance Dose: Preparation and Administration Instructions VEOPOZ for subcutaneous use must be prepared and administered by a healthcare provider. Preparation Instructions for Subcutaneous Maintenance Dose 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. 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. Gently swirl the vial(s) in an upright position. Do not shake the vial(s) as this may result in foaming. 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. 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.

Dosage forms and strengths

Injection: 400 mg/2 mL (200 mg/mL) as a clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. Injection: 400 mg/2 mL (200 mg/mL) in a single-dose vial. ( 3 )

Contraindications

4 CONTRAINDICATIONS VEOPOZ is contraindicated in: Patients with unresolved Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . VEOPOZ is contraindicated in patients with unresolved Neisseria meningitidis infection. ( 4 )

Warnings and precautions

Other Bacterial Infections : Interrupt treatment with VEOPOZ in patients who are undergoing treatment for a serious encapsulated bacterial infection until the infection is resolved. ( 5.2 ) Systemic Hypersensitivity Reactions : Interrupt infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. ( 5.3 ) Immune Complex Formation : Transition between other complement inhibitors has resulted in decreased drug concentrations and possible hypersensitivity reactions. Consider this potential if switching complement inhibitors to VEOPOZ. ( 5.4 ) 5.1 Serious Meningococcal Infections Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The use of VEOPOZ increases a patient's susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including nongroupable strains. Complete or update meningococcal vaccination (for serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) at least 2 weeks prior to administering the first dose of VEOPOZ, according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of VEOPOZ therapy. If urgent VEOPOZ therapy is indicated in a patient who is not up-to-date with both MenACWY and MenB vaccines according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis. The efficacy, duration, and drug regimens for antibacterial drug prophylaxis have not been studied in patients receiving complement inhibitors. Because of inhibition of complement activity by VEOPOZ, as well as risk of infection caused by nongroupable strains of N. meningitidis , vaccination does not eliminate the risk of meningococcal infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients and caregivers of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Interrupt treatment with VEOPOZ in patients who are undergoing treatment for serious meningococcal infection until the infection is resolved [see Contraindications (4) ] . 5.2 Other Bacterial Infections VEOPOZ blocks terminal complement activation; therefore, patients may have increased susceptibility to encapsulated bacterial infections, especially infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae , and to a lesser extent, Neisseria gonorrhoeae . Patients treated with VEOPOZ may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Patients receiving VEOPOZ are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination. Interrupt treatment with VEOPOZ in patients who are undergoing treatment for a serious encapsulated bacterial infection until the infection is resolved. Counsel patients about gonorrhea prevention and advise regular testing for patients at risk. 5.3 Systemic Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with administration of complement inhibitors. Interrupt VEOPOZ and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 5.4 Immune Complex Formation Immune complex formation has been reported during the transition of therapy between complement inhibitors, resulting in transient decrease in drug concentrations as well as symptoms suggestive of hypersensitivity reactions. However, this has not been studied in patients with CD55-deficient PLE switching from other complement inhibitors to pozelimab. The potential for immune complex formation should be considered if switching complement inhibitors.

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Meningococcal Infections [see Warnings and Precautions (5.1) ] Other Bacterial Infections [see Warnings and Precautions (5.2) ] Systemic Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immune Complex Formation [see Warnings and Precautions (5.4) ] Most common adverse reactions (in two or more patients) are: upper respiratory tract infection, fracture, urticaria, and alopecia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-855-583-6769 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VEOPOZ was evaluated in 10 patients with CD55-deficient PLE (ranging from 3 to 19 years of age) in a single-arm study [see Clinical Studies (14) ] . The median duration of exposure was 104 weeks (range: 75 to 140 weeks). Adverse reactions reported in two or more patients are summarized in Table 1. Table 1: Adverse Reactions Reported in Two or More VEOPOZ-Treated Patients with CD55-deficient PLE in a Clinical Trial Adverse Reactions VEOPOZ N=10 n (%) Upper respiratory tract infection Composed of similar terms 3 (30) Fracture 3 (30) Urticaria 2 (20) Alopecia 2 (20) Additionally, injection site reactions (including dermatitis and erythema), metabolic acidosis, gingival bleeding, increased blood uric acid, increased liver enzymes, hematuria and proteinuria were reported in one patient each. Vital Signs: Four patients reported elevated systolic and/or diastolic blood pressure readings above the normal range for age at multiple study visits.

Drug interactions

Intravenous Immunoglobulin : May decrease pozelimab concentrations; avoid concomitant use. If concomitant use cannot be avoided, monitor patients for worsening of clinical signs and symptoms of disease. ( 7.1 ) 7.1 Intravenous Immunoglobulin VEOPOZ has not been studied in combination with intravenous immunoglobulin. Intravenous immunoglobulin may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as pozelimab thereby decreasing serum pozelimab concentrations. Avoid concomitant use of intravenous immunoglobulin with VEOPOZ. If concomitant use cannot be avoided, monitor patients for worsening of clinical signs and symptoms of CD55-deficient PLE [see Clinical Pharmacology (12.3) ] .

Use in specific populations

8.1 Pregnancy 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 Animal Data In an enhanced pre- and postnatal development study, pregnant female monkeys were subcutaneously administered pozelimab-bbfg at doses of 5 or 50 mg/kg once weekly from confirmation of pregnancy (gestation day 20) through parturition (approximately gestation day 160). No adverse effects were observed on maintenance of pregnancy, pregnancy outcome, or on the development of offspring through postnatal day 90 at doses up to 3.3-3.8 times the predicted clinical exposures. 8.2 Lactation 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. 8.4 Pediatric Use The safety and effectiveness of VEOPOZ for the treatment of CD55-deficient PLE have been established in pediatric patients 1 year of age and older. Use of VEOPOZ for this indication is supported by a single-arm study in 10 patients with active CD55-deficient PLE [see Adverse Reactions (6.1) and Clinical Studies (14) ]. The safety and effectiveness of VEOPOZ have not been established in pediatric patients less than 1 year of age. 8.5 Geriatric Use CD55-deficient PLE is largely a disease of pediatric patients. VEOPOZ has not been studied in the geriatric population.

Pregnancy

Pediatric use

8.4 Pediatric Use The safety and effectiveness of VEOPOZ for the treatment of CD55-deficient PLE have been established in pediatric patients 1 year of age and older. Use of VEOPOZ for this indication is supported by a single-arm study in 10 patients with active CD55-deficient PLE [see Adverse Reactions (6.1) and Clinical Studies (14) ]. The safety and effectiveness of VEOPOZ have not been established in pediatric patients less than 1 year of age.

Geriatric use

8.5 Geriatric Use CD55-deficient PLE is largely a disease of pediatric patients. VEOPOZ has not been studied in the geriatric population.

Description

Pozelimab-bbfg, a complement inhibitor, is a recombinant monoclonal antibody (IgG4 isotype). Pozelimab-bbfg is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture and has an approximate molecular weight of 145 kDa. VEOPOZ (pozelimab-bbfg) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution supplied in a single-dose glass vial, free from visible particulates, for intravenous or subcutaneous use. Each vial contains 400 mg pozelimab-bbfg in 2 mL of solution with a pH of 5.8. Each mL contains 200 mg pozelimab-bbfg, arginine hydrochloride (21 mg), histidine (1.15 mg), L-histidine hydrochloride monohydrate (2.65 mg), polysorbate 80 (1.5 mg), sucrose (20 mg), and Water for Injection, USP.

Mechanism of action

12.1 Mechanism of Action Pozelimab-bbfg is a human, monoclonal immunoglobulin G4 P (IgG4 P ) antibody directed against the terminal complement protein C5 that inhibits terminal complement activation by blocking cleavage of C5 into C5a (anaphylatoxin) and C5b, thereby blocking the formation of the membrane-attack complex (C5b-C9, a structure mediating cell lysis).

How supplied

(pozelimab-bbfg) injection is a clear to slightly opalescent, colorless to pale yellow solution. It is supplied in a carton containing one single-dose glass vial of: 400 mg/2 mL (200 mg/mL) (NDC 61755-014-01). Store VEOPOZ vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Discard unused portion.

Storage

Store VEOPOZ vial refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Discard unused portion.

Patient information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients that they will be given a Patient Safety Card for VEOPOZ that they should carry with them at all times. This card describes symptoms of meningococcal, or other infection, which, if experienced, should prompt the patient to seek immediate medical evaluation. Meningococcal Infection Advise patients of the risk of meningococcal, and other bacterial infections. Inform patients of the need to complete or update meningococcal vaccination for both MenACWY and MenB at least 2 weeks prior to receiving the first dose of VEOPOZ and to be revaccinated according to current ACIP recommendations for meningococcal vaccines while on VEOPOZ therapy. Inform patients that vaccination may not prevent meningococcal infection. Inform patients of the signs and symptoms of meningococcal infection and advise patients to seek immediate medical attention if any signs or symptoms of infection occur [see Warnings and Precautions (5.1) ] . Other Bacterial Infections, Including Gonococcal Infection Inform patients of the increased risk of other bacterial infections, particularly those due to encapsulated bacteria. Inform patients of the need to receive vaccinations according to the ACIP recommendations. Advise patients to report any new signs and symptoms of infection. Counsel patients about gonorrhea prevention and advise patients at risk (e.g., sexually active) to seek regular testing [see Warnings and Precautions (5.2) ] . Systemic Hypersensitivity Reactions Advise patients to notify the healthcare provider and seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions (5.3) ].

Label text from the FDA structured product label by Regeneron Pharmaceuticals, Inc. (revised Dec 4, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Pozelimab in 1 product

Veopoz NDC products (1)

NDC	Strength & form	Labeler	Type
61755-014	Pozelimab 200 mg/mL Injection, Solution	Regeneron Pharmaceuticals, Inc.	BLA

Frequently asked questions

What is Veopoz used for?

What are the side effects of Veopoz?

Who makes Veopoz?

Veopoz is listed by 1 labeler in the FDA NDC directory, including Regeneron Pharmaceuticals, Inc..