Version July 2025
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 pozelimab, 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 pozelimab are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
CD55-deficient protein-losing enteropathy : Note: Patients must receive meningococcal vaccine at least 2 weeks prior to treatment initiation; revaccinate according to current guidelines. If urgent pozelimab initiation is necessary and vaccination is not up to date with MenACWY and MenB vaccines according to Advisory Committee on Immunization Practices recommendations, vaccinate and provide antibacterial prophylaxis.
Loading dose: IV: 30 mg/kg as a single dose on day 1.
Maintenance dose: SUBQ: 10 mg/kg once weekly starting on day 8; at week 4, dose may be increased to 12 mg/kg once weekly if inadequate clinical response after 3 weekly doses; maximum dose: 800 mg once weekly. Note: Doses >400 mg require 2 SUBQ injections.
Missed maintenance dose:
≤3 days from the assigned day: Administer the missed dose as soon as possible, then administer the next weekly dose on the regular schedule.
>3 days from the assigned day: Omit the missed dose, then administer the next weekly dose on the regular schedule.
The day the weekly dose is administered can be revised at any time as long as 96 hours elapse between doses.
There are no dosage adjustments provided in the manufacturer's labeling; however, pozelimab is not likely to undergo renal excretion.
There are no dosage adjustments provided in the manufacturer's labeling; however, pozelimab is not likely to undergo hepatic excretion.
Bacterial infections: Interrupt treatment in patients undergoing treatment for a serious meningococcal infection or a serious encapsulated bacterial infection until the infection resolves.
Hypersensitivity: Interrupt treatment and manage supportively.
Refer to adult dosing.
(For additional information see "Pozelimab: Pediatric drug information")
Dosage guidance:
Safety: Vaccinate patient against meningococcal infection at least 2 weeks prior to treatment initiation, according to current recommendations. If urgent therapy is needed in a patient who is not up to date, administer meningococcal vaccines as soon as possible and use antibacterial drug prophylaxis.
CD55-deficient protein-losing enteropathy:
Children and Adolescents:
Loading dose: IV: 30 mg/kg once on day 1.
Maintenance dose: SUBQ: 10 mg/kg/dose once weekly beginning 7 days after loading dose. If inadequate response after 3 maintenance doses, may increase to 12 mg/kg/dose once weekly. Maximum dose: 800 mg/dose.
Dosage adjustment for toxicity: Interrupt therapy in patients undergoing treatment for a serious encapsulated bacterial infection (eg, Neisseria meningitidis, Streptococcus pneumoniae) until the infection resolves.
There are no dosage adjustments provided in the manufacturer's labeling; however, pozelimab is not likely to undergo renal excretion.
There are no dosage adjustments provided in the manufacturer's labeling; however, pozelimab is not likely to undergo hepatic excretion.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
>10%:
Cardiovascular: Increased blood pressure
Dermatologic: Alopecia, urticaria
Neuromuscular & skeletal: Bone fracture
Respiratory: Upper respiratory tract infection
1% to 10%:
Endocrine & metabolic: Increased uric acid, metabolic acidosis
Gastrointestinal: Gingival hemorrhage
Genitourinary: Hematuria, proteinuria
Hepatic: Increased liver enzymes
Local: Injection-site reaction (including dermatitis and erythema at injection site)
Frequency not defined: Infection: Meningococcal infection
Patients with unresolved N. meningitidis infection.
Concerns related to adverse effects:
• Infections: Pozelimab blocks terminal complement activation and therefore may increase the risk for susceptibility to bacterial infections, especially encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and, to a lesser extent, Neisseria gonorrhoeae. Patients receiving pozelimab may be at increased risk for serious S. pneumoniae and H. influenzae type b (Hib) infections; vaccinate for S. pneumoniae and Hib according to the Advisory Committee on Immunization Practices (ACIP) recommendations. Therapy should be interrupted in patients undergoing treatment for a serious encapsulated bacterial infection until the infection resolves. Educate patients on the risks and prevention strategies for gonorrhea.
• Infusion reactions: Administration of pozelimab may result in infusion reactions, including anaphylaxis and hypersensitivity. If signs of cardiovascular instability or respiratory compromise occur, interrupt therapy and manage supportively.
• Meningococcal infections: Life-threatening and fatal meningococcal infections have been reported in vaccinated and unvaccinated patients treated with complement inhibitors. The use of pozelimab increases susceptibility to serious meningococcal infections (septicemia and/or meningitis). Meningococcal disease due to any serogroup may occur. Complete or update meningococcal vaccination (serogroups A, C, W, Y and B) at least 2 weeks prior to the first dose of pozelimab. If urgent pozelimab therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide antibacterial prophylaxis. Infection can be caused by nongroupable strains of N. meningitidis; therefore, vaccination does not eliminate the risk of infection despite presence of antibodies following vaccination. Educate patients on signs/symptoms of meningitis and steps necessary to seek immediate medical care. Consider pozelimab discontinuation in patients who are undergoing treatment for serious meningococcal infection. Revaccinate for meningococcal disease according to ACIP recommendations, taking the duration of pozelimab therapy into consideration.
Concurrent drug therapy issues:
• Immune complex formation: Transition between complement inhibitors has resulted in immune complex formation leading to a decrease in drug concentration and symptoms consistent with hypersensitivity reactions. Immune complex formation has not been observed with switching to pozelimab.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection [preservative free]:
Veopoz: Pozelimab-bbfg 400 mg/2 mL (2 mL) [contains polysorbate 80]
No
Solution (Veopoz Injection)
400 mg/2 mL (per mL): $20,769.23
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Prior to infusion, allow the diluted solution to warm to room temperature if refrigerated. Infuse through IV line that contains a 0.2- to 5-micron filter over a minimum of 1 hour; infusion rate should not exceed 1 g/hour. Do not administer other medications through the same IV line.
SUBQ: Administer dose into the abdomen, thigh, or upper arm. Rotate injection sites; do not administer into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact. Doses >400 mg should be separated into 2 injections administered at different sites.
Parenteral:
IV infusion (loading dose only): Infuse IV through a 0.2- to 5-micron filter over at least 1 hour; maximum rate: 1,000 mg/hour. If stored in refrigerator, allow to reach room temperature prior to administration. Infusion should be completed within 8 hours of preparation if not refrigerated or 24 hours if refrigerated after preparation. Observe patient for 30 minutes following infusion completion.
Subcutaneous injection (maintenance doses): Administer SUBQ into abdomen, thigh, or upper arm. Rotate injection sites and avoid injecting into moles, scars, or areas that are tender, bruised, red, scaly, hard, or not intact. If multiple injections are required for a single dose (ie, doses >400 mg), administer each injection at a different injection site. Observe patient for 30 minutes after completion of first SUBQ injection.
Missed maintenance dose: If it has been ≤3 days since dose was missed, administer as soon as possible, then resume regular once-weekly schedule. If >3 days since missed dose, skip dose and administer next dose on regularly scheduled day. Do not administer 2 doses on the same day. The day of weekly dose can change as long as there are ≥4 days (96 hours) between doses.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Veopoz: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761339s000lbl.pdf#page=16
CD55-deficient protein-losing enteropathy: Treatment of CD55-deficient protein-losing enteropathy, also known as CHAPLE disease, in adult and pediatric patients ≥1 year of age.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Crovalimab: Pozelimab may increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions may be increased. Pozelimab may decrease serum concentration of Crovalimab. Risk C: Monitor
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Immune Globulin: May decrease therapeutic effects of Pozelimab. Management: Avoid concurrent use of intravenous immunoglobulin with pozelimab. If the combination cannot be avoided, monitor for evidence of a diminished effect of pozelimab and worsening underlying disease. Risk D: Consider Therapy Modification
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Adverse events were not observed in animal reproduction studies.
Pozelimab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
It is not known if pozelimab is present in breast milk.
Pozelimab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Observe patient for 30 minutes after completion of IV infusion and first SUBQ dose for signs/symptoms of hypersensitivity. Monitor for signs and symptoms of infections at baseline and periodically during therapy; gonorrhea testing should be conducted in patients considered at risk for infection.
Pozelimab-bbfg is a human, monoclonal immunoglobulin G4P (IgG4P ) 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).
Distribution: Vd: 3.3 L (following 30 mg/kg IV); 8.6 L (following 600 mg SUBQ).
Metabolism: Degraded into small particles and amino acids through catabolic pathways similar to endogenous IgG.
Bioavailability: 51% (following 600 mg SUBQ).
Half-life elimination: 13.5 days (following 30 mg/kg IV); 14.1 days (following 600 mg SUBQ).
Time to peak: 7 days.
