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MedsAcross

Molecule

Pozelimab

Complement Inhibitor
Available on requestBiologicOrphanCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Pozelimab 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. MedsAcross supplies Pozelimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Complement Inhibitor, Complement Inhibitors
US FDA first approval
18 August 2023
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous, Subcutaneous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 0JJ21K6L2ICAS 2096328-94-6DrugBank DB15218Q121708361

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

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).

Source: US FDA prescribing information

Dosing overview

See the full prescribing information for meningococcal vaccine and prophylaxis recommendations prior to the first dose of VEOPOZ. Recommended Dosage: Day 1 (loading dose): Administer a single 30 mg/kg dose by intravenous infusion after dilution. 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. See full prescribing information for instructions on preparation and administration.

Source: US FDA prescribing information

Warnings and precautions

Boxed 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. Other Bacterial Infections: Interrupt treatment with VEOPOZ in patients who are undergoing treatment for a serious encapsulated bacterial infection until the infection is resolved. Systemic Hypersensitivity Reactions: Interrupt infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 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.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Meningococcal Infections Other Bacterial Infections Systemic Hypersensitivity Reactions Immune Complex Formation Most common adverse reactions (in two or more patients) are: upper respiratory tract infection, fracture, urticaria, and alopecia.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Pozelimab, sorted by availability.

MedicineManufacturerRegisterAvailability
Veopoz 400 mg/2 mL injectionIntravenous, subcutaneous Cold chainRegeneron PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 18 August 2023Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Pozelimab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Pozelimab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Pozelimab have?

The catalogue lists 1 brand names for Pozelimab, including Veopoz.

Is Pozelimab approved by the US FDA?

Yes. The US FDA first approved Pozelimab on 18 August 2023, according to Drugs@FDA.

Does Pozelimab need cold chain shipping?

At least one listed presentation of Pozelimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. VEOPOZ prescribing information (Regeneron Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 4 December 2025

Request Pozelimab for export supply

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