Pozelimab Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Applies to pozelimab: parenteral injection for iv or sub-q use.

Important warnings This medicine can cause some serious health issues

Serious Meningococcal Infections
• Life-threatening and fatal meningococcal infections reported in patients treated with complement inhibitors; such infections can become rapidly life-threatening or fatal if not recognized and treated early.¹

• Complete or update meningococcal vaccinations ≥2 weeks prior to administering first dose of pozelimab-bbfg, unless risks of delaying therapy outweigh those of developing meningococcal infection.¹ Follow the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor.¹

• Patients receiving pozelimab-bbfg at increased risk for invasive disease due to Neisseria meningitidis, even if they develop antibodies following vaccination.¹

• Monitor patients for early signs of meningococcal infections; evaluate immediately if infection suspected.¹

Side effects include:

Adverse effects reported in ≥2 patients include upper respiratory tract infection, fracture, urticaria, alopecia.

For healthcare professionals

Applies to pozelimab: injectable solution.

General adverse events

Most common adverse reactions were upper respiratory tract infection, fracture, urticaria, and alopecia.^[Ref]

Cardiovascular

• Frequency not reported: Elevated systolic blood pressure, elevated diastolic blood pressure^[Ref]

Dermatologic

• Very common (10% or more): Urticaria (20%), alopecia (20%)^[Ref]

Gastrointestinal

• Frequency not reported: Gingival bleeding^[Ref]

Hypersensitivity

• Frequency not reported: Systemic hypersensitivity reactions, immune complex formation^[Ref]

Local

• Frequency not reported: Injection site reactions (included dermatitis and erythema)^[Ref]

Metabolic

• Frequency not reported: Metabolic acidosis, increased blood uric acid^[Ref]

Musculoskeletal

• Very common (10% or more): Fracture (30%)^[Ref]

Nervous system

• Frequency not reported: Serious meningococcal infections^[Ref]

Other

• Frequency not reported: Bacterial infections^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (30%)^[Ref]

Genitourinary

• Frequency not reported: Hematuria, proteinuria^[Ref]

Hepatic

• Frequency not reported: Increased liver enzymes^[Ref]

Further information

Pozelimab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer