Pozelimab Dosage

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Usual Adult Dose for CHAPLE Syndrome

Initial dose: Day 1: 30 mg/kg by intravenous infusion over a minimum of 1 hour
Maintenance dose: Day 8 and thereafter: 10 mg/kg subcutaneously once a week
Maximum dose: 800 mg once a week

Comments:

• According to Advisory Committee on Immunization Practices (ACIP) guidelines, meningococcal vaccination should be completed at least 2 weeks before administering the first dose of this drug.
• The maintenance dosage may be increased to 12 mg/kg once a week if there is insufficient clinical response after at least three weekly doses.
• Doses greater than 400 mg require two injections.
• Do not exceed the maximum infusion rate of 1000 mg/hour.
• Monitor for 30 minutes after completing the infusion.
• This drug has not been studied in the geriatric population.

Use: For the treatment of adult patients with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

Usual Pediatric Dose for CHAPLE Syndrome

1 year or older:
Initial dose: Day 1: 30 mg/kg by intravenous infusion over a minimum of 1 hour
Maintenance dose: Day 8 and thereafter: 10 mg/kg subcutaneously once a week
Maximum dose: 800 mg once a week

Comments:

• According to ACIP guidelines, meningococcal vaccination should be completed at least 2 weeks before administering the first dose of this drug.
• The maintenance dosage may be increased to 12 mg/kg once a week if there is insufficient clinical response after at least three weekly doses.
• Doses greater than 400 mg require two injections.
• Do not exceed the maximum infusion rate of 1000 mg/hour.
• Monitor for 30 minutes after completing the infusion.

Use: For the treatment of pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• Serious meningococcal infections may occur in patients treated with this drug, which may be life-threatening or fatal if not recognized and treated early.
• Patients receiving this drug may develop invasive disease caused by Neisseria meningitidis, even if they develop antibodies after vaccination.

Recommendations:

• According to ACIP guidelines, meningococcal vaccination should be completed at least 2 weeks before administering the first dose of this drug, unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection.
• Monitor patients for signs of meningococcal infections and evaluate them immediately if infection is suspected.

CONTRAINDICATIONS:

• Unresolved Neisseria meningitidis infection

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer the diluted drug solution immediately after preparation.
• Doses greater than 400 mg require two injections.
• Infuse IV infusion through a sterile, in-line, or add-on 0.2-micron to 5-micron filter.
• Do not exceed the maximum infusion rate of 1000 mg/hour.
• Inject subcutaneous injection within 4 hours of preparation into the abdomen, thigh, or upper arm.
• Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
• Do not administer two doses on the same day to make up for a missed dose.
• If a subcutaneous maintenance dose is missed, administer it as soon as possible within 3 days.
• If more than 3 days have passed, skip the missed dose, and administer the next dose on the regularly scheduled day.

Storage requirements:
Vial:

• Store in a refrigerator at 2C to 8C (36F to 46F) in the original carton.
• Protect from light.
• Do not freeze.
• Do not shake.
• Discard unused portion.

Storage of diluted intravenous solution:

• Store at room temperature up to 25C (77F) for no more than 8 hours or refrigerate at 2C to 8C (36F to 46F) for no more than 24 hours from the time of preparation to the end of infusion.
• Do not freeze the diluted solution.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

Monitoring:
Nervous system: Meningococcal infections

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Carry patient safety card at all times.
• There is a risk of meningococcal and other bacterial infections with the use of this drug.
• Complete or update meningococcal vaccination at least 2 weeks prior to receiving the first dose of this drug.
• Revaccinate according to current ACIP recommendations for meningococcal vaccines during treatment with this drug.
• Vaccination may not prevent meningococcal infection.
• Seek immediate medical attention if any signs or symptoms of infection or systemic hypersensitivity reactions occur.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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