Pozelimab Dosage

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

Applies to the following strengths: bbfg 200 mg/mL

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.