Pozelimab

Pozelimab is a prescription medication indicated for the treatment of CD55-deficient protein-losing enteropathy, also known as CHAPLE disease in adult and pediatric patients aged 1 year and older

• Pozelimab is available under the following different brand names: Veopoz, pozelimab-bbfg.

Common side effects of Pozelimab include:

• upper respiratory tract infection 
• fracture 
• raised, red patches of skin that are often very itchy (hives)
• hair loss (alopecia)

Serious side effects of Pozelimab include:

• allergic (hypersensitivity) reactions include- chest pain, swelling of the face, tongue, or throat, trouble breathing, shortness of breath, feeling faint or passing out 

Rare side effects of Pozelimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 200 mg/mL (2-mL single-dose vial)

CHAPLE disease

Adult dosage

• Loading dose
  • Day 1: 30 mg/kg IV infusion after dilution x 1 dose  
• Maintenance dose
  • Day 8 and thereafter: 10 mg/kg SC every week
  • May be increased to 12 mg/kg every week (not to exceed 800 mg every week) if there is an inadequate clinical response after at least 3 weekly doses (ie, starting from week 4)
  • Doses more than 400 mg require 2 injections
• Pediatric dosage
• Children younger than 1 year: Safety and effectiveness not established
• Children aged 1 year and older
  • Loading dose
    • Day 1: 30 mg/kg IV infusion after dilution × 1 dose  
  • Maintenance dose
    • Day 8 and thereafter: 10 mg/kg SC every week
    • May be increased to 12 mg/kg every week (not to exceed 800 mg every week) if there is an inadequate clinical response after at least 3 weekly doses (ie, starting from week 4)
    • Doses more than 400 mg require 2 injections

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pozelimab has severe interactions with no other drugs
• Pozelimab has serious interactions with the following drugs:
  • efgartigimod alfa
  • efgartigimod/hyaluronidase SC
  • immune globulin IV (IGIV)
  • rozanolixizumab
• Pozelimab has moderate interactions with no other drugs
• Pozelimab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Unresolved Neisseria meningitidis infection

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pozelimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pozelimab?”

Cautions

• Unvaccinated patients treated with complement inhibitors; use increases susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including non-groupable strains
• Hypersensitivity reactions, including anaphylaxis, reported; interrupt and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur
• Immune complex formation reported during the transition between complement inhibitors, resulting in transiently decreased drug concentrations and possible hypersensitivity reactions; consider this potential if switching complement inhibitors
• Other bacterial infections
  • Pozelimab blocks terminal complement activation
  • May increase susceptibility to encapsulated bacterial infections, especially caused by Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae (lesser extent)
  • Vaccinate against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to ACIP guidelines
  • Therapy may cause an increased risk for infections due to these organisms, even if antibodies were developed following vaccination
  • Interrupt treatment in patients who are undergoing treatment for a serious encapsulated bacterial infection until the infection is resolved
  • Counsel patients about gonorrhoea prevention and advise regular testing for patients at risk
• Drug interaction overview
  • IV immunoglobulin
    • Avoid coadministration; if unavoidable, monitor for worsening of clinical signs and symptoms of a disease
    • IV immunoglobulins may decrease Pozelimab concentrations; avoid concomitant use

Pregnancy and Lactation

• There are no data on pozelimab use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• However, monoclonal antibodies can be actively transported across the placenta
• Lactation
  • There are no data on the presence of pozelimab in either human or animal milk, the effects on breastfed infants, or the effects on milk production
  • Endogenous maternal IgG and monoclonal antibodies are transferred into human milk
  • Effects of local gastrointestinal exposure and the extent of systemic exposure in breastfed infants to pozelimab are unknown