VEOPOZ Dosage & Rx Info | Uses, Side Effects

Veopoz Generic Name & Formulations

Legal Class

General Description

Pozelimab-bbfg 200mg/mL; soln for SC or IV inj after dilution; preservative-free.

Pharmacological Class

Complement inhibitor.

How Supplied

Single-dose vial (2mL)—1

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. Discard unused portion.

Manufacturer

Regeneron

Generic Availability

Mechanism of Action

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).

Veopoz Indications

Indications

CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.

Veopoz Dosage and Administration

Prior to Treatment Evaluations

Vaccinate patients for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current ACIP recommendations for patients receiving complement inhibitor at least 2 weeks prior to the first dose of Veopoz.

If urgent Veopoz therapy is needed for a patient who is not up-to-date, administer meningococcal vaccine(s) as soon as possible and give antibacterial drug prophylaxis. The efficacy, duration, and drug regimens for antibacterial drug prophylaxis have not been studied in patients receiving complement inhibitors, including Veopoz.

Adults and Children

<1yr: not established. See full labeling. Loading dose (LD): give as IV infusion over a minimum of 1hr; max 1000mg/hr. Maintenance dose (MD): give as SC inj into abdomen, thigh, or upper arm. Rotate inj sites; use different inj sites if administering more than 1 inj consecutively. For LD and MD: monitor for 30mins after completion. ≥1yr (Day 1 [LD]): initially a single 30mg/kg IV infusion; (Day 8 and thereafter [MD]): 10mg/kg SC inj once weekly; may increase to 12mg/kg once weekly, starting from Week 4 if inadequate response. Max 800mg once weekly. Doses >400mg require 2 inj.

Administration

Instructions for Intravenous Infusion Loading Dose

Infuse via an IV line containing a sterile, in-line, or add on 0.2 micron to 5-micron filter.
Infuse over a minimum of 1 hour (maximum rate of 1000mg/hour).
Do not co-administer other medications via the same IV line.
Monitor the patient for 30 minutes after completing the infusion.
After dilution, give Veopoz immediately. If the diluted solution is not used immediately, store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the end of the infusion or refrigerate at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to the end of infusion. If the diluted solution is refrigerated, allow the solution to come to room temperature prior to administration.

Subcutaneous Maintenance Dose: Administration Instructions

Inject into the abdomen, thigh, or upper arm. Rotate sites. Avoid injecting Veopoz into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact. If administering more than 1 injection, administer consecutively each at different injection sites.
Monitor the patient for 30 minutes after completing the first subcutaneous injection.

Veopoz Contraindications

Contraindications

Unresolved Neisseria meningitidis infection.

Veopoz Boxed Warnings

Boxed Warning

Serious meningococcal infections.

Veopoz Warnings/Precautions

Warnings/Precautions

Increased risk for serious meningococcal infections (septicemia and/or meningitis). Vaccinate or revaccinate for meningococcal disease (at least 2 weeks prior to treatment initiation) according to current ACIP guidelines. If urgent pozelimab-bbfg therapy is indicated, vaccinate immediately and give antibacterial drug prophylaxis. Monitor closely for signs of meningococcal infection; evaluate immediately if infection is suspected. Risk for other infections (eg, due to N. meningitidis [including gonococcal], S. pneumoniae, H. influenza type b); give prophylactic vaccinations accordingly. Interrupt pozelimab-bbfg if undergoing treatment for serious infection (eg, meningococcal, encapsulated bacterial) until resolved. Discontinue and treat if systemic hypersensitivity reactions occur. Potential for immune complex formation (during transition between complement inhibitors). Elderly: not studied. Pregnancy. Nursing mothers.

Pregnancy Considerations

Risk Summary

There are no available data on the use of Veopoz in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Monoclonal antibodies can be actively transported across the placenta.

Nursing Mother Considerations

Risk Summary

There are no available data on the presence of pozelimab-bbfg in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
Consider the development and health benefits of breastfeeding along with the mother’s clinical need for Veopoz and any potential adverse effects on the breastfed infant from Veopoz or from the underlying maternal condition.

Pediatric Considerations

Safety and efficacy have not been established in pediatric patients less than 1 year of age.

Geriatric Considerations

Veopoz has not been studied in the geriatric population.

Veopoz Pharmacokinetics

Absorption

Median (range) time to reach peak concentration: 7 (3–7) days.

Bioavailability: ~51%.

Distribution

Mean (SD) volume of distribution: 3.3 (0.4) L.

Mean (SD) apparent volume of distribution: 6.0 (0.9) L after 300mg SC; 8.6 (2.7) L after 600mg SC.

Metabolism

Catabolic pathways.

Elimination

Median (range) terminal half-life: 13.5 (10.0, 17.2) days after IV infusion; 14.1 (8.6, 17.3) days after SC inj.

Veopoz Interactions

Interactions

Avoid concomitant IV immunoglobulin; if unavoidable, monitor for signs/symptoms of worsening disease.

Veopoz Adverse Reactions

Adverse Reactions

Upper respiratory tract infection, fracture, urticaria, alopecia; meningococcal infection (may be fatal), systemic hypersensitivity reactions.

Veopoz Clinical Trials

Clinical Trials

The approval was based on data from an open-label phase 2/3 trial (ClinicalTrials.gov Identifier: NCT04209634), which evaluated the efficacy and safety of pozelimab in 10 patients (median age, 8.5 years) with CHAPLE disease. At baseline, mean serum albumin concentration was 2.2g/dL (range, 1.1-2.9g/dL).

Patients received a single loading dose of pozelimab 30mg/kg intravenously on day 1, followed by weight-based doses subcutaneously weekly. The primary endpoint of the study was the proportion of patients with active disease at baseline achieving both normalization of serum albumin and clinical outcome improvement.

Results showed all 10 patients achieved normalization of serum albumin at 12 weeks and maintained serum albumin concentrations within the normal range through at least 72 weeks of treatment. The median time for serum albumin to reach at least 3.5g/dL was reported to be 15.5 days (95% CI, 8-28).

Pozelimab was also associated with reductions in the total number of albumin transfusions and hospitalization days. In the 48 weeks prior to treatment, 5 of the 10 patients received a total of 60 albumin transfusions and 9 of the 10 were hospitalized for a total of 268 days. In the 48 weeks after starting treatment, 1 patient received 1 transfusion and 2 patients were hospitalized for a total of 7 days.

Findings also demonstrated that within the first 12 weeks, all patients reached normal serum IgG concentrations for age. This improvement was maintained through at least 72 weeks of treatment.

Veopoz Note

Not Applicable

Veopoz Patient Counseling

Patient Counseling

Meningococcal Infection

Advise patients of the risk for meningococcal, and other bacterial infections. Complete or update meningococcal vaccination for both MenACWY and MenB at least 2 weeks prior to receiving the first dose of Veopoz and to be revaccinated according to current ACIP recommendations.
Vaccination may not prevent meningococcal infection. Seek medical attention if any signs or symptoms of meningococcal infection occur.

Other Bacterial Infections, Including Gonococcal Infection

Advise patients of the increased risk for other bacterial infections, especially those due to encapsulated bacteria.
Advise patients of the need to receive vaccinations according to ACIP recommendations.
Report any new signs and symptoms of infection. Counsel patients about gonorrhea prevention and seek regular testing.

Systemic Hypersensitivity Reactions

Seek immediate medical attention if any symptoms of systemic hypersensitivity reactions occur.

Cost Savings Program

myRARE Patient Support

Veopoz

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