pozelimab (Rx)

Brand and Other Names:Veopoz, pozelimab-bbfg

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 200mg/mL (2-mL single-dose vial)

CHAPLE Disease

Indicated for CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease, in adults and pediatric patients aged ≥1 year

Loading dose

  • Day 1: 30 mg/kg IV infusion after dilution x 1 dose  

Maintenance dose

  • Day 8 and thereafter: 10 mg/kg SC qWeek
  • May be increased to 12 mg/kg qWeek (not to exceed 800 mg qWeek) if there is inadequate clinical response after at least 3 weekly doses (ie, starting from Week 4)
  • Doses >400 mg require 2 injections

Dosage Modifications

Renal or hepatic impairment

  • Not likely to undergo renal or hepatic excretion

Dosing Considerations

Vaccination and prophylaxis for meningococcal infection

  • Before first dose
    • Vaccinate for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor at least 2 weeks before administering the first dose
    • If urgent therapy is needed and patient is not up-to-date with vaccines for both MenACWY and MenB according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide antibacterial drug prophylaxis
    • Efficacy, duration, and drug regimens for antibacterial drug prophylaxis not studied in patients receiving complement inhibitors

Dosage Forms & Strengths

injectable solution

  • 200mg/mL (2-mL single-dose vial)

CHAPLE Disease

Indicated for CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease, in adults and pediatric patients aged ≥1 year

<1 year: Safety and effectiveness not established

≥1 year

  • Loading dose
    • Day 1: 30 mg/kg IV infusion after dilution x 1 dose  
  • Maintenance dose
    • Day 8 and thereafter: 10 mg/kg SC qWeek
    • May be increased to 12 mg/kg qWeek (not to exceed 800 mg qWeek) if there is inadequate clinical response after at least 3 weekly doses (ie, starting from Week 4)
    • Doses >400 mg require 2 injections

Dosage Modifications

Renal or hepatic impairment

  • Not likely to undergo renal or hepatic excretion

Dosing Considerations

Vaccination and prophylaxis for meningococcal infection

  • Before first dose
    • Vaccinate for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor at least 2 weeks before administering the first dose
    • If urgent therapy is needed and patient is not up-to-date with vaccines for both MenACWY and MenB according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide antibacterial drug prophylaxis
    • Efficacy, duration, and drug regimens for antibacterial drug prophylaxis not studied in patients receiving complement inhibitors
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Interactions

Interaction Checker

and pozelimab

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (4)

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. Coadministration of Fc receptor antagonists with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              • efgartigimod/hyaluronidase SC

                efgartigimod/hyaluronidase SC will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. Coadministration of Fc receptor antagonists with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              • immune globulin IV (IGIV)

                immune globulin IV (IGIV) will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. IV immunoglobulin may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as pozelimab, and thereby decrease serum pozelimab concentrations. If use is avoidable, monitor for worsening of clinical signs and symptoms of CHAPLE disease.

              • rozanolixizumab

                rozanolixizumab will decrease the level or effect of pozelimab by receptor binding competition. Avoid or Use Alternate Drug. Coadministration of Fc receptor antagonists with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  Upper respiratory tract infection (30%)

                  Fracture (30%)

                  Urticaria (20%)

                  Alopecia (20%)

                  Frequency Not Defined

                  Injection site reactions (including dermatitis and erythema)

                  Metabolic acidosis

                  Gingival bleeding

                  Increased blood uric acid

                  Increased liver enzymes

                  Hematuria

                  Proteinuria

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                  Warnings

                  Black Box Warnings

                  Serious meningococcal infections

                  • Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors
                  • Meningococcal infection may rapidly develop into life-threatening or fatal infection if not recognized and treated early
                  • Complete or update meningococcal vaccination (for serogroups A, C, W, and Y [MenACWY], and serogroup B [MenB]) at least 2 weeks before administering first dose, unless risks of delaying therapy outweigh risks of developing meningococcal infection
                  • Follow current ACIP recommendations for meningococcal vaccination in patients receiving a complement inhibitor
                  • Treated patients may be at increased risk for invasive disease caused by N. meningitidis, even if antibodies develop following vaccination
                  • Monitor for early signs of meningococcal infections and evaluate immediately if infection is suspected

                  Contraindications

                  Unresolved Neisseria meningitidis infection

                  Cautions

                  and 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 (see Black Box Warnings)

                  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 transition between complement inhibitors, resulting in transient 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 infection is resolved
                  • Counsel patients about gonorrhea 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 disease
                    • IV immunoglobulins may decrease pozelimab concentrations; avoid concomitant use
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                  Pregnancy & Lactation

                  Pregnancy

                  There are no data on pozelimab use in pregnant females 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

                  Animal data

                  • No adverse effects were observed on maintenance of pregnancy, pregnancy outcome, or on the developing offspring through postnatal day 90 at doses up to 3.3-3.8x the predicted clinical exposures

                  Lactation

                  There are no data on the presence of pozelimab in either human or animal milk, the effects on breastfed infants, or 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

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Monoclonal immunoglobulin G4P (IgG4P) antibody directed against terminal complement protein C5

                  C5 inhibits terminal complement activation by blocking cleavage of C5 into C5a (anaphylatoxin) and C5b, thereby blocking formation of the membrane-attack complex (C5b-C9, a structure mediating cell lysis)

                  Absorption

                  Bioavailability: 51%

                  Trough concentration: 180 mg/L (Week 1)

                  Peak plasma time: 7 days (post 300-mg or 600-mg SC dose)

                  Steady-state reached at ~20 weeks following SC injection qWeek in CD55-deficient PLE patients

                  Distribution

                  Vd

                  • IV: 3.3 L
                  • SC: 6-8.6 L

                  Metabolism

                  Expected to degrade into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG

                  Elimination

                  Half-life

                  • IV: 13.5 days
                  • SC: 14.1 days
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                  Administration

                  IV Compatibilities for Loading Dose

                  0.9% NaCl

                  Dextrose 5% (D5W)

                  Preparation

                  Remove vial(s) from refrigerator and recalibrate to room temperature 20-25ºC (68-77ºF) for at least 45 minutes before use

                  Visually inspect vial(s) for particulate matter and discoloration before administering; solution is clear to slightly opalescent, colorless to pale yellow solution; discard vial if solution is cloudy, discolored, or contains particulate matter

                  Gently swirl vial(s) in an upright position; do not shake vial(s) to avoid foaming

                  Use a 21-gauge stainless steel needle with Luer-Lok to withdraw the calculated volume from vial(s); discard any unused product remaining in the vial(s)

                  • IV preparation for loading dose

                    • Dilute in an IV infusion bag of 25-250 mL of either 0.9% NaCl or D5W to a final concentration of 6.7-20 mg/mL
                    • Mix diluted solution by gentle inversion; do not shake
                  • SC preparation for maintenance dose

                    • For dose >400 mg, prepare 2 separate injections for SC administration of total dose volume
                    • Change needle on syringe to an injection needle fulfilling the following criteria: 25- to 27-gauge and ½ or 5/8-inch stainless steel needle with Luer-Lok

                  IV Administration for Loading Dose

                  Infuse through an IV line containing a sterile, in-line or add on 0.2-micron to 5-micron filter

                  Infusion rate: Infuse over minimum of 1 hr; do not exceed 1000 mg/hr

                  Do not coadminister other medications through same IV line

                  Observe patient for 30 min once infusion completed

                  SC Administration for Maintenance Dose

                  Inject into abdomen, thigh, or upper arm

                  Rotate sites; do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact

                  When administering >1 injection, administer consecutively, each at different injection sites

                  Observe patient for 30 mins after completing the first SC injection

                  Missed SC dose

                  • Missed dose 3 days: Administer as soon as possible; do not double dose on the same day to make up for missed dose
                  • Missed dose >3 days: Skip missed dose and administer next dose on the regularly scheduled day
                  • In each case, patients may resume once-weekly dosing schedule
                  • Day of weekly administration can be changed, if necessary, as long as the time between 2 doses is at least 4 days (96 hours)

                  Storage

                  Unopened vials

                  • Refrigerate at 2-8ºC (36-46ºF) in the original carton to protect from light
                  • Do not freeze; do not shake
                  • Discard unused portion

                  Diluted IV solution for loading dose

                  • If not used immediately, store at room temperature up to 25ºC (77ºF) for 8 hr or refrigerate at 2-8Cº (36-46ºF) for 24 hr from time of preparation to end of infusion
                  • If refrigerated, allow diluted solution to come to room temperature before administering
                  • Discard unused diluted solution after 8 hr if stored at room temperature or after 24 hr if refrigerated
                  • Do not freeze diluted solution

                  Prepared SC injection

                  • Use within 4 hr of preparation
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.