Veopoz (pozelimab-bbfg)
Complement Inhibitors Injection Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pozelimab-bbfg, a recombinant monoclonal immunoglobulin G4 (IgG4) antibody, is a complement inhibitor directed against the terminal complement protein C5.
Pozelimab-bbfg is a human monoclonal immunoglobulin G4P (IgG4P) antibody directed against the terminal complement protein C5. Pozelimab inhibits terminal complement activation by blocking cleavage of C5 into C5a (anaphylatoxin) and C5b, which blocks the formation of the membrane-attack complex known as C5b-C9, which mediates cell lysis.
Following a single IV infusion of pozelimab-bbfg (administered over approximately 1 hour) in healthy patients, peak plasma concentrations exhibit dose-proportional increases; however, increases in mean AUC are greater than dose proportional (>16-fold) for total pozelimab serum concentrations between 3-30 mg/kg. The mean exposure (based on AUC) of pozelimab-bbfg increased by 3.5-fold with doses between 10-30 mg/kg. Single subcutaneous doses in healthy patients resulted in approximately a 1.5-fold increase in mean peak plasma concentrations and a 2.2-fold increase in mean AUC between doses of 300-600 mg.
Following the subcutaneous injection of pozelimab-bbfg 600 mg in healthy patients, the estimated bioavailability of the drug is 51%. Peak plasma concentrations of pozelimab-bbfg are attained at a median of 7 (range: 3-7) days following a single subcutaneous injection of 300 mg or 600 mg in healthy patients. In patients with CD55-deficient protein-losing enteropathy, steady state concentrations of pozelimab-bbfg are attained after approximately 20 weeks following once weekly subcutaneous injection.
Pozelimab-bbfg is expected to undergo degradation into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. Pozelimab-bbfg is eliminated via linear and non-linear pathways. Pozelimab-bbfg is mainly eliminated via linear non-saturable proteolytic pathways at higher concentrations, and predominantly through non-linear saturable C5 target-mediated pathways at lower concentrations.
Following administration of a single 30 mg/kg dose of pozelimab-bbfg via IV infusion in healthy patients, the median elimination half-life is 13.5 (range: 10-17.2) days. The median elimination half-life of a single 600 mg subcutaneous injection is 14.1 (range: 8.6-17.3) days. The pharmacokinetics of pozelimab-bbfg are significantly affected by body weight.
Generic name: pozelimab-bbfg
Drug class: Complement Inhibitors
Therapeutic class: Gastrointestinal Therapy Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Veopoz
Indications
The following indications are listed for Veopoz:
- Complement Hyperactivation Angiopathic Thrombosis Protein Losing Enteropathy
Also known as: Cd55-Deficient Protein-Losing Enteropathy, Chaple Disease.
Dosing
Both IV infusion and subcutaneous injections are required for complete dosing of pozelimab-bbfg.
Administer the loading dose of pozelimab-bbfg by IV infusion (after dilution); administer subsequent maintenance doses by subcutaneous injection.
The loading dose of pozelimab-bbfg must be diluted before use. Doses (both IV and subcutaneous) must be prepared and administered by a healthcare provider.
If a subcutaneous maintenance dose is missed, administer the dose as soon as possible within 3 days of the missed dose. If more than 3 days have passed since the missed dose, skip the missed dose and resume the usual dosing schedule; do not administer 2 doses on the same day to make up for a missed dose. In each case, patients can resume their regular once weekly dosing schedule. The weekly administration day may be adjusted if necessary, as long as a minimum of 4 days (96 hours) elapses between doses.
Pozelimab-bbfg is available as single-dose vials containing 200 mg/mL. Store the vials refrigerated at 2-8degreesC in the original carton to protect from light. Do not freeze or shake.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Veopoz 400 Mg/2 Ml Vial | Maintenance | Inject 10 mg/kg (not to exceed 800 mg) by subcutaneous route once weekly. |
No dosing information is available for this tab.
Drug interactions
Formal drug interaction studies have not been conducted with pozelimab-bbfg.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Pozelimab/Intravenous Immunoglobulin
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Pozelimab is an IgG4P antibody. Concurrent use of intravenous immunoglobulin which binds to FcRn may interfere with the FcRn recycling mechanism of pozelimab and decrease systemic exposure of pozelimab.(3)
CLINICAL EFFECTS: The levels and effectiveness of pozelimab may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of pozelimab states that concomitant use of intravenous immunoglobulin should avoided with pozelimab. If concomitant use cannot be avoided, monitor patients for worsening signs and symptoms of CD55-deficient protein-losing enteropathy.(3)
DISCUSSION: Clinical drug interaction studies with pozelimab have not been performed. Immunoglobulins may interfere with the endosomal FcRn recycling mechanism of monoclonal antibodies like pozelimab and decrease concentrations of pozelimab.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
*Unresolved Neisseria meningitidis infection.
There are no contraindication contraindications for this drug.
- Bacterial infection
- Meningococcal meningitis
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in >=2 patients receiving pozelimab-bbfg in clinical studies include upper respiratory tract infection, fracture, urticaria, and alopecia.
More Frequent
- Upper respiratory infection
Less Frequent
- Abnormal hepatic function tests
- Anaphylaxis
- Bacterial infection
- Hematuria
- Meningococcemia
More Frequent
- Alopecia
- Fracture
- Urticaria
Less Frequent
- Gingival bleeding
- Hyperuricemia
- Injection site sequelae
- Metabolic acidosis
- Proteinuria
Precautions
No enhanced messaging available.
Safety and effectiveness of pozelimab-bbfg for the treatment of CD55-deficient PLE are established in pediatric patients >=1 year of age. Use of pozelimab-bbfg for the treatment of CD55-deficient PLE is supported by a single-arm study in 10 pediatric patients 3-19 years of age with active disease.
Safety and effectiveness of pozelimab-bbfg are not established in pediatric patients <1 year of age.
No data are available on pozelimab-bbfg use during pregnancy 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.
A pre- and postnatal development study in pregnant monkeys evaluated subcutaneous administration of pozelimab-bbfg at doses of 5 or 50 mg/kg once weekly started at confirmation of pregnancy (gestation day 20), and continued through parturition (approximately gestation day 160). At doses up to 3.3-3.8 times the predicted clinical exposure (based on AUC), no adverse effects were observed for pregnancy maintenance, pregnancy outcomes, or offspring development through postnatal day 90.
It is not known if pozelimab-bbfg is present in human or animal milk, although endogenous maternal immune globulin G and monoclonal antibodies are known to transfer into human milk. The effects on the breast-fed child or on milk production are not known. The effects of local GI exposure and the extent of systemic exposure to the breast-fed child are unknown.
Weigh the developmental and health benefits of breast-feeding with the mother's clinical need for pozelimab-bbfg and the potential for adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
The manufacturer states that pozelimab-bbfg has not been studied in geriatric patients.
Because CD55-deficient PLE is largely a pediatric disease, pozelimab-bbfg has not been studied in geriatric patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Complement hyperactivation angiopathic thrombosis protein losing enteropathy | ||
| D84.1 | ICD10CM | Defects in the complement system |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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