VEOPOZ

In healthy subjects, single intravenous infusions of VEOPOZ over approximately one hour resulted in dose proportional increases in mean C max , but greater than proportional increases in mean AUC inf (>16-fold) for total pozelimab concentrations in serum between 3 mg/kg and 30 mg/kg. The mean AUC inf increased by 3.5-fold between 10 mg/kg and 30 mg/kg. In healthy subjects, single subcutaneous injections of VEOPOZ resulted in approximately 1.5-fold increase in mean C max and 2.2-fold increase in ...

The efficacy and safety of VEOPOZ were evaluated in a single-arm study (NCT04209634) where outcomes were compared to pre-treatment data in patients with active CD55-deficient protein-losing enteropathy (PLE) who had hypoalbuminemia. Diagnosis was based on a clinical history of PLE and with a confirmed genotype of biallelic CD55 loss-of-function mutation. Active CD55-deficient PLE was defined as hypoalbuminemia (serum albumin concentration of ≤3.2 g/dL) with one or more of the following signs or symptoms within the last six months: abdominal pain, diarrhea, peripheral edema, or facial edema. Pa...

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Meningococcal Infections [see Warnings and Precautions (5.1) ] Other Bacterial Infections [see Warnings and Precautions (5.2) ] Systemic Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immune Complex Formation [see Warnings and Precautions (5.4) ] Most common adverse reactions (in two or more patients) are: upper respiratory tract infection, fracture, urticaria, and alopecia. ...

VEOPOZ is contraindicated in: Patients with unresolved Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . VEOPOZ is contraindicated in patients with unresolved Neisseria meningitidis infection. ( 4 )

Other Bacterial Infections : Interrupt treatment with VEOPOZ in patients who are undergoing treatment for a serious encapsulated bacterial infection until the infection is resolved. ( 5.2 ) Systemic Hypersensitivity Reactions : Interrupt infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. ( 5.3 ) Immune Complex Formation : Transition between other complement inhibitors has resulted in decreased drug concentrations and pos...

7 DRUG INTERACTIONS Intravenous Immunoglobulin : May decrease pozelimab concentrations; avoid concomitant use. If concomitant use cannot be avoided, monitor patients for worsening of clinical signs and symptoms of disease. ( 7.1 ) 7.1 Intravenous Immunoglobulin VEOPOZ has not been studied in combination with intravenous immunoglobulin. Intravenous immunoglobulin may interfere with the endosomal ne...