PYZCHIVA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PYZCHIVA (PYZCHIVA).
Biosimilar to infliximab; a chimeric monoclonal antibody that binds to human tumor necrosis factor alpha (TNFα), neutralizing its activity and reducing inflammation.
| Metabolism | Metabolism is not fully characterized; likely degraded via proteolysis into small peptides and amino acids. |
| Excretion | Primarily eliminated via the reticuloendothelial system; renal excretion of intact drug is negligible (<1%). Biliary/fecal excretion accounts for <5% as intact drug. |
| Half-life | Terminal elimination half-life approximately 21-25 days (mean 23 days), consistent with IgG1 monoclonal antibody clearance; supports monthly dosing. |
| Protein binding | Binds to human serum albumin and other plasma proteins; protein binding >99% (mainly to albumin). |
| Volume of Distribution | Approximately 4.5-6.0 L (central compartment), 0.06-0.08 L/kg (assuming 70 kg); indicates limited distribution primarily in vascular space. |
| Bioavailability | Subcutaneous: approximately 72-89% (mean 80%) relative to IV administration (IV data from similar monoclonal antibodies). |
| Onset of Action | Subcutaneous: clinical improvement observed within 4-8 weeks (psoriasis); intravenous: not applicable as only SC formulation available. |
| Duration of Action | Duration of therapeutic effect approximately 12-16 weeks after single dose; sustained with repeated monthly dosing. |
Intravenous infusion of 300 mg over 60 minutes on days 1, 15, and 29, then every 4 weeks thereafter.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment recommended for renal impairment; safety and efficacy not established in severe renal impairment (eGFR <30 mL/min/1.73 m2). |
| Liver impairment | No formal studies in hepatic impairment; dose adjustment not recommended; caution in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Weight-based dosing: <60 kg: 15 mg/kg intravenously on days 1, 15, and 29, then every 4 weeks; ≥60 kg: 300 mg intravenously on same schedule. |
| Geriatric use | No specific dose adjustment required; limited data in patients >75 years of age; monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PYZCHIVA (PYZCHIVA).
| Breastfeeding | Minimal transfer into breast milk; M/P ratio not established. Ustekinumab is a large protein likely degraded in infant gut. Weigh benefits against potential for infant immunosuppression. |
| Teratogenic Risk | No human data; animal studies show no teratogenic effects. PYZCHIVA (ustekinumab) is a monoclonal antibody that crosses the placenta in the third trimester. Theoretical risk of immunosuppression in the neonate if administered after 30 weeks gestation. No known structural teratogenicity. |
| Fetal Monitoring |
■ FDA Black Box Warning
Increased risk of serious infections, including tuberculosis (TB) and invasive fungal infections, which may lead to hospitalization or death. Malignancies, including lymphoma, have been reported in children and adolescents treated with TNF blockers.
| Serious Effects |
Known hypersensitivity to infliximab or any murine proteins; severe infections such as sepsis or opportunistic infections; moderate to severe heart failure (NYHA Class III/IV).
| Precautions | Serious infections, invasive fungal infections, hepatitis B reactivation, tuberculosis reactivation, hepatotoxicity, hematologic cytopenias, hypersensitivity reactions, demyelinating disease, heart failure exacerbation, lupus-like syndrome, malignancy risk. |
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| Monitor for maternal infections. Neonatal exposure after late third-trimester use: observe for live vaccine responses (avoid live vaccines in infant for 6 months). No specific fetal monitoring required. |
| Fertility Effects | No known adverse effects on fertility in animal studies; human data lacking. No impact on sperm or oocyte quality reported. |