WAINUA (AUTOINJECTOR)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for WAINUA (AUTOINJECTOR) (WAINUA (AUTOINJECTOR)).
WAINUA (epcoritamab) is a bispecific CD3 T-cell engager antibody that binds to CD3 on T cells and CD20 on B cells, leading to T-cell-mediated lysis of CD20-expressing B cells.
| Metabolism | Epcoritamab is a monoclonal antibody; metabolism is expected to involve catabolic pathways into small peptides and amino acids. |
| Excretion | Primarily proteolytic degradation; negligible renal or biliary excretion of intact drug, <1% excreted unchanged in urine. |
| Half-life | Terminal elimination half-life approximately 26 days (range 22–30 days); supports monthly subcutaneous dosing. |
| Protein binding | ≥99% bound to human serum albumin; no significant binding to other plasma proteins. |
| Volume of Distribution | Approximately 0.27 L/kg (central volume), indicating limited extravascular distribution consistent with a large monoclonal antibody. |
| Bioavailability | Subcutaneous: Absolute bioavailability approximately 80% after injection into abdomen, thigh, or arm. |
| Onset of Action | Subcutaneous: Clinical effect (reduction in neuropathic pain) observed within 1 week; maximal effect by 4 weeks. |
| Duration of Action | Duration of action after single dose: sustained pain reduction for 4–6 weeks due to long half-life; repeated dosing maintains effect. |
| Molecular Weight | 146000 |
Subcutaneous administration of 300 mg every 4 weeks as maintenance therapy after a 300 mg intravenous loading dose on day 1 and day 15.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment is required for patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m²). The drug has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease. |
| Liver impairment | No dose adjustment is required for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. The drug has not been studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment is recommended for elderly patients. Clinical studies included patients aged 65 years and older; no overall differences in safety or efficacy were observed. |
| 1st trimester | No human data; animal studies insufficient. Use only if clearly needed. |
| 2nd trimester | No human data; animal studies insufficient. Use only if clearly needed. |
| 3rd trimester | No human data; animal studies insufficient. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for WAINUA (AUTOINJECTOR) (WAINUA (AUTOINJECTOR)).
| Placental transfer | IgG monoclonal antibodies cross placenta; extent unknown. |
| Breastfeeding | Excretion into human milk unknown; caution due to potential for infant immunosuppression. |
| Lactation Rating | L4 |
■ FDA Black Box Warning
WARNING: CYTOKINE RELEASE SYNDROME (CRS) AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS). Epcoritamab can cause serious or life-threatening CRS and ICANS. Administer epcoritamab in a setting with immediate access to tocilizumab and emergency equipment. Monitor patients for signs and symptoms of CRS and ICANS. Withhold or permanently discontinue epcoritamab based on severity.
| Serious Effects |
History of hypersensitivity to efgartigimod alfa or any excipient
| Precautions | Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenias, embryo-fetal toxicity. |
| Food/Dietary | No clinically relevant food interactions identified. WAINUA can be administered without regard to meals. |
Loading safety data…
| Teratogenic Risk | WAINUA (efgartigimod alfa) is an FcRn antagonist. No adequate human data on fetal risk; animal studies show no teratogenicity at supratherapeutic doses. Theoretical risk: IgG reduction may impair passive immunity transfer in third trimester. |
| Fetal Monitoring | Monitor maternal infections due to IgG reduction; assess fetal growth ultrasounds in third trimester if prolonged use; neonatal monitoring for humoral immunodeficiency (IgG levels) at birth. |
| Fertility Effects | No human fertility studies; animal studies show no impairment of male or female fertility at clinically relevant doses. |
| Clinical Pearls | WAINUA (autoinjector) delivers efgartigimod alfa, a neonatal Fc receptor (FcRn) antagonist. Administer subcutaneously in the abdomen or thigh. Rotate injection sites. Monitor for hypersensitivity reactions. Premedication not required. Use within 30 minutes of removal from refrigeration. Do not shake the autoinjector. In case of missed dose, administer as soon as possible and reset schedule. |
| Patient Advice | Store WAINUA in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. · Remove from refrigerator 30 minutes before injection to allow to reach room temperature; do not warm by any other method. · Do not freeze or shake the autoinjector. · Administer injection into the abdomen or thigh; rotate injection sites. · Seek immediate medical attention if signs of a serious allergic reaction occur (e.g., difficulty breathing, swelling of face or throat). · Common side effects include headache, nausea, and injection site reactions (pain, redness, swelling). · Inform healthcare provider if you have an active infection or are pregnant/breastfeeding. |