YUSIMRY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YUSIMRY (YUSIMRY).
YUSIMRY (adalimumab-adbm) is a tumor necrosis factor (TNF) blocker. It binds to TNF-alpha and neutralizes its activity, reducing inflammatory responses.
| Metabolism | Adalimumab-adbm is a monoclonal antibody; metabolism is via catabolic pathways to small peptides and amino acids. No involvement of CYP450 enzymes. |
| Excretion | Elimination occurs via reticuloendothelial system with catabolism into amino acids; no significant renal or biliary excretion of intact adalimumab. Mean renal excretion of adalimumab is <1% of dose as intact monoclonal antibody. |
| Half-life | Terminal elimination half-life ranges from 10 to 20 days (mean ~14 days) in adults; consistent with IgG1 monoclonal antibody clearance. Reduced half-life may be observed in patients with high tumor burden or concomitant methotrexate. |
| Protein binding | Adalimumab is a monoclonal antibody; specific protein binding is not applicable. It binds to soluble and membrane-bound TNF-α with high affinity (Kd ~0.1–1 nM). No significant binding to other plasma proteins. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 4.7–6.0 L (0.06–0.09 L/kg), indicating limited extravascular distribution consistent with a large monoclonal antibody primarily residing in the vascular space. |
| Bioavailability | Subcutaneous: Absolute bioavailability is estimated at 64% (range 50–80%) after a single 40 mg dose. Bioavailability is not reduced by injection site rotation or body mass index. |
| Onset of Action | Subcutaneous: Clinical improvement in rheumatoid arthritis symptoms may be observed as early as 1–2 weeks, with maximal effect typically seen by 12–24 weeks. |
| Duration of Action | Duration of clinical effect after single dose is approximately 4–8 weeks, correlating with serum concentrations; continued dosing required for sustained suppression of inflammatory activity. |
Subcutaneous: 200 mg every 2 weeks. For patients with body weight ≥100 kg, consider 200 mg every week. IV: 300 mg as a loading dose on day 1, then 200 mg every 2 weeks subcutaneously.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment is recommended based on GFR; use caution in severe renal impairment (CrCl <30 mL/min) due to limited data. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Use with caution; no specific recommendation. Child-Pugh Class C: Not recommended due to lack of data. |
| Pediatric use | Not approved for pediatric use; safety and efficacy in children under 18 years have not been established. |
| Geriatric use | No specific dose adjustment is required. Monitor for infections and adverse events more frequently due to age-related decline in immune function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for YUSIMRY (YUSIMRY).
| Breastfeeding | Adalimumab is excreted in human breast milk in low concentrations. M/P ratio not established. Pooled data indicate infant serum levels <1% of maternal levels. Limited data show no adverse effects in breastfed infants. Benefits of breastfeeding outweigh theoretical risk of immunosuppression. Caution in preterm neonates. |
| Teratogenic Risk | YUSIMRY (adalimumab-adaz) is a TNF-alpha inhibitor. Human data are limited; animal studies show no evidence of teratogenicity at doses up to 100 mg/kg. Monoclonal antibodies cross placenta primarily in third trimester, with fetal serum concentrations possibly exceeding maternal levels. Use in first and second trimesters likely poses minimal risk; third-trimester exposure may affect fetal immune response. Cases of adverse pregnancy outcomes reported but no consistent pattern. Risk cannot be excluded. |
■ FDA Black Box Warning
Increased risk of serious infections, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
| Serious Effects |
["Known hypersensitivity to adalimumab or any component of the formulation","Severe infections (e.g., sepsis, active tuberculosis)"]
| Precautions | ["Serious infections including TB, invasive fungal infections, and other opportunistic infections","Malignancies including lymphoma and leukemia","Hepatitis B virus reactivation","Demyelinating disease","Hematologic cytopenias","Congestive heart failure","Lupus-like syndrome","Vaccinations: avoid live vaccines","Hypersensitivity reactions"] |
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| Fetal Monitoring | Monitor for maternal infections; delay live vaccines in infant for 6 months after birth if maternal use in third trimester. No routine fetal monitoring specified. |
| Fertility Effects | No significant effects on fertility reported in animal studies. In humans, TNF inhibitors may improve fertility in women with inflammatory diseases by reducing disease activity. No evidence of impairment. |