YUFLYMA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YUFLYMA (YUFLYMA).
Tumor necrosis factor (TNF) alpha blocker; a monoclonal antibody that binds to soluble and membrane-bound TNF-alpha, inhibiting its interaction with TNF receptors and reducing inflammatory responses.
| Metabolism | Not metabolized by hepatic enzymes; elimination via reticuloendothelial system and proteolytic degradation. |
| Excretion | Adalimumab is primarily degraded into small peptides and amino acids via catabolic pathways; renal excretion of intact antibody is negligible. No biliary or fecal elimination data available. |
| Half-life | Terminal elimination half-life approximately 10-20 days (mean 14 days), supporting every-other-week dosing intervals. |
| Protein binding | Adalimumab binds specifically to tumor necrosis factor-alpha; non-specific protein binding is negligible. It is an IgG1 monoclonal antibody, not bound to albumin or other plasma proteins. |
| Volume of Distribution | Volume of distribution approximately 4.7-6.0 L (0.06-0.09 L/kg for a 70 kg individual), indicating limited extravascular distribution, consistent with a large monoclonal antibody primarily confined to the vascular and interstitial spaces. |
| Bioavailability | Subcutaneous administration: absolute bioavailability 64% (range 50-80%) after a 40 mg dose. |
| Onset of Action | Subcutaneous administration: clinical improvement may be observed within 1-2 weeks in rheumatoid arthritis patients, with maximal response typically by 12 weeks. |
| Duration of Action | Duration of clinical effect persists for approximately 2-3 weeks after a single subcutaneous dose, consistent with dosing interval of every other week; continued therapy required for sustained suppression of inflammation. |
40 mg subcutaneously every 2 weeks; may increase to 40 mg weekly if inadequate response.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment; not studied in severe renal impairment (CrCl <30 mL/min). |
| Liver impairment | No formal studies; caution in Child-Pugh B or C due to limited data. |
| Pediatric use | For plaque psoriasis: 0.8 mg/kg (max 40 mg) subcutaneously at week 0, then 0.4 mg/kg (max 20 mg) every other week starting week 1. For juvenile idiopathic arthritis: weight ≥15 kg: 20 mg subcutaneously every other week; weight ≥30 kg: 40 mg subcutaneously every other week. |
| Geriatric use | No specific dose adjustment; consider age-related comorbidities and potential for increased infection risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for YUFLYMA (YUFLYMA).
| Breastfeeding | Adalimumab is excreted in breast milk in low concentrations. The M/P ratio for adalimumab is approximately 0.001–0.005. Systemic absorption in the infant is minimal due to poor oral bioavailability. However, caution is advised in premature infants or those with gastrointestinal mucosal immaturity. The benefits of breastfeeding should be weighed against the potential risk of immunosuppression in the infant. |
| Teratogenic Risk | YUFLYMA (adalimumab-atto) is a TNF-alpha inhibitor. Based on extensive data with adalimumab, exposure during pregnancy does not suggest a major risk of malformations. However, because TNF-alpha inhibitors are IgG1 antibodies and cross the placenta actively during the third trimester, newborns exposed in utero may have immunosuppression and increased risk of infection. There is a potential for increased risk of preterm birth and low birth weight. No specific teratogenic effects have been consistently identified. |
■ FDA Black Box Warning
WARNING: SERIOUS INFECTIONS – Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. Discontinue if serious infection develops. Test for latent TB before initiation; treat if positive.
| Serious Effects |
Hypersensitivity to adalimumab or any component; severe active infection (including sepsis); moderate to severe heart failure (NYHA class III/IV).
| Precautions | Serious infections, including TB; hepatitis B reactivation; malignancy risk (including lymphoma); congestive heart failure worsening; hypersensitivity reactions; hematologic reactions; demyelinating disease; hepatotoxicity; lupus-like syndrome; increased risk in pediatric patients with malignancy. |
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| Fetal Monitoring | Monitor for maternal infections throughout pregnancy. For infants exposed in utero during the third trimester, monitor for infections and avoid live vaccines (e.g., BCG, rotavirus) for at least 5-6 months after birth. Assess infant for any signs of immunosuppression. Consider fetal ultrasound for growth parameters if preterm birth risk is identified. |
| Fertility Effects | TNF-alpha inhibitors like adalimumab may be associated with improved fertility in women with inflammatory conditions (e.g., rheumatoid arthritis) by reducing disease activity. There is no evidence of adverse effects on fertility in males or females. Animal studies do not indicate impaired fertility. |