IDACIO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IDACIO (IDACIO).
IDACIO is a biosimilar to adalimumab, a recombinant human IgG1 monoclonal antibody that binds specifically to tumor necrosis factor-alpha (TNF-alpha) and blocks its interaction with p55 and p75 cell surface TNF receptors. This neutralizes the pro-inflammatory effects of TNF-alpha, including cytokine release, adhesion molecule expression, and immune cell activation.
| Metabolism | IDACIO undergoes catabolism via peptide hydrolysis and amino acid recycling; no specific metabolic enzymes are involved. |
| Excretion | Primarily degraded to amino acids via catabolic pathways; renal excretion of intact drug is negligible (<1%). No significant biliary or fecal elimination of active drug. |
| Half-life | Terminal elimination half-life is approximately 11-17 days (mean 14 days). Supports every-other-week dosing for maintenance of therapeutic concentrations. |
| Protein binding | Approximately 80% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is about 6–8 L, indicating limited extravascular distribution (approximates plasma volume plus interstitial fluid). |
| Bioavailability | Subcutaneous bioavailability is approximately 58% (range 50–75%) relative to intravenous administration. |
| Onset of Action | Onset of clinical effect (e.g., reduction in RA symptoms) typically occurs within 2–12 weeks after initiation of subcutaneous administration. |
| Duration of Action | Duration of therapeutic effect is sustained for the dosing interval (2 weeks) with regular administration; after discontinuation, effect may persist for several months due to long half-life. |
40 mg subcutaneously once weekly. If methotrexate is not tolerated, monotherapy may be considered.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Insufficient data for severe renal impairment (CrCl <30 mL/min); use with caution. |
| Liver impairment | No formal studies; caution in Child-Pugh Class B or C. No specific dose recommendation available. Monitor liver function. |
| Pediatric use | For juvenile idiopathic arthritis: 40 mg (if ≥30 kg) or 20 mg (if 10 to <30 kg) subcutaneously every 2 weeks. For polyarticular juvenile idiopathic arthritis: 40 mg (if ≥30 kg) or 20 mg (if 10 to <30 kg) subcutaneously every 2 weeks. |
| Geriatric use | No specific dose adjustment; higher incidence of infections and lower body weight may require monitoring. Use same dosing as adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IDACIO (IDACIO).
| Breastfeeding | Adalimumab is excreted into breast milk in low concentrations, with a reported milk-to-plasma (M/P) ratio of approximately 0.001-0.005, indicating minimal transfer. Oral bioavailability of adalimumab in infants is low due to gastrointestinal degradation. Therefore, breastfeeding is generally considered compatible during adalimumab therapy, but caution is advised if the infant is premature or immunosuppressed. No adverse effects in breastfed infants have been reported. |
| Teratogenic Risk | Idacio (adalimumab) is an IgG1 monoclonal antibody that crosses the placenta in increasing amounts during the second and third trimesters. First trimester exposure is associated with minimal transfer; however, second and third trimester exposure may result in fetal serum levels similar to maternal levels. There is no evidence of teratogenicity in human studies; adalimumab does not increase the risk of major malformations above baseline. Risk to the fetus from first trimester exposure is low. From second trimester onward, there is a risk of immunosuppression and increased infection susceptibility in the neonate. |
■ FDA Black Box Warning
WARNING: RISK OF SERIOUS INFECTIONS AND MALIGNANCY. Patients treated with IDACIO are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), invasive fungal infections, and other opportunistic infections. Malignancies, including lymphoma, have been reported in patients treated with TNF blockers.
| Serious Effects |
["Known hypersensitivity to adalimumab or any component of the product.","Active serious infections including sepsis and tuberculosis."]
| Precautions | ["Serious infections: do not start IDACIO during active infections; monitor for new infections.","Tuberculosis: test for latent TB before initiation; treat latent TB prior to therapy.","Invasive fungal infections: consider empiric antifungal therapy in patients at risk.","Hepatitis B reactivation: screen for HBV; if reactivation occurs, discontinue IDACIO.","Malignancy: risk of lymphoma and other malignancies; monitor patients.","Anaphylaxis or serious allergic reactions may occur.","Hematologic cytopenias including pancytopenia and aplastic anemia.","Demyelinating disease: new-onset or exacerbation of CNS demyelinating disorders.","Congestive heart failure: use caution in patients with preexisting CHF.","Autoimmunity: formation of autoantibodies; rarely lupus-like syndrome.","Vaccinations: avoid live vaccines during therapy."] |
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| Fetal Monitoring | During pregnancy, monitor for maternal infection due to immunosuppression. Fetal monitoring should include serial growth ultrasounds to assess for intrauterine growth restriction (IUGR) and assess amniotic fluid volume, as well as routine prenatal care. Postnatal monitoring of the neonate includes observation for infections and assessment of vaccine response; live vaccines (e.g., BCG, rotavirus) should be avoided for 5 months after last in utero exposure due to risk of disseminated infection. |
| Fertility Effects | Adalimumab is not known to impair fertility in males or females. In animal studies, no adverse effects on reproductive indices were observed. In humans, limited data suggest no significant impact on fertility. However, underlying inflammatory conditions (e.g., rheumatoid arthritis) may affect fertility, which can improve with disease control. |