ABRILADA
Clinical safety rating
cautionComprehensive clinical and safety monograph for ABRILADA (ABRILADA).
Comprehensive clinical and safety monograph for ABRILADA (ABRILADA).
Rheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAnkylosing spondylitisCrohn's diseaseUlcerative colitisPlaque psoriasisHidradenitis suppurativaUveitis
Adalimumab is a recombinant human IgG1 monoclonal antibody that binds specifically to tumor necrosis factor alpha (TNFα) and neutralizes its biological activity by blocking its interaction with p55 and p75 cell surface TNF receptors. It also modulates biological responses induced or regulated by TNFα, including changes in adhesion molecules, chemotaxis, and apoptosis.
| Metabolism | Adalimumab is a monoclonal antibody that is metabolized via catabolism into peptides and amino acids. CYP450 enzymes are not involved. No active metabolites. |
| Excretion | Primarily degraded into amino acids and recycled or excreted in urine (less than 1% unchanged); no significant biliary/fecal elimination. |
| Half-life | Terminal elimination half-life approximately 10–14 days in adults, supporting every-other-week dosing; may be shorter in pediatric patients. |
| Protein binding | Approximately 95% bound to serum proteins, primarily alpha-1-acid glycoprotein and albumin. |
| Volume of Distribution | Approximately 4.7–6.0 L/kg, indicating extensive distribution into tissues consistent with a monoclonal antibody. |
| Bioavailability | Subcutaneous: approximately 64% (range 50–80%) absolute bioavailability relative to intravenous administration. |
| Onset of Action | Subcutaneous: clinical improvement may be observed within 1–2 weeks; full benefit often by 12 weeks. |
| Duration of Action | Effects persist for 2–4 weeks post-dose; drug levels remain above therapeutic threshold for approximately 28 days after a single dose. |
| Molecular Weight | 144000 |
80 mg subcutaneously every other week. For patients weighing ≥100 kg, 80 mg every week.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Not studied in severe renal impairment (CrCl <30 mL/min) or ESRD; use with caution. |
| Liver impairment | No formal studies in hepatic impairment. Use with caution in moderate to severe impairment (Child-Pugh B or C) due to limited data. |
| Pediatric use | Approved for pediatric plaque psoriasis (≥12 years): 80 mg subcutaneously every other week. For pediatric psoriatic arthritis (≥12 years): 80 mg subcutaneously every other week. For pediatric hidradenitis suppurativa (≥12 years, ≥60 kg): 160 mg on day 1, then 80 mg every other week. Pediatric Crohn's disease (≥6 years, ≥40 kg): 160 mg on day 1, then 80 mg on day 15, then 80 mg every other week; for <40 kg: 80 mg on day 1, then 40 mg on day 15, then 40 mg every other week. |
| Geriatric use | No specific dose adjustment required; but monitor for infections in patients ≥65 years due to increased risk. |
| 1st trimester | Adalimumab (ABRILADA is a biosimilar) crosses placenta; limited human data in first trimester. Consider risk-benefit; generally not recommended unless necessary. |
| 2nd trimester | Placental transfer increases; use only if clearly needed. Monitor for fetal effects. |
| 3rd trimester | Significant placental transfer in third trimester; may cause immunosuppression in newborn. Avoid use after mid-third trimester if possible; consider timing of last dose. |
Clinical note
Comprehensive clinical and safety monograph for ABRILADA (ABRILADA).
| Placental transfer | Active placental transfer occurs; levels in cord blood can be similar to maternal levels, especially in third trimester. IgG antibody crosses via FcRn. |
| Breastfeeding | Adalimumab is excreted into breast milk in low concentrations; limited data suggest minimal absorption in infants. Use with caution; consider developmental and health benefits of breastfeeding alongside mother's need for treatment. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | Abrilada (adalimumab-adbm) is a TNF-alpha inhibitor. Limited human data; animal studies show no evidence of teratogenicity. Potential risk of increased infection in neonates exposed in utero. First trimester: Minimal known risk. Second/third trimester: May cross placenta; theoretical risk of immunosuppression. |
| Fetal Monitoring | Monitor for maternal infection, especially tuberculosis. For fetal: growth ultrasound if used after 20 weeks due to possible placental transfer. |
| Fertility Effects | No known adverse effects on fertility. TNF-alpha inhibitors may be used in patients with infertility due to inflammatory conditions. |
■ FDA Black Box Warning
WARNING: SERIOUS INFECTIONS and MALIGNANCY. SERIOUS INFECTIONS: Patients treated with adalimumab are at increased risk for serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue adalimumab if a serious infection develops. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab.
| Serious Effects |
Known hypersensitivity to adalimumab or any component
| Precautions | Serious infections including tuberculosis, invasive fungal infections, and other opportunistic pathogens, Hepatitis B virus reactivation, Hypersensitivity reactions including anaphylaxis and angioneurotic edema, Neurologic events including new onset or exacerbation of demyelinating disorders, Hematologic events including pancytopenia and aplastic anemia, Congestive heart failure, Lupus-like syndrome, Malignancies including lymphoma, leukemia, and other malignancies |
| Food/Dietary | No significant food interactions. Grapefruit and other CYP450 modulators do not affect adalimumab. Take without regard to meals. |
| Clinical Pearls | ABRILADA (adalimumab) is a TNF-alpha inhibitor. Monitor for latent TB reactivation with PPD or IGRA before initiation. Injection site reactions are common; rotate sites and apply cold compresses. Avoid live vaccines during therapy. Assess for new-onset or worsening heart failure, demyelinating disorders, and cytopenias. Increased risk of serious infections; screen for HBV, HCV, and fungal infections. Consider temporarily holding therapy for major surgical procedures. |
| Patient Advice | Inspect injection site for redness, swelling, or itching; apply cold compress if needed. · Report signs of infection: fever, cough, painful urination, or skin wounds. · Avoid live vaccines (e.g., MMR, shingles, nasal flu) during treatment. · Review all current medications, including OTC and herbal supplements. · Notify healthcare provider before any planned surgery. · Use reliable contraception if of childbearing potential; continue 5 months after stopping. · Report new or worsening symptoms: shortness of breath, chest pain, numbness, vision changes. · Store ABRILADA in the refrigerator (36°F-46°F); do not freeze or shake. |
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