HULIO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HULIO (HULIO).
HULIO (adalimumab) is a recombinant human IgG1 monoclonal antibody that binds to tumor necrosis factor-alpha (TNFα) and neutralizes its activity by blocking its interaction with p55 and p75 cell surface TNF receptors. It also modulates biological responses induced or regulated by TNFα, including expression of adhesion molecules, chemotaxis, and neutrophil activation.
| Metabolism | Adalimumab is a monoclonal antibody that is catabolized into small peptides and amino acids via general protein degradation pathways. No significant cytochrome P450 (CYP) enzyme metabolism is involved. Clearance primarily via intracellular catabolism. |
| Excretion | Primarily eliminated via proteolytic catabolism; no significant renal or biliary excretion as intact monoclonal antibody. |
| Half-life | Approximately 11-17 days; supports monthly subcutaneous dosing in rheumatoid arthritis. |
| Protein binding | >99% bound to soluble and membrane-bound TNF-alpha; no specific binding to other serum proteins. |
| Volume of Distribution | Approximately 4.2-7.9 L (0.06-0.12 L/kg), indicating limited extravascular distribution. |
| Bioavailability | Subcutaneous: Approximately 80% (absolute bioavailability). |
| Onset of Action | Subcutaneous: Clinical improvement observed within 2 weeks of initial dose. |
| Duration of Action | Sustained clinical effect for 4 weeks post-dose; dosing interval is every 4 weeks. |
HULIO (adalimumab-atto) is administered subcutaneously. Adult dose: 40 mg every other week; for some indications, initial loading dose of 80 mg may be used.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for renal impairment; data limited in severe renal impairment. |
| Liver impairment | No formal studies; use with caution in severe hepatic impairment (Child-Pugh C); no adjustment recommended for mild to moderate. |
| Pediatric use | Juvenile idiopathic arthritis: weight-based dosing: 15 kg to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week. For other indications, refer to specific guidelines. |
| Geriatric use | No specific dose adjustment; consider increased risk of infections and overall health status; use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HULIO (HULIO).
| Breastfeeding | HULIO is excreted in breast milk in small amounts with a calculated relative infant dose of approximately 0.1% of the maternal dose. Milk-to-plasma ratio is estimated at 0.01-0.19. No adverse effects in breastfed infants have been reported. Caution recommended if breast abscess or severe infection occurs. |
| Teratogenic Risk | HULIO (adalimumab) is a monoclonal antibody IgG1 that crosses the placenta during the second and third trimesters. First trimester exposure is not associated with major congenital malformations based on pregnancy registry data. Second and third trimester exposure may increase risk of infant immune suppression, including increased infection risk and delayed hematopoietic recovery. Live vaccines should be avoided in infants exposed in utero for the first 6 months of life. |
■ FDA Black Box Warning
SERIOUS INFECTIONS: Patients treated with adalimumab are at increased risk for developing serious infections that may lead 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. Perform test for latent TB; if positive, treat TB prior to therapy. Monitor for signs/symptoms of active TB during treatment, even if initial test negative. 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 inactive component of the formulation","Active serious infections (including sepsis, tuberculosis, opportunistic infections)"]
| Precautions | ["Serious infections (bacterial, mycobacterial, fungal, viral, parasitic)","Reactivation of hepatitis B virus (HBV)","Malignancies (including lymphoma, leukemia, and solid tumors)","Neurologic events (including new onset or exacerbation of demyelinating disease)","Hypersensitivity reactions (including anaphylaxis)","Hematologic reactions (pancytopenia, aplastic anemia)","Congestive heart failure (worsening or new onset)","Autoimmunity (development of lupus-like syndrome)","Immunizations (avoid live vaccines during treatment)"] |
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| Fetal Monitoring | Monitor maternal signs of infection (TB, bacterial, fungal), injection site reactions, and neurologic symptoms. Fetal monitoring includes ultrasound for growth restriction if maternal disease activity is high. Infant monitoring after birth for signs of infection for first 6 months if exposed in utero. |
| Fertility Effects | HULIO does not impair fertility in animal studies. In humans, there is no evidence of adverse effects on sperm quality or ovulation. It is used in patients with autoimmune conditions that may affect fertility, and treatment may improve fertility by reducing disease activity. |