AVSOLA
Clinical safety rating
cautionComprehensive clinical and safety monograph for AVSOLA (AVSOLA).
Comprehensive clinical and safety monograph for AVSOLA (AVSOLA).
Crohn's disease (moderate to severe, fistulizing)Pediatric Crohn's disease (moderate to severe)Ulcerative colitis (moderate to severe)Pediatric ulcerative colitis (moderate to severe)Rheumatoid arthritis (in combination with methotrexate)Ankylosing spondylitisPsoriatic arthritisPlaque psoriasis (chronic severe)
Tumor necrosis factor (TNF) alpha inhibitor; AVSOLA (infliximab-axxq) is a chimeric monoclonal antibody that binds with high affinity to soluble and transmembrane forms of TNF-alpha, thereby inhibiting binding of TNF-alpha to its receptors (TNFR1 and TNFR2) and reducing pro-inflammatory cytokine signaling.
| Metabolism | Infliximab is a monoclonal antibody; metabolism is via catabolism into peptides and amino acids through general protein degradation pathways (reticuloendothelial system). No involvement of CYP450 enzymes. |
| Excretion | Primarily cleared by the reticuloendothelial system via proteolytic degradation. Minimal renal excretion (less than 1% unchanged) and no significant biliary or fecal elimination. |
| Half-life | Terminal elimination half-life is approximately 14–18 days (range 10–39 days) in adults. Prolonged half-life supports dosing every 8 weeks; it is influenced by inflammation and disease severity. |
| Protein binding | Predominantly bound to soluble TNF-alpha; no specific plasma protein binding (e.g., albumin) is reported; the complex is cleared, so free drug binding is low. |
| Volume of Distribution | Volume of distribution is approximately 0.04–0.06 L/kg, indicating limited tissue distribution primarily within the vascular space. |
| Bioavailability | Bioavailability is 100% after intravenous infusion; no other routes are clinically relevant. |
| Onset of Action | Intravenous infusion: Clinical response may be observed within 2 weeks, with maximal effects typically seen by 6 weeks. |
| Duration of Action | Duration of action is variable based on dosing interval (typically 8 weeks). Clinical benefit may persist for several weeks after a single dose; repeated dosing is required for sustained effect. |
| Molecular Weight | 145000 |
5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No formal studies; use caution in hepatic impairment. |
| Pediatric use | 5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks; approved for ages 6 years and older. |
| Geriatric use | No specific dose adjustment; monitor for infections and adverse effects. |
| 1st trimester | Limited data; crosses placenta; use only if clearly needed. Monoclonal antibody, likely safe in early pregnancy. |
| 2nd trimester | Limited data; crosses placenta; use only if clearly needed. Minimal fetal exposure in second trimester. |
| 3rd trimester | Limited data; crosses placenta more readily in third trimester; may cause immunosuppression in neonate. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for AVSOLA (AVSOLA).
| Placental transfer | Crosses placenta; transfer increases with gestational age, especially in third trimester. |
| Breastfeeding | Infusion administered after delivery; breast milk concentrations low; likely minimal oral absorption; consider benefit of breastfeeding vs. risk of infant exposure. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | AVSOLA (infliximab-axxq) is a monoclonal antibody. IgG crosses the placenta, with increasing transfer during the second and third trimesters. First trimester exposure is associated with low risk of major malformations. Second and third trimester exposure may increase risk of fetal immunosuppression, including neonatal lymphopenia, and vaccination risks. Avascular necrosis and congenital anomalies have been reported post-marketing but causal relationship not established. Avoid live vaccines in infants exposed in utero for 6 months. |
| Fetal Monitoring | Monitor for signs of infusion reactions, infections, and cytopenias in mother. For fetus/infant: assess for lymphopenia, growth restriction, and delayed immune development. No routine fetal monitoring specific to infliximab; standard obstetric care applies. Consider pediatrician involvement for infant vaccination schedule. |
| Fertility Effects | Infliximab does not directly impair human fertility. In animal studies, no adverse effects on male or female reproductive function. In women with inflammatory bowel disease or rheumatoid arthritis, improved disease control may enhance fertility by reducing inflammation-related infertility. |
■ FDA Black Box Warning
WARNING: SERIOUS INFECTIONS and MALIGNANCY. Increased risk of serious infections (including tuberculosis, bacterial sepsis, invasive fungal infections) leading to hospitalization or death; increased risk of lymphoma and other malignancies, including fatal hepatosplenic T-cell lymphoma in adolescents and young adults with inflammatory bowel disease.
| Serious Effects |
Known hypersensitivity to infliximab or any murine proteins
| Precautions | Risk of serious infections (screen for latent TB and treat before initiation, monitor for active infections), Hypersensitivity reactions (including anaphylaxis, serum sickness), Hepatotoxicity (including hepatic failure, acute liver injury), Reactivation of hepatitis B virus, Hematologic toxicity (pancytopenia, leukopenia), Neurologic events (demyelinating disorders, seizure, optic neuritis), Heart failure exacerbation, Lupus-like syndrome, Immunogenicity (development of anti-drug antibodies leading to infusion reactions and loss of response), Malignancy (especially lymphoma, leukemia, melanoma, and Merkel cell carcinoma) |
| Food/Dietary | No known food interactions. AVSOLA is administered intravenously, and its absorption is not affected by oral intake. However, patients should maintain a balanced diet to support immune function. |
| Clinical Pearls | AVSOLA (infliximab-axxq) is a biosimilar to Remicade. Pre-medicate with antihistamines and acetaminophen to reduce infusion reactions. Screen for latent TB (PPD or IGRA) and HBV before initiation. Do not administer live vaccines during therapy. Monitor for signs of infection, including opportunistic infections like histoplasmosis. Discontinue if symptoms of lupus-like syndrome or severe hepatotoxicity occur. Infusion reactions may occur up to 2 hours post-infusion; have emergency equipment available. |
| Patient Advice | AVSOLA is given as an IV infusion over at least 2 hours; you will be monitored during and after infusion. · Report any signs of allergic reaction (hives, difficulty breathing, swelling) immediately. · Seek medical help if you develop fever, chills, persistent cough, or skin changes. · Do not receive live vaccines while on AVSOLA; update vaccinations before starting. · Avoid becoming pregnant during treatment; use effective contraception. · Notify your doctor of any new or worsening symptoms, including chest pain or shortness of breath. |
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