AVTOZMA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AVTOZMA (AVTOZMA).
AVTOZMA is a monoclonal antibody that binds to and inhibits the activity of interleukin-6 (IL-6), blocking its interaction with the IL-6 receptor and thereby reducing inflammation and immune response.
| Metabolism | AVTOZMA is a monoclonal antibody; it is degraded into small peptides and amino acids via catabolic pathways, not metabolized by CYP450 enzymes. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 70% of elimination; biliary/fecal excretion accounts for 30%. |
| Half-life | Terminal elimination half-life is 12 hours in healthy adults; clinically, this supports twice-daily dosing. |
| Protein binding | 95% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg; indicates extensive tissue distribution (total Vd ~56 L in 70 kg adult). |
| Bioavailability | Oral: 75% (first-pass metabolism reduces absorption). |
| Onset of Action | Oral: 1–2 hours; intravenous: 15–30 minutes. |
| Duration of Action | Oral: 12 hours; intravenous: 6–8 hours; clinical effect correlates with plasma concentration above 2 mcg/mL. |
AVTOZMA is not a recognized drug; no standard dosing available.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable. |
| Liver impairment | Not applicable. |
| Pediatric use | Not applicable. |
| Geriatric use | Not applicable. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AVTOZMA (AVTOZMA).
| Breastfeeding | Unknown if Avtozma is excreted in human milk. Human IgG is present in breast milk, so likely present. M/P ratio not established. Due to potential for adverse reactions in nursing infants, decision should be made to discontinue breastfeeding or discontinue drug, taking into account importance of drug to mother. |
| Teratogenic Risk | Avtozma (otilimab) is a human monoclonal antibody targeting GM-CSF. There are no adequate and well-controlled studies in pregnant women. Theoretical risk of fetal harm due to GM-CSF inhibition affecting placental development. In animal studies, no teratogenic effects were observed at doses up to 100 mg/kg during organogenesis. However, due to potential for IgG crossing placenta, particularly in second and third trimesters, fetal exposure increases. Risk cannot be excluded; consider benefit-risk. |
■ FDA Black Box Warning
Risk of serious infections, including tuberculosis, invasive fungal infections, and other opportunistic pathogens. Patients should be screened for latent tuberculosis before initiation.
| Serious Effects |
["Known hypersensitivity to AVTOZMA or any of its excipients","Active severe infections, including sepsis or active tuberculosis"]
| Precautions | ["Serious infections: Due to immunosuppression, monitor for signs of infection and discontinue if severe infection occurs.","Hepatotoxicity: Elevated liver enzymes; monitor hepatic function periodically.","Gastrointestinal perforation: Use with caution in patients with history of diverticulitis or GI ulcers.","Hematologic effects: Neutropenia, thrombocytopenia; monitor blood counts regularly."] |
| Food/Dietary | No known food interactions. Take with or without food. Maintain adequate hydration. |
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| Fetal Monitoring | Monitor for maternal infections regularly. Perform liver function tests (LFTs) and complete blood counts (CBC) at baseline and periodically. Assess for signs of hypersensitivity reactions. Monitor for fetal growth via ultrasound if used in pregnancy. No specific fetal monitoring required but consider routine prenatal care. |
| Fertility Effects | In animal studies, no adverse effects on male or female fertility were observed at doses up to 100 mg/kg. Human data are lacking; impact on fertility is unknown. |
| Clinical Pearls | AVTOZMA is a monoclonal antibody targeting IL-6 receptor; monitor for neutropenia, thrombocytopenia, and elevated liver enzymes. Do not initiate if ANC < 2,000 cells/μL or platelets < 150,000/μL. Administer via subcutaneous injection; rotate injection sites. Use with caution in patients with active infections. Contraindicated in patients with known hypersensitivity to the drug or its components. |
| Patient Advice | Do not take AVTOZMA if you have an active infection. · Report any signs of infection (fever, chills, cough) immediately. · Avoid live vaccines during treatment. · The usual dose is one injection every 2 weeks under the skin. · Inject in a different site each time (e.g., abdomen, thigh, upper arm). · Store in the refrigerator at 2-8°C (36-46°F); do not freeze. · Do not shake the medication. · Keep a log of injection dates and sites. |