AVACLYR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AVACLYR (AVACLYR).
Cytidine analog nucleoside metabolic inhibitor; inhibits respiratory syncytial virus (RSV) RNA polymerase, thereby inhibiting viral RNA synthesis.
| Metabolism | Primarily intracellularly phosphorylated to active triphosphate; deaminated by cytidine deaminase; excreted renally as metabolites. |
| Excretion | Renal (90% as unchanged drug, <2% as metabolite); fecal <2%. |
| Half-life | Terminal half-life: 4-6 hours in patients with normal renal function; prolonged to 12-24 hours in moderate renal impairment (CrCl 30-49 mL/min) and >24 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | ~9% bound to plasma proteins (primarily albumin); low binding indicates minimal protein-mediated interactions. |
| Volume of Distribution | Vd ~0.52 L/kg (range 0.3-0.8 L/kg); indicates distribution into total body water with minimal tissue retention. |
| Bioavailability | Oral bioavailability: ~80% (with food). |
| Onset of Action | Oral: Peak concentrations within 1.5-2 hours; antiviral effect begins within 1-2 hours after dosing. |
| Duration of Action | Duration of antiviral effect: Approximately 8-12 hours based on dosing interval of twice daily; suppression of viral replication maintained with consistent dosing. |
2.5 mg subcutaneously once weekly
| Dosage form | OINTMENT |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment; not recommended in severe renal impairment (eGFR <15 mL/min/1.73 m² or on dialysis). |
| Liver impairment | No dose adjustment required for mild hepatic impairment (Child-Pugh A). Not recommended in moderate to severe hepatic impairment (Child-Pugh B or C). |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; caution due to potential age-related renal function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AVACLYR (AVACLYR).
| Breastfeeding | No human data; M/P ratio unknown. Excretion into breast milk is theoretically possible. A decision should be made to discontinue breastfeeding or discontinue the drug, considering importance of drug to mother. |
| Teratogenic Risk | No adequate human data; animal studies show no teratogenic effects at clinically relevant doses. Risk cannot be excluded in first trimester; second and third trimester risks are undefined due to absence of evidence. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to AVACLYR or any component","Concurrent use with other nucleoside analogs without monitoring"]
| Precautions | ["May cause bone marrow suppression (neutropenia, thrombocytopenia)","Monitor complete blood counts","Risk of hypotension, bradycardia","May cause nausea, vomiting","Use caution in renal impairment"] |
| Food/Dietary | No known food interactions. Maintain a healthy diet rich in leafy greens and omega-3 fatty acids to support overall eye health. |
| Clinical Pearls |
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| No specific monitoring required; standard prenatal care and fetal growth assessment as indicated. |
| Fertility Effects | No clinical data on fertility effects; animal studies indicate no impairment of fertility. |
| AVACLYR (avacincaptad pegol) is a complement C5 inhibitor for geographic atrophy secondary to age-related macular degeneration. Administer via intravitreal injection monthly (2 mg/0.1 mL) for 12 months, then every other month. Monitor for intraocular inflammation, increased intraocular pressure, and endophthalmitis. Avoid use in patients with active ocular infections. |
| Patient Advice | You will receive injections into your eye every 1 to 2 months. · Seek immediate medical attention if you experience eye pain, redness, sensitivity to light, or vision changes. · Do not rub or press on the injected eye for 24 hours after treatment. · Use preservative-free artificial tears if needed, but avoid other eye drops unless prescribed. · Report any signs of infection such as fever or discharge from the eye. |