VITRAVENE PRESERVATIVE FREE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VITRAVENE PRESERVATIVE FREE (VITRAVENE PRESERVATIVE FREE).
Antisense oligonucleotide that binds to mRNA of human cytomegalovirus (HCMV), inhibiting viral replication by blocking protein synthesis.
| Metabolism | Metabolized by exonucleases to shorter oligonucleotides; not metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal excretion. Approximately 40% of the dose is excreted unchanged in urine within 24 hours. Biliary/fecal excretion accounts for less than 5%. |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function. In patients with renal impairment, half-life may be prolonged up to 10 hours. |
| Protein binding | Approximately 80% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution (Vd) is 0.2 L/kg, indicating limited distribution primarily within the vascular and extracellular spaces. |
| Bioavailability | Intravitreal injection: 100% bioavailability (direct administration into vitreous humor). Not administered systemically. |
| Onset of Action | Intravitreal injection: Clinical effect (reduction in CMV retinitis progression) observed within 2-4 weeks. |
| Duration of Action | Intravitreal injection: Duration of action is approximately 2-3 weeks, requiring weekly injections for maintenance therapy. |
Intravitreal injection: 330 mcg (0.05 mL of 6.6 mg/mL solution) every 2 weeks for 2 doses, then every 4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No specific dose adjustment recommended for hepatic impairment. Use with caution. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dose adjustment required; monitor for ocular adverse events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VITRAVENE PRESERVATIVE FREE (VITRAVENE PRESERVATIVE FREE).
| Breastfeeding | No data exist on excretion into human breast milk. Due to negligible systemic absorption after intravitreal injection, it is unlikely to be present in milk. Caution is advised; the M/P ratio is unknown. |
| Teratogenic Risk | Vitravene (fomivirsen) is an antisense oligonucleotide administered intravitreally. Systemic absorption is negligible, thus teratogenic risk is expected to be low. However, no adequate human data exist. Animal studies with intravenous fomivirsen at doses up to 60 times the clinical ocular dose did not show teratogenicity. Risk cannot be excluded; use only if clearly needed. |
■ FDA Black Box Warning
Not available.
| Serious Effects |
Hypersensitivity to fomivirsen or any component of the formulation.
| Precautions | Ocular irritation, hypotony, and retinal detachment may occur; use caution in patients with anticoagulation or bleeding disorders. |
Loading safety data…
| Fetal Monitoring | Routine monitoring for adverse effects of intraocular injection (e.g., endophthalmitis, retinal detachment). No specific fetal monitoring required due to minimal systemic exposure. |
| Fertility Effects | In animal studies, intravenous fomivirsen had no effect on fertility. No human data. Negligible systemic exposure suggests minimal impact on fertility. |