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. |
| Molecular Weight | 6682.4 |
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 | Not recommended unless clearly needed; animal studies show no teratogenicity, but no adequate human data. |
| 2nd trimester | Use only if potential benefit justifies risk; no known harm. |
| 3rd trimester | Use only if potential benefit justifies risk; no known harm. |
Clinical note
Comprehensive clinical and safety monograph for VITRAVENE PRESERVATIVE FREE (VITRAVENE PRESERVATIVE FREE).
| Placental transfer | Unlikely due to high molecular weight and polar nature; no data available. |
| Breastfeeding | Excretion in human milk unknown; caution advised due to potential for immune suppression. |
| Lactation Rating |
■ FDA Black Box Warning
Not available.
| Serious Effects |
Hypersensitivity to fomivirsen or any component
| Precautions | Ocular irritation, hypotony, and retinal detachment may occur; use caution in patients with anticoagulation or bleeding disorders. |
| Food/Dietary | No known food interactions. No dietary restrictions required for intravitreal fomivirsen. |
| Clinical Pearls | Vitravene (fomivirsen) is an intravitreal antisense oligonucleotide for cytomegalovirus (CMV) retinitis in immunocompromised patients. It is preservative-free, and a single-use vial should be used immediately after opening. Administer via intravitreal injection after adequate anesthesia and antisepsis. Monitor for intraocular inflammation, retinal detachment, and increased intraocular pressure post-injection. Do not use in patients with recent ocular surgery or active ocular infection. Contraindicated in patients with hypersensitivity to fomivirsen. |
Loading safety data…
| L3 (Moderately Safe) |
| 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. |
| 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. |
| Patient Advice | This medication is injected directly into your eye to treat a viral infection of the retina. · You may experience temporary blurred vision, eye pain, or floaters after the injection; report severe or persistent symptoms. · Avoid rubbing or pressing on the injected eye; use prescribed eye drops as directed. · Attend all follow-up appointments to monitor for complications such as retinal detachment or increased eye pressure. · Inform your doctor if you have a history of ocular surgery, glaucoma, or bleeding disorders. |