VEVYE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VEVYE (VEVYE).
Vevye (cyclosporine ophthalmic solution) is a calcineurin inhibitor immunosuppressant. It inhibits T-cell activation by binding to cyclophilin, forming a complex that blocks calcineurin, thereby preventing dephosphorylation and nuclear translocation of nuclear factor of activated T-cells (NFAT), reducing pro-inflammatory cytokine production (e.g., IL-2). In ocular tissues, it suppresses inflammation and immune-mediated responses, increasing tear production through anti-inflammatory effects on lacrimal glands.
| Metabolism | Primarily metabolized in the liver by cytochrome P450 3A4 (CYP3A4) and to a lesser extent by CYP3A5. After topical ocular administration, systemic absorption is low (<0.1% of dose), but absorbed drug undergoes extensive hepatic metabolism with elimination via bile and feces. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20% as metabolites; 10% other |
| Half-life | Terminal elimination half-life: 12-15 hours in healthy adults; prolonged to 24-30 hours in renal impairment (CrCl <30 mL/min) |
| Protein binding | 98% bound primarily to albumin |
| Volume of Distribution | Vd: 0.2-0.3 L/kg, indicating primarily extracellular distribution |
| Bioavailability | Oral: 85%; Intravenous: 100% |
| Onset of Action | Oral: 30-60 minutes; Intravenous: immediate |
| Duration of Action | Duration: 12-24 hours for therapeutic effect; clinical notes: sustained release formulation extends to 24 hours |
VEVYE (voclosporin) 23.7 mg orally twice daily in combination with mycophenolate mofetil and corticosteroids.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated if eGFR <30 mL/min/1.73m2 unless on dialysis. For eGFR 30-45 mL/min/1.73m2, reduce dose to 15.8 mg twice daily. Monitor eGFR closely. |
| Liver impairment | Not recommended in patients with severe hepatic impairment (Child-Pugh class C). For moderate impairment (Child-Pugh class B), reduce dose to 15.8 mg twice daily. No adjustment for mild impairment (Child-Pugh class A). |
| Pediatric use | Safety and efficacy not established in pediatric patients under 18 years. |
| Geriatric use | No specific dose adjustment recommended; start at the lower end of dosing range due to age-related renal impairment and potential comorbidities. Monitor renal function and blood pressure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VEVYE (VEVYE).
| Breastfeeding | No human data; M/P ratio unknown. Consider benefits of breastfeeding vs potential risk to infant; use with caution. |
| Teratogenic Risk | No human data; animal studies show no teratogenicity at clinically relevant doses. Risk cannot be excluded; use only if benefit outweighs risk. First trimester: limited data; avoid if possible. Second/third trimesters: no known fetal effects. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to cyclosporine or any component of the formulation.","Active ocular infections (bacterial, fungal, viral, or protozoal)."]
| Precautions | ["Potential for ocular infections (including herpes simplex keratitis) and delayed wound healing; use with caution in patients with active ocular infections.","May cause increased intraocular pressure (IOP); monitor IOP in patients with glaucoma.","Risk of nephrotoxicity and hypertension with prolonged systemic exposure (low risk with ophthalmic use).","Not for use with contact lenses in place; remove lenses before instillation and wait at least 15 minutes before reinserting.","May cause burning, stinging, or blurred vision upon instillation."] |
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| Monitor maternal blood pressure, renal function, electrolytes during pregnancy. Fetal ultrasound for growth and amniotic fluid volume. |
| Fertility Effects | No known effect on fertility in animal studies. No human data. |