Verkazia 1 mg/mL
cyclosporine · EMULSION · Harrow Eye, LLC
Verkazia is a emulsion containing cyclosporine at 1 mg/mL, taken ophthalmic. Manufactured by Harrow Eye, LLC.
Key Facts
- Brand Name
- Verkazia
- Generic Name
- cyclosporine
- NDC Code (Product)
82667-014- Manufacturer
- Harrow Eye, LLC
- Strength
- 1 mg/mL
- Dosage Form
- EMULSION
- Route
- OPHTHALMIC, TOPICAL
- Marketing Status
- Application #
- NDA214965
- Drug Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 02/01/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Verkazia ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon, and evening) in each affected eye ( 2 ) 2.1 General Dosing Information Gently shake the single-dose vial several times to obtain a uniform, white, opaque emulsion before use. Contact lenses should be removed before applying Verkazia and may be reinserted 15 minutes after administration. If a dose is missed, treatment should be continued as normal, at the next scheduled administration. If more than one topical ophthalmic product is being used, administer the eye drops at least 10 minutes apart to avoid diluting products. Administer Verkazia 10 minutes prior to using any eye ointment, gel or other viscous eye drops. Discard the vial immediately after use. 2.2 Recommended Dosage and Dose Administration Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon, and evening) into each affected eye. Treatment can be discontinued after signs and symptoms are resolved and can be reinitiated if there is a recurrence.
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions following the use of Verkazia were eye pain (12%) and eye pruritus (8%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA‑approved patient labeling. 6.1 Clinical Trials Experience Since clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the VEKTIS study, a multicenter, randomized, double-masked, placebo‑controlled trial, a total of 57 patients received Verkazia dosed four times a day (QID) for 4 months. Forty-two (42) patients received Verkazia in an 8 month extension, safety follow-up of the VEKTIS study. In the NOVATIVE study, a multicenter, randomized, double-masked, placebo‑controlled trial, 39 patients received Verkazia 1 mg/mL dosed QID for one month. A total of 53 patients received Verkazia 1 mg/mL QID during a 3-month safety follow‑up. The majority of the treated patients were male …
Frequently Asked Questions
What is Verkazia used for?
Verkazia contains cyclosporine. It is a emulsion taken ophthalmic. Consult your doctor for specific uses.
Is Verkazia a controlled substance?
Verkazia is not classified as a controlled substance by the DEA.
What is the generic name for Verkazia?
The generic name for Verkazia is cyclosporine. There are 12 other brand versions of cyclosporine.
What is the NDC code for Verkazia 1 mg/mL?
The NDC (National Drug Code) for Verkazia 1 mg/mL is 82667-014, listed by Harrow Eye, LLC.