verkazia
Pharmaranks rates Verkazia 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Verkazia (Cyclosporine) is a calcineurin inhibitor immunosuppressant used to treat Rheumatoid Arthritis, Focal Segmental Glomerulosclerosis, Systemic Lupus Erythematosus, Myasthenia Gravis.
Cyclosporine · by Harrow Eye
Available as a generic: Gengraf
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cyclosporine
- Drug class
- Calcineurin Inhibitor Immunosuppressant
- Form
- Emulsion
- Strength
- Cyclosporine 0.1%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Harrow Eye
- Half-life
- about 8.4 hours (range 5 to 18 hours) (how long it stays in your system)
- What the pharmacy pays
- ~$52.85 for 30 — not your price
- FDA application
- NDA214965
What is Verkazia?
From the FDA label:Verkazia (cyclosporine ophthalmic emulsion) 0.1% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine is a white or almost white powder. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl-L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.61 Verkazia ophthalmic emulsion is a sterile, unpreserved topical emulsion. It appears as a milky-white homogeneous emulsion. It has an osmolality of approximately 265 mOsmol/kg and a pH of 5-7. Each mL of Verkazia ophthalmic emulsion contains: Active: Cyclosporine 1 mg/mL. Inactives: Cetalkonium chloride, Glycerol, Medium-chain triglycerides, Poloxamer 188, Sodium Hydroxide to adjust pH, Tyloxapol and Water for Injection. Structural Formula
How to use
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. 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…
Side effects
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 (79%). The most common adverse reactions reported in greater than 5% of patients were eye pain (12%) and eye pruritus (8%) which were usually transitory and occurred during instillation (Table 1). Table 1: Adverse…
Warnings
Important safety information
To avoid the potential for eye injury and contamination, advise patient not to touch the vial tip to the eye or other surfaces ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury or contamination, advise patients not to touch the vial tip to the eye or other surfaces. 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury or contamination, advise patients not to touch the vial tip to the eye or other surfaces.
Who should not take Verkazia
None None ( 4 )
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Grapefruit & grapefruit juice
Watch out for: grapefruit and grapefruit juice (and, for some drugs, Seville oranges).
Grapefruit blocks a gut enzyme (CYP3A4) that normally breaks this medicine down, so more of it can enter your blood — raising the risk of side effects.
What to do: Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Source: Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA
Storing Verkazia, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Do not freeze Verkazia.”
How long does Cyclosporine stay in your body?
The elimination half-life of cyclosporine is about 8.4 hours (range 5 to 18 hours) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This figure is for the modified formulation (Neoral). Cyclosporine's disposition from blood is biphasic; the ~8.4-hour value is the terminal (elimination) half-life, not the faster distribution phase. The older non-modified formulation (Sandimmune) has a longer terminal half-life of about 19 hours (range 10 to 27 hours), so the number depends on which product a person takes. Half-life is not the same as the drug-test/detection window — elimination is almost entirely biliary (only ~6% appears in urine), and cyclosporine is extensively metabolized to numerous metabolites, so measurable drug can persist longer than the parent half-life implies. Not a prodrug; no single active metabolite that clinically outlasts the parent.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: NEORAL (cyclosporine) capsule/oral solution — FDA label, DailyMed.
Drug class
How this class works, per Calcineurin Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- rheumatoid arthritis
- focal segmental glomerulosclerosis
- systemic lupus erythematosus
- myasthenia gravis
- psoriasis
See how Verkazia ranks — best-rated calcineurin inhibitor immunosuppressant for:
Dosage forms
Emulsion
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Verkazia treat?
- Verkazia (Cyclosporine) may be used to treat rheumatoid arthritis, focal segmental glomerulosclerosis, systemic lupus erythematosus, myasthenia gravis, psoriasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Verkazia work?
- Verkazia is a calcineurin inhibitor immunosuppressant. Calcineurin inhibitors block an enzyme called calcineurin inside immune T-cells, which stops the cells from making interleukin-2 and other signaling chemicals. This keeps T-cells from activating and multiplying, dialing down the immune attack that drives organ rejection or autoimmune disease.
- How is Verkazia rated?
- pharmaranks gives Verkazia a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Verkazia cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $52.85 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Verkazia?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Verkazia. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Verkazia?
- Verkazia is marketed by Harrow Eye. You can see Harrow Eye's full profile, rating, and other products on pharmaranks.
- Is Verkazia a brand-name or generic drug?
- Verkazia is a brand-name product with the active ingredient Cyclosporine. Lower-cost generic equivalents containing Cyclosporine are available — ask your pharmacist.
- Is Verkazia available over the counter?
- No. Verkazia is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Verkazia come in?
- Verkazia is currently marketed as emulsion, per the FDA's National Drug Code Directory.
- What class of drug is Verkazia?
- Verkazia is classified as calcineurin inhibitor immunosuppressant, per the FDA's Established Pharmacologic Class.
- Is Verkazia FDA-registered?
- Verkazia is on record with the U.S. FDA under application number NDA214965. You can verify this on its official FDA label.
- Has Verkazia been recalled by the FDA?
- Verkazia has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Verkazia safe?
- There's no single safe-or-not verdict. pharmaranks gives Verkazia a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Verkazia?
- Verkazia's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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verkazia
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