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Trifluridine

Generic: Trifluridine

Verified·Apr 23, 2026
Manufacturer
Taiho
NDC
61314-044
ICD-10 indication
B00.52

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About Trifluridine

What is this medication? Trifluridine is an antiviral prescription medication primarily used as an ophthalmic solution to treat eye infections caused by the herpes simplex virus. It is specifically prescribed for conditions such as primary keratoconjunctivitis and recurrent epithelial keratitis. By focusing on the infection within the eye, the medication helps to reduce inflammation and protect the cornea from damage that could lead to vision loss.

This medication works by inhibiting the replication of viral DNA, which prevents the herpes virus from multiplying and spreading to healthy cells. Patients are typically instructed to apply the drops several times a day until the infection clears, following a specific schedule determined by a healthcare provider. While it is effective at controlling active viral outbreaks in the ocular area, it is not a permanent cure for the virus itself.

Copay & patient assistance

  • Patient Copay Amount: $0
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Eligible commercially insured patients; program is not available for patients covered by state or federally funded healthcare programs (e.g., Medicare, Medicaid, TRICARE).
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for Trifluridine. Official source: DailyMed (NLM) · Label effective Aug 1, 2024

Indications and usage
INDICATIONS AND USAGE: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Dosage and administration
DOSAGE AND ADMINISTRATION: Instill one drop of Trifluridine Ophthalmic Solution onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the cornea ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended. If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of trifluridine for periods exceeding 21 days should be avoided because of potential ocular toxicity.
Contraindications
CONTRAINDICATIONS: Trifluridine Ophthalmic Solution is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.
Warnings
WARNINGS: The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION ).
Adverse reactions
ADVERSE REACTIONS: The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.
Use in pregnancy
Pregnancy: Teratogenic Effects: Trifluridine was not teratogenic at doses up to 5 mg/kg/day (23 times the estimated human exposure) when given subcutaneously to rats and rabbits. However, fetal toxicity consisting of delayed ossification of portions of the skeleton occurred at dose levels of 2.5 and 5 mg /kg /day in rats and at 2.5 mg/kg/day in rabbits. In addition, both 2.5 and 5 mg/kg/day produced fetal death and resorption in rabbits. In both rats and rabbits, 1 mg/kg/day (5 times the estimated human exposure) was a no-effect level. There were no teratogenic or fetotoxic effects after topical application of trifluridine (approximately 5 times the estimated human exposure) to the eyes of rabbits on the 6th through the 18th days of pregnancy. In a non-standard test, trifluridine solution has been shown to be teratogenic when injected directly into the yolk sac of chicken eggs. There are no adequate and well-controlled studies in pregnant women. Trifluridine Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How Trifluridine appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

42%

2,292 of 5,509 plans

Most common tier

Tier 4

On 28% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)65
20%
Tier 2 (generic)87
26%
Tier 3 (preferred brand)84
26%
Tier 4 (non-preferred brand)93
28%

Step therapy: 0% of formularies

Quantity limits: 9% of formularies

Coverage breadth: 329 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.