ketotifen, drug-eluting contact lens (Rx)

Brand and Other Names:Acuvue Theravision with Ketotifen
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

drug-eluting contact lens

  • 19mcg/lens

Allergic Conjunctivitis

Daily disposable etafilcon A drug-eluting contact lens packaged with an H1 histamine receptor antagonist, indicated for prevention of ocular itch owing to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear, and do not have more than 1 D of astigmatism

Insert 1 lens per eye qDay; discard lens after single day’s use

See fitting instruction guide for professional fitting instructions and information

Dosage Forms & Strengths

drug-eluting contact lens

  • 19mcg/lens

Allergic Conjunctivitis

Daily disposable etafilcon A drug-eluting contact lens packaged with an H1 histamine receptor antagonist, indicated for prevention of ocular itch owing to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear, and do not have more than 1 D of astigmatism

<11 years: Safety and efficacy not established

≥11 years: Insert 1 lens per eye qDay; discard lens after single day’s use

See fitting instruction guide for professional fitting instructions and information

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Adverse Effects

1-10%

Eye irritation (≥1%)

Eye pain (≥1%)

Instillation site irritation (≥1%)

Frequency Not Defined

Corneal ulceration

Corneal infections

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Warnings

Contraindications

Ocular hyperemia

Corneal hypoesthesia

Corneal infection

Cautions

Corneal ulcers: Do not insert lenses with corneal epithelial breakdown, corneal ulceration, dry eye disease, or with injury or abnormality that affects the eyelids or anterior segment of the eye; wearing lenses overnight or smoking increases risk of corneal ulceration

Contact lens-related complications: Do not use to treat or prevent lens-related symptoms including irritation, discomfort, or redness; if patient experiences symptoms of contact lens intolerance or keratitis, remove lens(es) immediately; instruct patients experiencing excessive tearing, vision changes, or redness of the eye to contact eye care professional immediately

Chemical exposures: If chemicals of any kind are splashed into eyes, flush eyes immediately with water and contact eye care professional immediately or visit hospital emergency room without delay

Acanthamoeba keratitis: Do not wear while swimming or in hot tubs; do not rinse lenses with tap water owing to impurities that may contaminate or damage lenses and lead to eye infection or injury

Backup eyeglasses: All contact lens wearers require a functional pair of eyeglasses when unable to wear contact lenses

Eye protection: Determine need for eye protective equipment for job/tasks

Concomitant use of eye drops: Do not use eye drops or eye medications containing benzalkonium chloride simultaneously; wait at least 10 minutes after eye drop application before inserting/reinserting lenses

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Pregnancy & Lactation

Pregnancy

There are no human data that establish the presence or absence of drug-associated risk in pregnant females

Animal data

  • Oral administration of 45 mg/kg/day ketotifen to pregnant rabbits resulted in increased incidence of retarded ossification of the sternebrae; this dose (normalized to body surface area) was ~23,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.038 mg
  • An oral dose of 50 mg/kg/day ketotifen (~13,000 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity, a slight increase in postnatal mortality and a slight decrease in body weight gain in offspring during the first 4 days post-partum

Lactation

No information regarding presence or absence of ketotifen fumarate or its metabolites in human milk, or on breastfed infants and milk production

Ketotifen fumarate identified in breast milk in rats following oral administration; unknown whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Histamine-1 (H1) receptor antagonist; stabilizes mast cells and prevents eosinophil accumulation; this action prevents onset of ocular allergic itch allowing for continued lens wear during episodes of allergen exposure

Ketotifen duration of action demonstrated through 12 hr

The device component acts as a refracting medium to focus light rays on retina to correct refractive ametropia for as long as the lens is worn (up to 24 hr while awake)

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Administration

Ophthalmic Administration

Prevention of itch demonstrated to last through 12 hr; however, may be worn beyond 12 hr for vision correction

Maximum daily wearing time determined by eye care professional based on patient’s individual response to contact lenses

Remove lenses prior to sleep

Do not use eye drops containing benzalkonium chloride simultaneously with this product; wait 10 minutes after applying eye drop with benzalkonium chloride before inserting or reinserting lenses

If the lens sticks (stops moving), instruct patient to remove lens; may apply a few drops of non-preserved sterile saline solution directly to eye to assist with removal

Consult eye care professional if non-movement of lens continues after a few minutes

Do not use contact lens cleaning and disinfectant solutions with lens

DO not use if sterile blister package is opened or damaged

Storage

Store at 15-25ºC (59-77ºF)

Protect from light

Store lenses in carton until use

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.