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ACUVUE Theravision with Ketotifen ketotifen fumarate 0.019 mg Drug-Eluting Contact Lens — NDC 60123-019-30 (Billing 60123-0019-30)

by Johnson & Johnson Vision Care, Inc. · 30 BLISTER PACK in 1 CARTON / 1 DRUG-ELUTING CONTACT LENS in 1 BLISTER PACK

This is a package of ACUVUE Theravision with Ketotifen ketotifen fumarate 0.019 mg Drug-Eluting Contact Lens from Johnson & Johnson Vision Care, Inc., no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 60123-0019-30
🏷️ FDA NDC (as labeled) 60123-019-30 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 60123-019-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60123 labeler · 019 product · 30 package
Barcode (UPC-A, from the NDC)
3 6012301930 4
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60123-019-30
Product NDC 60123-019
11-digit billing NDC 60123001930
Application # NDA022388
SPL Set ID d222d68c-911e-48a9-9bde-a1ca7e992d18
Established class (EPC) Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route INTRAOCULAR
Dosage form DRUG-ELUTING CONTACT LENS
Substance KETOTIFEN FUMARATE
Why two NDCs? The FDA registers this code as 60123-019-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 60123-0019-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It relieves or prevents itchy eyes from allergies. The drops give temporary relief from itching due to pollen, ragweed, grass, and animal hair and dander. The ACUVUE Theravision le...
  • If you are an adult or a child 3 or older, use 1 drop in each affected eye twice a day, 8 to 12 hours apart. Don't use them more than twice daily. If your child is under 3, check w...
  • Take your contact lenses out before using the drops. Then wait at least 10 minutes before putting them back in. If you use other eye products too, leave at least 5 minutes between...
  • Stop the drops and talk to a doctor if you have eye pain, changes in vision, redness, or itching that gets worse or lasts more than 72 hours. With the ACUVUE Theravision lens, take...
📖 Read our full Ketotifen guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60123-0019-30 You're viewing this Main listing 30 BLISTER PACK in 1 CARTON / 1 DRUG-ELUTING CONTACT LENS in 1 BLISTER PACK 2022-02-28 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ACUVUE Theravision with Ketotifen 0.019 mgthis 60123-0019-30 Johnson 1 drug — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
First FDA approval
Feb 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 25, 2022 RLD RS ⏳ ~3.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9962376 — drug product
US 9474746 — drug product
2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 9962376 ↗ Drug product — Jun 27, 2030
US 9474746 ↗ Drug product — Mar 27, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2030 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 7A314HQM0I
    Pentetic acid is a chelating agent, a chemical that binds to metals. It's used in some medicines to prevent metal ions from interfering with drug stability or effectiveness.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJohnson & Johnson Vision Care, Inc.
Application holderJOHNSON AND JOHNSON VISION CARE INC
FDA applicationNDA022388 (NDA)
Labeler code60123
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE ACUVUE ® Theravision™ with Ketotifen is a daily wear, daily disposable etafilcon A drug-eluting contact lens for prevention ocular itch due 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. The lens contains an H 1 histamine receptor antagonist for the prevention of ocular itch due to allergic conjunctivitis. The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours in a single day.

ACUVUE ® Theravision™ with Ketotifen is a daily wear, daily disposable etafilcon A drug-eluting contact lens packaged with an H 1 histamine receptor antagonist, indicated for the prevention ocular itch due 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. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Insert one lens per eye per day. Discard lens after a single day's use. ( 2.1 ) Lenses should be removed prior to sleeping. ( 2.1 )

2.1General Dosing Information One ACUVUE ® Theravision™ with Ketotifen should be inserted per eye per day. Discard lens after a single day's use. ACUVUE ® Theravision™ with Ketotifen may be worn beyond twelve hours for vision correction.

Lenses should be removed prior to sleeping. The maximum daily wearing time should be determined by the Eye Care Professional based upon the patient's individual response to contact lenses. Patients tend to over wear the lenses initially.

The Eye Care Professional should emphasize the importance of adhering to the initial maximum daily wearing time. Regular checkups, as determined by the Eye Care Professional, are also extremely important. Eye drops containing benzalkonium chloride should not be used simultaneously with this product.

Patients should wait 10 minutes after applying eye drop with benzalkonium chloride before inserting or reinserting lenses. If the lens sticks (stops moving), the patient should be instructed to remove the lens. A few drops of non-preserved sterile saline solution may be applied directly to the eye to assist with removal.

If non-movement of the lens continues after a few minutes, the patient should immediately consult their Eye Care Professional. Do not use contact lens cleaning and disinfectant solutions with ACUVUE ® Theravision™ with Ketotifen.

2.2Contact Lens Fitting Information See the ACUVUE® Theravision™ with Ketotifen Fitting Instruction Guide for professional fitting instructions and information.

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Daily disposable etafilcon A drug-eluting contact lens with ketotifen (19 mcg per lens). Daily disposable etafilcon A drug-eluting contact lens with ketotifen (19 mcg per lens) ( 3 )

⛔ Contraindications 88 words ▾

4 CONTRAINDICATIONS Ocular Hyperemia ( 4.1 ) Corneal Hypoesthesia ( 4.2 ) Corneal Infections ( 4.3 )

4.1Ocular Hyperemia ACUVUE® Theravision™ with Ketotifen is contraindicated in patients with ocular hyperemia and should not be inserted into red or irritated eye(s). Remove ACUVUE Theravision with Ketotifen immediately if eye(s) becomes red or irritated.

4.2Corneal Hypoesthesia ACUVUE Theravision with Ketotifen is contraindicated in patients with decreased corneal sensation.

4.3Corneal Infections ACUVUE Theravision with Ketotifen is contraindicated in patients with any corneal infection (bacterial, fungal, protozoal or viral).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Corneal Ulcer: Remove lenses ( 5.1 ) Contact Lens Related Complications: Remove lenses ( 5.2 ) Chemical Exposures: Flush eyes with water ( 5.3 ) Acanthamoeba Keratitis: Do not wear while swimming ( 5.4 )

5.1Corneal Ulcers ACUVUE Theravision with Ketotifen should not be inserted if the patient has corneal epithelial breakdown, corneal ulceration, dry eye disease, injury or abnormality that affects the eyelids or anterior segment of the eye. Contact lens wear may worsen these conditions and lead to sight threatening complications. If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of the eye, the patient should be instructed to immediately remove the lenses, and promptly contact the Eye Care Professional.

Studies have shown that when daily wear users wear their lenses overnight, the risk of ulcerative keratitis is greater than among those who do not wear them overnight. Contact lens wearers who are smokers have a higher incidence of corneal ulcers than nonsmokers.

5.2Contact Lens-Related Complications ACUVUE Theravision with Ketotifen should not be used to treat or prevent lens-related symptoms including irritation, discomfort or redness. ACUVUE Theravision with Ketotifen insertion could result in serious injury if a patient is experiencing these symptoms. Patients should be cautioned that proper use and care of contact lenses and lens care products are essential for the safe use of these products.

If patients experience symptoms of contact lens intolerance or keratitis, the lens(es) should be IMMEDIATELY REMOVED.

5.3Chemical Exposures If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.

5.4Acanthamoeba Keratitis ACUVUE Theravision with Ketotifen should not be worn while swimming or in hot tubs. The lens should not be rinsed in water from the tap. Tap water contains many impurities that can contaminate or damage the lenses and may lead to eye infection or injury. Contact lens wear in these settings increases the risk of sight threatening eye infections from microorganisms.

5.5Backup Spectacles Eye Care Professionals should instruct the patient to always have a functional pair of spectacles with a current prescription available to use if the patient becomes unable to wear contact lenses, or in circumstances where contact lens wear is not advised.

5.6Eye Protection Patients should be advised to notify the employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that the patient not wear contact lenses.

5.7Concomitant Use of Eye Drops or Eye Medications Eye Drops or Eye Medications containing benzalkonium chloride should not be used simultaneously with ACUVUE® Theravision™ with Ketotifen. Wait at least 10 minutes after eye drop application before inserting lenses.

🤒 Adverse Reactions 194 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular Hyperemia [see Contraindications (4.1) ] Corneal Hypoesthesia [see Contraindications (4.2) ] Corneal Infections [see Contraindications (4.3) ] Corneal Ulcers [see Warnings and Precautions (5.1) ] Contact Lens-Related Complications [see Warning and Precautions (5.2) ] Chemical Exposure [see Warnings and Precautions (5.3) ] Acanthamoeba Keratitis [see Warnings and Precautions (5.4) ] The most commonly observed adverse reactions in clinical studies, occurring in ≥ 1% of ACUVUE ® Theravision™ with Ketotifen treated eyes, were eye irritation, eye pain, and instillation site pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Johnson & Johnson Vision Care, Inc. at 1-800-843-2020 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice. The most commonly observed adverse reactions in clinical studies, occurring in ≥1% of ACUVUE ® Theravision™ with Ketotifen treated eyes, were eye irritation, eye pain, and instillation site irritation.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ACUVUE ® Theravison™ with Ketotifen administration in pregnant women to inform a drug-associated risk. ACUVUE ® Theravison™ with Ketotifen is not absorbed systemically following ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Oral administration of ketotifen fumarate to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data ] .

Data Human Data There are no human data that establish the presence or absence of drug-associated risk with the use of ACUVUE ® Theravision™ with Ketotifen by pregnant women. Animal Data Oral administration of 45 mg/kg/day ketotifen to pregnant rabbits resulted in an increased incidence of retarded ossification of the sternebrae. This dose (normalized to body surface area) was approximately 23,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.038 mg.

No adverse embryofetal effects were observed in rats or rabbits orally administered 100 mg/kg/day and 15 mg/kg/day, respectively, during organogenesis. These doses (normalized to body surface area) were approximately 26,000 and 7,700 times higher than the MRHOD, respectively. An oral dose of 50 mg/kg/day ketotifen (approximately 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 four days post-partum.

8.2Lactation Risk Summary There is no information regarding the presence or absence of ketotifen fumarate or its metabolites in human milk following use of ACUVUE ® Theravision™ with Ketotifen, or on the breastfed infants and milk production. Ketotifen fumarate has been identified in breast milk in rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk.

The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ACUVUE ® Theravision™ with Ketotifen and any potential adverse effects on the breast-fed child from ketotifen fumarate.

8.3Pediatric Use The safety and efficacy of ACUVUE ® Theravision™ with Ketotifen in pediatric patients below the age of 11 years has not been established.

8.4Geriatric Use Clinical studies of etafilcon A with ketotifen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ACUVUE ® Theravison™ with Ketotifen administration in pregnant women to inform a drug-associated risk. ACUVUE ® Theravison™ with Ketotifen is not absorbed systemically following ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Oral administration of ketotifen fumarate to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data ] .

Data Human Data There are no human data that establish the presence or absence of drug-associated risk with the use of ACUVUE ® Theravision™ with Ketotifen by pregnant women. Animal Data Oral administration of 45 mg/kg/day ketotifen to pregnant rabbits resulted in an increased incidence of retarded ossification of the sternebrae. This dose (normalized to body surface area) was approximately 23,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.038 mg.

No adverse embryofetal effects were observed in rats or rabbits orally administered 100 mg/kg/day and 15 mg/kg/day, respectively, during organogenesis. These doses (normalized to body surface area) were approximately 26,000 and 7,700 times higher than the MRHOD, respectively. An oral dose of 50 mg/kg/day ketotifen (approximately 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 four days post-partum.

🧒 Pediatric Use 26 words ▾

8.3Pediatric Use The safety and efficacy of ACUVUE ® Theravision™ with Ketotifen in pediatric patients below the age of 11 years has not been established.

🧓 Geriatric Use 30 words ▾

8.4Geriatric Use Clinical studies of etafilcon A with ketotifen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology 99 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Device Component In its hydrated state, the lens when placed on the cornea, acts as a refracting medium to focus light rays on the retina to correct refractive ametropia for as long as the lens is worn (up to 24 hours while awake). Drug Component Ketotifen fumarate, a benzocycloheptathiophene derivative, is a H 1 receptor antagonist that stabilizes mast cells and prevents eosinophil accumulation. This action prevents the onset of ocular allergic itch allowing for continued lens wear during episodes of allergen exposure and has been demonstrated to last through 12 hours.

🧬 Mechanism of Action 96 words ▾

12.1Mechanism of Action Device Component In its hydrated state, the lens when placed on the cornea, acts as a refracting medium to focus light rays on the retina to correct refractive ametropia for as long as the lens is worn (up to 24 hours while awake). Drug Component Ketotifen fumarate, a benzocycloheptathiophene derivative, is a H 1 receptor antagonist that stabilizes mast cells and prevents eosinophil accumulation. This action prevents the onset of ocular allergic itch allowing for continued lens wear during episodes of allergen exposure and has been demonstrated to last through 12 hours.

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ACUVUE ® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) is a daily disposable contact lens, 19 mcg ketotifen per lens is supplied in a plastic blister bowl and a foil laminated lidstock containing a buffered ketotifen solution. The plastic package is marked with base curve, lens diameter, diopter (lens power), date of manufacture, expiration date and lot number. ACUVUE ® Theravision™ with Ketotifen is supplied in a 30-count carton containing 30 foil sealed blister packages containing etafilcon A contact lens with 19 mcg ketotifen (NDC 60123-019-30).

Store at 15°C to 25°C (59°F to 77°F). Protect from light. Store lenses in carton until use.

DO NOT to use if the ACUVUE ® Theravision™ with Ketotifen lens sterile blister package is opened or damaged.

📦 Storage and Handling 36 words ▾

Store at 15°C to 25°C (59°F to 77°F). Protect from light. Store lenses in carton until use. DO NOT to use if the ACUVUE ® Theravision™ with Ketotifen lens sterile blister package is opened or damaged.

📋 Description ~1 min read ▾

11 DESCRIPTION ACUVUE ® Theravision™ with Ketotifen is a sterile, soft (hydrophilic), spherical daily wear, daily disposable etafilcon A drug-eluting contact lens containing ketotifen, an H 1 receptor antagonist, for topical administration to the eyes. Ketotifen fumarate is a white to brownish-yellow, fine crystalline powder. The buffered packaging solution of ACUVUE ® Theravision™ with Ketotifen has a pH range of 6.6 to 7.3 and an osmolality of not more than 460 mOsm/Kg.

This product does not contain an antimicrobial preservative. Contains: Active: ketotifen 19 mcg equivalent to 43 mcg ketotifen fumarate per lens Inactives: boric acid, calcium hydroxide, pentetic acid, sodium chloride, sodium borate, and water. Chemical Name: 4,9-Dihydro-4-(1-methyl-4-piperidylidene)-10H-benzo[4,5]cyclohepta[1,2-b] thiophen-10-one fumarate (1:1).

Structural Formula: Molecular formula of C 19 H 19 NOS∙C 4 H 4 O 4 (C 19 H 19 NOS as free base) Molecular weight of 425.50 g/mol (309.43 g/mol as the free base) The contact lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1, 1, 1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. ACUVUE ® Theravision™ with Ketotifen contact lenses are tinted blue using blue 2-hydroxyethyl methacrylate to make the lenses more visible for handling. Physical/Optical Properties of the Lens: Refractive Index:

1.40Visible Light Transmission: 90% minimum Ultraviolet Light Tranmission: (316 nm to 380 nm) UVA 30% maximum Ultraviolet Light Tranmission: (280 nm to 315 nm) UVB 5% maximum Surface Character: Hydrophilic Water Content: 59% Oxygen Permeability: 21.4 × 10 -11 (cm 2 /sec) (mL O 2 /mL × mmHg) at 35°C (boundary corrected, edge corrected) Dimensional Properties of the Lens: Diameter: 14.2 mm Center Thickness: Minus Lens - varies with power (e.g. -4.00D: 0.084 mm) Plus Lens - varies with power (e.g. +4.00D: 0.190 mm) Base Curve: 8.5 mm and 9.0 mm Power: -0.50D to -10.00D (in 0.25D increments) -10.50D to -12.00D (in 0.50D increments) +0.50D to +6.00D (in 0.25D increments) Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Fitting See the ACUVUE® Theravision™ with Ketotifen FITTING INSTRUCTION GUIDE for professional fitting instructions and information. Wearing Schedule (Daily Wear) Advise patients that ACUVUE ® Theravision™ with Ketotifen should not be used to treat red eye(s).

Remove lens(es) immediately if the eye(s) become red or irritated. A single ACUVUE ® Theravision™ with Ketotifen should be worn in each eye per day and should be discarded upon removal each day. The lens should not be worn beyond the period recommended by an eye care professional.

Advise patients that ACUVUE ® Theravision™ with Ketotifen should be removed prior to sleep. Lens Handling and Care Advise patients to not use if the ACUVUE ® Theravision™ with Ketotifen lens sterile blister package is opened or damaged. Advise patients to always wash and rinse hands before handling lenses.

Advise patients to avoid contaminating hands or lenses with cosmetics, lotions, soaps, creams, deodorants or sprays. Instruct patients to put in lenses prior to applying makeup. Advise patients not to touch contact lenses if hands have any foreign materials as microscopic scratches of the lenses may occur, which can cause distorted vision and/or injury to the eye.

Instruct patients to examine the lens after opening to be sure that it is a single, moist, clean lens that is free of any nicks or tears. If the lens appears damaged, patients should be instructed NOT to use it. Instruct patients not to use contact lens cleaning and disinfectant solutions with ACUVUE ® Theravision™ with Ketotifen.

Discard lens after a single day's use. Advise patients that ACUVUE® Theravision™ with Ketotifen should not be worn while swimming or in hot tubs. Contact lens wear in these settings increases the risk of sight threatening eye infections from microorganisms.

If the lens sticks (stops moving), the patient should be instructed to remove the lens. A few drops of non-preserved sterile saline solution may be applied directly to the eye to assist with removal. If non-movement of the lens continues after a few minutes, the patient should immediately consult their Eye Care Professional.

Patients should be advised to notify the employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that the patient not wear contact lenses. Advise patients to avoid all harmful or irritating vapors and fumes while wearing lenses.

If aerosol products, such as hair spray, are used while wearing lenses, exercise caution and keep eyes closed until the spray has settled. Instruct patients to never use tweezers, fingernails, or other tools to remove lenses from the lens container. Instead, patients should remove ACUVUE ® Theravision™ with Ketotifen from the blister container packing solution using their fingertips.

Patients should not touch the lens with fingernails. The patients should be advised to never rinse the lenses in water from the tap. Tap water contains many impurities that can contaminate or damage the lenses and may lead to eye infection or injury.

Advise patients to always dispose of lenses when removed and have spare non-medicated lenses or spectacles available. Concomitant Use of Other Medications Advise patients to consult with their eyecare professional before using any medicine in the eyes. Advise patients that eye drops containing benzalkonium chloride should not be used simultaneously with ACUVUE® Theravision™ with Ketotifen.

Instruct patients to wait 10 minutes after eye drop application before inserting lenses. Daily self-examination Instruct the patient to immediately remove the lens if any eye discomfort, eye pain, eye redness or decreased vision are experienced. If the symptoms stop after lens removal, the patient should discard the lens(es) and replace with new non-medicated lens(es).

ACUVUE ® Theravision™ with Ketotifen should not be worn… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The safety and efficacy of ACUVUE ® Theravision™ with Ketotifen was assessed in two double-masked, randomized, placebo-controlled clinical conjunctival allergen challenge (CAC) studies (CR-4483 and CR-4484) and two 12-week safety studies (CR-4490 and CR-4539). Patients in these studies had allergic conjunctivitis induced by an ocular allergen challenge and refractive ametropia (myopia and hyperopia) suitable for contact lens wear without more than

1.00D of astigmatism. A total of 244 patients (488 eyes) were evaluate in the CAC studies. A total of 491 subjects were exposed to ACUVUE ® Theravision™ with Ketotifen over a period of 12 weeks in the safety studies.

These four studies demonstrated that ACUVUE ® Theravision™ with Ketotifen was safe and more effective than placebo (1 • DAY ACUVUE ® ) in preventing ocular itching in patients with allergic conjunctivitis. ACUVUE ® Theravision™ with Ketotifen reduced ocular itching within 3 minutes and the response was sustained for up to 12 hours after lens insertion. Visual acuity was comparable between ACUVUE ® Theravision™ with Ketotifen and 1•DAY ACUVUE ® .

Not all refractive powers, design configurations, or lens parameters available were tested in clinical investigation of the lenses. Therefore, when selecting an appropriate lens design, the Eye Care Professional should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness and optic zone diameter. The potential impact of these factors on the patient's ocular health should be carefully weighed against the patient's need for refractive correction and prevention of itching associated with allergic conjunctivitis; therefore, the continuing ocular health of the patient and lens performance on the eye should be carefully monitored by the prescribing Eye Care Professional.

🧪 Nonclinical Toxicology 153 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No information is available on the carcinogenic potential of ketotifen fumarate. Mutagenesis Ketotifen fumarate was determined to be non-mutagenic in a battery of in vitro and in vivo mutagenicity assays including: Ames test, in vitro chromosomal aberration test with V79 Chinese hamster cells, in vivo micronucleus assay in mouse, and mouse dominant lethal test. In addition, extracts of etafilcon A with ketotifen (19 mcg/lens) prepared in 0.9% sodium chloride or dimethyl sulfoxide were shown to be non-mutagenic in the Ames test.

Impairment of Fertility Treatment of male rats with oral doses of ketotifen >10 mg/kg/day (approximately 2,600 times the MRHOD) for 70 days prior to mating resulted in mortality and a decrease in fertility. Treatment with ketotifen did not impair fertility in female rats receiving up to 50 mg/kg/day of ketotifen orally (approximately 13,000 times the MRHOD) for 15 days prior to mating.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 150 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No information is available on the carcinogenic potential of ketotifen fumarate. Mutagenesis Ketotifen fumarate was determined to be non-mutagenic in a battery of in vitro and in vivo mutagenicity assays including: Ames test, in vitro chromosomal aberration test with V79 Chinese hamster cells, in vivo micronucleus assay in mouse, and mouse dominant lethal test. In addition, extracts of etafilcon A with ketotifen (19 mcg/lens) prepared in 0.9% sodium chloride or dimethyl sulfoxide were shown to be non-mutagenic in the Ames test.

Impairment of Fertility Treatment of male rats with oral doses of ketotifen >10 mg/kg/day (approximately 2,600 times the MRHOD) for 70 days prior to mating resulted in mortality and a decrease in fertility. Treatment with ketotifen did not impair fertility in female rats receiving up to 50 mg/kg/day of ketotifen orally (approximately 13,000 times the MRHOD) for 15 days prior to mating.

📖 Instructions for Use ~3 min read ▾

ACUVUE ® Theravision™ with Ketotifen (etafilcon A lens with ketotifen) For Eye Itch for Daily Disposable Wear FITTING INSTRUCTION GUIDE Rx Only CAUTION: US Federal law restricts this device to sale by or on the order of a licensed practitioner PRODUCT DESCRIPTION For full prescribing information see the ACUVUE® Theravision™ with Ketotifen Package Insert . ACUVUE ® Theravision™ with Ketotifen is a sterile, soft (hydrophilic), spherical etafilcon A drug-eluting contact lens containing ketotifen, an H1 receptor antagonist, for topical administration to the eyes.

Ketotifen fumarate is a white to brownish-yellow, fine crystalline powder with a molecular formula of C 19 H 19 NOS-C 4 H 4 O 4 and formula weight of 425.50 g/mol. The buffered packaging solution of ACUVUE ® Theravision™ with Ketotifen has a pH of 6.6 to 7.3 and an osmolality of 380 to 460 mOsm/Kg. Contains: Active: ketotifen 19 mcg per lens Inactives: boric acid, calcium hydroxide, pentetic acid, sodium chloride, sodium borate, and water.

Chemical Name: 10 H -Benzo[4,5]cyclohepta[1,2-b]thiophen-10-one, 4,9 dihydro-4-(1-methyl-4-piperidinylidene)-, hydrogen fumarate. Structural Formula: .This product does not contain an antimicrobial preservative. The contact lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1, 1, 1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate.

ACUVUE ® Theravision™ with Ketotifen contact lenses are tinted blue using blue 2-hydroxyethyl methacrylate to make the lenses more visible for handling. Physical/Optical Properties of the Lens: Specific Gravity (calculated): 0.98 –

1.12 Refractive Index:

1.40Visible Light Transmittance: 90% minimum Surface Character: Hydrophilic Water Content: 59% Oxygen Permeability (D/k): VALUE 21.4 × 10 -11 (cm 2 /sec) Fatt(boundary corrected, edge corrected) (ml O 2 /ml × mm Hg) at 35°C METHOD Dosage Forms and Strengths: etafilcon A drug-eluting contact lens with ketotifen (19 mcgper lens). How Supplied: Each ACUVUE ® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) lens is supplied in a foil-sealed plastic package containing a buffered ketotifen solution.

The plastic package is marked with base curve, diopter power, diameter, lot number and expiration date. AVAILABLE LENS PARAMETERS The ACUVUE ® Theravision™ with Ketotifen Brand Contact Lenses are hemispherical shells of the following dimensions: Diameter (DIA): 14.2 mm Center Thickness: Minus Lens - varies with power (e.g. -4.00D: 0.084 mm) Plus Lens - varies with power (e.g. +4.00D: 0.190 mm) Base Curve (BC): 8.5 mm and 9.0 mm Powers (D): -0.50D to -10.00D (in 0.25D increments) -10.50D to -12.00D (in 0.50D increments) +0.50D to +6.00D (in 0.25D increments) ACTIONS See CLINICAL PHARMACOLOGY, Mechanism of Action section of the ACUVUE ® Theravision™ with Ketotifen Package Insert.

INDICATIONS AND USES See INDICATIONS AND USAGE section of the ACUVUE ® Theravision™ with Ketotifen Package Insert. CONTRAINDICATIONS (REASONS NOT TO USE) See CONTRAINDICATIONS section of the ACUVUE ® Theravision™ with Ketotifen Package Insert. WARNINGS See WARNINGS AND PRECAUTIONS section of the ACUVUE ® Theravision™ with Ketotifen Package Insert.

PRECAUTIONS See WARNINGS AND PRECAUTIONS section of the ACUVUE ® Theravision™ with Ketotifen Package Insert. ADVERSE REACTIONS See ADVERSE REACTIONS section of the ACUVUE ® Theravision™ with Ketotifen Package Insert. FITTING GENERAL FITTING GUIDELINES Patient Selection You should first assess the patient's needs to ensure that the patient is an appropriate candidate for ACUVUE ® Theravision™ with Ketotifen.

ACUVUE ® Theravision™ with Ketotifen, like other soft contact lenses, will require the appropriate and usual physiological and diagnostic assessments necessary to ensure proper patient selection. Pre-Fitting Examination A pre-fitting patient history and examination are necessary to: Determine whether a patient is a suitable candidate… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL - 30 Lens Blister Pack Carton NDC 60123-019-30 19 mcg per lens ACUVUE ® Theravision™ with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen) 1 DAY FOR EYE ITCH 30 CONTACT LENSES PRINCIPAL DISPLAY PANEL - 30 Lens Blister Pack Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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