ACUVUE® Theravision™ with Ketotifen is contraindicated in patients with:
- Ocular hyperemia and should not be inserted into red or irritated eye(s). Remove ACUVUE® TheravisionTM with Ketotifen immediately if eye(s) become red or irritated.
- Decreased corneal sensation
- Any corneal infection (bacterial, fungal, protozoal, or viral)
ACUVUE® TheravisionTM 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.
Contact Lens-Related Complications
ACUVUE® TheravisionTM with Ketotifen should not be used to treat or prevent lens-related symptoms including irritation, discomfort, or redness. ACUVUE® TheravisionTM 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, keratitis, the lens(es) should be IMMEDIATELY REMOVED.
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.
ACUVUE® TheravisionTM 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.
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.
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.
Concomitant Use of Eye Drops or Eye Medications
Eye drops or eye medications containing benzalkonium chloride should not be used simultaneously with ACUVUE® TheravisionTM with Ketotifen. Wait at least 10 minutes after eye drop application before inserting lenses.
There are no adequate and well-controlled studies of ACUVUE® Theravision™ with Ketotifen administration in pregnant women to inform a drug-associated risk. ACUVUE® Theravision™ 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.
There is no information regarding the presence or absence of ketotifen fumarate or its metabolites in human milk following the use of ACUVUE® TheravisionTM with Ketotifen, in breastfed infants or on milk production. It is not known whether topical or 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® TheravisionTM with Ketotifen and any potential adverse effects on the breast-fed child from ketotifen fumarate.
The safety and efficacy of ACUVUE® Theravision™ with Ketotifen in pediatric patients below the age of 11 years has not been established.
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.
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.
Please see full
Prescribing Information and
Patient Instruction Guide.
References: 1.ACUVUE® Theravision™ with Ketotifen. Prescribing information. Johnson & Johnson Vision Care, Inc. 2022