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LATISSE is a brand name for Bimatoprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LATISSE® (bimatoprost) is indicated for: treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Patients without visible eyelashes were not studied. 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Not applicable. 2 Recommended Dose and Dosage Adjustment Special device and administration procedure are recommended for delivering proper dose of LATISSE once nightly. This is done by adding ONLY ONE drop of the drug solution on a special applicator with which the medication is applied to the upper eyelid margin of one eye following a specified administration procedure.
4 Administration. As a result, only a small fraction of the solution applied to the applicator/device is actually administered on the dermal part of the upper eye lid margin of each eye per day. The recommended administration procedure should be closely followed to ensure the recommended dose is properly applied.
4 Administration. Additional applications of LATISSE will not increase the growth of eyelashes and may increase the risk of adverse reactions. 5 Post-Market Adverse Drug Reactions. LATISSE (bimatoprost) Page 5 of 29 Upon discontinuation of treatment, eyelash growth is expected to gradually return to its pre- treatment level.
Health Canada has not authorized an indication for pediatric use. 3 Reconsititution Not applicable. 4 Administration Intended for dermal topical application to the upper eyelid margin. The following administration procedure should be closely followed to ensure that recommended dose is administered.
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place ONLY one drop of LATISSE solution on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes.
The upper lid margin in the area of lash growth should feel lightly moist without runoff. Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use.
Repeat for the opposite eyelid margin using a NEW sterile applicator. Do not apply directly in the eye. Do not add more than one drop to an applicator. Blot any excess solution outside the upper eyelid margin with a tissue or other absorbent material.
Do not administer the medication more than once daily. Do not apply to the lower eyelash line. Do not use the same applicator for more than one eye. Do not reuse applicators. Do not alter the applicator in any form. Do not use any other brush/applicator to apply LATISSE.
1 Adverse Reaction Overview In one multicentre, double-masked, randomized, vehicle-controlled, parallel study of 4 months duration (Study 192024-032), most adverse events detected were ocular, mild to moderate, and not serious. The most frequently reported adverse events with the use of LATISSE were eye pruritis, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid.
These events occurred in less than 4% of patients (see Table 2). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In the clinical study (192924-032) 278 subjects with hypotrichosis, otherwise healthy (without ocular or systemic diseases) were treated with LATISSE for four months.
Subjects (n=251) followed a post- treatment period that lasted 4 weeks. Adverse reactions that were reported by greater than 1% of subjects enrolled in Study 192024-032 are presented in Table 2. 0) a Conjunctival hyperaemia was the only preferred term that was reported by a statistically significantly higher percentage of subjects in the bimatoprost group compared with the vehicle group.
1% (41/141) of subjects in the vehicle group reported at least 1 adverse event (AE), a difference that was not statistically significant. Four subjects in each treatment group discontinued the study due to an LATISSE (bimatoprost) Page 12 of 29 adverse event.
The adverse events that led to study discontinuation by the 4 subjects in the vehicle group were lymphoma, eyelid erythema, conjunctival hemorrhage (all mild or moderate severity), and low IOP (severe). The adverse events that led to study discontinuation by the 4 subjects in the bimatoprost group were eczema, dry eye, eye inflammation, and contact dermatitis, all of which were of mild or moderate severity.
General Patients who receive treatment with LATISSE should be informed of the possibility of increased iris pigmentation (IP). Carcinogenesis and Mutagenesis Bimatoprost was neither carcinogenic nor mutagenic in animals and in vitro studies.
See 16 NON- CLINICAL TOXICOLOGY. Driving and Operating Machinery As with any ocular medication, if transient blurred vision occurs after application to the upper eyelashes, the patient should wait until the vision clears before driving or using machinery.
05 mg/mL as preservative, citric acid monohydrate, purified water, sodium chloride and sodium phosphate dibasic heptahydrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LATISSE (bimatoprost) Page 8 of 29 Hepatic/Biliary/Pancreatic LATISSE has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
Ophthalmologic Iris Pigmentation:
Bimatoprost-containing products, including LUMIGAN ophthalmic solution and LATISSE, have been associated with IP. 5 Post-Market-Adverse Drug Reactions. Based on clinical experience with bimatoprost-containing products, iris color changes may not be noticeable for weeks to several months or longer, although there are some reports associated with shorter duration of treatment.
The related causes are not known. 5 Post-Market-Adverse Drug Reactions. Typically in bimatoprost-associated IP, increased brown pigmentation around the pupil spreads concentrically towards the periphery of the iris. This may affect the entire iris.
The color change may not be symmetrical in the iris of an eye or between the irises of the two eyes. Darker or brown spots in iris were reported in some of the post-marketing cases of LATISSE. 5 Post-Market-Adverse Drug Reactions. Bimatoprost-induced IP is most likely permanent.
LATISSE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bimatoprost in Canada.
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See PATIENT MEDICATION INFORMATION, How to take LATISSE section. 5 Missed Dose If a dose is missed, patients should be instructed to return to their regular routine the following day.
All were ongoing at the time of discontinuation, with the exception of contact dermatitis, which had resolved without sequelae. The adverse event of eye inflammation was considered by the investigator to be unrelated to treatment. Adverse reactions reported with bimatoprost ophthalmic solution (LUMIGAN) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema, conjunctival hyperemia, macular edema, eyelid edema, periorbital erythema, abnormal hair growth, iritis, deepened lid sulcus, enophthalmos, infections (primarily colds and upper respiratory tract infections), hypertension, headaches, dizzinesss, nausea, asthenia, eye pruritus, eyelid pruritus, irritation eye, erythema eyelid, blepharal pigmentation.
3 Less Common Clinical Trial Adverse Reactions Clinical studies have shown increased IP in glaucoma patients treated with bimatoprost ophthalmic products. 05%, respectively. 03%, the risk of LATISSE-associated IP is expected to be very low.
However, during the post-marketing phase, there have been reports of IP associated with the use of LATISSE. 5 Post- Market Adverse Reactions. For LUMIGAN the following ocular AEs (<1%) were blepharospasm, eyelid oedema, chalazion, eye oedema, hordeolum, conjunctival bleb, conjunctival folliculosis, eyelid pain, iritis (ocular inflammation), keratitis, visual field defect, vitreous floaters.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Not applicable. 5 Post-Market Adverse Reactions In addition to what has been observed in clinical trials, the following adverse reactions have been identified during post marketing use of LATISSE in clinical practice.
Because post marketing reporting is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions. Eye disorders: blepharitis, eye discharge, eye pain, eye swelling, eyelid edema, eyelid irritation, eyelid pain, eyelids pruritus, foreign body sensation in eyes, increased lacrimation, iris hyperpigmentation, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis, skin exfoliation of the eyelid and/or periorbital area, vision blurred LATISSE (bimatoprost) Page 13 of 29 It is clear that bimatoprost exposure levels with LATISSE are a fraction of that seen with LUMIGAN use in glaucoma, if used according to recommended conditions; […]
Treatment with LATISSE should be discontinued if IP is observed. Because overall exposure to bimatoprost is considerably lower with LATISSE than with LUMIGAN ophthalmic solution, under approved conditions of use, it is expected that the risk of IP associated with LATISSE would be very low compared to the risk associated with the use of LUMIGAN.
However, there have been higher numbers of reports of IP with LATISSE use than anticipated. Because improper use may play a role in increasing the risk of IP with LATISSE, it is important to emphasize the correct use of the product and advise patients to use LATISSE according to the specialized administration procedure.
4 Administration.
Contamination of LATISSE or Applicators:
The tip of the LATISSE bottle should not be allowed to contact the eye, surrounding structures, fingers or any other surface in order to avoid eye injury or contamination of the solution. It is important to use LATISSE solution as instructed, by placing one drop on the single-use-per eye applicator.
The accompanying sterile applicators should only be used on one eye and then discarded since reuse of applicators increases the potential for contamination and infections. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
See PATIENT MEDICATION INFORMATION, How to take LATISSE section.
Effects on Intraocular Pressure:
Bimatoprost ophthalmic solution (LUMIGAN) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients without elevated IOP, LATISSE lowered IOP, however, the magnitude of the reduction was not cause for clinical concern.
In ocular hypertension studies with LUMIGAN, it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP lowering effect. In patients using LUMIGAN or other prostaglandin analogs for the treatment of elevated IOP, the concomitant use of LATISSE may interfere with the desired reduction in IOP.
Patients using prostaglandin analogs including LUMIGAN for LATISSE (bimatoprost) Page 9 of 29 IOP reduction should only use LATISSE after consulting with their physician and should be monitored for changes to their IOP. g. uveitis) because the inflammation may be exacerbated.
03% ophthalmic solution (LUMIGAN) for elevated IOP. LATISSE should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Use with Contact Lenses:
Contact lenses should be removed prior to application of LATISSE and may be reinserted 15 minutes following its administration. Patients should be advised that LATISSE contains benzalkonium chloride, which may be absorbed by soft contact lenses.
Renal LATISSE has not been studied in patients with renal impairment and should therefore be used with caution in such patients. 6 mg/kg/day (approximately 103 times the human exposure based on Area Under the Curve (AUC) levels after ocular administration).
Skin Hair Growth Outside the Treatment Area:
There is the potential for hair growth to occur in areas where LATISSE comes in repeated contact with the skin surface. It is important to apply LATISSE only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess LATISSE from the eyelid margin to avoid it running onto the cheek or other skin areas.
Lid Pigmentation:
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital […]