Latisse (Drops) Instructions for Use

Marketing Authorization Holder

Allergan, Inc. (USA)

Manufactured By

Allergan Sales, LLC (USA)

ATC Code

S01EE03 (Bimatoprost)

Active Substance

Bimatoprost (Rec.INN registered by WHO)

Dosage Form

Latisse

Drops for topical application 0.03%: dropper bottle 3 ml

Dosage Form, Packaging, and Composition

Drops for topical application in the form of a transparent, almost colorless solution.

Excipients: benzalkonium chloride, sodium phosphate heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid, sodium hydroxide, water.

3 ml – dropper bottles (1) – cardboard packs (1) complete with applicators (60 pcs.) – cardboard holders.

Clinical-Pharmacological Group

Prostaglandin analogue. Drug for the treatment of hypotrichosis

Pharmacotherapeutic Group

Remedy for hypotrichosis

Pharmacological Action

Bimatoprost is a structural analogue of prostaglandin.

The exact mechanism of action is unknown, but it is assumed that eyelash growth occurs due to an increase in the number of eyelashes, as well as an increase in the duration of the hair follicle growth phase or the eyelash growth phase.

Pharmacokinetics

When bimatoprost is instilled in the dosage form of 0.03% drops for topical application, it has been shown that the maximum plasma concentration of the drug is reached within 10 minutes after application and decreases to the lower limit of quantification (0.025 ng/ml) within 1.5 hours.

The mean values of maximum plasma concentration (C_max) and area under the concentration-time curve (AUC) on days 7 and 14 of bimatoprost application were approximately the same (0.08 ng/ml and 0.09 ng×h/ml, respectively). No significant systemic accumulation was noted.

Bimatoprost is moderately distributed in body tissues with a volume of distribution at steady state of 0.67 L/kg.

In blood plasma, Bimatoprost is predominantly in a protein-bound state. Only 12% of bimatoprost is in free form in the systemic circulation. Bimatoprost reaches the systemic circulation mainly unchanged. Then oxidation, ethylation and glucuronidation occur with the formation of a number of metabolites.

When bimatoprost was administered intravenously at a dose of 3.12 mg/kg to 6 healthy volunteers, the C_max of the drug in plasma was 12.2 ng/ml.

The half-life (T_1/2) was about 45 minutes. The total clearance of bimatoprost is 1.5 L/h/kg. Up to 67% of the active substance is excreted by the kidneys, and 25% through the gastrointestinal tract.

Indications

• Treatment of eyelash hypotrichosis (insufficient eyelash growth).

ICD codes

Dosage Regimen

The drug is used once at night.

The face should be pre-cleansed of decorative cosmetics and contact lenses should be removed. One drop of Latisse is applied to the sterile applicator supplied with the kit, and the drug is evenly applied to the skin of the upper eyelid along the lash line, running the brush along the edge of the upper eyelid.

The upper eyelid in the area of the lash line should be slightly moistened, but without the drug flowing beyond the lash line.

To avoid excessive wetting of the eyelid, excess drug should be removed. The applicator must be discarded after a single use. The procedure of applying the drug to the upper eyelid is repeated for the other eye, using another sterile applicator.

Reuse of applicators is prohibited.

Do not use any other applicator (except for the sterile applicators supplied with the kit) or brush to apply Latisse.

The drug should not be applied to the lower eyelid. Avoid contact of the bottle dropper with any surfaces to avoid contamination.

Adverse Reactions

Eye itching, conjunctival hyperemia, eyelid skin hyperpigmentation, eye irritation, dry eye syndrome, eyelid redness.

The listed side effects were observed in less than 4% of cases. A decrease in intraocular pressure is possible.

Contraindications

• Hypersensitivity to the components of the drug;
• Age under 18 years;
• Pregnancy;
• Breastfeeding period.

With caution: aphakia, pseudophakia, damage to the posterior lens capsule, as well as in the presence of risk factors for the development of macular edema, long-term diabetes mellitus, high cholesterol, nephropathy, arterial hypertension, especially with high diastolic pressure, in patients with uveitis due to the possible progression of this disease.

Use in Pregnancy and Lactation

In animal studies, when bimatoprost was taken orally at a dose that was 33-97 times higher than the recommended dose for topical use, miscarriages were observed.

When used at a dose 41 times higher than the therapeutic dose, a reduction in gestation periods, an increase in the frequency of fetal death, and a decrease in the body weight of newborns were noted. Controlled studies of Latisse in pregnant women in the dosage form of 0.03% drops for topical application have not been conducted.

Animal studies have confirmed the penetration of bimatoprost into breast milk.

If the drug is prescribed during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in nephropathy.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

The treatment effect develops gradually, in most patients up to 2 months.

Patients should be warned that the effect of the drug is not permanent, and a gradual return to the original state is expected after discontinuation of Latisse. In addition, differences in eyelash length, thickness, color intensity, total number of eyelashes or uneven growth, and/or changes in the direction of eyelash growth are possible.

If the patient forgot to apply Latisse, it is applied at the usual time the next day.

Effect on intraocular pressure (IOP)

Bimatoprost reduces intraocular pressure.

In clinical studies, the use of Latisse was accompanied by a decrease in IOP both in patients with high IOP and with normal IOP. With concomitant use of Latisse and prostaglandin analogues (including bimatoprost in the form of eye drops) used to reduce IOP in patients with ocular hypertension, a decrease in the hypotensive effect is possible. IOP monitoring is recommended.

Iris pigmentation

Increased pigmentation of the iris, especially with dark pigment, is possible; this effect may be irreversible.

Increased iris pigmentation was observed during the instillation of eye drops. The change in pigmentation is primarily associated with an increase in melanin content, as well as an increase in the number of melanocytes. The duration of the increased pigmentation effect is unknown. Significant increase in iris pigmentation is not an indication for discontinuation of Latisse.

Eyelid skin pigmentation

Bimatoprost has been reported to cause darkening of the eyelid skin and periorbital area.

It is assumed that pigmentation may increase throughout the entire time of using Latisse, but in most patients it is reversible and gradually disappears after discontinuation of the drug.

Hair growth outside the treatment area

Hair growth is possible on those areas of the skin where the drug was accidentally applied.

It is important to apply Latisse only to the skin of the upper eyelid margin along the lash line using the supplied sterile applicator; do not allow Latisse to come into contact with the skin of the face.

Preventing microbial contamination of Latisse and applicators

To reduce the risk of eye infection, it is recommended to use Latisse strictly in accordance with the instructions; the tip of the dropper bottle and the applicator brush should not come into contact with any surfaces, and you should not touch them with your fingers.

The supplied sterile applicator must be used only once; after use, the applicator is discarded.

Use when wearing contact lenses

Latisse contains benzalkonium chloride, which can be adsorbed by soft contact lenses, cause eye irritation and discoloration of soft contact lenses.

Contact lenses must be removed before applying the drug and reinserted no earlier than 15 minutes later.

If any symptoms from the organ of vision occur (eye injury, infectious complication, etc.), with a sudden decrease in visual acuity, if a planned ophthalmic surgery is necessary, as well as if side effects occur, you should consult an ophthalmologist to decide on the possibility of further treatment with Latisse.

The shelf life of the drug after first opening the bottle is 28 days.

Effect on the ability to drive vehicles and mechanisms

No adverse effects are expected.

Overdose

There is no information on cases of Latisse overdose.

In case of accidental overdose, therapy should be symptomatic.

Drug Interactions

If an eye drop drug containing Bimatoprost is used in patients with glaucoma or high intraocular pressure, the degree of intraocular pressure reduction may be less pronounced with simultaneous use of Latisse.

Cases of incompatibility are unknown.

Storage Conditions

At a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

The shelf life is 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.