Iheezo

Description for Iheezo

IHEEZO™ is a sterile, single-patient-use ophthalmic gel preparation for topical ocular anesthesia containing chloroprocaine hydrochloride as the active pharmaceutical ingredient. Chloroprocaine hydrochloride is an ester anesthetic. It is a water-soluble white crystalline powder and its chemical name is 2-(Diethylamino)ethyl 4-amino-2-chlorobenzoate monohydrochloride. The molecular weight is 307.22 and the molecular formula is C₁₃H₁₉ClN₂O₂·HCl. It is represented by the following structural formula:

IHEEZO™ contains: Active: 30 mg of chloroprocaine hydrochloride (equivalent to 26 mg of chloroprocaine) per gram of gel.

Inactive ingredients: Hydroxyethyl Cellulose (HEC), and Water for Injection. The pH may be adjusted to 3.0 to 5.0 with Hydrochloric Acid. This product does not contain an antimicrobial preservative.

Uses for Iheezo

IHEEZO™ is indicated for ocular surface anesthesia.

Dosage for Iheezo

The recommended dose of IHEEZO™ is 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO™ may be reapplied as needed to maintain anesthetic effect.

HOW SUPPLIED

Dosage Forms And Strengths

IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% contains 24 mg of chloroprocaine hydrochloride per vial (800 mg of gel).

Storage And Handling

IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% is supplied as a sterile, clear, colorless to light yellow gel in a single-patient-use vial. Each single-patient-use vial contains 24 mg chloroprocaine in 800 mg of gel.

Aluminum pouch containing 1 LDPE single-patient-use vial of IHEEZO™. The outer surface of the vial is not sterile.

NDC 82667-300-01 Package of 1 unit of 1.25 mL single-patient-use vial (800 mg filled)
NDC 82667-300-10 Package of 10 units of 1.25 mL single-patient-use vials (800 mg filled)

Storage

Store at 15°C to 25°C (59°F to 77°F). Discard after use.

Manufactured by Laboratoire Unither 1 Rue de l’Arquerie 50200 COUTANCES France. Distributed by Harrow Eye, LLC 102 Woodmont Blvd. Suite 610 Nashville, TN 37205 USA. Revised: Sep 2022

Side Effects for Iheezo

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO™ or placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO™ or placebo.

The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO™ administration were mydriasis, conjunctival hyperemia and eye irritation.

Adverse Reactions Reported In Controlled Trials

Table 1: Adverse Reactions in 5% or more of IHEEZO™ Treated Patients in Studies 1 and 2

Preferred Term	IHEEZO™	Placebo
	N=151 n (%)	N=50 n (%)
Mydriasis	39 (26%)	1 (2%)
Conjunctival hyperemia	16 (11%)	6 (12%)
Eye irritation	9 (6%)	2 (4%)

Drug Interactions for Iheezo

No Information provided

Warnings for Iheezo

Included as part of the PRECAUTIONS section.

Precautions for Iheezo

Not For Injection Or Intraocular Administration

IHEEZO™ should not be injected or intraocularly administered.

Corneal Injury Due To Insensitivity

Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

Corneal Opacification

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

Risk Of Contamination

Do not touch the dropper tip to any surface as this may contaminate the gel.

For Administration By Healthcare Provider

IHEEZO™ is indicated for administration under the direct supervision of a healthcare provider. IHEEZO™ is not intended for patient self-administration.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Long-term studies in animals to evaluate carcinogenic potential of chloroprocaine have not been conducted.

Mutagenesis

2-chloroprocaine and the main metabolite, ACBA, were negative in the in vitro bacterial reverse mutation test (Ames assay) and the in vitro chromosome aberrations assay.

Impairment Of Fertility

Studies in animals to evaluate the impairment of fertility have not been conducted with chloroprocaine.

Use In Specific Populations

Pregnancy

Risk Summary

There are no adequate and well-controlled studies of IHEEZO use in pregnant women to inform a drug associated risk. There are no animal reproduction studies for chloroprocaine.

Lactation

Risk Summary

There are no data on the presence of chloroprocaine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IHEEZO and any potential adverse effects on the breastfed infant from IHEEZO.

Pediatric Use

The safety and effectiveness of IHEEZO™ have not been established in pediatric patients.

Geriatric Use

No overall differences in safety or effectiveness of IHEEZO™ have been observed between elderly and younger patients.

Overdose Information for Iheezo

No Information provided

Contraindications for Iheezo

IHEEZO™ is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

Uses for Iheezo

IHEEZO™ is indicated for ocular surface anesthesia.

Dosage for Iheezo

The recommended dose of IHEEZO™ is 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO™ may be reapplied as needed to maintain anesthetic effect.

HOW SUPPLIED

Dosage Forms And Strengths

IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% contains 24 mg of chloroprocaine hydrochloride per vial (800 mg of gel).

Storage And Handling

IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% is supplied as a sterile, clear, colorless to light yellow gel in a single-patient-use vial. Each single-patient-use vial contains 24 mg chloroprocaine in 800 mg of gel.

Aluminum pouch containing 1 LDPE single-patient-use vial of IHEEZO™. The outer surface of the vial is not sterile.

NDC 82667-300-01 Package of 1 unit of 1.25 mL single-patient-use vial (800 mg filled)
NDC 82667-300-10 Package of 10 units of 1.25 mL single-patient-use vials (800 mg filled)

Storage

Store at 15°C to 25°C (59°F to 77°F). Discard after use.

Manufactured by Laboratoire Unither 1 Rue de l’Arquerie 50200 COUTANCES France. Distributed by Harrow Eye, LLC 102 Woodmont Blvd. Suite 610 Nashville, TN 37205 USA. Revised: Sep 2022

Patient Information for Iheezo

Eye Care Precaution

Do not touch the dropper tip to any surface as this may contaminate the gel.

Advise patients that their eyes will be insensitive for up to 20 minutes due to the effect of the anesthetic, and that care should be taken to avoid accidental injuries.