Omidria

OMIDRIA — phenylephrine and ketorolac injection, solution, concentrate
Omeros Corporation

1 INDICATIONS AND USAGE

Omidria® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

2 DOSAGE AND ADMINISTRATION

Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure for a single patient.

The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions.

Do not use if the solution is cloudy or if it contains particulate matter.

3 DOSAGE FORMS AND STRENGTHS

Omidria is an intraocular solution containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac for use in a single patient.

4 CONTRAINDICATIONS

Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Elevated Blood Pressure

Systemic exposure to phenylephrine can cause elevations in blood pressure.

5.2 Cross-Sensitivity or Hypersensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these drugs.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

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

Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of adult patients as seen in the combined clinical trial results from three randomized, placebo-controlled studies [see Clinical Studies (14)].

Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Adult Patients
MedDRA Preferred Term Placebo (N=462) Omidria (N=459)
n (%) n (%)
Ocular Events
Anterior Chamber Inflammation 102 (22%) 111 (24%)
Intraocular Pressure Increased 15 (3%) 20 (4%)
Posterior Capsule Opacification 16 (4%) 18 (4%)
Eye Irritation 6 (1%) 9 (2%)
Foreign Body Sensation in Eyes 11 (2%) 8 (2%)

In a safety study that enrolled 72 pediatric patients up to 3 years old, no overall difference in safety was observed between pediatric and adult patients.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on Omidria use in pregnant women or animals to inform any drug-associated risks. Oral administration of ketorolac to rats during late gestation produced dystocia and increased pup mortality at a dose 740-times the plasma exposure at the recommended human ophthalmic dose (RHOD). Since human systemic exposure to Omidria following a lens replacement procedure is low [see Clinical Pharmacology (12.3) ], the applicability of animal findings to the risk of Omidria in humans during pregnancy is unclear. Omidria should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Ketorolac plasma concentrations are detectable following ocular Omidria administration [see Clinical Pharmacology (12.3)]. The use of Omidria during late pregnancy should be avoided.

Data

Animal Data

No well-controlled animal reproduction studies have been conducted with Omidria or phenylephrine.

Ketorolac, administered during organogenesis, did not cause embryofetal abnormalities or mortalities in rabbits or rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses produced systemic exposure that is 1150 times and 4960 times the plasma exposure (based on Cmax ) at the RHOD, respectively. When administered to rats during late gestation (after Day 17 of gestation) at oral doses up to 1.5 mg/kg/day (740 times the plasma exposure at the RHOD), ketorolac produced dystocia and increased pup mortality.

8.2 Lactation

Risk Summary

There are no data on the presence of Omidria in human milk, the effects on the breastfed infant, or the effects on milk production. Howerver, systemic exposure to Omidria, following a lens replacement procedure is low [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Omidria and any potential adverse effects on the breastfed child from Omidria.

8.4 Pediatric Use

The safety and effectiveness of Omidria have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). Use of Omidria in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old [see Clinical Studies (14)].

No overall differences in safety were observed between pediatric and adult patients.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and adult patients.

10 OVERDOSAGE

Systemic overdosage of phenylephrine may cause a rise in blood pressure. It may also cause headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Supportive care is recommended.

11 DESCRIPTION

Omidria is a sterile aqueous solution, containing the α1 -adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution.

The descriptions and structural formulae are:

Phenylephrine Hydrochloride Drug Substance:

Common Name: phenylephrine hydrochloride
Chemical Name: (-)-m -Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride
Molecular Formula: C9 H13 NO2 · HCl
Molecular Weight: 203.67 g/mole

Figure 1: Chemical Structure for Phenylephrine HCl

Figure 1

Ketorolac Tromethamine Drug Substance:

Common Name: ketorolac tromethamine
Chemical Name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
Molecular Formula: C15 H13 NO3 · C4 H11 NO3
Molecular Weight: 376.40 g/mole

Figure 2: Chemical Structure for Ketorolac Tromethamine

Figure 2
(click image for full-size original)

Omidria is a clear, colorless to slightly yellow, sterile solution concentrate with a pH of approximately 6.3.

Each vial of Omidria contains:

Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac.

Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.

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