Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Aerie Pharmaceuticals Ireland, Limited, Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland
Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.
Treatment with Rhokiinsa should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
The recommended dosage is one drop in the affected eye(s) once daily in the evening. Patients should not instill more than one drop in the affected eye(s) each day.
If one dose is missed, treatment should continue with the next dose in the evening.
The safety and efficacy of Rhokiinsa in children below the age of 18 years have not been established. No data are available.
For ocular use.
No data on potential interactions specific to netarsudil is currently available (see section 4.5). If netarsudil is to be used concomitantly with other topical ophthalmic medicinal products, each medicinal product should be administered at least five (5) minutes apart. Due to netarsudil’s vasodilating properties, other eye drops should be administered before. Eye ointments should be administered last.
Contact lenses should be removed prior to instillation of netarsudil and may be reinserted 15 minutes following its administration (see section 4.4).
The tip of the dispensing container should avoid contacting the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Systemic exposure to netarsudil following topical ocular administration has been shown to be negligible. If topical overdose of netarsudil should occur, the eye(s) may be flushed with tap water. Treatment of an overdose would include supportive and symptomatic therapy.
3 years.
Opened bottle: 4 weeks after first opening the bottle. Do not store above 25°C.
Store in a refrigerator (2°C–8°C) until opened.
For storage conditions after first opening of the medicinal product, see section 6.3.
Rhokiinsa is supplied sterile in opaque white low density polyethylene bottles (2.5 ml fill in a 4 ml container) and tips with white polypropylene caps and anti-tamper seals.
Carton containing 1 bottle.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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