If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended. If RHOPRESSA is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart [see Patient Counseling Information (17)]. 

 

3 DOSAGE FORMS AND STRENGTHS 

  

 

Ophthalmic solution containing 0.2 mg/mL of netarsudil.

 

4 CONTRAINDICATIONS 

 

None.

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Bacterial Keratitis 

 

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information (17)].

 

5.2 Use with Contact Lenses 

 

Contact lenses should be removed prior to instillation of RHOPRESSA and may be reinserted 15 minutes following its administration.

 

6 ADVERSE REACTIONS 

 

6.1 Clinical Trials 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 rates in the clinical studies of another drug and may not reflect the rates observed in practice.

 

The most common ocular adverse reaction observed in controlled clinical studies with RHOPRESSA dosed once daily was conjunctival hyperemia which was reported in 53% of patients. Other common (approximately 20%) ocular adverse reactions reported were: corneal verticillata, instillation site pain, and conjunctival hemorrhage. Instillation site erythema, corneal staining, blurred vision, increased lacrimation, erythema of eyelid, and reduced visual acuity were reported in 5-10% of patients.

 

Corneal Verticillata 

 

Corneal verticillata occurred in approximately 20% of the patients in controlled clinical studies. The corneal verticillata seen in RHOPRESSA-treated patients were first noted at 4 weeks of daily dosing. This reaction did not result in any apparent visual functional changes in patients. Most corneal verticillata resolved upon discontinuation of treatment.

 

8 USE IN SPECIFIC POPULATIONS 

  

 

  

 

8.1 Pregnancy 

 

Risk Summary 

 

There are no available data on RHOPRESSA use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology (12.3)]. Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures [see Data].

 

Data 

 

Animal Data