ROCKLATAN(netarsudil and latanoprost ophthalmic solution)0.02%/0.005%, for topical ophthalmic(一)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ROCKLATAN™ safely and effectively. See full prescribing information
for ROCKLATAN™.
ROCKLATAN(netarsudil and latanoprost ophthalmic solution)0.02%/0.005%, for topical ophthalmic use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
ROCKLATAN™ 0.02%/0.005% is a fixed dose combination of a Rhokinase inhibitor and a prostaglandin F2α analogue indicated for the reductionof elevated intraocular pressure (IOP) in patients with open-angle glaucomaor ocular hypertension.
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening.
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing netarsudil 0.2 mg/mL (0.02%) andlatanoprost 0.05 mg/mL (0.005%).
WARNINGS AND PRECAUTIONS
Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) andeyelashes can occur. Iris pigmentation likely to be permanent.
Eyelash Changes: Gradual change to eyelashes including increasedlength, thickness and number of lashes. Usually reversible.
ADVERSE REACTIONS
The most common adverse reaction is conjunctival hyperemia (59%). Othercommon adverse reactions were: instillation site pain (20%), corneal verticillata(15%), and conjunctival hemorrhage (11%).
To report SUSPECTED ADVERSE REACTIONS, contact AeriePharmaceuticals, Inc. at 1-855-740-1924, or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Thimerosal: In vitro studies have shown that precipitation occurs when eyedrops containing thimerosal are mixed with latanoprost 0.005%. If such drugsare used, they should be administered at least 5 minutes apart.
See 17 for PATIENT COUNSELING INFORMATION
Revised: 03/2019
------------------------------------------------------------
Full Prescribing Information: Contents*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Herpetic Keratitis
5.6 Bacterial Keratitis
5.7 Use with Contact Lenses
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dosecombination of a Rho kinase inhibitor and a prostaglandin F2α analogue indicated for the reduction ofelevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
2. DOSAGE AND ADMINISTRATION
The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose ismissed, treatment should continue with the next dose in the evening. The dosage of ROCKLATAN shouldnot exceed once daily.
ROCKLATA |
