ROCKLATAN(netarsudil and latanoprost ophthalmic solution)0.02%/0.005%, for topical ophthalmic(三)
TAN and may be reinserted15 minutes after administration.
6. ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed inthe clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug andmay not reflect the rates observed in clinical practice.
The most common ocular adverse reaction observed in controlled clinical studies with ROCKLATAN wasconjunctival hyperemia which was reported in 59% of patients. Five percent of patients discontinuedtherapy due to conjunctival hyperemia. Other common ocular adverse reactions reported were: instillationsite pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuityreduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% ofpatients.
Other adverse reactions that have been reported with the individual components and not listed aboveinclude:
Netarsudil 0.02%
Instillation site erythema, corneal staining, increased lacrimation, and erythema of eyelid.
Latanoprost 0.005%
Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of theiris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid,upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema,myalgia/arthralgia/back pain, and rash/allergic reactions.
7. DRUG INTERACTIONS
Although specific drug interaction studies have not been conducted with ROCKLATAN, in vitro studieshave shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost ophthalmic solution 0.005%. If such drugs are used, they should be administered at least five (5) minutes
apart.
The combined use of two or more prostaglandins or prostaglandin analogs including latanoprostophthalmic solution 0.005% is not recommended. It has been shown that administration of theseprostaglandin drug products more than once daily may decrease the IOP lowering effect or causeparadoxical elevations in IOP.
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate and well-controlled studies of ROCKLATAN ophthalmic solution or itspharmacologically active ingredients (netarsudil and latanoprost) in pregnant women to inform any drugassociated risk. However, systemic exposure to netarsudil from ocular administration is low [see ClinicalPharmacology (12.3)].
Reproduction studies of latanoprost showed embryofetal lethality in rabbits. No embryofetal lethality wasobserved at a dose approximately 15 times higher than the recommended human ophthalmic dose(RHOD). Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis didnot produce adverse embryofetal effects at clinically relevant systemic exposures. ROCKLATAN shouldbe used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Data
Animal Data
Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions andembryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the RHOD, based onCmax). The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C |
