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Anwendungsgebiete

1. INDICATIONS AND USAGE ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ROCKLATAN ® is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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Warnhinweise und Vorsichtsmaßnahmen

5. WARNINGS AND PRECAUTIONS

Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.2 )
Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.3 )

5.1Epithelial Corneal Edema

ROCKLATAN contains netarsudil which has been associated with Epithelial corneal edema, described as honeycomb or bullous, and has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures that could affect corneal endothelial function. Epithelial corneal edemal typically resolves upon discontinuation of ROCKLATAN. Advise patients to notify their physician if they experience eye pain or decreased vision while using ROCKLATAN [see Adverse Reactions ( 6.2 ) and Patient Counselling Information ( 17 )] .

5.2Pigmentation

ROCKLATAN contains latanoprost which has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5. WARNINGS AND PRECAUTIONS

Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.2 )
Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.3 )

5.1Epithelial Corneal Edema

5.2Pigmentation

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

There are no adequate and well-controlled studies of ROCKLATAN ophthalmic solution or its pharmacologically active ingredients (netarsudil and latanoprost) in pregnant women to inform any drug associated risk. However, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology ( 12.3 ) ]. Reproduction studies of latanoprost showed embryofetal lethality in rabbits. No embryofetal lethality was observed 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 did not produce adverse embryofetal effects at clinically relevant systemic exposures. ROCKLATAN should be 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 and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the RHOD, based on C max ).

The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ). Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe.

The NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max ). Reproduction studies have been performed with latanoprost in rats and rabbits. In 4 of 16 pregnant rabbits, no viable fetuses were present at a dose that was approximately 80 times higher than the RHOD. Latanoprost did not produce embryofetal lethality in rabbits at a dose approximately 15 times higher than the RHOD.

Nebenwirkungen

6. ADVERSE REACTIONS The most common adverse reaction is conjunctival hyperemia (59%). Other common adverse reactions were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1 800 757 9195, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common ocular adverse reaction observed in controlled clinical studies with ROCKLATAN was conjunctival hyperemia which was reported in 59% of patients.

Five percent of patients discontinued therapy due to conjunctival hyperemia. Other common ocular adverse reactions reported were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% of patients. Other adverse reactions from clinical trials that have been reported with the individual components and not listed above include: 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 the iris, 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.

6.2Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of ROCKLATAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Netarsudil 0.02% Eye disorders: Epithelial corneal edema has been reported in some patients with pre-existing corneal stromal edema or ocular procedures that could affect corneal endothelial function. [see Warnings and Precautions ( 5.1 )] .

Rocklatan

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Epithelial Corneal Edema

5.2Pigmentation

Zwei Arzneimittel in einer Frage?

Rocklatan

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Epithelial Corneal Edema

5.2Pigmentation

Zwei Arzneimittel in einer Frage?

5.3Eyelash Changes

5.4Intraocular Inflammation

5.5Macular Edema

5.6Herpetic Keratitis Reactivation of Herpes

5.7Bacterial Keratitis

5.8Use with Contact Lenses

Wechselwirkungen

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

6.1Clinical Trials Experience

6.2Postmarketing Experience

Packungen

Dokumente

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