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Indications and Important Safety Information
Click the links to go to each product's Indication(s) and Important Safety Information.
DURYSTA® (bimatoprost intracameral implant) Important Information
Indications and Usage
DURYSTA® (bimatoprost intracameral implant) is indicated for
the reduction of intraocular pressure (IOP) in patients with open angle
glaucoma (OAG) or ocular hypertension (OHT).
Important Safety Information
Contraindications
DURYSTA is contraindicated in patients with: active or suspected ocular or
periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs’
Dystrophy); prior corneal transplantation or endothelial cell transplants
(e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]);
absent or ruptured posterior lens capsule, due to the risk of implant
migration into the posterior segment; hypersensitivity to bimatoprost or
to any other components of the product.
Warnings and Precautions
The presence of DURYSTA implants has been associated with corneal adverse
reactions and increased risk of corneal endothelial cell loss.
Administration of DURYSTA should be limited to a single implant per eye
without retreatment. Caution should be used when prescribing DURYSTA in
patients with limited corneal endothelial cell reserve.
DURYSTA should be used with caution in patients with narrow iridocorneal
angles (Shaffer grade ˂3) or anatomical obstruction (e.g., scarring) that
may prohibit settling in the inferior angle.
Macular edema, including cystoid macular edema, has been reported during
treatment with ophthalmic bimatoprost, including DURYSTA intracameral
implant. DURYSTA should be used with caution in aphakic patients, in
pseudophakic patients with a torn posterior lens capsule, or in patients
with known risk factors for macular edema.
Prostaglandin analogs, including DURYSTA, have been reported to cause
intraocular inflammation. DURYSTA should be used with caution in patients
with active intraocular inflammation (e.g., uveitis) because the
inflammation may be exacerbated.
Ophthalmic bimatoprost, including DURYSTA intracameral implant, has been
reported to cause changes to pigmented tissues, such as increased
pigmentation of the iris. Pigmentation of the iris is likely to be
permanent. Patients who receive treatment should be informed of the
possibility of increased pigmentation. While treatment with DURYSTA can be
continued in patients who develop noticeably increased iris pigmentation,
these patients should be examined regularly.
Intraocular surgical procedures and injections, including DURYSTA, have
been associated with endophthalmitis. Proper aseptic technique must always
be used with administering DURYSTA, and patients should be monitored
following the administration.
Adverse Reactions
In controlled studies, the most common ocular adverse reaction reported by
27% of patients was conjunctival hyperemia. Other common adverse reactions
reported in 5%-10% of patients were foreign body sensation, eye pain,
photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular
pressure increased, corneal endothelial cell loss, vision blurred, iritis,
and headache.
Please see full Prescribing Information, or visit
https://www.rxabbvie.com/pdf/durysta_pi.pdf
OZURDEX® (dexamethasone intravitreal implant) Important Information
Indications and Usage
Diabetic Macular Edema
OZURDEX® (dexamethasone intravitreal implant) is a
corticosteroid indicated for the treatment of diabetic macular edema.
Retinal Vein Occlusion
OZURDEX® is a corticosteroid indicated for the treatment of
macular edema following branch retinal vein occlusion (BRVO) or central
retinal vein occlusion (CRVO).
Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious
uveitis affecting the posterior segment of the eye.
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection
procedure should be carried out under controlled aseptic conditions.
Following the intravitreal injection, patients should be monitored for
elevation in intraocular pressure and for endophthalmitis. Patients should
be instructed to report any symptoms suggestive of endophthalmitis without
delay.
IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® (dexamethasone
intravitreal implant) is contraindicated in patients with active or
suspected ocular or periocular infections including most viral diseases of
the cornea and conjunctiva, including active epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial
infections, and fungal diseases.
Glaucoma: OZURDEX® is contraindicated in patients with
glaucoma, who have cup to disc ratios of greater than 0.8.
Torn or Ruptured Posterior Lens Capsule: OZURDEX® is
contraindicated in patients whose posterior lens capsule is torn or ruptured
because of the risk of migration into the anterior chamber. Laser posterior
capsulotomy in pseudophakic patients is not a contraindication for
OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients
with known hypersensitivity to any components of this product.
Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections,
including those with OZURDEX®, have been associated with
endophthalmitis, eye inflammation, increased intraocular pressure, and
retinal detachments. Patients should be monitored regularly following the
injection.
Steroid-related Effects: Use of corticosteroids including
OZURDEX® may produce posterior subcapsular cataracts, increased
intraocular pressure, glaucoma, and may enhance the establishment of
secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of
ocular herpes simplex because of the potential for reactivation of the viral
infection.
Adverse Reactions
Diabetic Macular Edema:
Ocular adverse reactions reported by greater than or equal to 1% of patients
in the two combined 3-year clinical trials following injection of
OZURDEX® for diabetic macular edema include: cataract (68%),
conjunctival hemorrhage (23%), visual acuity reduced (9%), conjunctivitis
(6%), vitreous floaters (5%), conjunctival edema (5%), dry eye (5%),
vitreous detachment (4%), vitreous opacities (3%), retinal aneurysm (3%),
foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior
chamber inflammation (2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular
adverse reactions reported by greater than or equal to 5% of patients
include: hypertension (13%) and bronchitis (5%).
Increased Intraocular Pressure: IOP elevation greater than or equal
to 10 mm Hg from baseline at any visit was seen in 28% of OZURDEX®
patients versus 4% of sham patients. 42% of the patients who received
OZURDEX® were subsequently treated with IOP-lowering medications
during the study versus 10% of sham patients.
The increase in mean IOP was seen with each treatment cycle, and the mean
IOP generally returned to baseline between treatment cycles (at the end of
the 6-month period).
Cataracts and Cataract Surgery: The incidence of cataract
development in patients who had a phakic study eye was higher in the
OZURDEX® group (68%) compared with Sham (21%). The median time of
cataract being reported as an adverse event was approximately 15 months in
the OZURDEX® group and 12 months in the Sham group. Among these
patients, 61% of OZURDEX® subjects versus 8% of sham-controlled
subjects underwent cataract surgery, generally between Month 18 and Month 39
(Median Month 21 for OZURDEX® group and 20 for Sham) of the
studies.
Retinal Vein Occlusion and Posterior Segment Uveitis
Adverse reactions reported by greater than 2% of patients in the first 6
months following injection of OZURDEX® for retinal vein occlusion
and posterior segment uveitis include: intraocular pressure increased (25%),
conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%),
ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and
headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8.
During the initial treatment period, 1% (3/421) of the patients who received
OZURDEX® required surgical procedures for management of elevated
IOP.
Please see full prescribing information or visit
https://www.rxabbvie.com/pdf/ozurdex_pi.pdf
