Ocriplasmin- Jetrea- @- (Oct 2012) - Ophthalmic
Drug Name:Ocriplasmin- Jetrea- @- (Oct 2012) - Ophthalmic
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
JETREA® (ocriplasmin) Intravitreal Injection,2.5 mg/mL
Initial U.S. Approval: 2012
Drug Name- Jetrea
Active Ingredient - Ocriplasmin
To treat eye condition called symptomatic vitromacular adhesion(VMA)
ages 12 years and older
Indication-
Eye condition called symptomatic vitromacular adhesion(VMA) ages
12 years and older
Approved by FDA on 17-10--2012 (Ref- FDA approved List- 2012)
Adverse Reaction:
The most commonly reported reactions (. 5%) in patients treated with JETREA
were -
vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision,
macular hole, reduced visual acuity, visual impairment, and retinal edema.
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Decreases in vision due to progression of the condition with traction may occur
requiring surgical intervention. Patients should be monitored and instructed
to report any symptoms without delay.
.
Intravitreal injection procedure associated effects (intraocular inflammation/infection,
intraocular hemorrhage and increased IOP) may occur following an
intravitreal injection. Patients should be monitored and instructed to report
any symptoms without delay.
.
Potential for lens subluxation.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
JETREA is a proteolytic enzyme indicated for the treatment of symptomatic
vitreomacular adhesion.
DOSAGE AND ADMINISTRATION
Must dilute before use.
For single use ophthalmic intravitreal injection only.
The recommended dose is 0.125 mg (0.1 mL of the diluted solution)
administered by intravitreal injection to the affected eye once as a single dose.
DOSAGE FORMS AND STRENGTHS
Single-use glass vial containing JETREA 0.5 mg in
0.2 mL solution for intravitreal injection (2.5 mg/mL).
Patient Information:
PATIENT COUNSELING INFORMATION
In the days following JETREA administration, patients are at risk of developing
intraocular inflammation/infection.
Advise patients to seek immediate care from an ophthalmologist if the eye
becomes red, sensitive to light, painful, or develops a change in vision
Patients may experience temporary visual impairment after receiving an
intravitreal injection of JETREA .
Advise patients to not drive or operate heavy machinery until this visual
impairment has resolved. If visual impairment persists or decreases further,
advise patients to seek care from an ophthalmologist.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Ocriplasmin has proteolytic activity against protein components of the vitreous body
and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen),
thereby dissolving the protein matrix responsible for the vitreomacular adhesion (VMA).
2. Pharmacokinetics
The intravitreal pharmacokinetics of ocriplasmin were determined in a clinical study
in patients scheduled for vitrectomy where 0.125 mg ocriplasmin (corresponding
to an average concentration of 29 mcg ocriplasmin per mL vitreous volume
[approximately 4.3 mL/eye]) was administered as a single intravitreal dose
at different time points prior to vitrectomy.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C.
Animal reproduction studies have not been conducted with ocriplasmin.
There are no adequate and well-controlled studies of ocriplasmin in pregnant women.
It is not known whether ocriplasmin can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity.
JETREA should be given to a pregnant woman only if clearly needed.
2. Nursing Mothers
It is not known whether ocriplasmin is excreted in human milk. Because many drugs
are excreted in human milk, and because the potential for absorption and harm
to infant growth and development exists, caution should be exercised when
JETREA is administered to a nursing woman.
3.. Pediatric Use
The use of Jetrea in pediatric patients is not recommended.
A single center, randomized, placebo controlled, double masked clinical study
to investigate the safety and efficacy of a single intravitreal injection of 0.175 mg
ocriplasmin in pediatric subjects as an adjunct to vitrectomy was conducted
in 24 eyes of 22 patients.
There were no statistical or clinical differences between groups for the induction
of total macular PVD, any of the secondary endpoints or adverse events.
4.. Geriatric Use
In the clinical studies, 384 and 145 patients were . 65 years and of these 192 and
73 patients were . 75 years in the JETREA and vehicle groups respectively.
No significant differences in efficacy or safety were seen with increasing
age in these studies.
