ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Ocriplasmin (United States and Canada: Not available): Drug information

Ocriplasmin (United States and Canada: Not available): Drug information
(For additional information see "Ocriplasmin (United States and Canada: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Jetrea [DSC]
Brand Names: Canada
  • Jetrea [DSC]
Pharmacologic Category
  • Ophthalmic Agent;
  • Vitreolytic
Dosing: Adult

Note: Jetrea has been discontinued in the United States for >1 year.

Vitreomacular adhesion

Vitreomacular adhesion: Intravitreal: 0.125 mg once (as a single dose to the affected eye).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

5% to 20%: Ophthalmic: Intraocular inflammation (7%), decreased visual acuity (6%), blurred vision, conjunctival hemorrhage, eye pain, macular degeneration, photopsia, retinal edema, visual impairment, vitreous opacity

<5%:

Cardiovascular: Hyperemia

Ophthalmic: Chromatopsia (2%; primarily described as yellowish vision), abnormal electroretinogram (a- and b-wave amplitude decrease; ≤1%), anterior chamber inflammation, cataract, conjunctival hyperemia, decreased pupillary reflex, dry eye syndrome, eye discomfort, increased intraocular pressure, iritis, macular edema, metamorphopsia, photophobia, retinal degeneration, visual disturbance (contralateral eye), vitreous detachment

<1%, postmarketing, and/or case reports: Nocturnal amblyopia, retinal detachment (pre-vitrectomy)

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Canadian labeling: Hypersensitivity to ocriplasmin or any component of the formulation; active or suspected ocular or periocular infections.

Warnings/Precautions

Concerns related to adverse effects:

• Decreased vision: May cause decreased visual acuity as a result of condition progression with traction, which may require surgical intervention. Monitor visual acuity appropriately.

• Dyschromatopsia: May cause dyschromatopsia, described as yellowish vision.

• Intravitreal injection: Intraocular inflammation, infection, hemorrhage, and/or increased intraocular pressure may result after intravitreal injection. In clinical trials, intraocular inflammation occurred at a higher rate with ocriplasmin when compared to placebo; intraocular inflammation events were typically mild and transient.

• Lens subluxation: Administration of higher than recommended doses may result in lens subluxation.

• Retinal breaks: After ocriplasmin administration, retinal detachment or retinal tear (with or without retinal detachment) may occur before, during, or after vitrectomy. Instruct patients to report symptoms suggestive of retinal detachment or endophthalmitis (eg, ocular pain, redness, photophobia, blurred/decreased vision).

Other warnings/precautions:

• Appropriate use: Repeat administration in the same eye is not recommended. If the contralateral eye requires treatment, treatment is not recommended within 7 days of the initial injection.

Product Availability

Jetrea has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravitreal [preservative free]:

Jetrea: 0.375 mg/0.3 mL (0.3 mL [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (Jetrea Intravitreal)

0.375 mg/0.3 mL (per 0.3 mL): $3,555.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravitreal:

Jetrea: 0.375 mg/0.3 mL ([DSC]); 0.5 mg/0.2 mL ([DSC])

Administration: Adult

For intravitreal injection only. Must be diluted prior to use. Adequate anesthesia and a broad-spectrum antimicrobial agent should be administered prior to the procedure. Administer the diluted solution to the mid-vitreous by inserting the injection needle 3.5 to 4 mm posterior to the limbus, aiming toward the center of the vitreous cavity and avoiding the horizontal meridian. Treatment of the second eye, if needed, is not recommended within 7 days of the first injection. Repeated administration to the same eye is not recommended.

Use: Labeled Indications

Vitreomacular adhesion: Treatment of symptomatic vitreomacular adhesion (VMA)

Medication Safety Issues
International issues:

Jetrea: Brand name for ocriplasmin [US] may be confused with Jetrex brand name for dextromethorphan, guaifenesin, bromhexine and chlorpheniramine maleate [India]

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Systemic exposure following a single intravitreal injection is expected to be low.

Breastfeeding Considerations

It is not known if ocriplasmin is present in breast milk. Systemic exposure following a single intravitreal injection is expected to be low. The manufacturer recommends that caution be exercised when administering ocriplasmin to breastfeeding women.

Monitoring Parameters

Following intravitreal injection, immediately monitor for elevation in intraocular pressure, signs of endophthalmitis, retinal detachment, or decreased vision.

Mechanism of Action

Ocriplasmin is a recombinant form of human plasmin that acts as a proteolytic within the vitreous body and vitreoretinal interface. Protein matrix components responsible for the vitreomacular adhesion (eg, laminin, fibronectin, and collagen) are lysed by ocriplasmin.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Detectable levels in systemic circulation are not expected after intravitreal injection

Metabolism: Endogenous protein catabolism pathway; rapidly inactivated by protease inhibitor alpha-2-antiplasmin or alpha-2-macroglobulin

Note: <3% of the administered dose is detected in vitreous fluid 24 hours after administration.

  1. Jetrea (ocriplasmin) [prescribing information]. Iselin, NJ: ThromboGenics Inc; February 2017.
  2. Jetrea (ocriplasmin) [product monograph]. Mississauga, Ontario, Canada: Alcon Canada Inc; September 2018.
  3. Stalmans P, Benz MS, Gandorfer A, et al. Enzymatic Vitreolysis With Ocriplasmin for Vitreomacular Traction and Macular Holes. N Engl J Med. 2012;367(7):606-615. [PubMed 22894573]
Topic 86876 Version 104.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟