ocriplasmin intravitreal (Rx)

Brand and Other Names:Jetrea
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal solution

  • 0.5mg/0.2mL (undiluted solution)
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Vitreomacular Adhesion

Proteolytic enzyme indicated for treatment of symptomatic vitreomacular adhesion

0.125 mg (0.1 mL of diluted solution) by intravitreal injection to affected eye once as a single injection (see Administration)

Administration

Must dilute before use

For single use ophthalmic intravitreal injection only

Each vial should only be used to provide a single injection for the treatment of a single eye; if contralateral eye requires treatment, a new vial should be used and the sterile filed, syringe, gloves, drapes, eyelid speculum, injection needles should be changed

Repeated injection in the same eye not recommended

Intravitreal injection preparation

  • Remove vial (2.5 mg/mL corresponding to 0.5 mg ocriplasmin) from the freezer and allow to thaw to room temperature (within a few minutes)
  • Once completely thawed, remove the protective flip-off cap from vial and disinfect vial top with alcohol wipe
  • Using aseptic technique, add 0.2 mL of 0.9% NaCl (sterile, preservative-free injection) to vial and gently swirl until solutions are mixed
  • Visually inspect vial for particulate matter; use only if clear, colorless solution without visible particles
  • Withdraw all diluted solution using 19-gauge needle and discard needle after vial contents withdrawn (do not use needle used to withdraw drug for intravitreal injection)
  • Replace need with 30-gauge needle, carefully expel air bubbles and excess drug from the syringe and adjust the dose to the 0.1 mL mark on the syringe (ie, 0.125 mg ocriplasmin)
  • Use solution immediately (contains no preservatives)
  • Discard vial and any unused portion of the diluted solution after single use

Safety and efficacy not established; use in children not recommended

Vitrectomy clinical trial results described within the prescribing information found no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints or adverse events (24 eyes of 22 pediatric patients)

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Adverse Effects

>10%

Conjunctival hemorrhage (17.4%)

Vitreous floaters (16.6%)

Eye pain (12.3%)

1-10%

Photopsia (9%)

Increased IOP (8.8%)

Macular hole (7.6%)

Intraocular inflammation (7.1%)

Blurred vision (6.7%)

Macular edema (4.3%)

Decreased vision acuity (5.7%)

Retinal edema (4.3%)

Photophobia (3.4%)

Intraocular hemorrhage (2.4%)

Dyschromatopsia (2%)

Vitreous detachment (1.9%)

Retinal tear (without detachment) (1.1%)

Electroretinographic changes (1%)

<1%

Lens subluxation

Retinal detachment

Postmarketing Reports

Night blindness

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Warnings

Contraindications

None

Cautions

Decrease of ≥3 line BCVA; these decreases in vision were due to progression of the condition and many required surgical intervention

Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased IOP

Potential for lens subluxation

Retinal breaks (eg, detachment, tear) reported

Dyschromatopsia (yellowish vision) and electroretinographic changes (a- and b-wave amplitude decreases) reported

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk; caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Elicits proteolytic activity against protein components within the vitreous body and vitreoretinal interface (eg, laminin, fibronectin, collagen), thereby dissolving the protein matrix responsible for vitreomacular adhesion

Absorption

0.125 mg dose corresponds to 29 mcg/mL vitreous volume

Detectable systemic levels not expected

Vitreous levels: 12 mcg/mL (within 30 min post injection); 0.5 mcg/mL (24 hr post injection)

Metabolism

Enters endogenous protein catabolism pathway and is rapidly inactivated via interactions with protease inhibitor alpha2-antiplasmin or alpha2-macroglobulin

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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