Ocriplasmin

Name: Ocriplasmin

Cautions for Ocriplasmin

Contraindications

  • Manufacturer states none known.1

Warnings/Precautions

Decreased Vision

A decrease of ≥3 lines of best corrected visual acuity reported.1 The majority of cases were attributed to progression of VMA with traction; many such cases required surgical intervention.1 Monitor patients appropriately.1

Intravitreal Injection-related Effects

Intraocular inflammation or infection, intraocular hemorrhage, and increased IOP reported.1 Most cases of intraocular inflammation were mild and transient.1

Monitor patients for elevation of IOP immediately following intravitreal injection.1 (See Administration under Dosage and Administration.) Instruct patients to promptly report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain or redness, photophobia, blurred or decreased vision).1

Lens Subluxation

Lens subluxation reported in at least one patient who received an intravitreal dose of 0.175 mg (1.4 times the recommended dose).1 Lens subluxation also reported in animals receiving a single dose that produced vitreous concentrations 1.4 times those achieved with the recommended dose; in monkeys receiving a second intravitreal dose 28 days after the first dose, lens subluxation was reported in 100% of treated eyes.1

Repeated administration in the same eye is not recommended.1

Retinal Breaks

Retinal detachment and retinal tear (without detachment) reported following ocriplasmin treatment; occurred before, during, or after vitrectomy.1

Dyschromatopsia

Dyschromatopsia, described as yellowish vision, reported.1 In approximately half of such cases, electroretinographic changes also reported.1

Immunogenicity

As with all therapeutic proteins, potential for immunogenicity exists; however, immunogenicity to ocriplasmin not evaluated.1

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether ocriplasmin is distributed into milk.1 Caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

No substantial differences in efficacy or safety relative to younger patients.1

Common Adverse Effects

Vitreous floaters,1 2 conjunctival hemorrhage,1 2 eye pain,1 2 photopsia,1 2 blurred vision,1 2 macular hole,1 reduced visual acuity,1 visual impairment,1 2 retinal edema.1

Ocriplasmin Pharmacokinetics

Absorption

Bioavailability

The theoretical average vitreous concentration achieved immediately after intravitreal injection is approximately 29 mcg/mL (0.125 mg-dose delivered to 4.3 mL of vitreous volume).1 4

Systemic concentrations expected to be low or undetectable following intravitreal injection because of the small dose (0.125 mg) administered.1

Elimination

Metabolism

Undergoes autolysis in vitreous.4 In systemic circulation,4 rapidly inactivated by protease inhibitor α2-antiplasmin or α2-macroglobulin of the endogenous protein catabolism pathway.1

Following intravitreal injection in a limited number of patients undergoing vitrectomy, mean vitreous concentrations declined rapidly.1 At 24 hours postinjection, mean vitreous concentrations were <3% of the theoretical vitreous concentration achieved immediately after injection.1

Elimination Route

Endogenous protein catabolism.1

Stability

Storage

Parenteral

Injection

Frozen at or below -20°C.1 Protect from light.1 Store in original package until use.1

Actions

  • Proteolytic enzyme; exhibits activity against protein components (e.g. collagen, fibronectin, laminin) of the vitreous body and the vitreoretinal interface.1 2 9 13 14

  • Promotes liquefaction of the vitreous body and detachment of the vitreous from the retina (posterior vitreous detachment [PVD]) by dissolving the protein matrix responsible for VMA.1 8 9 10 13

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ocriplasmin, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ocriplasmin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ocriplasmin.

Review Date: October 4, 2017

In Summary

More frequently reported side effects include: decreased visual acuity and intraocular inflammation. See below for a comprehensive list of adverse effects.

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