RETISERT Implant (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch & Lomb Incorporated

Λέξεις κλειδιά

24208-416

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1. Indications and Usage

RETISERT is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

2. Dosage and Administration

2.1 Dosing Information RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is implanted into the posterior segment of the affected eye through a pars plana incision. The implant contains one ...

3. Dosage Forms and Strengths

0.59 mg fluocinolone acetonide intravitreal implant.

4. Contraindications

4.1 Viral, Bacterial, Mycobacterial and Fungal Infections of Ocular Structures Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial ...

5. Warnings and Precautions

5.1 Cataract Formation Use of corticosteroids may result in posterior subcapsular cataract formation. Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic ...

6. Adverse Reactions

6.1 Clinical Trials Experience Ocular Events The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter ...

8.1. Pregnancy

No adequate animal reproduction studies have been conducted with fluocinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low ...

8.3. Nursing Mothers

It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

8.5. Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

11. Description

RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 ...

12.1. Mechanism of Action

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, ...

12.3. Pharmacokinetics

In a subset of patients who received the intravitreal implant, and had blood samples taken at various times (weeks 1, 4 and 34) after implantation, plasma levels of fluocinolone acetonide were below the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed on RETISERT to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide. Fluocinolone acetonide was not genotoxic <em>in ...

14. Clinical Studies

In two randomized, double-masked, multicenter controlled clinical trials, 224 patients with chronic (a one year or greater history) non-infectious uveitis affecting the posterior segment of one or both ...

16.1. How Supplied

The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer ...

16.2. Storage and Handling

Store in the original container at 15° to 25°C (59° to 77°F). <b>Protect from freezing.</b>

17. Patient Counseling Information

Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT. As with any surgical procedure, there is risk involved. ...