Susvimo

— THERAPEUTIC CATEGORIES —
  • Miscellaneous ocular agents

Susvimo Generic Name & Formulations

General Description

Ranibizumab 100mg/mL; soln for intravitreal use (via ocular implant); preservative-free.

Pharmacological Class

Vascular endothelial growth factor (VEGF) inhibitor.

How Supplied

Kit (single-dose vial + initial fill needle)—1; Single-dose vial—1; Refill needle—1

Manufacturer

Generic Availability

NO

Susvimo Indications

Indications

In adults with neovascular (wet) age-related macular degeneration (AMD) who have previously responded to at least 2 intravitreal injections of a VEGF inhibitor.

Susvimo Dosage and Administration

Adult

See full labeling. Give by intravitreal implant. 2mg (0.02mL of 100mg/mL) continuously delivered via implant. Refill every 24 weeks (approx. 6 months). Supplemental treatment: 0.5mg (0.05mL of 10mg/mL) intravitreal inj into the affected eye while implant is in place, as clinically needed.

Children

Not established.

Susvimo Contraindications

Contraindications

Ocular or periocular infections. Active intraocular inflammation.

Susvimo Boxed Warnings

Boxed Warning

Endophthalmitis.

Susvimo Warnings/Precautions

Warnings/Precautions

Do not administer as bolus intravitreal inj. Do not substitute with other ranibizumab products. Monitor routinely following insertion. Endophthalmitis: treat promptly if occurs; delay dose (refill-exchange) until resolved. Rhegmatogenous retinal detachment: treat promptly; delay dose in presence of retinal detachment or retinal breaks. Evaluate retinal periphery prior to implant insertion. Risk of implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival blebs, conjunctival erosion or retraction. Decreased visual acuity for 2 months post-op. Improper filling of the implant due to air bubbles; see full labeling. Deflection of the implant due to eye procedures (eg, B-scan ultrasound, scleral depression, gonioscopy). Advise females of reproductive potential to use effective contraception during and for at least 12 months after the last dose. Pregnancy. Nursing mothers.

Susvimo Pharmacokinetics

See Literature

Susvimo Interactions

Interactions

Increased risk of vitreous hemorrhage with antithrombotic medication (eg, oral anticoagulants, aspirin, NSAIDs); temporarily interrupt these prior to implant insertion.

Susvimo Adverse Reactions

Adverse Reactions

Conjunctival hemorrhage/hyperemia/edema, iritis, eye pain, vitreous floaters, foreign body sensation in eyes, headache, hypotony of eye, vitreous detachment, corneal disorder/abrasion/edema.

Susvimo Clinical Trials

See Literature

Susvimo Note

Not Applicable

Susvimo Patient Counseling

See Literature