ranibizumab

REMS

Lucentis, Byooviz, and Cimerli

Treatment of the following disorders:
- Neovascular (wet) age-related macular degeneration,
- Macular edema following retinal vein occlusion,
- Myopic choroidal neovascularization.

Lucentis and Cimerli

Treatment of the following disorders:
- Diabetic macular edema,
- Diabetic retinopathy.

Susvimo

Neovascular (wet) age-related macular degeneration in patients who have previously responded to ≥2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Ocular/periocular infections;
Active intraocular inflammation (Susvimo only).

Use Cautiously in:

OB: Use in pregnancy only if clearly needed;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: MI

EENT: conjunctival hemorrhage, eye pain, ↑intraocular pressure, intraocular inflammation, vitreal floaters, conjunctival bleb (Susvimo), conjunctival erosion/retraction (Susvimo), ↓visual acuity (Susvimo), endophthalmitis, implant dislocation (Susvimo), retinal detachment, retinal vasculitis (with or without occlusion), vitreous hemorrhage

Neuro: STROKE

Interactions ⬆ ⬇

Drug-drug:

↑risk of serious intraocular inflammation with verteporfin.

Availability ⬆ ⬇

Solution for intravitreal injection: 0.3 mg/0.05 mL (vial or prefilled syringe); 0.5 mg/0.05 mL (vial or prefilled syringe); 10 mg/0.1 mL (vial)

Route/Dosage ⬆ ⬇

Macular Degeneration

Intravitreal (Adults ): Injection: 0.5 mg once monthly; after 4 mo, injections may be given every 1–3 mo. Implant: 2 mg (0.02 mL of 100 mg/mL solution) delivered continuously with refills administered every 24 wk (~every 6 mo). Supplemental intravitreal injections (Lucentis or Byooviz) of 0.5 mg may be administered to the affected eye while implant is in place, if needed.

Macular Edema Following Retinal Vein Occlusion

Intravitreal (Adults ): 0.5 mg once monthly.

Diabetic Macular Edema and Diabetic Retinopathy

Intravitreal (Adults ): 0.3 mg once monthly.

Myopic Choroidal Neovascularization

Intravitreal (Adults ): 0.5 mg once monthly for up to 3 mo. May be retreated if needed.

US Brand Names ⬆ ⬇

Byooviz, Cimerli, Lucentis, Susvimo

Action ⬆ ⬇

Binds to VEGF-A receptor sites, preventing the binding of endogenous VEGF-A, resulting in decreased endothelial proliferation, vascular leakage, and new vessel formation.

Therapeutic effects:

Decreased progression of visual loss.

Classifications ⬆ ⬇

Therapeutic Classification: ocular agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Intravitreal injection results in complete local bioavailability. Very low serum levels are achieved.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 9 days (intravitreal injection); 25 wk (intravitreal implant).

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
intravitreal (injection)	unknown	after injection	1 mo
intravitreal (implant)	unknown	26 days	6 mo

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of ranibizumab to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic eye exams may be needed.
Advise patient to notify ophthalmologist immediately if eye becomes red, swollen, sensitive to light, or painful or develops a change in vision.
Advise patient to promptly report and seek treatment for signs and symptoms of retinal detachment (flashing lights, central vision loss, dark areas in visual field, floaters, vitreal hemorrhage [cobwebs or specks that drift across visual field], blurred or cloudy vision, flashing lights, near-complete vision loss [typically unilateral] that is worse in the morning).
Warn patient to avoid driving or other activities requiring clear vision until drug effects are realized due to potential for ↓ visual acuity.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇