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.

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.

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

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.

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.

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)

Assessment ⬆ ⬇

Assess eye for signs and symptoms of infection frequently during wk following injection.
Check perfusion of optic nerve head immediately after injection; use tonometry to measure intraocular pressure prior to and 30 min following the injection.
Monitor for signs and symptoms of retinal detachment such as flashing lights (photopsias), central vision loss, dark areas in visual field, and floaters; report and treat promptly with an intervention. Therapy interruption required. Slit lamp exam and/or indirect ophthalmoscopy may be needed along with prompt treatment by ophthalmologist.
Monitor for signs and symptoms of vitreal hemorrhage, such as cobwebs or specks that drift across visual field, floaters, blurred or cloudy vision, flashing lights, near-complete vision loss (typically unilateral) that is worse in the morning; ↑ risk in patients on antithrombotic drugs (anticoagulants, aspirin, NSAIDs). Therapy interruption may be necessary.
Assess for changes in visual acuity; maintenance or improvement in visual acuity indicates efficacy.

Implementation ⬆ ⬇

Do not administer solutions that are discolored or contain particulate matter. Attach threaded plastic threader rod to the rubber stopper inside barrel of syringe. Do not pull back on plunger.
- Adequate analgesia and a broad-spectrum antibiotic should be given prior to injection.
Should be administered as an ophthalmic intravitreal injection only by an ophthalmologist. Vial: Withdraw vial contents through a 5-micron gauge filter needle attached to a 1-mL tuberculin syringe. Discard filter needle after withdrawal. Replace filter needle with sterile 30-gauge ×½-inch needle for intravitreal injection. Expel contents until plunger tip is aligned with line marking 0.05 mL on syringe. Each vial should be used for only one eye. If contralateral eye requires treatment, use new vial and equipment. Refrigerate solution and protect from light; do not freeze. Once at room temperature, use unopened vials within 72 hr.Prefilled SyringeConfirm correct dosage of prefilled syringe (0.3 mg [orange finger grip] or 0.5 mg [clear finger grip]). Only open the sealed tray under aseptic conditions. Only use product if the syringe cap is attach to the Luer lock. Snap off the syringe cap without turning or twisting. Attach a 30-gauge ×½-inch needle. Remove any air bubbles and use within 15 min. Push the plunger until the edge below the dome of the stopper is aligned with the 0.05 mL dose mark. Refrigerate and store prefilled syringes in original carton; protect from light. Do not freeze.

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.

Evaluation/Desired Outcomes ⬆ ⬇

Slowing of vision loss.

US Brand Names ⬆ ⬇

Byooviz, Cimerli, Lucentis, Susvimo

Code ⬆

NDC Code

50242- Genentech, Inc.
- 50242-078- Susvimo
  - 50242-078-12- 1 VIAL in 1 CARTON (50242-078-12) / 1 mL in 1 VIAL

50242- Genentech, Inc.
- 50242-078- Susvimo
  - 50242-078-55- 1 VIAL in 1 CARTON (50242-078-55) / 1 mL in 1 VIAL

50242- Genentech, Inc.
- 50242-080- LUCENTIS
  - 50242-080-03- 1 SYRINGE, GLASS in 1 CARTON (50242-080-03) / .05 mL in 1 SYRINGE, GLASS

50242- Genentech, Inc.
- 50242-080- LUCENTIS
  - 50242-080-88- 1 SYRINGE, GLASS in 1 CARTON (50242-080-88) / .05 mL in 1 SYRINGE, GLASS

50242- Genentech, Inc.
- 50242-082- LUCENTIS
  - 50242-082-03- 1 SYRINGE, GLASS in 1 CARTON (50242-082-03) / .05 mL in 1 SYRINGE, GLASS

50242- Genentech, Inc.
- 50242-082- LUCENTIS
  - 50242-082-88- 1 SYRINGE, GLASS in 1 CARTON (50242-082-88) / .05 mL in 1 SYRINGE, GLASS

50242- Genentech, Inc.
- 50242-183-
  - 50242-183-06- 35000 mL in 1 CONTAINER (50242-183-06)

68225- Patheon Italia S.p.A.
- 68225-123-
  - 68225-123-00- 1800 VIAL, SINGLE-DOSE in 1 BOX (68225-123-00) / .05 mL in 1 VIAL, SINGLE-DOSE

71082- Frueh Verpackungstechnik AG
- 71082-110-
  - 71082-110-10- 1 SYRINGE, GLASS in 1 BLISTER PACK (71082-110-10) / .05 mL in 1 SYRINGE, GLASS

71082- Frueh Verpackungstechnik AG
- 71082-110-
  71082-110-11- 1 SYRINGE, GLASS in 1 BLISTER PACK (71082-110-11) / .05 mL in 1 SYRINGE, GLASS

71082- Frueh Verpackungstechnik AG
- 71082-111-
  71082-111-10- 1 SYRINGE, GLASS in 1 BLISTER PACK (71082-111-10) / .05 mL in 1 SYRINGE, GLASS

71082- Frueh Verpackungstechnik AG
- 71082-111-
  71082-111-11- 1 SYRINGE, GLASS in 1 BLISTER PACK (71082-111-11) / .05 mL in 1 SYRINGE, GLASS

82775- POLPHARMA BIOLOGICS SA
- 82775-100-
  82775-100-01- 1000 g in 1 BOTTLE (82775-100-01)

83832- Labor Zollinger AG
- 83832-110-
  83832-110-10- 1 SYRINGE, GLASS in 1 BLISTER PACK (83832-110-10) / .05 mL in 1 SYRINGE, GLASS

83832- Labor Zollinger AG
- 83832-110-
  83832-110-11- 1 SYRINGE, GLASS in 1 BLISTER PACK (83832-110-11) / .05 mL in 1 SYRINGE, GLASS

83832- Labor Zollinger AG
- 83832-111-
  83832-111-10- 1 SYRINGE, GLASS in 1 BLISTER PACK (83832-111-10) / .05 mL in 1 SYRINGE, GLASS

83832- Labor Zollinger AG
- 83832-111-
  83832-111-11- 1 SYRINGE, GLASS in 1 BLISTER PACK (83832-111-11) / .05 mL in 1 SYRINGE, GLASS

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇