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Ranibizumab

Generic Medicine
Indications

Ranibizumab is indicated for the treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy, including non-proliferative (NPDR) and proliferative (PDR), in patients with DME
  • Myopic choroidal neovascularization (mCNV)
Pharmacology

Ranibizumab is a monoclonal antibody fragment that binds to the receptor-binding site of active forms of vascular endothelial growth factor A (VEGF-A), including the biologically active cleaved form VEGF110. VEGF-A is a key mediator of pathological ocular neovascularization and vascular permeability, contributing to diseases such as neovascular AMD, mCNV, diabetic retinopathy, diabetic macular edema, and macular edema following retinal vein occlusion. By binding to VEGF-A, ranibizumab prevents its interaction with VEGFR1 and VEGFR2 receptors on endothelial cells. This inhibition reduces endothelial cell proliferation, vascular leakage, and abnormal new blood vessel formation.

Dosage Administration

Neovascular (Wet) Age-Related Macular Degeneration (AMD): Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. In the 9 months after three initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. Patients should be assessed regularly. Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly.

Macular Edema Following Retinal Vein Occlusion (RVO): Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). In Studies RVO-1 and RVO-2, patients received monthly injections of Ranibizumab for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly.

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR): Ranibizumab 0.3 mg (0.05 mL of 6 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Myopic Choroidal Neovascularization (mCNV): Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL Ranibizumab solution) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) for up to 3 months. Patients may be retreated if needed.

Interactions

Drug interaction studies have not been conducted with ranibizumab.

Contraindications

Ocular or periocular infections: Ranibizumab is contraindicated in patients with ocular or periocular infections.

Hypersensitivity: It is contraindicated in patients with known hypersensitivity to ranibizumab or any of its excipients. Hypersensitivity reactions may present as severe intraocular inflammation.

Side Effects

Reported adverse reactions include:

  • Endophthalmitis and retinal detachment
  • Increased intraocular pressure
  • Thromboembolic events
  • Fatal events in patients with baseline DME and diabetic retinopathy (DR)
Pregnancy & Lactation

There are no adequate and well-controlled studies of ranibizumab use in pregnant women. No data are available regarding its presence in human milk or its effects on the breastfed infant or milk production.

Precautions & Warnings

Endophthalmitis and retinal detachment: Intravitreal injections, including ranibizumab, have been associated with endophthalmitis and retinal detachment. Strict aseptic technique must be used during administration. Patients should be closely monitored after injection for early detection and treatment of infection.

Intraocular pressure increase: Temporary increases in intraocular pressure may occur before or after injection (within 60 minutes). IOP should be monitored before and after treatment and managed appropriately.

Thromboembolic events: Although the incidence is low, arterial thromboembolic events (ATEs) may occur with intravitreal VEGF inhibitors. ATEs include nonfatal stroke, nonfatal myocardial infarction, and vascular death (including unexplained deaths).

Therapeutic Class

Drugs for Age-Related Macular Degeneration (AMD)

Storage Conditions

Store at 2°C–8°C. Protect from light. Keep out of reach of children.

Common Questions

What is Ranibizumab for?

What does Ranibizumab do?

What are the side effects of Ranibizumab?

What happens if you use too much Ranibizumab?

Is Ranibizumab safe for pregnant women?

No available drugs found

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