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Cimerli®

GoodRx

Ranibizumab-eqrn · intravitreal injection

Injections & Implants

Indication
CIMERLI, a vascular endothelial growth factor (VEGF) inhibitor, 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 (DR); Myopic Choroidal Neovascularization (mCNV)
Contraindications
  • Ocular or periocular infections
  • Known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI
Available Forms
0.5 mg (0.05 mL of 10 mg/mL) single-dose vial, 0.3 mg (0.05 mL of 6 mg/mL) single-dose vial
Mechanism of Action
Ranibizumab products bind to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF 110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, mCNV, DR, DME and macular edema following RVO. The binding of ranibizumab products to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Dosage
Neovascular (Wet) Age-Related Macular Degeneration (AMD): CIMERLI 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. Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly. Macular Edema Following Retinal Vein Occlusion (RVO): CIMERLI 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). Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR): CIMERLI 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): CIMERLI 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed.
Warnings & Precautions
  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering CIMERLI. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
  • Increases in Intraocular Pressure: Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI and manage appropriately.
  • Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). In pooled Studies D-1 and D-2, the ATE rate at 2 years was 7.2% with 0.5 mg ranibizumab, 5.6% with 0.3 mg ranibizumab, and 5.2% with control.
  • Retinal Vasculitis with or without Occlusion: Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with CIMERLI in patients who develop these events. Patients should be instructed to report any change in vision without delay.
  • Fatal Events: In patients with DME and DR at baseline in pooled Studies D-1 and D-2, fatalities in the first 2 years occurred in 4.4% of patients treated with 0.5 mg ranibizumab, 2.8% treated with 0.3 mg ranibizumab, and 1.2% of control patients. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.
Common Side Effects
The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.
Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. Based on the anti-VEGF mechanism of action for ranibizumab products, treatment with ranibizumab products may pose a risk to human embryofetal development. CIMERLI should be given to a pregnant woman only if clearly needed.
Lactation: There are no data available on the presence of ranibizumab products in human milk, the effects of ranibizumab products on the breastfed infant or the effects of ranibizumab products on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when CIMERLI is administered to a nursing woman.
Pediatric Use
The safety and effectiveness of CIMERLI in pediatric patients have not been established.