Cimerli (ranibizumab-eqrn)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ranibizumab, a recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody fragment, is a vascular endothelial growth factor A (VEGF-A) antagonist.
Ranibizumab-nuna and ranibizumab-eqrn are biosimilars to ranibizumab. The FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).
Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch.
Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Both of the currently available ranibizumab biosimilars have interchangeable data at this time.
Ranibizumab, a recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody fragment, is a vascular endothelial growth factor A (VEGF-A) antagonist. Ranibizumab binds to active forms of human VEGF-A, including the cleaved form (VEGF110), and inhibits their biologic activity. VEGF-A induces neovascularization (angiogenesis) and increases vascular permeability, which appear to play a role in the pathogenesis and progression of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Binding of ranibizumab to VEGF-A prevents VEGF-A from binding to VEGF receptors (i.e., VEGFR-1, VEGFR-2) on the surface of endothelial cells, reducing endothelial cell proliferation, angiogenesis, and vascular permeability. Ranibizumab has been shown in clinical studies to reduce retinal thickening and vascular permeability associated with age-related macular degeneration; however, retinal thickness data did not provide information useful in influencing treatment decisions, and the area of vascular permeability was not correlated with visual acuity. Reductions in retinal thickness also have been observed with ranibizumab therapy in patients with macular edema following retinal vein occlusion and in those with diabetic macular edema.
Following monthly intravitreal injection in patients with neovascular (wet) age-related macular degeneration, peak serum ranibizumab concentrations attained were substantially below the concentration thought to be necessary to inhibit the biologic activity of VEGF-A by 50%. Based on population pharmacokinetic analysis, peak serum ranibizumab concentrations are predicted to be reached at approximately 1 day following monthly intravitreal injection. In humans, ranibizumab concentrations in serum are predicted to be approximately 90,000-fold lower than those in the vitreous.
Serum ranibizumab concentrations in patients with retinal vein occlusion and patients with diabetic macular edema and diabetic retinopathy are similar to those observed in patients with neovascular age-related macular degeneration. Based on the disappearance of ranibizumab from serum, the estimated average elimination half-life of ranibizumab from the vitreous is approximately 9 days.
Two ranibizumab biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in the table below. (See Table 1.)
Generic name: ranibizumab-eqrn
Pronunciation: (ra-ni-BIZ-oo-mab)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Cimerli
Indications
The following indications are listed for Cimerli:
- Branch Retinal Vein Occlusion With Macular Edema
- Central Retinal Vein Occlusion With Macular Edema
- Choroidal Neovascularization
- Diabetic Macular Edema
- Diabetic Retinopathy
- Neovascular Age-Related Macular Degeneration
Also known as: Armd With Choroidal Neovascularization, Choroid Neovascularization, Diabetic Retinitis, Fundus Diabeticus, Macular Edema Following Branch Retinal Vein Occlusion (Brvo), Macular Edema Following Central Retinal Vein Occlusion (Crvo), Senile Macular Degeneration With Subretinal Neovascularization, Senile Macular Retinal Degeneration.
Dosing
No dosing information is available for this tab.
Ranibizumab is administered by intravitreal injection only into the affected eye(s).
Ranibizumab is commercially available as single-dose prefilled syringes containing 0.3 or 0.5 mg of the drug for intravitreal injection. Ranibizumab-nuna is available as single-dose vials containing 0.5 mg of the drug for intravitreal injection, and ranibizumab-eqrn is available as single-dose vials containing 0.3 mg or 0.5 mg of the drug for intravitreal injection.
Because of the risk of infection and endophthalmitis, proper aseptic technique must always be used when preparing and administering the drug.
Prior to intravitreal administration of ranibizumab-nuna and ranibizumab-eqrn, the entire contents of the appropriate vial should be withdrawn through a sterile 5-mcm, 19-gauge filter needle into a 1-mL sterile Luer lock syringe. The filter needle is then replaced with a sterile 30-gauge, 1/2-inch needle for intravitreal injection. To obtain the appropriate ranibizumab dose (0.3 or 0.5 mg), the contents in the Luer lock syringe should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.
To prepare a dose of ranibizumab, remove the prefilled syringe from the syringe tray using aseptic technique. Do not use the syringe if the cap is detached from the Luer lock, the syringe is damaged, or particulate matter, cloudiness, or discoloration is present. To remove the syringe cap, snap off (do not turn or twist) the syringe cap. Attach a 30-gauge, 1/2-inch sterile injection needle firmly onto the syringe. Dislodge any air bubbles in the syringe prior to administration.
Ranibizumab products should be injected under controlled aseptic conditions (including use of sterile gloves, a sterile drape, and a sterile eyelid speculum or equivalent) following adequate anesthesia and administration of a broad-spectrum anti-infective agent.
Each prefilled syringe and vial of the drug should be used only for the treatment of a single eye. If the contralateral eye requires treatment, a new prefilled syringe or vial should be used and the sterile field, syringe, gloves, drape, eyelid speculum, and filter and injection needles should be changed prior to administration to the other eye.
Ranibizumab products should be stored at 2-8degreesC in the original carton; the injection should not be frozen and should be protected from light. Prior to use, unopened vials of ranibizumab-nuna can be stored at up to 30degreesC for up to 72 hours.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Specific drug interaction studies have not been conducted to date with ranibizumab.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Ocular or periocular infections.
*Known hypersensitivity (e.g., severe intraocular inflammation) to ranibizumab products or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects occurring more frequently in patients receiving ranibizumab than those receiving sham injections include conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of ranibizumab products have not been established in pediatric patients.
Studies have not been conducted with ranibizumab products in pregnant women; it is not known whether ranibizumab can cause fetal harm when administered during pregnancy. In embryofetal studies in animals, fetal skeletal abnormalities were observed when pregnant animals were exposed to serum ranibizumab concentrations higher than those produced with single eye treatments in humans. Based on its mechanism as a VEGF antagonist, it is possible that ranibizumab may adversely affect embryofetal development or reproductive capacity. The drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
It is not known whether ranibizumab products are distributed into human milk, or if they have any effects on the breastfed infant or on milk production. Because many drugs are excreted in human milk, caution is advised if ranibizumab products are administered in nursing women.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ranibizumab and any potential adverse effects of the drug on the breastfed child.
The manufacturers make no specific dosage recommendations for geriatric patients.
In clinical studies, approximately 76% of patients randomized to ranibizumab were 65 years of age or older and 51% were 75 years of age or older. No substantial differences in efficacy, safety, or systemic exposure relative to younger adults were observed.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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