nufymco
ranibizumab-leyk · by formycon ag
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Overview
Ranibizumab-leyk is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-leyk binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-leyk, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system. NUFYMCO (ranibizumab-leyk) injection is a sterile, clear and colorless to pale yellow solution in a single-dose glass vial for intravitreal injection. NUFYMCO is supplied as a sterile, preservative-free solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL ranibizumab-leyk (0.5 mg dose vial) or 6 mg/mL ranibizumab-leyk (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α- trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.
How to use
For ophthalmic intravitreal injection only ( 2.1 ) Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 2.2 ): NUFYMCO 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) ( 2.3 ): NUFYMCO 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) ( 2.4 ): NUFYMCO 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) ( 2.5 ): NUFYMCO 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. 2.1 General Dosing Information FOR OPHTHALMIC INTRAVITREAL INJECTION. Vials : A 5-micron sterile filter needle (19-gauge x 1-1/2 inch), a 1-mL Luer lock syringe and a…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis and Retinal Detachments [see Warnings and Precautions ( 5.1 )] Increases in Intraocular Pressure [see Warnings and Precautions ( 5.2 )] Thromboembolic Events [see Warnings and Precautions ( 5.3 )] Fatal Events in patients with DME and DR at baseline [see Warnings and Precautions ( 5.4 )] 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 ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of NUFYMCO has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. 6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal…
Warnings
Important safety information
Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection ( 5.1 ). Increases in intraocular pressure (IOP) have been noted both pre- and post‑intravitreal injection ( 5.2 ). There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ( 5.3 ). Fatal events occurred more frequently in patients with DME and DR at baseline, who were treated monthly with ranibizumab compared with control ( 5.4 ). 5.1 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 NUFYMCO. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [see Dosage and Administration ( 2.6 , 2.7 ) and Patient Counseling Information ( 17 )] . 5.2 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 NUFYMCO and manage appropriately [see Dosage and Administration ( 2.7 )] . 5.3 Thromboembolic Events Although there was a low rate of…
Interactions
Drug interaction studies have not been conducted with ranibizumab products. Ranibizumab intravitreal injection has been used adjunctively with PDT. Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.
Dosage forms
INJECTION
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Frequently asked questions
- What is Nufymco?
- Ranibizumab-leyk is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-leyk binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-leyk, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system. NUFYMCO (ranibizumab-leyk) injection is a sterile, clear and colorless to pale yellow solution in a single-dose glass vial for intravitreal injection. NUFYMCO is supplied as a sterile, preservative-free solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL ranibizumab-leyk (0.5 mg dose vial) or 6 mg/mL ranibizumab-leyk (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α- trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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