Ranibizumab is a vascular endothelial growth factor inhibitor sold in the U.S. under 2 brand and generic names, for diabetic retinopathy, macular edema and retinal vein occlusion. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Lucentis (application BLA125156). Other ranibizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For ophthalmic intravitreal injection only ( 2.1 ) Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 2.2 ): LUCENTIS 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 ): LUCENTIS 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 ): LUCENTIS 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 ): LUCENTIS 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. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD) LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL…
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 LUCENTIS-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [see Warnings and Precautions (5.1) ] , rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to 0.5 mg LUCENTIS in 440 patients with neovascular AMD in Studies AMD-1, AMD-2,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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| 1 | 72/100 | Prescription | Injectable | — | — | View → | |
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Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Ocular or Periocular Infections LUCENTIS is contraindicated in patients with ocular or periocular infections. 4.2 Hypersensitivity LUCENTIS is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Drug interaction studies have not been conducted with LUCENTIS. LUCENTIS 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 LUCENTIS was administered 7 days (± 2 days) after PDT.
| 72/100 |
| Prescription |
| Injectable |
| — |
| — |
| View → |