Lucentis
(Ranibizumab)Dosage & Administration
For ophthalmic intravitreal injection only (
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Lucentis Prescribing Information
Dosage and Administration, General Dosing Information (FOR OPHTHALMIC INTRAVITREAL INJECTION. | 8/2023 | ||||||||||||||||||||||||||||||||||||||||
Dosage and Administration, Preparation for Administration (Prefilled Syringe: The prefilled syringe is sterile and is for single-dose only. Do not use the product if the packaging is damaged or has been tampered with.To prepare LUCENTIS for intravitreal administration, please adhere to these instructions for use. Read all the instructions carefully before using the prefilled syringe. The opening of the sealed tray and all subsequent steps should be done under aseptic conditions. For the intravitreal injection, a 30-gauge × ½ inch sterile injection needle should be used (not provided). Note: the dose must be set to 0.05 mL.
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Dosage and Administration, Administration (The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection. Prior to and 30 minutes following the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry. Monitoring may also consist of a check for perfusion of the optic nerve head immediately after the injection [see Warnings and Precautions (5.2)] . Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection[see Warnings and Precautions (5.1)] .Each prefilled syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new prefilled syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needle should be changed before LUCENTIS is administered to the other eye. No special dosage modification is required for any of the populations that have been studied (e.g., gender, elderly). | 8/2023 | ||||||||||||||||||||||||||||||||||||||||
Warnings and Precautions, 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 LUCENTIS. Discontinue treatment with LUCENTIS in patients who develop these events. Patients should be instructed to report any change in vision without delay [see Patient Counseling Information (17)] . | 2/2024 | ||||||||||||||||||||||||||||||||||||||||
LUCENTIS is indicated for the treatment of patients with:
For ophthalmic intravitreal injection only (
- Neovascular (Wet) Age-Related Macular Degeneration (AMD) ():
2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD)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. 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
[see Clinical Studies (14.1)].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
[see Clinical Studies (14.1)].
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 Macular Edema Following Retinal Vein Occlusion (RVO)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).
In Studies RVO-1 and RVO-2, patients received monthly injections of LUCENTIS 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
[see Clinical Studies (14.2)].
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). - Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) ():
2.4 Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)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).
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 Myopic Choroidal Neovascularization (mCNV)LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL LUCENTIS 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
[see Clinical Studies (14.5)].
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.
Single-dose prefilled syringe designed to provide 0.05 mL for intravitreal injection.
- Colorless to pale yellow 10 mg/mL solution (LUCENTIS 0.5 mg)
- Colorless to pale yellow 6 mg/mL solution (LUCENTIS 0.3 mg)
There are no adequate and well-controlled studies of LUCENTIS administration in pregnant women.
Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [Cmax]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose
An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received intravitreal injections of ranibizumab every 14 days starting on Day 20 of gestation, until Day 62 at doses of 0, 0.125, and 1 mg/eye. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted Cmaxlevels with single eye treatment in humans. No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed.
Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab
Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. 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 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.
LUCENTIS should be given to a pregnant woman only if clearly needed.
- Ocular or periocular infections ()
4.1 Ocular or Periocular InfectionsLUCENTIS is contraindicated in patients with ocular or periocular infections.
- Hypersensitivity ()
4.2 HypersensitivityLUCENTIS is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.