Ranibizumab

What is Ranibizumab?

Ranibizumab (LUCENTIS), a vascular endothelial growth factor (VEGF) inhibitor used to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

What are the uses of this medicine?

LUCENTIS is used 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)

How does this medicine work?

• Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110.
• 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.
• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• ocular or periocular infections
• known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS

What drug interactions can this medicine cause?

• Drug interaction studies have not been conducted with LUCENTIS.

Is this medicine FDA approved?

• Initial U.S. Approval: 2006

How should this medicine be used?

Recommended dosage:

• For ophthalmic intravitreal injection only

Neovascular (Wet) Age-Related Macular Degeneration (AMD):

• LUCENTIS 0.5 mg (0.05 mL) 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):

• LUCENTIS 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR):

• LUCENTIS 0.3 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Myopic Choroidal Neovascularization (mCNV):

• LUCENTIS 0.5 mg (0.05 mL) 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.

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.
• Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection.
• Each prefilled syringe or vial should only be used 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, drapes, eyelid speculum, filter needle (vial only), and injection needles should be changed before LUCENTIS is administered to the other eye.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-use prefilled syringe designed to provide 0.05 mL for intravitreal injections:
• 10 mg/mL solution (LUCENTIS 0.5 mg)
• 6 mg/mL solution (LUCENTIS 0.3 mg)

Single-use glass vial designed to provide 0.05 mL for intravitreal injections:

• 10 mg/mL solution (LUCENTIS 0.5 mg)
• 6 mg/mL solution (LUCENTIS 0.3 mg)

This medicine is available in fallowing brand namesː

• LUCENTIS

What side effects can this medication cause?

The most common side effects of this medicine include:

• hemorrhage
• eye pain
• vitreous floaters
• increased IOP

What special precautions should I follow?

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Proper aseptic injection technique should always be used when administering LUCENTIS. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
• Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with LUCENTIS. Monitor intraocular pressure prior to and following intravitreal injection with LUCENTIS and manage appropriately
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
• Fatal events occurred more frequently in patients with DME and DR at baseline, who were treated monthly with LUCENTIS compared with control.

What to do in case of emergency/overdose?

• No additional unexpected adverse reactions were seen.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of LUCENTIS administration in pregnant women.
• LUCENTIS should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of LUCENTIS in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RANIBIZUMAB

Inactive ingredient:

• HISTIDINE MONOHYDROCHLORIDE
• HISTIDINE
• TREHALOSE DIHYDRATE
• POLYSORBATE 20
• WATER

Who manufactures and distributes this medicine?

Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA

• LUCENTIS® is a registered trademark of Genentech, Inc.

What should I know about storage and disposal of this medication?

• LUCENTIS should be refrigerated at 2º-8ºC (36º-46ºF).
• DO NOT FREEZE.
• Do not use beyond the date stamped on the label.
• Protect LUCENTIS prefilled syringes and vials from light and store in the original carton until time of use.
• Do not open LUCENTIS prefilled syringe sealed tray until time of use.

• Dailymed label info on Ranibizumab
• FDA Ranibizumab

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