Ranibizumab Ophthalmic

Ranibizumab is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with a certain type of eye disease, new blood vessels grow under the retina where they leak blood and fluid. This is known as the "wet form" of macular degeneration.

Ranibizumab ophthalmic (for the eyes) is used to treat wet age-related macular degeneration. Ranibizumab is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels.

Ranibizumab may also be used for purposes not listed in this medication guide.

You should not receive ranibizumab if you are allergic to it, or if you have any type of infection in or around your eyes.

Before you receive this medication, tell your doctor if you have glaucoma, or a history of blood clots or stroke.

Call your doctor at once if you have sudden vision problems, eye pain or irritation, discharge or bleeding from the eye, swelling around your eye, seeing flashes of light or "floaters" in your vision, sudden numbness or weakness in your body, sudden severe headache, or problems with speech or balance.

Call your doctor for instructions if you miss an appointment to receive your ranibizumab injection. The timing of your monthly injections is very important for this medication to be effective.

You should not receive ranibizumab if you are allergic to it, or if you have any type of infection in or around your eyes.

To make sure you can safely receive ranibizumab ophthalmic, tell your doctor if you have glaucoma, or a history of blood clots or stroke.

FDA pregnancy category C. It is not known whether ranibizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ranibizumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ranibizumab is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with certain types of eye disorders, new blood vessels grow under the retina where they leak blood and fluid.

Ranibizumab ophthalmic (for the eyes) is used to treat the "wet form" of age-related macular degeneration. Ranibizumab is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels.

Ranibizumab may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss an appointment to receive your ranibizumab injection.

Other drugs may interact with ranibizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to ranibizumab ophthalmic: intraocular solution

Along with its needed effects, ranibizumab ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ranibizumab ophthalmic:

• Blindness
• bloody eye
• blurred vision or loss of vision
• decreased vision or other changes in vision
• disturbed color perception
• dizziness
• double vision
• dry eye
• eye pain
• fainting
• feeling of having something in the eye
• halos around lights
• headache
• night blindness
• overbright appearance of lights
• pain or tenderness around the eyes and cheekbones
• red, sore eyes
• redness of the white part of the eyes or inside of the eyelids
• redness, swelling, or itching of the eyelid
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across a part of vision
• sensitivity of the eye to light
• tearing of the eyes
• tunnel vision
• watering of the eyes

• Body aches or pain
• chest pain
• chills
• cough
• difficulty with breathing
• dry mouth
• fainting
• fast, slow, or irregular heartbeat
• general feeling of discomfort or illness
• head congestion
• hoarseness, loss of voice, or other voice changes
• loss of consciousness
• muscle aches and pains
• nasal congestion
• pain in the chest, groin, or legs, especially the calves
• painful blisters on the trunk of the body
• pale skin
• runny nose
• severe, sudden headache
• shivering
• slow wound healing
• slurred speech
• sneezing
• sore throat
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sudden, unexplained shortness of breath
• sweating
• tightness in the chest
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness

Some side effects of ranibizumab ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• difficulty having a bowel movement (stool)
• difficulty with moving
• muscle stiffness
• swelling or redness in the joints

No adjustment recommended.

Although Not as Effective, the Following Dosing Regimens May Be Used in Patients with Neovascular (Wet) AMD:
-Administer 3 monthly doses followed by less frequent dosing with regular assessment. In the 9 months after 3 initial monthly doses, less frequent dosing with 4 to 5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1 to 2 letter gain.

-Administer 1 dose every 3 months after 4 monthly doses with regular assessment. 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.

Data not available.