Pronunciation:

ra-ni-BIZ-oo-mab

Brand Names:

• Byooviz
• Cimerli
• Lucentis
• Susvimo

Dosage Forms:

• Solution
• Implant

Warnings:

Warning: EndophthalmitisThe ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis .

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Monoclonal Antibody Fragment

Uses of This Medicine:

Ranibizumab is used to treat neovascular (wet) age-related macular degeneration (AMD). It is also used in diabetic patients who have diabetic macular edema (DME). Susvimo® is used in patients who have responded to at least 2 injections of a vascular endothelial growth factor (VEGF) inhibitor. AMD is a disorder of the retina in the eye that causes blurring of vision or blindness. Ranibizumab works by changing the amount of blood that gets to the eye.

Ranibizumab is also used to treat myopic choroidal neovascularization (mCNV).

Ranibizumab is used to treat macular edema (swelling of the back of the eye) after retinal vein occlusion (a blood vessel in the eye is blocked). Macular edema can cause loss of vision. This medicine is also used to treat diabetic retinopathy (eye problem caused by diabetes).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ranibizumab in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ranibizumab in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Glaucoma—Use with caution. May make these conditions worse.

• Eye infection or
• Eye swelling, active—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Lucentis®: An ophthalmologist (eye doctor) will give you this medicine as a shot into the eye. This medicine is usually given once a month (about every 28 days). In some patients, it may be given once every 3 months after the first 4 injections.

Susvimo®: This medicine is an implant that is inserted through the white part of the eye (sclera) by a doctor. Your doctor will refill the implant device every 6 months (at least every 24 weeks). Your doctor will give you instructions to follow after you receive the implant or the refill, and after the implant is removed.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

Your eye doctor will want to check your progress at regular visits, especially during the first few days after you receive this medicine, to make sure this medicine is working properly and to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 12 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Serious eye or vision problems (eg, eye infection or bleeding, retinal detachment, conjunctival bleb, erosion, retinal vasculitis with or without occlusion, or retraction) may occur with this medicine. Check with your eye doctor right away if your eye becomes red, sensitive to light, painful, or watery, or if you have eye bleeding or discharge, a feeling that something is in your eye, or a change or loss of vision several days after you receive this medicine. Also, tell your eye doctor if you feel increased pressure in your eye.

Tell your doctor right away if your implant has moved out of place. You may need a surgery to correct this movement.

Damage to the implant septum (self-sealing part where ranibizumab is given to fill the implant) may occur with Susvimo®. This may cause problems when you receive a refill for your implant. Your doctor may remove the implant or change your treatment if your implant has been damaged.

Tell your doctor that you have Susvimo® implanted in your eye before you have an MRI.

Do not drive or do anything else that could be dangerous until your eye shield can be removed and you can see. Do not rub or touch the area of the eye where the implant is inserted. Wash your hands first, if you have to touch your eye.

This medicine may increase your risk of blood clots, heart attack, or stroke. Check with your doctor right away if you are having pain in your chest, groin, or legs, especially the calves, difficulty or trouble breathing, a severe, sudden headache, slurred speech, sudden loss of coordination, sudden, severe weakness or numbness in your arm or leg, or vision changes.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

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

Less common

Body aches or pain

chest pain or tightness

chills

cough

difficulty or trouble 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

pain in the chest, groin, or legs, especially the calves

painful blisters on the trunk of the body

pale skin

runny or stuffy 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

sweating

trouble sleeping

unexplained weight loss

unusual tiredness or weakness

Some side effects 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:

More common

Back pain

difficulty having a bowel movement (stool)

difficulty with moving

muscle stiffness

swelling or redness in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.