Ranibizumab (Intraocular)

Ranibizumab is used to treat neovascular (wet) age-related macular degeneration (AMD). Susvimo™ is for patients who have responded to at least 2 injections of a vascular endothelial growth factor (VEGF) inhibitor. AMD is a condition affecting the retina in the eye that can cause blurred vision or blindness. Ranibizumab works by altering the amount of blood that reaches 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) following retinal vein occlusion (when a blood vessel in the eye is blocked). It is also used for diabetic patients with diabetic macular edema (DME). Macular edema can lead to vision loss. This medicine is also used to treat diabetic retinopathy (an eye issue caused by diabetes).

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

Your eye doctor will want to check how you are doing at regular visits, especially in the first few days after you receive this medicine, to ensure it is working properly and to look for any side effects.

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

Serious eye or vision problems (for example, eye infection or bleeding, retinal detachment, conjunctival bleb, erosion, or retraction) may happen with this medicine. Contact your eye doctor immediately if your eye becomes red, sensitive to light, painful, or watery, or if you experience eye bleeding or discharge, a sensation of something in your eye, or any change or loss of vision several days after you receive this medicine. Also, inform 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 surgery to fix this issue.

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

Let your doctor know that you have Susvimo™ implanted in your eye before you have an MRI.

Do not drive or engage in any activities that could be dangerous until your eye shield is removed and you can see properly. Do not rub or touch the area of your eye where the implant is inserted. Wash your hands first if you need to touch your eye.

This medicine may increase your risk of blood clots, heart attack, or stroke. Contact your doctor immediately if you experience chest pain, pain in your groin or legs (especially your calves), difficulty breathing, a severe sudden headache, slurred speech, sudden loss of coordination, sudden severe weakness or numbness in your arm or leg, or any changes in vision.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done to understand the effects of ranibizumab in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of ranibizumab.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

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

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

Along with its beneficial effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require 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.

In the U.S.

• Byooviz
• Cimerli
• Lucentis
• Susvimo

Available Dosage Forms:

• Solution
• Implant

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Monoclonal Antibody Fragment

Find detailed information on biosimilars for this medication.

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.

• What are anti-VEGF injections for macular degeneration?