Ranibizumab Injection and Implant

IMPORTANT WARNING:

Ranibizumab implant (Susvimo) may cause a greater risk of endophthalmitis (infection of tissues or fluids inside the eyeball) compared to ranibizumab injection (Lucentis). Talk to your doctor about the risks of receiving ranibizumab implant.

IMPORTANT NOTICE:

Ranibizumab injection is available as several different products that are considered to be biologic medications (medications made from living organisms). These biosimilar products are highly similar to ranibizumab injection and work the same way as ranibizumab injection in the body. Therefore, the term ranibizumab injection products will be used to represent these medications in this discussion.

WHY is this medicine prescribed?

Ranibizumab injection products are used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities). Ranibizumab implant (Susvimo) is also used to treat wet age-related macular degeneration after at least two successful treatments with ranibizumab or a similar medication. Ranibizumab injection products are also used to treat myopic choroidal neovascularization (mCNV; a complication in near-sighted people where new blood vessels can grow in the back of the eye) and to treat macular edema after retinal vein occlusion (an eye disease caused by blockage of blood flow from the eye that leads to blurry vision and vision loss). Ranibizumab injection (Lucentis) is also used to treat diabetic macular edema (an eye disease caused by diabetes that can lead to vision loss) and diabetic retinopathy (damage to the eyes caused by diabetes). Ranibizumab is in a class of medications called vascular endothelial growth factor A (VEGF-A) antagonists. It works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ranibizumab injection products come as a solution (liquid) to be injected into the eye by a doctor. It is usually given in a doctor's office every month. Your doctor may give you injections on a different schedule if that is best for you.

Ranibizumab also comes as an implant to be inserted into the white part of your eye with a needle by a doctor in a medical office or clinic. The implant will need to refilled by injecting with more solution into it every 6 months by a doctor in a medical office or a clinic.

Before you receive a ranibizumab injection product or implant, your doctor will clean your eye to prevent infection and numb your eye to reduce discomfort during the injection or implant. You may feel pressure in your eye when the medication is injected. After your injection, your doctor will need to examine your eyes before you leave the office.

After having the implant inserted, you may be asked to keep your head above shoulder level for the rest of the day, which includes sleeping with 3 or more pillows under your head when you sleep. You will also be provided with an eye shield which should not be removed until told to do so by your doctor and should be worn for at least 7 nights after the implant was inserted. Do not push, rub or touch that part of the eye for 30 days after the implant insertion (underneath the eyelid in the upper and outer part of the eye) or 7 days after the implant is refilled.

Ranibizumab controls certain eye conditions, but does not cure them. Your doctor will watch you carefully to see how well ranibizumab works for you. Talk to your doctor about how long you should continue treatment with ranibizumab.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ranibizumab injection products or implant,

• tell your doctor and pharmacist if you are allergic to ranibizumab, any other medications, or any of the ingredients in ranibizumab injection products or implant. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have an infection in or around your eyes, inflammation in your eye, or any other eye condition. Your doctor may not give you ranibizumab until the infection or inflammation is gone.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ranibizumab, call your doctor.

• your doctor may prescribe antibiotic eye drops for you to use for a few days after you receive each injection or implant. Talk to your doctor about how to use these eye drops.

• ask your doctor if there are any activities you should avoid during your treatment with ranibizumab injection products or implant.

• you should plan to have someone drive you home after your treatment.

• tell your doctor if you will be having a magnetic resonance imaging exam (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body) during your treatment with ranibizumab implant.

• talk to your doctor about testing your vision at home during your treatment. Check your vision in both eyes as directed by your doctor, and call your doctor if there are any changes in your vision.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive ranibizumab, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Ranibizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dry or itchy eyes
• teary eyes
• feeling that something is in your eye
• nausea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• worsening eye pain, eye redness, discharge from the eyes, puffy eyelids or swelling of the eyes, or blurred, lost or decreased vision
• eye sensitivity to light
• bleeding in or around the eye
• seeing ''floaters'' or small specks
• seeing flashing lights
• chest pain
• shortness of breath
• slow or difficult speech
• weakness or numbness of an arm or leg
• implant movement or discoloration
• sudden feeling that something is in your eye, seeing a bulge over the white part of your eye, eye discharge or watering of the eye when being treated with the implant

Ranibizumab injection products or implant may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.