Susvimo (Initial Fill) 10 mg/0.1 mL intravitreal implant solution

Generic name:
Ranibizumab implant - intraocular

Pronunciation
(RA-ni-BIZ-ue-mab)

Brand name(s)
Susvimo

This medication implant is used to deliver ranibizumab into the eye. The implant and the procedures to place and use it properly may have an increased risk of serious side effects such as eye infection and eye damage. Tell your doctor right away if you have vision changes such as decreased vision, sensitivity to light, or seeing flashing lights or a curtain or veil covering part of your vision or an increase in moving spots or what looks like spider webs. Also tell your doctor right away if you have increasing eye pain, or a sudden feeling that something is in your eye, bleeding or redness in the white of the eye, or if you have eye discharge, or watering of the eye. Proper treatment may require immediate medical or surgical treatment.

This medication implant is used to treat a certain serious eye condition (age-related macular degeneration). It is used by people who have had at least 2 injections of ranibizumab or a similar medication injected into the eye with good results. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels. This medication may help prevent decreased vision and blindness.

Read the Medication Guide provided by your pharmacist before you start using ranibizumab implant and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is an implant placed into the affected eye(s) by a health care professional. The affected eye is numbed before the procedure. Your eye will be monitored before and after placement. Your implant device will be refilled as directed by your doctor, usually every 6 months. To help prevent serious side effects, carefully follow your doctor's instructions after the implant is placed, after each refill procedure, and after the implant is removed. Use any eye drops exactly as directed by your doctor.

After the implant is placed, keep your head above shoulder level for the rest of the day. Sleep with your head on 3 or more pillows during the day and night after the implant is inserted. Do not remove the eye shield from your eye until you are told to do so by your doctor. For at least 7 nights after the insertion, wear the eye shield when sleeping. Do not push on or rub the eye, or touch the implant area for 30 days after the insertion. Many patients will need to wait a month after the implant procedure to do strenuous activities, but ask your doctor what length of time is safest in your case.

After the refill procedure, do not push on the eye, rub the eye, or touch the implant area for 7 days. If you miss a scheduled refill, contact your health care provider right away to schedule a new appointment.

After implant removal, keep your head above shoulder level for the rest of the day. Sleep with your head on 3 or more pillows during the day and night after the implant is removed. Wear an eye shield for at least 7 nights. Do not do strenuous activities until 14 days after the implant removal.

Your health care provider should give you an implant card after you receive the implant. Keep the card in a safe place and show it to all your health care provider(s). You may only receive an MRI under very specific conditions if you have this implant.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Eye pain, blood, or redness on the white of the eye may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication device has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication device do not have serious side effects.

Tell your doctor right away if you notice that the implant has moved out of place.

The medication in this device may sometimes increase the risk of serious (possibly fatal) blood clots. This may lead to stroke, heart attack, and other blood vessel problems. Get medical help right away if you develop:

• symptoms of stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving ranibizumab implant, tell your doctor or pharmacist if you are allergic to ranibizumab; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent eye infection

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not drive, use machinery, or do anything that needs clear vision until the eye shield can be removed and you can see.

Avoid rubbing your eye or touching the implant area as much as you can. If you have to rub or touch your eye, wash your hands first.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, this medication is unlikely to pass into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Medical tests (such as eye exams) should be done while you are using this medication. Keep all medical appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a scheduled refill, contact your health care provider right away to schedule a new appointment.

Not applicable. The device placement, refill, and removal procedures are done in a clinic or doctor's office. The device and medication will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.