Cimerli is used to treat neovascular (wet) age-related macular degeneration (AMD), which occurs when abnormal blood vessels grow under the macula and retina in the eye.

Cimerli is used to treat macular edema (swelling) caused by diabetes or by a blockage in the blood vessels. it is also used to treat diabetic retinopathy, the most common cause of vision loss in people with diabetes.

Cimerli is also used to treat myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness.

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

Warnings

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

Call your doctor at once if you have sudden vision problems, eye pain or redness, or if your eyes are more sensitive to light.

The timing of your monthly injections is very important for this medicine to be effective.

Before taking this medicine

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

To make sure this medicine is safe for you, tell your doctor if you have:

• glaucoma; or

• a history of blood clots or stroke.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Cimerli passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Cimerli is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Cimerli is usually given once every month.

For people with macular degeneration: After you have received the first 3 or 4 injections, your doctor may change your injection schedule to once every 3 months.

Follow your doctor's dosing instructions very carefully. The timing of your monthly injections is very important for this medication to be effective.

To be sure this medicine is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any follow-up visits to your doctor.

Usual Adult Dose for Macular Degeneration:

0.5 mg via intravitreal injection once a month (approximately 28 days)

Comment: Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. Patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly.

Use: Neovascular (wet) age-related macular degeneration (AMD)

Usual Adult Dose for Macular Edema Following Retinal Vein Occlusion (RVO):

0.5 mg via intravitreal injection once a month (approximately 28 days)

Use: Macular edema following retinal vein occlusion (RVO)

Usual Adult Dose for Diabetic Macular Edema (DME):

0.3 mg via intravitreal injection once a month (approximately 28 days)

Use: Diabetic macular edema (DME)

Usual Adult Dose for Diabetic Retinopathy:

0.3 mg via intravitreal injection once a month (approximately 28 days)

Use: Diabetic retinopathy

Usual Adult Dose for Myopic Choroidal Neovascularization (mCNV):

0.5 mg via intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed.

Use: Myopic choroidal neovascularization (mCNV):

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

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Cimerli side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cimerli may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• increased sensitivity to light;

• discharge or bleeding from the eye;

• seeing flashes of light or "floaters" in your vision;

• sudden numbness or weakness (especially on one side of the body); or

• sudden severe headache, problems with speech or balance.

Common side effects may include:

• eye pain or irritation;

• feeling like something is in your eye;

• itchy or watery eyes;

• dry eyes, puffy eyelids;

• blurred vision;

• sinus pain, sore throat, cough; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with Cimerli, 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.