Pronunciation:

ra-ni-BIZ-oo-mab - eqrn

Brand Names:

• Cimerli

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Ranibizumab

Uses of This Medicine:

Ranibizumab-eqrn is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurring of vision or blindness. Ranibizumab-eqrn works by changing the amount of blood that gets to the eye.

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

Ranibizumab-eqrn is also used to treat macular edema (swelling of the back of the eye) after retinal vein occlusion (a blood vessel in the eye is blocked). It is also used in diabetic patients who have diabetic macular edema (DME). 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-eqrn 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-eqrn 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:

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

Proper Use of This Medicine:

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.

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.

Serious eye or vision problems (eg, eye infection or bleeding, retinal detachment) 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.

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.

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

bloody urine

blurred vision

body aches or pain

burning, numbness, tingling, or painful sensations

change or loss of vision

chills

cough

decreased amount of urine

diarrhea

disturbed color perception

ear congestion

eye pain, irritation

fever

general feeling of discomfort or illness

halos around lights

headache

increased blood pressure

increased thirst

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nausea

night blindness

overbright appearance of lights

pain or tenderness around eyes and cheekbones

pale skin

redness of the eye

seeing floating dark spots or material before the eyes

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

shivering

sore throat

stuffy or runny nose

sweating

swelling of the face, fingers, hands, ankles, feet, or lower legs

tearing of the eyes

trouble breathing

trouble sleeping

tunnel vision

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weakness in the arms, hands, legs, or feet

weight gain

Less common

Chest tightness

cough producing mucus

difficulty in moving

dizziness

fainting

fast or irregular heartbeat

joint pain

muscle stiffness

redness, swelling, or itching of the eyelid

redness of the white part of the eyes or inside of the eyelids

sensitivity of the eye to light

Incidence not known

Chest pain or discomfort

confusion

difficulty in speaking

inability to move the arms, legs, or facial muscles

inability to speak

pain or discomfort in the arms, jaw, back or neck

slow speech

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

Constipation

heartburn

Less common

Slow wound healing

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.