Ranibizumab-eqrn (Intraocular)

Ranibizumab-eqrn is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a condition of the retina in the eye that can lead to blurred vision or blindness. Ranibizumab-eqrn works by changing the amount of blood that reaches the eye.

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

Ranibizumab-eqrn is also used to treat macular edema (swelling in the back of the eye) after retinal vein occlusion (when a blood vessel in the eye is blocked). It is also used for diabetic patients who have 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 is to be given only by or under the direct supervision of your doctor.

Your eye doctor will want to check how you are doing at regular visits, especially during the first few days after you get this medicine, to ensure it is working properly and to watch for unwanted effects.

Serious eye or vision issues (like eye infection or bleeding, retinal detachment) may happen with this medicine. Contact your eye doctor immediately if your eye becomes red, sensitive to light, painful, or watery, or if you have eye bleeding or discharge, a sensation of something in your eye, or any change or loss of vision several days after you get this medicine. Also, inform your eye doctor if you feel increased pressure in your eye.

This medicine may raise your risk of blood clots, heart attack, or stroke. Contact your doctor right away if you experience pain in your chest, groin, or legs, especially in 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of the medicine. For this medicine, keep the following in mind:

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 about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how age affects the results of ranibizumab-eqrn in children. Safety and effectiveness have not been proven.

Geriatric

Studies conducted so far have not found any specific problems in elderly patients that would limit the usefulness of ranibizumab-eqrn.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. 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 specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Be sure to tell your doctor if you have any other medical problems, especially:

• Eye infection or
• Severe eye swelling—This medicine should not be used in patients with these conditions.

Along with its needed effects, Cimerli may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 Cimerli. Your health care professional may also 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.

In the U.S.

• Cimerli

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Ranibizumab

Find detailed information on biosimilars for this medication.

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.

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