Ranibizumab-eqrn (intraocular route)


    Brand Name

    US Brand Name

    Cimerli


    Description

    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.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    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.

    Pediatric

    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.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ranibizumab-eqrn in the elderly.

    Breastfeeding

    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.

    Drug Interactions

    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

    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

    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 it is working properly and to check for unwanted effects.

    Serious eye or vision problems (eg, eye infection or bleeding, retinal detachment, or retinal vasculitis with or without occlusion) 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 your eye bleeds or has discharge, you feel that something is in your eye, or you have 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 have pain in your chest, groin, or legs, especially the calves, 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

    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.






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