Description
Aflibercept-mrbb injection is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurred vision or blindness. Aflibercept-mrbb works by changing the amount of blood that gets to the retina.
Aflibercept-mrbb injection is also used to treat macular edema after retinal vein occlusion. It is also used to treat diabetic macular edema (DME) and diabetic retinopathy. Macular edema is swelling in the back of the eye and may cause vision loss. Retinal vein occlusion is a blockage of a blood vessel in the eye. Swelling can occur when the blood vessel is blocked.
This medicine is to be given only by your doctor.
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 aflibercept-mrbb injection 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 aflibercept-mrbb injection in the elderly.
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:
- Blood clots, history of or
- Detached retina (eye disorder) or
- Endophthalmitis (inflammation of the eye) or
- Heart attack, history of or
- Increased pressure in the eye or
- Stroke, history of—Use with caution. May make these conditions worse.
- Eye infection or
- Eye swelling, active—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.
Precautions
Your eye doctor will want to check your progress closely and 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.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control before the first dose, during treatment, and for 3 months after the last dose to keep from getting pregnant. If you think you have become pregnant while receiving this medicine, tell your doctor right away.
Serious eye problems (eg, retinal detachment, endophthalmitis, increased pressure inside the eye, 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, or painful, or if you see flashes or sparks of light, have a change in vision, or feel increased pressure in the eye several days after the injection.
This medicine may increase your risk for blood clots. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty breathing, a severe, sudden headache, slurred speech, a sudden loss of coordination, severe weakness or numbness in the arm or leg, or vision changes.
This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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
- blurred vision
- change in vision
- decreased vision
- eye pain
- loss of vision
- redness of the eye
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
Less common
- Pain at the injection site
- sensitivity of the eyes to light
- swelling of the eye
- swelling of the eyelids
- tearing
- watering of the eyes
Rare
- Chest tightness
- fast heartbeat
- hives, itching, skin rash
- headache
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing or swallowing
Incidence not known
- Chest pain or discomfort
- nausea
- pain in the chest, groin, or legs, especially the calves
- pain or discomfort in the arms, jaw, back, or neck
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sweating
- vomiting
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.
CON-XXXXXXXX
