Cimerli
Generic name: ranibizumab-eqrn (ophthalmic)
Dosage form: intravitreal injection
Drug class: Anti-angiogenic ophthalmic agents
What is Cimerli?
Cimerli is a prescription medicine that is injected by intravitreal injection into the eye once a month. It is used to prevent vision loss or blindness in certain eye conditions that cause fluid to leak into the macula, including wet age-related macular degeneration resulting from the growth of abnormal blood vessels, and macular edema.
Cimerli is made from a human antibody fragment. It works by inhibiting the biologic activity of human vascular endothelial growth factor A (VEGF-A), a protein that is thought to play an important role in the formation of new blood vessels.
Cimerli is the second approved biosimilar to Lucentis (ranibizumab), but is the first interchangeable biosimilar, which means it may be substituted for Lucentis without consulting the prescriber.
What is Cimerli used for?
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:
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glaucoma; or
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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.
What other drugs will affect Cimerli?
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.
How is Cimerli given?
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.
Dosing information
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):
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment to receive your Cimerli injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving Cimerli?
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:
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eye pain or redness, swelling around your eyes;
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blurred vision, tunnel vision, eye pain, or seeing halos around lights;
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increased sensitivity to light;
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discharge or bleeding from the eye;
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seeing flashes of light or "floaters" in your vision;
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sudden numbness or weakness (especially on one side of the body); or
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sudden severe headache, problems with speech or balance.
Common side effects may include:
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eye pain or irritation;
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feeling like something is in your eye;
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itchy or watery eyes;
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dry eyes, puffy eyelids;
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blurred vision;
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sinus pain, sore throat, cough; or
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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.
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Cimerli Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Cimerli.
Lucentis (ranibizumab) - Genentech, Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 10 mg/mL (0.5 mg/0.05 mL) |
Pre-Filled Syringe | 6 mg/mL (0.3 mg/0.05 mL) |
Single-Dose Vial | 10 mg/mL (0.5 mg/0.05 mL) |
Single-Dose Vial | 6 mg/mL (0.3 mg/0.05 mL) |
View Lucentis information in detail.
Susvimo (ranibizumab) - Genentech, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/mL |
View Susvimo information in detail.
Lucentis interchangeable products
Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.
Pharmacy laws for biosimilar prescribing may vary by state.
Byooviz (ranibizumab-nuna) - Samsung Bioepis Co., Ltd.
Formulation type | Strength |
---|---|
Single-Dose Vial | 10 mg/mL |
View Byooviz information in detail.
Cimerli (ranibizumab-eqrn) - Sandoz Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 10 mg/mL (0.5 mg/0.05 mL) |
Single-Dose Vial | 6 mg/mL (0.3 mg/0.05 mL) |
Popular FAQ
What are biosimilar drugs and how do they compare to biologics?
A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. One example is Amjevita (adalimumab-atto), the first biosimilar approved for Humira (adalimumab) in 2016.
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