Vascular Endothelial Growth Factor InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Cimerli
RANIBIZUMAB-EQRN
1 INDICATIONS AND USAGE CIMERLI is indicated for the treatment of patients with: CIMERLI, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: • Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) • Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) • Diabetic Macular Edema (DME) ( 1.3 ) • Diabetic Retinopathy (DR) ( 1.4 ) • Myopic Choroidal Neovascularization (mCNV) ( 1.5 ) 1.1 Neovascular (Wet) Age-Related Macular Degene...
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Brand names:CIMERLI
Quick Reference
Medicine ClassVascular Endothelial Growth Factor Inhibitor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- RANIBIZUMAB-EQRN
- Medicine class
- Vascular Endothelial Growth Factor Inhibitor
- Brand names
- CIMERLI
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life was approximately 9 days
- FDA approved
- Yes
What Is Cimerli?
1 INDICATIONS AND USAGE CIMERLI is indicated for the treatment of patients with: CIMERLI, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: • Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) • Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) • Diabetic Macular Edema (DME) ( 1.3 ) • Diabetic Retinopathy (DR) ( 1.4 ) • Myopic Choroidal Neovascularization (mCNV) ( 1.5 ) 1.1 Neovascular (Wet) Age-Related Macular Degene...
Cimerli (RANIBIZUMAB-EQRN) belongs to the Vascular Endothelial Growth Factor Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Cimerli. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Cimerli with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Cimerli is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE CIMERLI is indicated for the treatment of patients with: CIMERLI, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: • Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) • Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) • Diabetic Macular Edema (DME) ( 1.3 ) • Diabetic Retinopathy (DR) ( 1.4 ) • Myopic Choroidal Neovascularization (mCNV) ( 1.5 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) 1.5 Myopic Choroidal Neovascularization (mCNV)
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION For ophthalmic intravitreal injection only ( 2.1 ) • Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 2.2 ): CIMERLI 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). • Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. • Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly. • Macular Edema Following Retinal Vein Occlusion (RVO) ( 2.3 ): CIMERLI 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) ( 2.4 ): CIMERLI 0.3 mg (0.05 mL of 6 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days). • Myopi
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Endophthalmitis and Retinal Detachments [see Warnings and Precautions ( 5.1 )] • Increases in Intraocular Pressure [see Warnings and Precautions ( 5.2 )] • Thromboembolic Events [see Warnings and Precautions ( 5.3 )] • Fatal Events in patients with DME and DR at baseline [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ).
- To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
- at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [see Warnings and Precautions ( 5.1 )] , rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
- 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The data below reflect exposure to 0.5 mg ranibizumab in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3;
- in 259 patients with macular edema following RVO.
Serious
- 5 WARNINGS AND PRECAUTIONS • Endophthalmitis and retinal detachments may occur following intravitreal injections.
- Patients should be monitored following the injection ( 5.1 ).
- • Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection ( 5.2 ).
- • There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ( 5.3 ).
- • Fatal events occurred more frequently in patients with DME and DR at baseline, who were treated monthly with ranibizumab compared with control ( 5.4 ).
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection ( 5.1 ). • Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection ( 5.2 ). • There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ( 5.3 )
How Cimerli Works
12.1 Mechanism of Action Ranibizumab products bind to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF 110 . VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, mCNV, DR, DME and macular edema following RVO. The binding of ranibizumab products to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Pharmacokinetics
Half-Life
half-life was approximately 9 days
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Cimerliwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
CIMERLI should be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Do not use beyond the expiry date stamped on the label. Protect CIMERLI vials from light and store in the original carton until time of use.
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Cimerli
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.