CIMERLI .3 mg/.05mL
ranibizumab-eqrn · INJECTION, SOLUTION · Coherus BioSciences Inc
CIMERLI is a injection, solution containing ranibizumab-eqrn at .3 mg/.05mL, taken intravitreal. Manufactured by Coherus BioSciences Inc.
Key Facts
- Brand Name
- CIMERLI
- Generic Name
- ranibizumab-eqrn
- NDC Code (Product)
70114-440- Manufacturer
- Coherus BioSciences Inc
- Strength
- .3 mg/.05mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVITREAL
- Marketing Status
- Application #
- BLA761165
- Drug Class
- Vascular Endothelial Growth Factor Inhibitor [EPC]
- Marketing Start
- 10/03/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & Administration
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). • Myopic Choroidal Neovascularization (mCNV) ( 2.5 ): CIMERLI 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) …
Contraindications
4 CONTRAINDICATIONS • Ocular or periocular infections ( 4.1 ) • Hypersensitivity ( 4.2 ) 4.1 Ocular or Periocular Infections CIMERLI is contraindicated in patients with ocular or periocular infections. 4.2 Hypersensitivity CIMERLI is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Drug Interactions
7 DRUG INTERACTIONS Drug interaction studies have not been conducted with ranibizumab products. Ranibizumab intravitreal injection has been used adjunctively with PDT. Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.
Adverse Reactions
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 can…
Frequently Asked Questions
What is CIMERLI used for?
CIMERLI contains ranibizumab-eqrn. It is a injection, solution taken intravitreal. Consult your doctor for specific uses.
Is CIMERLI a controlled substance?
CIMERLI is not classified as a controlled substance by the DEA.
What is the generic name for CIMERLI?
The generic name for CIMERLI is ranibizumab-eqrn. There are no other listed brand versions of ranibizumab-eqrn.
What is the NDC code for CIMERLI .3 mg/.05mL?
The NDC (National Drug Code) for CIMERLI .3 mg/.05mL is 70114-440, listed by Coherus BioSciences Inc.
Other CIMERLI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)