CIMERLI- ranibizumab-eqrn injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RANIBIZUMAB (UNII: ZL1R02VT79) (RANIBIZUMAB - UNII:ZL1R02VT79)

Available from:

Coherus BioSciences Inc

Administration route:

INTRAVITREAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CIMERLI is indicated for the treatment of patients with:           CIMERLI is contraindicated in patients with ocular or periocular infections. 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. Risk Summary There are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [C max ]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see Animal Data]

Product summary:

CIMERLI (ranibizumab-eqrn) injection is a colorless to pale yellow solution supplied in: EACH CARTON IS FOR SINGLE-EYE USE ONLY. 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CIMERLI- RANIBIZUMAB-EQRN INJECTION, SOLUTION
COHERUS BIOSCIENCES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIMERLI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIMERLI.
CIMERLI™ (RANIBIZUMAB-EQRN) INJECTION, FOR INTRAVITREAL USE
INITIAL U.S. APPROVAL: 2022
CIMERLI (RANIBIZUMAB-EQRN) IS INTERCHANGEABLE WITH LUCENTIS (RANIBIZUMAB INJECTION).
INDICATIONS AND USAGE
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)
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) 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) 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) 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) is recommended to be initially administered
by intravitreal injection once a
month (approximately 28 days) for up to three months. Patients may be
retreated if needed.
DOSAGE FORMS AND STRENGTHS
Single-dose glass vial designed to provide 0.0