Access full prescribing information, medication guides, and important safety documents for Glatiramer Acetate Injection from Ajenat Pharmaceuticals.
Life-threatening and fatal anaphylaxis can occur at any time following initiation of therapy — from as early as after the first dose, up to years after initiation of treatment.
Make patients aware that anaphylaxis symptoms may overlap with immediate post-injection reaction symptoms. Contraindicated with history of hypersensitivity. See full Boxed Warning in Full PI.
All documents below are FDA-approved and current. Medication Guides must be dispensed to each patient when filling this prescription.
NDC 82983-429-30 | White plunger | 30 syringes/carton
NDC 82983-430-12 | Blue plunger | 12 syringes/carton
Glatiramer Acetate Injection — Approved by the FDA
A Medication Guide is required to be dispensed to each patient when filling this prescription.
This guide contains important safety information that patients must read before starting and at each refill.
The IFU provides step-by-step instructions for preparing and injecting Glatiramer Acetate Injection, including diagrams.
20 mg Prefilled Syringe — White Plunger
NDC 82983-429-30
40 mg Prefilled Syringe — Blue Plunger
NDC 82983-430-12
Healthcare professionals and patients are encouraged to report negative side effects of prescription drugs to the FDA.
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FDA MedWatch Phone Reporting Line
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For medical questions about Glatiramer Acetate Injection prescribing information, contact our Medical Information line.
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Glatiramer Acetate Injection is a prescription medicine. Always consult your healthcare provider before starting, stopping, or changing your treatment.