Copaxone 40 mg/mL
Glatiramer Acetate · INJECTION, SOLUTION · Teva Neuroscience, Inc.
Copaxone is a injection, solution containing glatiramer acetate at 40 mg/mL, taken subcutaneous. Manufactured by Teva Neuroscience, Inc..
Key Facts
- Brand Name
- Copaxone
- Generic Name
- Glatiramer Acetate
- NDC Code (Product)
68546-325- Manufacturer
- Teva Neuroscience, Inc.
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA020622
- Marketing Start
- 01/29/2014
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous injection only; doses are not interchangeable ( 2.1 ) COPAXONE 20 mg/mL per day ( 2.1 ) COPAXONE 40 mg/mL three times per week ( 2.1 ) Before use, allow the solution to warm to room temperature ( 2.2 ) 2.1 Recommended Dose COPAXONE is for subcutaneous use only [see Dosage and Administration ( 2.2 )] . Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are: COPAXONE 20 mg per mL: administer once per day or COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable. 2.2 Instructions for Use Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe. Areas for subcutaneous self-injection include arms…
Contraindications
4 CONTRAINDICATIONS COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.2 )] Chest Pain [see Warnings and Precautions ( 5.3 )] Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.4 )] Potential Effects on Immune Response [see Warnings and Precautions ( 5.5 )] Hepatic Injury [see Warnings and Precautions ( 5.6 )] In controlled studies of COPAXONE 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) In a controlled study of COPAXONE 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 t…
Frequently Asked Questions
What is Copaxone used for?
Copaxone contains Glatiramer Acetate. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Copaxone a controlled substance?
Copaxone is not classified as a controlled substance by the DEA.
What is the generic name for Copaxone?
The generic name for Copaxone is Glatiramer Acetate. There are 10 other brand versions of Glatiramer Acetate.
What is the NDC code for Copaxone 40 mg/mL?
The NDC (National Drug Code) for Copaxone 40 mg/mL is 68546-325, listed by Teva Neuroscience, Inc..
Other Copaxone Dosages
Other Glatiramer Brands
See all →- Glatopa40 mg/mL0781-3250
- Glatiramer Acetate40 mg/mL47335-991
- Glatiramer Acetate20 mg/mL0378-6960
- Glatopa40 mg/mL63629-8816
- GLATIRAMER ACETATE20 mg/mL11797-764
- Glatiramer Acetate20 mg/mL0832-6084
- GLATIRAMER ACETATE40 mg/mL11797-765
- Glatopa20 mg/mL0781-3234
- Glatopa20 mg/mL63629-8815
- GLATIRAMER ACETATE20 mg/mL70710-1548
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)