GLATIRAMER ACETATE 40 mg/mL
glatiramer acetate · INJECTION, SOLUTION · Italfarmaco SpA
GLATIRAMER ACETATE is a injection, solution containing glatiramer acetate at 40 mg/mL, taken subcutaneous. Manufactured by Italfarmaco SpA.
Key Facts
- Brand Name
- GLATIRAMER ACETATE
- Generic Name
- glatiramer acetate
- NDC Code (Product)
11797-765- Manufacturer
- Italfarmaco SpA
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA208468
- Marketing Start
- 11/10/2025
Recall History
Teva Pharmaceuticals USA, Inc.
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Teva Pharmaceuticals USA
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Teva Pharmaceuticals USA, Inc.
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Glatiramer acetate injection 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. Glatiramer acetate injection 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 ) Glatiramer acetate injection 20 mg/mL per day ( 2.1 ) Glatiramer acetate injection 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 Glatiramer acetate injection 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: Glatiramer acetate injection 20 mg per mL: administer once per day or Glatiramer acetate injection 40 mg per mL: administer three times per week and at least 48 hours apart Glatiramer acetate injection 20 mg per mL and glatiramer acetate injection 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 …
Contraindications
4 CONTRAINDICATIONS Glatiramer acetate injection 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 glatiramer acetate injection 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 glatiramer acetate injection 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 cann…
Frequently Asked Questions
What is GLATIRAMER ACETATE used for?
GLATIRAMER ACETATE contains glatiramer acetate. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is GLATIRAMER ACETATE a controlled substance?
GLATIRAMER ACETATE is not classified as a controlled substance by the DEA.
What is the generic name for GLATIRAMER ACETATE?
The generic name for GLATIRAMER ACETATE is glatiramer acetate. There are 9 other brand versions of glatiramer acetate.
What is the NDC code for GLATIRAMER ACETATE 40 mg/mL?
The NDC (National Drug Code) for GLATIRAMER ACETATE 40 mg/mL is 11797-765, listed by Italfarmaco SpA.