COPAXONE- glatiramer acetate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLATIRAMER ACETATE (UNII: 5M691HL4BO) (GLATIRAMER - UNII:U782C039QP)

Available from:

Teva Neuroscience, Inc.

INN (International Name):

GLATIRAMER ACETATE

Composition:

GLATIRAMER ACETATE 20 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Risk Summary Available human data on the use of COPAXONE in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development ( see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled stu

Product summary:

COPAXONE (glatiramer acetate injection) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution supplied as: Some glatiramer acetate products can be administered by an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time [see Warnings and Precautions (5.6) and Patient Counseling Information (17)]. Store COPAXONE refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store COPAXONE at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze COPAXONE. If a COPAXONE syringe freezes, it should be discarded.

Authorization status:

New Drug Application

Summary of Product characteristics

COPAXONE- GLATIRAMER ACETATE INJECTION, SOLUTION
TEVA NEUROSCIENCE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COPAXONE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COPAXONE.
COPAXONE (GLATIRAMER ACETATE INJECTION), FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2) 11/2023
Warnings and Precautions (5.6) 11/2023
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 (1).
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)
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/mL in a single-dose prefilled syringe with a white
plunger (3)
Injection: 40 mg/mL in a single-dose, prefilled syringe with a blue
plunger (3)
CONTRAINDICATIONS
Known hypersensitivity to glatiramer acetate or mannitol (4)
WARNINGS AND PRECAUTIONS
Immediate Post-Injection Reaction (flushing, chest pain, palpitations,
tachycardia, anxiety, dyspnea,
throat constriction, and/or urticaria), may occur within seconds to
minutes after injection and are
generally transient and self-limiting (5.1)
Chest pain, usually transient (5.2)
Lipoatrophy and skin necrosis may occur. Instruct patients in proper
injection technique and to rotate
injection sites (5.3)
COPAXONE can modify immune response (5.4)
Hepatic Injury: if signs or symptoms of hepatic dysfunction occur,
consider discontinuing COPAXONE
(5.5)
Glatiramer Acetate Products and Administration Errors: Using an
optional autoinjector that is not
compatible for use with TEVA’s COPAXONE may increase the risk for
medication errors, such as dose
omission or administration of a partial dose. (5.6)
ADVERSE REACTIONS