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Safety

Incidence of Adverse Reactions in Controlled Clinical Trials1,2

  • GA injection 20 mg/mL per day
  • GA injection 40 mg/mL three times per week

GA injection 20 mg/mL per day

In controlled studies of GA 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.

Among 563 patients treated with GA injection in blinded placebo-controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction.

Table: Adverse Reactions in a Controlled Clinical Trial with an Incidence ≥ 2% of Patients and More Frequent with GA Injection (20 mg/mL Daily) than with Placebo

  Glatiramer Acetate Injection 20 mg/mL
(n = 563) %		Placebo (n = 564) %
General Disorders and Administration Site Conditions Injection Site Erythema 43 10
Injection Site Pain 40 20
Injection Site Pruritus 27 4
Injection Site Mass 26 6
Injection Site Edema 19 4
Chest Pain 13 6
Injection Site Inflammation 9 1
Injection Site Reaction 8 1
Injection Site Hypersensitivity 4 0
Injection Site Fibrosis 2 1
Injection Site Atrophy* 2 0
Respiratory, Thoracic and Mediastinal DisordersDyspnea144
Skin and Subcutaneous Tissue DisordersRash1911
Vascular DisordersVasodilatation205

*Injection site atrophy comprises terms relating to localized lipoatrophy at injection site

GA injection 40 mg/mL three times per week

In a controlled study of GA injection 40 mg/mL, most common adverse reactions (≥ 10% and ≥ 1.5 times higher than placebo) were: injection site reactions.

Among 943 patients treated with GA injection 40 mg/mL three times per week in a blinded, placebo controlled trial, approximately 3% of the subjects discontinued treatment because of an adverse reaction.

Table: Adverse Reactions in a Controlled Clinical Trial with an Incidence ≥ 2% of Patients and More Frequent with GA Injection (40 mg/mL Three Times per Week) than with Placebo

Glatiramer Acetate Injection 40 mg/mL
(n = 943) % 		Placebo (n = 461) %
General Disorders and Administration Site Conditions Injection Site Erythema 22 2
Injection Site Pain 10 2
Injection Site Mass 6 0
Injection Site Pruritus 6 0
Injection Site Edema 6 0
Injection Site Inflammation 2 0

INDICATION

GLATIRAMER ACETATE INJECTION is indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

GLATIRAMER ACETATE INJECTION is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of patients exposed to GLATIRAMER ACETATE INJECTION 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to GLATIRAMER ACETATE INJECTION 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur within seconds to minutes after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was experienced by 13% of GLATIRAMER ACETATE INJECTION 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of GLATIRAMER ACETATE INJECTION 40 mg per mL patients compared to 1% on placebo.

While some episodes of chest pain occurred in the context of the immediate post-injection reactions that are described, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than one such episode, and episodes usually began at least one month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because GLATIRAMER ACETATE INJECTION can modify immune response, it may interfere with immune functions. For example, treatment with GLATIRAMER ACETATE INJECTION may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that GLATIRAMER ACETATE INJECTION does this, but there has not been a systematic evaluation of this risk.

Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, have been reported with GLATIRAMER ACETATE INJECTION. Hepatic injury has occurred from days to years after initiating treatment with GLATIRAMER ACETATE INJECTION. If signs or symptoms of liver dysfunction occur, consider discontinuation of GLATIRAMER ACETATE INJECTION.

The most common adverse reactions observed in controlled studies of GLATIRAMER ACETATE INJECTION 20 mg per mL and 40 mg per mL, were injection site reactions (ISRs), vasodilatation, rash, dyspnea and chest pain; ISRs were one of the most common adverse reactions leading to discontinuation of GLATIRAMER ACETATE INJECTION. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with GLATIRAMER ACETATE INJECTION than placebo.