A DEMONSTRATED SAFETY AND TOLERABILITY PROFILE1

Pregnancy

Pregnancy Category B1

Animal studies have failed to demonstrate a risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, COPAXONE® should be used in pregnancy only if clearly needed.1

Tolerability

In the 3-times-a-week COPAXONE® 40 mg/mL clinical trial1

  • 91% of patients treated with COPAXONE® 40 mg/mL stayed on therapy for over 12 months
  • Approximately 3% of patients treated with COPAXONE® 40 mg/mL discontinued treatment due to an adverse reaction

Drug Interactions

Interactions between COPAXONE® and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of COPAXONE® with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. COPAXONE® has not been formally evaluated in combination with interferon beta.1

In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions.1

Most common adverse reactions (≥2% of patients and more frequent with 3-times-a-week COPAXONE® 40 mg/mL vs placebo)1

Event

COPAXONE® 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%

Pyrexia

3%

2%

Influenza-like illness

3%

2%

Injection site inflammation

2%

0%

Chills

2%

0%

Chest Pain

2%

1%

Infections and infestations:

Nasopharyngitis

11%

9%

Respiratory tract infection viral

3%

2%

Respiratory, Thoracic, and Mediastinal Disorders:

Dyspnea

3%

0%

Vascular Disorders:

Vasodilatation

3%

0%

Gastrointestinal Disorders:

Nausea

2%

1%

Skin and Subcutaneous Tissue Disorders:

Erythema

2%

0%

Rash

2%

1%

 

Pregnancy

Pregnancy Category B1

Animal studies have failed to demonstrate a risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, COPAXONE® should be used in pregnancy only if clearly needed.1

Tolerability

In daily COPAXONE® 20 mg/mL clinical trials1

  • Approximately 5% of patients treated with COPAXONE® 20 mg/mL discontinued treatment due to an adverse reaction

Drug Interactions

Interactions between COPAXONE® and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of COPAXONE® with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. COPAXONE® has not been formally evaluated in combination with interferon beta.1

In controlled clinical studies of daily COPAXONE® 20 mg/mL, the most common adverse reactions were injection site reactions, vasodilatation, rash, dyspnea, and chest pain.1

Most common adverse reactions (≥2% of patients and more frequent with daily COPAXONE® 20 mg/mL vs placebo)1

Event

COPAXONE® 20 mg/mL (n=563)

Placebo
(n=564)

Blood and lymphatic system disorders:

Lymphadenopathy

7%

3%

Cardiac disorders:

Palpitations

9%

4%

Tachycardia

5%

2%

Eye disorders:

Eye disorder

3%

1%

Diplopia

3%

2%

Gastrointestinal disorders:

Nausea

15%

11%

Vomiting

7%

4%

Dysphagia

2%

1%

General disorders and administration site conditions:

Injection site erythema

43%

10%

Injection site pain

40%

20%

Injection site pruritis

27%

4%

Injection site mass

26%

6%

Asthenia

22%

21%

Pain

20%

17%

Injection site edema

19%

4%

Chest pain

13%

6%

Injection site inflammation

9%

1%

Edema

8%

2%

Injection site reaction

8%

1%

Pyrexia

6%

5%

Injection site hypersensitivity

4%

0%

Local reaction

3%

1%

Chills

3%

1%

Face edema

3%

1%

Edema peripheral

3%

2%

Injection site fibrosis

2%

1%

Injection site atrophy*

2%

0%

Immune system disorders:

Hypersensitivity

3%

2%

Infections and infestations:

Infection

30%

28%

Influenza

14%

13%

Rhinitis

7%

5%

Bronchitis

6%

5%

Gastroenteritis

6%

4%

Vaginal candidiasis

4%

2%

Metabolism and nutrition disorders:

Weight increased

3%

1%

Musculoskeletal and connective tissue disorders:

Back pain

12%

10%

Neoplasms benign, malignant and unspecified (incl cysts and polyps): 

Benign neoplasm of skin

2%

1%

Nervous system disorders:

Tremor

4%

2%

Migraine

4%

2%

Syncope

3%

2%

Speech disorder

2%

1%

Psychiatric disorders:

Anxiety

13%

10%

Nervousness

2%

1%

Renal and urinary disorders:

Micturition urgency

5%

4%

Respiratory, thoracic and mediastinal disorders:

Dyspnea

14%

4%

Cough

6%

5%

Laryngospasm

2%

1%

Skin and subcutaneous tissue disorders:

Rash

19%

11%

Hyperhidrosis

7%

5%

Pruritis

5%

4%

Urticaria

3%

1%

Skin disorder

3%

1%

Vascular disorders:

Vasodilatation

20%

5%

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

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Indication

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.

Important Safety Information

Contraindication: COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Immediate Post-Injection Reaction: Approximately 16% of patients exposed to COPAXONE® 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) 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.

Chest Pain: Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 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 Reaction described above, 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 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

Lipoatrophy and Skin Necrosis: 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.

Potential Effects on Immune Response: Because COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® 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 COPAXONE® does this, but there has not been a systematic evaluation of this risk.

Common Adverse Reactions: In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).

In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).

ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.

Please see full Prescribing Information for COPAXONE®.

Injections for 3-times-a-week COPAXONE® 40 mg must be at least 48 hours apart.

Reference: 1. COPAXONE® (glatiramer acetate injection) Current Prescribing Information. Teva Neuroscience, Inc.

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