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A DEMONSTRATED SAFETY AND TOLERABILITY PROFILE1

Pregnancy

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. 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.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

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. 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.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%

Peripheral edema

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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Reference:

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

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