Copaxone Side Effects

Generic name: glatiramer

Note: This document contains side effect information about glatiramer. Some of the dosage forms listed on this page may not apply to the brand name Copaxone.

Some side effects of Copaxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to glatiramer: subcutaneous kit

Some people receiving a glatiramer (the active ingredient contained in Copaxone) injection have had a severe reaction. Tell your caregiver right away if you feel anxious, warm, itchy, tingly, or have a pounding heartbeat, tightness in your throat, or trouble breathing during the injection. This type of reaction may occur even after you have been using glatiramer for several months.

Get emergency medical help if you have any of these signs of an allergic reaction while taking glatiramer: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using glatiramer and call your doctor at once if you have a serious side effect such as:

• chest pain;

• severe rash or skin irritation;

• dizziness, sweating, trouble breathing;

• pounding heartbeats or fluttering in your chest; or

• severe pain where the injection is given.

Less serious side effects include:

• redness, minor pain, itching, swelling, or a hard lump where the injection was given;

• flushing (warmth, redness, or tingly feeling);

• double vision;

• nausea, vomiting, increased urge to urinate or have a bowel movement;

• weakness, back pain;

• runny nose;

• swelling in your hands or feet;

• vaginal itching or discharge;

• fever, chills, body aches, flu symptoms, sore throat; or

• white patches or sores inside your mouth or on your lips.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to glatiramer: subcutaneous kit, subcutaneous powder for injection

Local

Local side effects have included injection site reactions which have been reported to occur frequently compared to placebo. Injection site reactions have included injection site pain (73%), erythema (66%), inflammation (49%), pruritus (40%), injection site mass (27%), induration (13%), welts (11%), and urticaria (5%).

Cardiovascular

Cardiovascular side effects noted in premarketing clinical trials have included transient chest pain in approximately 25% of patients. The pain usually lasted only a few minutes, and may or may not have been associated with postinjection reactions. Vasodilation (27%) and palpitations (17%) have been reported. Hypertension has also been frequently reported.

The chest pain did not lead to further adverse clinical sequelae, although EKG monitoring was not performed during initial investigations. The episodes usually begin at least 1 month after initiation of treatment. The etiology and clinical significance of this symptom is unknown.

Hematologic

Hematologic side effects including lymphadenopathy have been reported in up to 25% of patients.

Gastrointestinal

Gastrointestinal symptoms have included nausea (22%) and bowel urgency.

Respiratory

Respiratory side effects have included dyspnea (19%) and hyperventilation.

Hepatic

A 71-year-old male who had suffered from multiple sclerosis since 1992 experienced acute exacerbation of autoimmune hepatitis coincident with glatiramer (the active ingredient contained in Copaxone) therapy. He was treated with interferon beta-1b between 1994 and 2004. In January 2004, the interferon treatment was interrupted because of elevated serum liver enzyme activities. Two months later, glatiramer acetate 20 mg once a day was initiated. In May 2004, he presented with malaise and jaundice which was associated with elevated serum liver enzyme activities. In November 2005, the patient re-presented with fever, uncharacteristic abdominal symptoms, and elevated serum liver enzyme activities. At this stage, he was diagnosed with autoimmune hepatitis. As therapy, the patient commenced on budesonide 3 mg three times a day. The treatment led to a significant improvement of liver function tests. He was subsequently put on mycophenolate mofetil.

Hepatic side effects have been reported rarely. At least one case of hepatitis has been reported, in addition to a case of acute exacerbation of autoimmune hepatitis.

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