Applies to eteplirsen: intravenous solution.

Serious side effects of Eteplirsen

Along with its needed effects, eteplirsen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking eteplirsen:

More common

• Loss of balance control
• vomiting

Other side effects of Eteplirsen

Some side effects of eteplirsen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blistering, burning, crusting, dryness, or flaking of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin

For Healthcare Professionals

Applies to eteplirsen: intravenous solution.

General

The most commonly reported adverse events were balance disorder and vomiting.^[Ref]

Cardiovascular

Postmarketing reports: Flushing^[Ref]

Dermatologic

Very common (10% or more): Contact dermatitis (25%), rash, urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (38%)^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions^[Ref]

Local

Very common (10% or more): Catheter site pain

Postmarketing reports: Cyanosis of the lips^[Ref]

Metabolic

Postmarketing reports: Dehydration^[Ref]

Nervous system

Very common (10% or more): Balance disorder (38%), headache^[Ref]

Respiratory

Very common (10% or more): Cough

Postmarketing reports: Bronchospasm^[Ref]

Other

Postmarketing reports: Malaise, pyrexia, protein urine present^[Ref]