XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.
XEOMIN is a prescription medicine used in adults:
- that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).
- that is injected into muscles and used to:
- treat increased muscle stiffness in the arm because of upper limb spasticity.
- treat the abnormal head position and neck pain with cervical dystonia (CD).
- treat abnormal spasm of the eyelids (blepharospasm) in adults.
It is not known if XEOMIN is safe and effective in children under 18 years of age.
XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:
- Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
- Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.
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