PrabotulinumtoxinA-xvfs (pra-bot-ue-LYE-num-tox-in-ay - xvfs)

Improves the appearance of deep facial lines or wrinkles.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how prabotulinumtoxinA-xvfs works. Tell your doctor if you are using an aminoglycoside antibiotic, muscle relaxer, or other botulinum toxin products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease, trouble swallowing or breathing, a nerve or muscle disorder (including Lou Gehrig disease, Lambert-Eaton syndrome, or myasthenia gravis), eye problems, or a cranial nerve disorder. Tell your doctor if you have previously received botulinum toxin for any reason.
• This medicine may cause the following problems:
  • Muscle weakness, loss of bladder control, trouble swallowing, speaking, or breathing, blurred vision (caused by the toxin spreading to other parts of your body)
  • Increased risk of heart rhythm problems or heart attack
  • Eye or vision problems, including reducing eye blinking, tear production, and cornea problems
• This medicine may cause vision problems or muscle weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine is made from donated human blood. Some human blood products have transmitted viruses, although the risk is low because donors and blood are both tested for viruses. Talk with your doctor if you are concerned.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, trouble urinating, or painful urination
• Chest pain that may spread to your arms, jaw, back, or neck, nausea, unusual sweating
• Eye pain, severe irritation, severe trouble seeing, double vision, vision problems that do not go away, droopy eyelids
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Muscle weakness
• Trouble swallowing, breathing, or speaking
• Unusual weakness or tiredness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088