PrabotulinumtoxinA-xvfs Injection

Name: PrabotulinumtoxinA-xvfs Injection

What special precautions should I follow?

Before receiving prabotulinumtoxinA-xvfs injection,

  • tell your doctor and pharmacist if you are allergic to prabotulinumtoxinA-xvfs injection, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), or rimabotulinumtoxinB (Myobloc). Also, tell your doctor if you are allergic to any other medications or any of the ingredients in prabotulinumtoxinA-xvfs injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin (Neo-Fradin), streptomycin, or vancomycin; cholinesterase inhibitors such as ambenonium (Mytelase), donepezil (Aricept), galantamine (Razadyne), neostigmine (Prostigmin), physostigmine, pyridostigmine (Mestinon, Regonol), rivastigmine (Exelon), and tacrine (Cognex); medications for allergies, colds, or sleep; medications for glaucoma, inflammatory bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; or muscle relaxants. Also tell your doctor if you have received injections of any botulinum toxin product including abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), or rimabotulinumtoxinB (Myobloc) previously, especially within the past four months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have swelling or other signs of infection in the area where prabotulinumtoxinA-xvfs injection will be injected. Your doctor will not inject the medication into an area that is infected.
  • tell your doctor if you have or have ever had any side effect from any botulinum toxin product, bleeding problems, or heart disease.
  • your doctor will examine you to see if the medication is likely to work for you. PrabotulinumtoxinA-xvfs injection may not smooth your wrinkles or may cause other problems if you have drooping eyelids; trouble raising your eyebrows; or swelling or weakness of your forehead muscles.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving prabotulinumtoxinA-xvfs injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving prabotulinumtoxinA-xvfs injection.
  • you should know that prabotulinumtoxinA-xvfs injection may cause loss of strength or muscle weakness all over the body or impaired vision. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.

What side effects can this medication cause?

PrabotulinumtoxinA-xvfs injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • nasal congestion, runny nose, sneezing, or sore throat
  • pain, swelling, redness, bleeding, bruising, or tenderness in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, at any time during the first several weeks after your treatment, call your doctor immediately or get emergency medical treatment:

  • hives
  • itching
  • rash
  • shortness of breath
  • swelling of the hands, feet, ankles, or lower legs
  • dizziness or fainting

PrabotulinumtoxinA-xvfs injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose usually do not appear right after receiving the injection. If you received too much prabotulinumtoxinA-xvfs or if you swallowed the medication, tell your doctor right away and also tell your doctor if you experience any of the following symptoms during the next several weeks:

  • muscle weakness
  • difficulty breathing

Brand names

  • Jeuveau®
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