pronounced as (dax" i bot" ue lye' num tox" in ay")

Brand Name(s): Daxxify®

Why is this medicine prescribed?

DaxibotulinumtoxinA-lanm injection is used to temporarily smooth frown lines (wrinkles between the eyebrows) in adults 18 years of age and older. DaxibotulinumtoxinA-lanm injection is in a class of medications called neurotoxins. It blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

DaxibotulinumtoxinA-lanm injection comes as a powder to be mixed with a liquid and injected into a muscle by a healthcare provider. Your healthcare provider may adjust the dose until they find the best dose for you. DaxibotulinumtoxinA-lanm injection should not be administered more frequently than every 3 months.

One brand or type of botulinum toxin cannot be substituted for another.

DaxibotulinumtoxinA-lanm injection may help to control your condition, but will not cure it. It may take a few days or up to several weeks before you feel the full benefit of daxibotulinumtoxinA-lanm injection.

What special precautions should I follow?

Before receiving daxibotulinumtoxinA-lanm injection,

  • tell your doctor if you are allergic to daxibotulinumtoxinA-lanm, onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB (Myobloc). Also, tell your doctor if you are allergic to any other medications or any of the ingredients in daxibotulinumtoxinA-lanm injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving daxibotulinumtoxinA-lanm. Also tell your doctor if you have received injections of any botulinum toxin product in the past 4 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 daxibotulinumtoxinA-lanm injection will be injected. Your doctor will not inject the medication into an area that is infected.
  • tell your doctor if you have ever had any side effect from any botulinum toxin product, eye or face surgery, or bleeding problems. Also tell your doctor if you have or have ever had heart disease. Irregular heartbeat and heart attack have occurred after receiving daxibotulinumtoxinA-lanm injection, which may be more likely to occur in patients who already have or had a history of heart disease.
  • if you will be receiving daxibotulinumtoxinA-lanm injection to treat wrinkles, your doctor will examine you to see if the medication is likely to work for you. DaxibotulinumtoxinA-lanm injection may not smooth your wrinkles or may cause other problems if you have drooping eyelids, trouble raising your eyebrows, or any other change in the way your face normally looks.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving daxibotulinumtoxinA-lanm, call your doctor.
  • you should know that daxibotulinumtoxinA 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 after receiving an injection.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving daxibotulinumtoxinA-lanm injection.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do in case of 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 daxibotulinumtoxinA-lanm 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:

  • weakness
  • difficulty moving any part of your body
  • difficulty breathing
  • difficulty swallowing

What side effects can this medicine cause?

DaxibotulinumtoxinA-lanm injection may cause side effects. Ask your doctor which side effects you are most likely to experience, since some side effects may be related to (or occur more often in) the part of the body where you received the injection. Tell your doctor if any of these symptoms are severe or do not go away:

  • pain, tenderness, swelling, redness, bleeding, or bruising in the place where you received the injection
  • headache
  • back, bone, muscle, or joint pain
  • nasal congestion, sore throat, or runny nose
  • frequent urination or pain when you urinate

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:

  • double, blurred, or decreased vision
  • eyelid swelling
  • vision changes (such as light sensitivity or blurred vision)
  • difficulty moving the face
  • dry, irritated, or painful eyes
  • irregular heartbeat
  • chest pain
  • difficulty moving the face
  • shortness of breath
  • wheezing
  • fainting
  • dizziness
  • rash
  • hives
  • itching

DaxibotulinumtoxinA-lanm injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

What other information should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about daxibotulinumtoxinA-lanm injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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