daxibotulinumtoxinA (Daxxify)

What is the most important information I should know about daxibotulinumtoxinA (Daxxify)?

The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

What is daxibotulinumtoxinA (Daxxify)?

DaxibotulinumtoxinA (Daxxify) is used in adults to temporarily lessen the appearance of facial wrinkles.

DaxibotulinumtoxinA (Daxxify) may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving daxibotulinumtoxinA (Daxxify)?

Tell your doctor if you have or ever had:

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a side effect after prior use of botulinum toxin;
• a breathing disorder such as asthma or emphysema;
• problems with swallowing;
• heart problems;
• bleeding problems;
• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
• dry eyes after receiving botulinum toxin in the past;
• a planned surgery;
• surgery on your face; or
• received other botulinum toxin injection in the past 4 months.

It is not known whether daxibotulinumtoxinA (Daxxify) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

How is daxibotulinumtoxinA (Daxxify) given?

DaxibotulinumtoxinA (Daxxify) injections should be given only by a trained medical professional, even when used for cosmetic purposes.

DaxibotulinumtoxinA (Daxxify) is injected into a muscle by a healthcare provider. DaxibotulinumtoxinA (Daxxify) injections should be spaced at least 3 months apart.

Your doctor may occasionally change your dose until your doctor determine the best dose.

Using this medicine more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since DaxibotulinumtoxinA (Daxxify) has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

What should I avoid while receiving daxibotulinumtoxinA (Daxxify)?

DaxibotulinumtoxinA (Daxxify) may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

What are the possible side effects of daxibotulinumtoxinA (Daxxify)?

The botulinum toxin contained in daxibotulinumtoxinA (Daxxify) can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

• hoarse voice, trouble breathing, talking, or swallowing;
• vision changes, eye pain, blurred vision, drooping eyelids, severely dry or irritated eyes (your eyes may be more sensitive to light);
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats; or
• loss of bladder control.

Common side effects may include:

• drooping eyelids;
• headache; or
• loss of the ability to move the muscles in the face.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect daxibotulinumtoxinA (Daxxify)?

Tell your doctor about all your other medicines, especially:

• an antibiotic such as amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin;
• a muscle relaxer;
• inhaled anesthetics;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson's disease;
• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome; or
• seizure medicine.

This list is not complete and many other drugs may affect daxibotulinumtoxinA (Daxxify). This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about daxibotulinumtoxinA (Daxxify).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.01. Revision date: 3/3/2023.