DaxibotulinumtoxinA

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

DaxibotulinumtoxinA (Daxxify) is also used in adults to treat cervical dystonia (which causes abnormal head position and neck pain).

DaxibotulinumtoxinA (Daxxify) may also be used for other reasons not mentioned in this medication guide.

DaxibotulinumtoxinA (Daxxify) injections must be given only by a trained medical professional, even for cosmetic use.

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

Your doctor may change your dose from time to time until they find the best dose for you.

Do not get botulinum toxin injections from more than one medical professional at the same time. If you switch healthcare providers, be sure to inform your new provider how long it has been since your last botulinum toxin injection.

Using this medicine more often than prescribed will not make it work better and may lead to serious side effects.

The botulinum toxin in daxibotulinumtoxinA (Daxxify) can move to other parts of the body beyond the injection site. This may lead to serious, life-threatening side effects.

Contact your doctor immediately if you experience a hoarse voice, drooping eyelids, vision issues, severe muscle weakness, loss of bladder control, or difficulty breathing, talking, or swallowing. Some of these effects can happen up to several weeks after receiving a botulinum toxin injection.

You should not receive daxibotulinumtoxinA (Daxxify) if you have an infection in the area where the injection will be given or if you are allergic to botulinum toxin or any other botulinum toxin injection, such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), incobotulinumtoxinA (XEOMIN), or prabotulinumtoxinA-xvfs (JEUVEAU).

Tell your doctor if you have or have ever had:

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a side effect after previous 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 another 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.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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

Call your doctor immediately if you experience any of these side effects (which can occur up to several hours or several weeks after an injection):

• hoarse voice, difficulty breathing, talking, or swallowing;
• changes in vision, 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 an area that was not injected with the medication);
• chest pain or pressure, pain that spreads to your jaw or shoulder, irregular heartbeats; or
• loss of bladder control.

Common side effects of daxibotulinumtoxinA may include:

• cold symptoms such as a stuffy nose, sneezing, sore throat;
• pain or redness at the injection site;
• muscle weakness;
• drooping eyelids;
• headache; or
• loss of the ability to move facial muscles.

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

Usual Adult Dose for Glabellar Lines:

Inject 8 units (0.1 mL) intramuscularly into each of 5 sites (two injections in each corrugator muscle and one injection in the procerus muscle) for a total dose of 40 unitsComments:-Refer to manufacturer information for specific administration instructions, including dilution, needle orientation, and injection site diagrams.-The safety and effectiveness of dosing more frequently than every 3 months have not been clinically evaluated.Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients

Usual Adult Dose for Cervical Dystonia:

Inject 125 to 250 units intramuscularly as a divided dose among affected musclesComments:-When selecting the first dose of this drug in patients who have previously been treated with another botulinum toxin, the prior dose, response to therapy, duration of effect, and adverse event history should be considered.-Dysphagia may be reduced by limiting the dosage injected into the sternocleidomastoid muscle.-Refer to manufacturer information for specific administration instructions, including dilution.Use: For the treatment of cervical dystonia in adult patients

Since DaxibotulinumtoxinA (Daxxify) works for a limited time and is administered at long intervals, missing a dose is not likely to cause harm.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not show up immediately, but they can include muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

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

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.