DAXXIFY is an injection containing the active ingredient daxibotulinumtoxinA-lanm, which is a type A botulinum toxin that acts as an acetylcholine release inhibitor and neuromuscular blocking agent. It is provided as a sterile, preservative-free, lyophilized powder intended for intramuscular use after reconstitution, and is available in single-dose vials containing either 50 or 100 units. Key inactive ingredients include a 35-amino acid peptide (RTP004), L-histidine, L-histidine HCl monohydrate, polysorbate 20, and trehalose dihydrate.

How should I use this medication?

This medication is injected into a muscle. It is given by your care team in a hospital or clinic setting. A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Dryness or irritation of the eyes, eye pain, change in vision, sensitivity to light -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -Spread of botulinum toxin effects—unusual weakness or fatigue, blurry or double vision, trouble swallowing, hoarseness or trouble speaking, trouble breathing, loss of bladder control Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Eyelid drooping -Headache -Muscle weakness -Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) -Bleeding disorder -Having or recent surgery -Heart disease -Infection -Lung disease -Myasthenia gravis -Nerve or muscle disease -Trouble swallowing -An unusual or allergic reaction to daxibotulinumtoxinA, other botulinum toxins, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Atropine -Antihistamines for allergy, cough, and cold -Certain antibiotics, such as gentamicin, neomycin, tobramycin -Certain medications for bladder problems, such as oxybutynin or tolterodine -Certain medications for stomach problems, such as dicyclomine or hyoscyamine -Certain medications for travel sickness, such as scopolamine -Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl -Ipratropium -Medications that relax muscles -Other botulinum toxin injections

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. This medication will cause weakness in the muscle where it is injected. Tell your care team if you feel unusually weak in other muscles. Call emergency services if you have problems breathing, swallowing, or talking. You may get muscle weakness, blurred vision, double vision, or drooping eyelids. Do not drive or operate machinery until you know how this medication affects you. This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

What are the most serious risks of this medication?

This medicine may cause symptoms of a serious condition called botulism. The effects of this medicine can spread away from the place it was injected to other areas of the body. These symptoms can happen within hours, days, or weeks after your injection.