LetibotulinumtoxinA Injection

What is this medication?

LETIBOTULINUMTOXINA (LET i BOT ue LYE num TOX in AY) decreases the appearance of facial wrinkles. It works by relaxing muscles in the face, which softens wrinkles.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

They need to know if you have any of these conditions:

• Bleeding disorder
• Having or recent surgery
• Heart disease
• Infection
• Lung or breathing disease, such as COPD or asthma
• Nerve or muscle conditions, such as ALS, myasthenia gravis, or Lambert-Eaton syndrome
• Trouble swallowing
• An unusual or allergic reaction to botulinum toxin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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.

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 helps muscles relax near the injection site. In some cases, these effects may spread to other areas of the body. This can cause a serious condition called botulism. Symptoms may occur hours, days, or weeks after your injection. Call emergency services right away if you have problems breathing, swallowing, or talking.

This medication may cause muscle weakness and blurred vision. 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 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):

• Dry mouth
• Eyelid drooping
• Fatigue
• Headache
• 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.

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.