Pronunciation:

dax-i-bot-ue-LYE-num-tox-in-ay - lanm

Brand Names:

• Daxxify

Dosage Forms:

• Powder for Solution

Warnings:

The effects of all botulinum toxin products, including daxibotulinumtoxinA-lanm, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for daxibotulinumtoxinA-lanm, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

DaxibotulinumtoxinA

Uses of This Medicine:

DaxibotulinumtoxinA-lanm is used cosmetically to improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines).

DaxibotulinumtoxinA-lanm is a botulinum toxin A product. It works on the nervous system to relax the muscles.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of daxibotulinumtoxinA-lanm in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daxibotulinumtoxinA-lanm in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• LetibotulinumtoxinA-wlbg

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
• Cornea or eye problems or
• Heart or blood vessel disease or
• Heart rhythm problem (eg, arrhythmia) or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle or nerve problem) or
• Myasthenia gravis (severe muscle weakness)—May increase risk for more serious side effects.

• Breathing problems (eg, asthma, emphysema) or
• Dysarthria (trouble with speaking) or
• Dysphagia (trouble with swallowing) or
• Dysphonia (voice problem) or
• Ptosis (droopy eyelid) or
• Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.

• Dermatochalasis (excess skin in the upper or lower eyelid) or
• Facial asymmetry or
• Patients with thick oily skin or deep scars or
• Thinning, weakness, or wasting away of the skin, severe at the injection site—Use with caution. May not work as well in patients with these conditions.

• Infection at the injection site—Should not be used in patients with this condition.

Proper Use of This Medicine:

Your doctor will give you this medicine in a medical facility. It is given as a shot into one of your muscles in your face. This medicine should not be received more than 1 time every 3 months.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use Daxxify™ to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require an immediate treatment in a hospital or clinic.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness while you are receiving this medicine.

This medicine may increase the risks of heart rhythm problems (eg, arrhythmia) or heart attack. These are more likely to occur if you have heart or blood vessel disease. Check with your doctor right away if you have dizziness, fainting, fast, slow, or irregular heartbeat, chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, or vomiting.

This medicine may reduce blinking of the eye, tear production, and cornea problems. Check with your doctor right away if blurred vision, eye irritation, increased sensitivity of the eyes to sunlight, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause eye or vision problems, loss of strength, or muscle weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Drooping upper eyelids

partial or slight paralysis of the face

Incidence not known

Blurred vision

change in color vision

change in patterns and rhythms of speech

chest pain, discomfort, or tightness

cough

difficulty seeing at night

difficulty swallowing

dizziness

double vision

dry eye

eye irritation

fainting

fast, slow, or irregular heartbeat

feeling of discomfort

fever

hives, itching, or skin rash

hoarseness

increased sensitivity of the eyes to sunlight

infection from breathing foreign substance into the lungs

joint inflammation

loss of bladder control

muscle aches and weakness

nausea

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seeing double

slurred speech

sore throat

sweating

swollen lymph glands

trouble breathing

trouble in speaking

voice changes

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

headache

Incidence not known

Redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.