Pronunciation:

ab-oh-bot-ue-LYE-num-tox-in-ay

Brand Names:

• Dysport

Dosage Forms:

• Powder for Solution

Warnings:

The effects of abobotulinumtoxinA and all botulinum toxin products 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 but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms .

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Botulinum Toxin Type A

Uses of This Medicine:

AbobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). This medicine is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines). It is also used to treat upper and lower limb spasms.

AbobotulinumtoxinA 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 abobotulinumtoxinA in children with cervical dystonia, and in children younger than 2 years of age with lower limb spasms or upper limb spasms, including spasms caused by cerebral palsy. Safety and efficacy have not been established.

Use of abobotulinumtoxinA to treat glabellar lines is not recommended in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abobotulinumtoxinA in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have falls, weakness, or side effects related to the eyes, which may require caution in patients receiving abobotulinumtoxinA for lower limb spasticity and glabellar lines.

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
• Dermatochalasis (a skin problem) or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle and nerve problem) or
• Myasthenia gravis (severe muscle weakness) or
• Sebaceous skin, thick (oily or fatty skin) or
• Surgery on the face, history of—May increase risk for more serious side effects.

• Breathing problems (eg, asthma, emphysema) or
• Dysphagia (trouble swallowing) or
• Muscle weakness or atrophy at the injection site or
• Ptosis (droopy eyelid) or
• Sebaceous skin, thick (oily or fatty skin) or
• Surgery on the face—Use with caution. May make these conditions worse.

• Cow's milk protein allergy, history of or
• Infection at the injection site—Should not be used in patients with these conditions.

• 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.

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.

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

Your doctor will only use Dysport® to treat your condition. Other botulinum toxin products may not work the same way and require a different dose. Tell your doctor if you have received botulinum toxin for any reason in the last 4 months.

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.

This medicine may cause serious allergic reactions, including anaphylaxis or serum sickness. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, fever, joint swelling, muscle aches, or any swelling of your hands, face, or mouth after using this medicine.

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 immediate treatment in a medical facility.

This medicine may cause eye dryness when used in the treatment of glabellar lines. You may have reduced tear production, reduced blinking, and eye problems. Check with your doctor right away if eye pain or irritation, sensitivity of the eyes to sunlight, or other changes in vision occur during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may make your muscles weak and cause vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

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:

More common

Blurred vision

decreased vision

difficulty with swallowing or speaking

double vision

dry eyes

eye pain

hoarseness

itching of the eyes

muscle or bone pain

muscle weakness

problems with focusing of the eyes

seeing double

seizures

stuffy or runny nose

sore throat

voice changes

Less common

Blistering, burning, crusting, dryness, or flaking of the skin

body aches or pain

chest tightness

chills

cough

cough producing mucus

diarrhea

difficult or labored breathing

ear congestion

fever

general feeling of discomfort or illness

headache

itching, scaling, severe redness, soreness, or swelling of the skin

joint pain

loss of appetite

loss of voice

muscle aches and pains

nausea

shivering

sneezing

stiff muscles

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in color vision

difficulty seeing at night

dizziness

fast heartbeat

flushing or redness of the skin

hives, itching, rash

increased sensitivity of the eyes to sunlight

partial or slight paralysis of the face

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

unusually warm skin

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 the 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

dry mouth

Less common

Drooping upper eyelids

pain or tenderness around the eyes and cheekbones

Incidence not known

Dizziness or lightheadedness

feeling of constant movement of self or surroundings

sensation of spinning

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.