Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
DRG-20073026
