Abobotulinumtoxina (Intramuscular route)
- Powder for Solution
Warnings:Intramuscular route(Powder for Solution)
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. In unapproved uses, including upper limb spasticity in children, and in approved indications, spread of effect has reported at doses comparable to or lower than the maximum recommended total dose .
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 available only with your doctor's prescription and will be administered by 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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of abobotulinumtoxinA in children with cervical dystonia or upper limb spasms, and in children younger than 2 years of age with lower limb spasms. Safety and efficacy have not been established.
Use of abobotulinumtoxinA to treat glabellar lines is not recommended in children.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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
- Ptosis (droopy eyelid)—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.
Proper Use of This Medicine:
Your doctor will give you this medicine in a hospital or clinic. This medicine 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 or pharmacist if you have any questions.
Your doctor will only use abobotulinumtoxinA (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.
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 hospital or clinic.
This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.
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:
- More common
- Difficulty with swallowing or speaking
- muscle or bone pain
- muscle weakness
- sore throat
- voice changes
- Less common
- Blistering, burning, crusting, dryness, or flaking of the skin
- body aches or pain
- cough producing mucus
- difficult or labored breathing
- ear congestion
- general feeling of discomfort or illness
- itching, scaling, severe redness, soreness, or swelling of the skin
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- stiff muscles
- stuffy or runny nose
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
- Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- fast heartbeat
- flushing or redness of the skin
- hives, itching, rash
- partial or slight paralysis of the face
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusually warm skin
- 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
- blurred vision
- decreased vision
- double vision
- dry eyes
- dry mouth
- eye pain
- itching of the eyes
- problems with focusing of the eyes
- seeing double
- Less common
- Drooping upper eyelids
- pain or tenderness around the eyes and cheekbones
- Incidence not known
- Change in color vision
- difficulty seeing at night
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- increased sensitivity of the eyes to sunlight
- sensation of spinning
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:
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:
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.
Last Updated: 9/4/2017