The effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms hours to weeks after injection consistent with botulinum toxin effects. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. Children treated for spasticity likely have the greatest risk, but symptoms can also occur in adults. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses .
Botulinum Toxin Type A
OnabotulinumtoxinA is used to treat certain eye conditions, such as blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) or strabismus (a condition where the eyes do not line up properly). This medicine is also used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck) and some types of axillary hyperhidrosis (severe sweating of the armpits). It is used for increased muscle stiffness in the elbow, wrist, and finger muscles in adults with upper limb spasticity. It is also used for increased muscle stiffness in the ankle and toe muscles in adults with lower limb spasticity. It is also used to prevent headaches in patients with chronic migraine (severe headaches for 15 or more days a month lasting 4 or more hours a day). OnabotulinumtoxinA is used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines) and crow's feet lines around the eyes (lateral canthal lines). It is also used to treat urinary incontinence (loss of bladder control) in patients with an overactive bladder caused by nervous system disorders (eg, multiple sclerosis, spinal cord injury). It is also used to treat overactive bladder with symptoms such as loss of bladder control, increased urge to urinate, and frequent need to urinate in patients who have failed treatment with other medicines.
OnabotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.
OnabotulinumtoxinA is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.
This medicine is available only with your doctor's prescription and will be administered by your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, onabotulinumtoxinA is used in certain patients with the following medical conditions:
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 12 years of age for blepharospasm or strabismus, or in children younger than 16 years of age for cervical dystonia, or in children younger than 18 years of age for chronic migraine, hyperhidrosis, upper and lower limb spasticity, or overactive bladder. Use of onabotulinumtoxinA to treat glabellar lines and lateral canthal lines is not recommended in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of onabotulinumtoxinA in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving onabotulinumtoxinA.
|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:
Your doctor will give you this medicine in a hospital or clinic. This medicine is given as a shot under your skin or into one of your muscles.
You may be given medicine to numb the area where the shot will be injected. If you receive the medicine around your eyes, you may be given eye drops or ointment to numb the area. After your injection, you may need to wear a protective contact lens or eye patch.
If you are treated for excessive sweating, shave your underarms but do not use deodorant for 24 hours before your injection. Avoid exercise, hot foods or liquids, or anything else that could make you sweat for 30 minutes before your injection.
This medicine works slowly. For neck disorders, you should have improvement within 2 to 6 weeks after your injection. For upper arm stiffness, you should have improvement within 4 to 6 weeks after your injection. Eyelid disorders should improve within 3 days to 2 weeks after your injection. Strabismus should improve within 1 or 2 days after the injection, and the improvement should last for 2 to 6 weeks. Once your condition has improved, the medicine will last about 3 months, then the effects of the medicine will slowly go away. You might need more injections when the effects of the medicine wear off. The recommended re-treatment schedule for chronic migraine is every 12 weeks.
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 onabotulinumtoxinA (Botox® or Botox® Cosmetic) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.
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 an immediate treatment in a hospital or clinic.
This medicine may make your muscles weak and cause vision problems (such as bleeding inside the eye). 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 may reduce blinking of the eye which can lead to an increased risk of eye problems (such as corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
After you have received this medicine and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.
This medicine may increase your chances of having bronchitis or upper respiratory tract infections when given for upper limb spasticity. Tell your doctor right away if you have trouble breathing, sneezing, sore throat, coughing, or a fever.
This medicine may cause a condition called autonomic dysreflexia in patients with nervous system disorders (such as spinal cord injury). It can be a life-threatening condition and requires immediate medical attention. Call your doctor right away if you have headache, increased sweating, slow heartbeat, warmth or redness in your face, neck, or arm, or have problems in urinating while using this medicine.
This medicine is made from donated human blood. Some human blood products have transmitted 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 about this risk if you are concerned.
Check with your doctor right away if you have difficulty urinating or a burning sensation while urinating after receiving this medicine.
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.
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.