Why is this medication prescribed?OnabotulinumtoxinA injection (Botox) is used to relieve the symptoms of cervical dystonia (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions) in adults, strabismus (an eye muscle problem that causes the eyes to turn inward or outward) and blepharospasm (uncontrollable tightening of the eyelid muscles that may cause blinking, squinting, and abnormal eyelid movements) in people 12 years of age and older, and upper limb spasticity (increased muscle stiffness) in the elbow, wrist, and fingers in adults. OnabotulinumtoxinA injection (Botox) is also used to control severe underarm sweating in adults that cannot be treated with products that are applied to the skin. This medication is also used to prevent headaches in patients with chronic migraine (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light) that happen on 15 or more days each month and last for 4 hours or longer each time in people 18 years of age and older. OnabotulinumtoxinA injection (Botox Cosmetic) is used to temporarily smooth frown lines (wrinkles between the eyebrows) in adults up to 65 years of age. OnabotulinumtoxinA injection is in a class of medications called neurotoxins. When onabotulinumtoxinA injection is injected into a muscle, it blocks the nerve signals that cause uncontrollable tightening and movements of the muscle. When onabotulinumtoxinA injection is injected into a sweat gland, it decreases the activity of the gland to reduce sweating.
How should this medication be used?OnabotulinumtoxinA injection comes as a powder to be mixed with a liquid and injected into a muscle or into the skin by a doctor. Your doctor will choose the best place to inject the medication in order to treat your condition. If you are using onabotulinumtoxinA to treat frown lines, cervical dystonia, blepharospasm, strabismus, upper limb spasticity, or chronic migraine, you may receive additional injections every 3 to 4 months, depending on your condition and on how long the effects of the treatment last. If you are using onabotulinumtoxinA injection to treat severe underarm sweating, you may need to receive additional injections once every 6 to 7 months or when your symptoms return.
If you are receiving onabotulinumtoxinA injection to treat severe underarm sweating, your doctor will probably perform a test to find the areas that need to be treated. Your doctor will tell you how to prepare for this test. You will probably be told to shave your underarms and not to use nonprescription deodorants or antiperspirants for 24 hours before the test.
Your doctor will probably start you on a low dose of onabotulinumtoxinA injection and gradually change your dose according to your response to the medication.
Your doctor may use an anesthetic cream, a cold pack, or eye drops to numb your skin or eyes before injecting onabotulinumtoxinA.
One brand or type of botulinum toxin cannot be substituted for another.
OnabotulinumtoxinA injection may help control your condition but will not cure it. It may take a few days or up to several weeks before you feel the full benefit of onabotulinumtoxinA injection. Ask your doctor when you can expect to see improvement, and call your doctor if your symptoms do not improve during the expected time.
Are there other uses for this medicine?OnabotulinumtoxinA injection is also sometimes used to treat other conditions in which abnormal muscle tightening causes pain, abnormal movements, or other symptoms. OnabotulinumtoxinA injection is also sometimes used to treat excessive sweating of the hands, excessive sweating that occurs during or after eating, many types of wrinkles of the face, tremor (uncontrollable shaking of a part of the body), -and anal fissures (a split or tear in the tissue near the rectal area). The medication is also sometimes used to improve the ability to move in children with cerebral palsy (condition that causes difficulty with movement and balance) or adults who have had a stroke. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
- Botox® Cosmetic
What special precautions should I follow?
Before receiving onabotulinumtoxinA injection,
- tell your doctor and pharmacist if you are allergic to onabotulinumtoxinA, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), rimabotulinumtoxinB (Myobloc), any other medications, or any of the ingredients in onabotulinumtoxinA injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, kanamycin, lincomycin (Lincocin), neomycin (Neo-Fradin, Neo-Rx), polymyxin, streptomycin, and tobramycin (Tobi); cholinesterase inhibitors such as ambenonium (Mytelase), donepezil (Aricept), galantamine (Razadyne), neostigmine (Prostigmin), physostigmine, pyridostigmine (Mestinon, Regonol), rivastigmine (Exelon), and tacrine (Cognex); magnesium sulfate; medications for allergies, colds, or sleep; muscle relaxants; and quinidine. Also tell your doctor if you have received injections of any botulinum toxin product in the past four months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have swelling or other signs of infection in the area where onabotulinumtoxinA will be injected. Your doctor will not inject the medication into an infected area.
- tell your doctor if you have ever had any side effect from any botulinum toxin product or eye or face surgery and if you have or have ever had bleeding problems; seizures; hyperthyroidism (a condition that occurs when the thyroid gland produces too much thyroid hormone); or heart disease.
- if you will be receiving onabotulinumtoxinA injection to treat wrinkles, your doctor will examine you to see if the medication is likely to work for you. OnabotulinumtoxinA injection may not smooth your wrinkles or may cause other problems if you have drooping eyelids; trouble raising your eyebrows; excess skin on your eyelids; deeply scarred, thick, or oily skin; or if your wrinkles cannot be smoothed by spreading them apart with your fingers.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving onabotulinumtoxinA injection, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving onabotulinumtoxinA injection.
- you should know that onabotulinumtoxinA injection may cause loss of strength or muscle weakness all over the body or impaired vision. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.
- if you are receiving onabotulinumtoxinA injection to treat upper limb spasticity, you will probably also need to be treated with physical therapy and other treatments. OnabotulinumtoxinA injection can be used along with these treatments, but not instead of these treatments. Follow all of your doctor's and/or therapist's instructions.
- if you are receiving onabotulinumtoxinA injection to treat a condition that limited your activities, talk to your doctor about increasing your activities after your treatment. Your doctor will probably want you to increase your activities gradually as your body adjusts to the effects of your treatment.
What special dietary instructions should I follow?Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?OnabotulinumtoxinA injection may cause side effects. Ask your doctor which side effects you are most likely to experience since some side effects may be related to (or occur more often in) the part of the body where you received the injection. Tell your doctor if any of these symptoms are severe or do not go away:
- pain, tenderness, or bruising in the place where you received the injection
- tight muscles
- dry mouth
- runny nose or congestion
- pain or tightness in the face
- dry or irritated eyes
- teary eyes
- difficulty closing the eyes
- sweating from parts of the body other than the underarm
- vision changes
- eyelid swelling
- difficulty moving the face
- irregular heartbeat
- chest pain
- pain in the arms, back, neck, or jaw
- shortness of breath
- swelling of the hands, feet, ankles, or lower legs
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I do in case of overdose?In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose usually do not appear right after receiving the injection. If you received too much onabotulinumtoxinA or if you swallowed the medication, tell your doctor right away and also tell your doctor if you experience any of the following symptoms during the next several weeks:
- difficulty moving any part of your body
- difficulty breathing
What other information should I know?Keep all appointments with your doctor.
Ask your pharmacist any questions you have about onabotulinumtoxinA injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Important warningOnabotulinumtoxinA injection may spread from the area of injection and cause symptoms of botulism, including severe or life threatening difficulty breathing or swallowing. People who develop difficulty swallowing during their treatment with this medication may continue to have this difficulty for several weeks. They may need to be fed through a feeding tube to avoid getting food or drink into their lungs. Symptoms can occur within hours of an injection with onabotulinumtoxinA or as late as several weeks after treatment. Symptoms may occur in people of any age being treated for any condition, but no one has yet developed these symptoms after receiving onabotulinumtoxinA injection at recommended doses to treat frown lines, blepharospasm, or strabismus. The risk is probably highest in children being treated for abnormal muscle tightening. Tell your doctor if you have or have ever had any swallowing problems or breathing problems, such as asthma or emphysema, or any condition that affects your muscles or nerves such as amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken), motor neuropathy (condition in which the muscles weaken over time), myasthenia gravis (condition that causes certain muscles to weaken, especially after activity), or Lambert-Eaton syndrome (condition that causes muscle weakness that may improve with activity). If you experience any of the following symptoms, call your doctor immediately: loss of strength or muscle weakness all over the body; double or blurred vision; drooping eyelids; difficulty swallowing, breathing, or speaking; or inability to control urination.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with onabotulinumtoxinA injection and each time you receive treatment. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.