OnabotulinumtoxinA injection (BOTOX)

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 people 16 years of age and older;

• Relieve the symptoms of strabismus (an eye muscle problem that causes the eye 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;

• Prevent headaches in people older than 18 years of age with chronic migraine (severe, throbbing headaches that are sometimes accompanied by nausea and sensitivity to sound or light) who have 15 or more days each month with headaches lasting 4 hours a day or longer;

Botox injection

• Treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in people 18 years of age and older when other medications do not work well enough or cannot be taken;

• Treat spasticity (muscle stiffness and tightness) of muscles in the arms and legs in people 2 years of age and older;

• treat severe underarm sweating in people 18 years of age and older who cannot be treated with products applied on the skin;

• Treat incontinence (leakage of urine) in people 18 years of age and older with overactive bladder (condition in which the bladder muscles have uncontrollable spasms) caused by nerve problems such as spinal cord injury or multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control), who cannot be treated with oral medication.

• temporarily smooth frown lines (wrinkles between the eyebrows) in adults 18 years of age and older,

• temporarily smooth crow’s feet lines (wrinkles near the outer corner of the eye) in adults 18 years of age and older,

• and to temporarily smooth forehead lines in adults 18 years of age and older.

OnabotulinumtoxinA injection is in a class of medications called neurotoxins. When onabotulinumtoxinA is injected into a muscle, it blocks the nerve signals that cause uncontrollable tightening and movements of the muscle. When onabotulinumtoxinA is injected into a sweat gland, it decreases the activity of the gland to reduce sweating. When onabotulinumtoxinA is injected into the bladder, it decreases bladder contractions and blocks signals that tell the nervous system that the bladder is full.


How should this medicine be used?

OnabotulinumtoxinA injection comes as a powder to be mixed with a liquid and injected into a muscle, into the skin, or into the wall of the bladder by a doctor.

Your doctor will choose the best place to inject the medication in order to treat your condition. If you are receiving onabotulinumtoxinA to treat frown lines, forehead lines, crow’s feet lines, cervical dystonia, blepharospasm, strabismus, spasticity, urinary incontinence, overactive bladder, 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 receiving 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.

If you are receiving onabotulinumtoxinA injection to treat urinary incontinence, your doctor may prescribe antibiotics for you to take for 1-3 days before your treatment, on the day of your treatment and for 1 to 3 days after your treatment.

Your doctor may change your dose of onabotulinumtoxinA injection to find the dose that will work best for you.

Your doctor may use an anesthetic cream, or a cold pack, to numb your skin, or eye drops to numb your 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.
Before receiving onabotulinumtoxinA injection,

• tell your doctor and pharmacist if you are allergic to:

onabotulinumtoxinA, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB (Myobloc).

Also, tell your doctor if you are allergic to 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, polymyxin, streptomycin, and tobramycin; anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); antihistamines; aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); c heparin; medications for allergies, colds, or sleep; muscle relaxants; and platelet inhibitors such as clopidogrel (Plavix). dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), and ticlopidine (Ticlid). Also tell your doctor if you have received injections of any botulinum toxin product including abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB (Myobloc) within the past four months. Your doctor may need to change the doses or schedule of your medications or monitor you carefully for side effects. Many other medications may also interact with onabotulinumtoxinA, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have swelling or other signs of infection or weakness in the area where onabotulinumtoxinA will be injected. Your doctor will not inject the medication into an area that is infected or weak.

• if you will be receiving onabotulinumtoxinA injection to treat urinary incontinence, tell your doctor if you have a urinary tract infection (UTI), which may include symptoms such as pain or burning when you urinate, frequent urination, or fever; or if you have urinary retention (inability to fully empty the bladder) and do not regularly empty your bladder with a catheter. Your doctor will probably not treat you with onabotulinumtoxinA injection.

• tell your doctor if you have ever had any side effect from any botulinum toxin product, or eye or face surgery, if you have or have ever had bleeding problems; seizures; hyperthyroidism (a condition that occurs when the thyroid gland produces too much thyroid hormone), diabetes, or lung 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; or any other change in the way your face normally looks.

• if you are 65 years and older and will be receiving onabotulinumtoxinA (Botox Cosmetic) injection to temporarily smooth crow’s feet, forehead lines, or frown lines, you should know that this treatment has not worked as well for older adults compared to adults younger than 65 years of age.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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.

• 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 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, swelling, redness, bleeding, or bruising in the place where you received the injection

• tiredness

• neck pain

• headache

• drowsiness

• muscle pain, stiffness, tightness, weakness, or spasm

• pain or tightness in the face or neck

• dry mouth

• nausea

• constipation

• anxiety

• sweating from parts of the body other than the underarms

• cough, sneezing, fever, nasal congestion, or sore throat
Some side effects can be serious.

If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, at any time during the first several weeks after your treatment, call your doctor immediately or get emergency medical treatment:

• double, blurred, or decreased vision

• eyelid swelling

• vision changes (such as light sensitivity or blurred vision)

• dry, irritated, or painful eyes

• difficulty moving the face

• seizures

• irregular heartbeat

• chest pain

• pain in the arms, back, neck, or jaw

• shortness of breath

• fainting

• dizziness

• rash

• hives

• itching

• swelling of the hands, feet, ankles, or lower legs

• cough, coughing up mucus, fever, or chills

• inability to empty your bladder on your own

• pain or burning when urinating or frequent urination

• blood in urine

• fever