Treats migraines, the leakage of urine, and severe underarm sweating. Can even improve the appearance of wrinkles between the eyebrows, in the skin at the outer corner of your eyes, and forehead.
OnabotulinumtoxinA is a prescription medication used to treat muscle problems of the eyes, neck, elbows, wrists, and fingers. It is also used to treat migraines, the leakage of urine, severe underarm sweating, wrinkles between the eyebrows, wrinkles in the skin at the outer corner of your eyes, and forehead lines.
OnabotulinumtoxinA is a toxin produced by bacteria. It belongs to a class of drugs called neurotoxins, which relax muscles by decreasing nerve signals to those muscles.
This medication comes in an injectable form and is injected into the muscle (IM) by a healthcare professional.
Common side effects include difficulty breathing and swallowing, dry mouth, and pain at the injection site.
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OnabotulinumtoxinA Cautionary Labels
Uses of OnabotulinumtoxinA
OnabotulinumtoxinA is a prescription medicine that is injected into muscles and used:
- to treat leakage of urine (incontinence) in adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day
- to treat cervical dystonia in adult patients to reduce the severity of abnormal head position and neck pain
- to treat upper and lower limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
- to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough
- to treat spasticity in adult patients
OnabotulinumtoxinA Cosmetic is a prescription medicine that is used for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. It is also used for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. In addition, onabotulinumtoxinA cosmetic is used for the temporary improvement of forehead lines.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
OnabotulinumtoxinA Brand Names
OnabotulinumtoxinA Drug Class
OnabotulinumtoxinA is part of the drug class:
Side Effects of OnabotulinumtoxinA
OnabotulinumtoxinA can cause serious side effects including swallowing and breathing difficulties that can be life threatening. See the FDA Black Box Warning and "Drug Precautions" sections.
Other side effects include:
- dry mouth
- discomfort or pain at the injection site
- neck pain
- eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes
- urinary tract infection in people being treated for urinary incontinence
- inability to empty your bladder on your own and are being treated for urinary incontinence
- allergic reactions. Symptoms of an allergic reaction to onabotulinumtoxinA may include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint.
These are not all the possible side effects of onabotulinumtoxinA. Talk to your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you take:
- clindamycin (Cleocin)
- colistimethate (Coly-Mycin)
- lincomycin (Lincocin)
- neomycin (Neo-Fradin, Neo-Rx)
- tobramycin (Tobi)
- cholinesterase inhibitors such as ambenonium (Mytelase)
- donepezil (Aricept)
- galantamine (Razadyne)
- neostigmine (Prostigmin)
- pyridostigmine (Mestinon, Regonol)
- rivastigmine (Exelon)
- tacrine (Cognex)
- magnesium sulfate
- medications for allergies, colds, or sleep
- muscle relaxants
Also tell your doctor if you have received injections of any botulinum toxin product in the past four months.
This is not a complete list of onabotulinumtoxinA drug interactions. Ask your doctor or pharmacist for more information.
OnabotulinumtoxinA may cause serious side effects that can be life threatening, including:
- Problems breathing or swallowing
- Spread of toxin effects
These problems can happen hours, days, to weeks after an injection of onabotulinumtoxinA. Call your doctor or get medical help right away if you have any of these problems after treatment with onabotulinumtoxinA.
Do not take onabotulinumtoxinA if you:
- are allergic to any of the ingredients in onabotulinumtoxinA
- had an allergic reaction to any other botulinum toxin product such as Myobloc, Dysport, or Xeomin
- have a skin infection at the planned injection site
- are being treated for urinary incontinence and have a urinary tract infection (UTI)
- are being treated for urinary incontinence and find that you cannot empty your bladder on your own (and you are not routinely catheterized)
OnabotulinumtoxinA may cause loss of strength or general muscle weakness, or vision problems within hours to weeks of taking onabotulinumtoxinA. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
OnabotulinumtoxinA Cosmetic contains human albumin, a derivative of human blood. There is an extremely remote risk for transmission of viral diseases. This risk is reduced by effective donor screening and product manufacturing processes. No cases of transmission of viral diseases have ever been identified.
OnabotulinumtoxinA Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of onabotulinumtoxinA there are no specific foods that you must exclude from your diet when receiving onabotulinumtoxinA.
Before receiving onabotulinumtoxinA tell your doctor about all your medical conditions, including if you:
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
- have allergies to any botulinum toxin product
- had any side effect from any botulinum toxin product in the past
- have or have had a breathing problem, such as asthma or emphysema
- have or have had swallowing problems
- have or have had bleeding problems
- have plans to have surgery
- had surgery on your face
- have weakness of your forehead muscles, such as trouble raising your eyebrows
- have drooping eyelids
- have any other change in the way your face normally looks
- have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever.
- have problems emptying your bladder on your own and are being treated for urinary incontinence
Tell your doctor if you are pregnant or breastfeeding.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.
OnabotulinumtoxinA and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. OnabotulinumtoxinA should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.
OnabotulinumtoxinA and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if onabotulinumtoxinA is excreted in human breast milk or if it will harm your baby.
- OnabotulinumtoxinA is an injection that your doctor will give you.
- OnabotulinumtoxinA is injected into your affected muscles or skin.
- OnabotulinumtoxinA Cosmetic is injected into your affected muscles.
- Your doctor may change your dose of onabotulinumtoxinA, until you and your doctor find the best dose for you.
- Your doctor will tell you how often you will receive your dose of onabotulinumtoxinA injections.
Indication specific dosage and administration recommendations should be followed. In treating adult patients for one or more indications, the maximum cumulative dose should generally not exceed 360 Units, in a 3 month interval.
Symptoms of overdose after onabotulinumtoxinA injection may include difficulty breathing, difficulty moving parts of the body, and weakness. These symptoms may not appear right away. Call your doctor or seek emergency medical attention right away if you experience any of these symptoms.
OnabotulinumtoxinA FDA Warning
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.