Clinical Information
Gen. Code and Des.
13722 onabotulinumtoxinA INJECTION VIAL 100 UNIT
GCN and Des.
23360 onabotulinumtoxinA INJECTION VIAL 100 UNIT
Strength
100UN
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92920000 OTHER MISCELLANEOUS THERAPEUTIC AGENTS
12209200 SKELETAL MUSCLE RELAXANTS, MISCELLANEOUS
Active Ingredients
3535 onabotulinumtoxinA 93384431
BOTOX - botulinum toxin type a injection, powder, lyophilized, for solution
Allergan, Inc.
Overactive Bladder
BOTOX (onabotulinumtoxinA) for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Detrusor Overactivity associated with a Neurologic Condition
BOTOX is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
1.2 Chronic Migraine
BOTOX is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Important limitations
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
1.4 Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
1.5 Primary Axillary Hyperhidrosis
BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Important limitations
The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
2.1 Instructions for Safe Use
The potency Units of BOTOX (onabotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see Warnings and Precautions (5.1) and Description (11)].
Indication specific dosage and administration recommendations should be followed. When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 Units, in a 3 month interval.
The safe and effective use of BOTOX depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. An understanding of standard electromyographic techniques is also required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia. Physicians administering BOTOX must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease, especially when injecting near the lungs.
2.2 Preparation and Dilution Technique
Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detrusor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2� to 8�C).
DOSAGE FORMS AND STRENGTHS
Single-use, sterile 100 Units or 200 Units vacuum-dried powder for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection USP prior to injection.
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Swallowing, Speaking or Breathing Difficulties, or Other Unusual Symptoms
Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if any existing symptom worsens [see Boxed Warning and Warnings and Precautions (5.2, 5.6)].
bility to Operate Machinery or Vehicles
Advise patients that if loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
Voiding Symptoms after Bladder Injections
After bladder injections for urinary incontinence, advise patients to contact their physician if they experience difficulties in voiding or burning sensation upon voiding.
What is the most important information I should know about BOTOX and BOTOX Cosmetic? BOTOX and BOTOX Cosmetic 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 BOTOX or BOTOX Cosmetic. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX or BOTOX Cosmetic: 1. Problems swallowing, speaking, or breathing. These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX or BOTOX Cosmetic.
People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with BOTOX or BOTOX Cosmetic.
Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving BOTOX or BOTOX Cosmetic have the highest risk of getting these problems.
2. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
loss of strength and muscle weakness all over the body
double vision
blurred vision and drooping eyelids
hoarseness or change or loss of voice (dysphonia)
trouble saying words clearly (dysarthria)
loss of bladder control
trouble breathing
trouble swallowing
These symptoms can happen hours, days, to weeks after you receive an injection of BOTOX or BOTOX Cosmetic.These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving BOTOX or BOTOX Cosmetic?"There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines and/or crow's feet lines.What are BOTOX and BOTOX Cosmetic? BOTOX is a prescription medicine that is injected into muscles and used:
to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
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 increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity.
to treat increased muscle stiffness in ankle and toe muscles in adults with 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.
BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.BOTOX Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).BOTOX Cosmetic is a prescription medicine that is injected into the area around the side of the eyes to improve the look of crow's feet lines in adults for a short period of time (temporary).You may receive treatment for frown lines and crow's feet lines at the same time.It is not known whether BOTOX is safe or effective in people younger than:
18 years of age for treatment of urinary incontinence
18 years of age for treatment of chronic migraine
18 years of age for treatment of spasticity
16 years of age for treatment of cervical dystonia
18 years of age for treatment of hyperhidrosis
12 years of age for treatment of strabismus or blepharospasm
BOTOX Cosmetic is not recommended for use in children younger than 18 years of age.It is not known whether BOTOX and BOTOX Cosmetic are safe or effective to prevent headaches in people with migraine who have 14 or fewer headache days each month (episodic migraine).It is not known whether BOTOX and BOTOX Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.Who should not take BOTOX or BOTOX Cosmetic? Do not take BOTOX or BOTOX Cosmetic if you:
are allergic to any of the ingredients in BOTOX or BOTOX Cosmetic. See the end of this Medication Guide for a list of ingredients in BOTOX and BOTOX Cosmetic.
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 (only applies to people who are not routinely catheterizing)
What should I tell my doctor before taking BOTOX or BOTOX Cosmetic? 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). See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"
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
are pregnant or plan to become pregnant. It is not known if BOTOX or BOTOX Cosmetic can harm your unborn baby.
are breast-feeding or plan to breastfeed. It is not known if BOTOX or BOTOX Cosmetic passes into breast milk.
Tell your doctor about all the medicines you take , including prescription and nonprescription medicines, vitamins and herbal products. Using BOTOX or BOTOX Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX or BOTOX Cosmetic in the past. Especially tell your doctor if you:
have received any other botulinum toxin product in the last four months
have received injections of botulinum toxin, such as Myobloc � (rimabotulinumtoxinB), Dysport � (abobotulinumtoxinA), or Xeomin �(incobotulinumtoxinA) in the past. Be sure your doctor knows exactly which product you received.
have recently received an antibiotic by injection
take muscle relaxants
take an allergy or cold medicine
take a sleep medicine
take anti-platelets (aspirin-like products) and/or anti-coagulants (blood thinners)
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.How should I take BOTOX or BOTOX Cosmetic?
BOTOX or BOTOX Cosmetic is an injection that your doctor will give you.
BOTOX is injected into your affected muscles, skin, or bladder.
BOTOX Cosmetic is injected into your affected muscles.
Your doctor may change your dose of BOTOX or BOTOX Cosmetic , until you and your doctor find the best dose for you.
Your doctor will tell you how often you will receive your dose of BOTOX or BOTOX Cosmetic injections.
What should I avoid while taking BOTOX or BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX or BOTOX Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"
What are the possible side effects of BOTOX and BOTOX Cosmetic? BOTOX and BOTOX Cosmetic can cause serious side effects. See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"Other side effects of BOTOX and BOTOX Cosmetic include:
dry mouth
discomfort or pain at the injection site
tiredness
headache
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
painful urination in people being treated for urinary incontinence
inability to empty your bladder on your own and are being treated for urinary incontinence. If you have difficulty fully emptying your bladder after getting BOTOX , you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
allergic reactions. Symptoms of an allergic reaction to BOTOX or BOTOX Cosmetic may include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Tell your doctor if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of BOTOX and BOTOX Cosmetic. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about BOTOX and BOTOX Cosmetic: Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.This Medication Guide summarizes the most important information about BOTOX and BOTOX Cosmetic. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BOTOX and BOTOX Cosmetic that is written for healthcare professionals.What are the ingredients in BOTOX and BOTOX Cosmetic? Active ingredient: botulinum toxin type AInactive ingredients: human albumin and sodium chlorideManufactured by: Allergan Pharmaceuticals Ireland a subsidiary of: Allergan, Inc. 2525 Dupont Dr. Irvine, CA 92612�2016 Allergan. All rights reserved. All trademarks are the property of their respective owners.Patented. See: www.allergan.com/products/patent_notices
