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onabotulinumtoxinA

Generic Name: onabotulinumtoxinA (Botox) (ON a BOT ue LYE num TOX in A)
Brand Name: Botox, Botox Cosmetic

What is onabotulinumtoxinA (Botox)?

OnabotulinumtoxinA (Botox), also called botulinum toxin type A, is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botox is used to treat cervical dystonia (severe spasms in the neck muscles), muscle spasms in the arms and hands, and severe underarm sweating (hyperhidrosis).

Botox is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botox is also used to treat overactive bladder and incontinence (urine leakage) caused by nerve disorders such as spinal cord injury or multiple sclerosis.

Botox is also used to prevent chronic migraine headaches in adults who have migraines for more than 15 days per month, each lasting 4 hours or longer. Botox should not be used to treat a common tension headache.

Botox Cosmetic is used to temporarily lessen the appearance of facial wrinkles.

Botox may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Botox?

You should not receive this medication if you have an infection in the area where the medicine will be injected. Botox should not be used to treat overactive bladder and incontinence if you have a current bladder infection or if you are unable to urinate and you do not routinely use a catheter.

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The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several hours or several weeks after a botulinum toxin injection.

What should I discuss with my healthcare provider before I receive Botox?

You should not receive this medication if you are allergic to botulinum toxin, or if you have:

  • an infection in the area where the medicine will be injected; or

  • (for overactive bladder and incontinence) if you have a current bladder infection or if you are unable to urinate and you do not routinely use a catheter.

To make sure Botox is safe for you, tell your doctor if you have:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

  • myasthenia gravis;

  • Lambert-Eaton syndrome;

  • a breathing disorder such as asthma or emphysema;

  • problems with swallowing;

  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

  • a change in the normal appearance of your face;

  • bleeding problems;

  • heart disease;

  • if you have had or will have surgery (especially on your face);

  • if you have ever received other botulinum toxin injections such as Dysport or Myobloc (especially in the last 4 months); or

  • if you have ever had a side effect after receiving a botulinum toxin in the past.

Botox is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether botulinum toxin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Botox can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Botox given?

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

This medicine is injected into a muscle. A doctor, nurse, or other healthcare provider will give you this injection. Botox injections should be spaced at least 3 months apart.

Your injection may be given into more than one area at a time, depending on the condition being treated.

While receiving botulinum toxin injections for an eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

If you are being treated for excessive sweating, shave your underarms about 24 hours before you will receive your injection. Do not apply underarm antiperspirants or deodorants for 24 hours before you receive the injection. Avoid exercise and hot foods or beverages within 30 minutes before the injection.

It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to improve. You may notice the greatest improvement at 6 weeks after injection.

It may take only 1 to 3 days after injection before eye muscle spasm symptoms begin to improve. You may notice the greatest improvement at 2 to 6 weeks after injection.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Botox?

Botox may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid using underarm antiperspirants or deodorants for 24 hours after a botulinum toxin injection if you are being treated for excessive underarm sweating.

Avoid going back to your normal physical activities too quickly after receiving an injection.

Botox side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in Botox can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects, some of which can occur up to several hours or several weeks after an injection:

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

  • trouble breathing, talking, or swallowing;

  • hoarse voice, drooping eyelids;

  • loss of bladder control;

  • eyelid swelling, crusting or drainage from your eyes, problems with vision;

  • pain or burning when you urinate, little or no urinating; or

  • chest pain, irregular heartbeats.

Common side effects may include:

  • muscle weakness near where the medicine was injected;

  • bruising, bleeding, pain, redness, or swelling where the injection was given;

  • headache, muscle stiffness, neck or back pain, pain in your arms or legs;

  • increased sweating in areas other than the underarms; or

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

OnabotulinumtoxinA dosing information

Usual Adult Dose for Blepharospasm:

OnabotulinumtoxinA (Botox):

Reconstituted solution is injected using a sterile, 27 to 30 gauge needle without electromagnetic guidance:

Initial dose: 1.25 to 2.5 units (0.05 to 0.1 mL) intramuscularly each into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia.

The cumulative dose of OnabotulinumtoxinA (Botox) in a 30 day period should not exceed 200 units.

The initial effect of the injections is usually seen within 3 days and reaches a peak at 1 to 2 weeks posttreatment. Each treatment lasts approximately 3 months, after which the procedure may be repeated. At repeat treatment sessions, the dose may be increased up to 2-fold if the response from the initial treatment is considered insufficient (usually defined as an effect that does not last longer than 2 months). However, there appears to be little benefit obtainable from injecting more than 5 Units per site. Injecting onabotulinumtoxinA more frequently than every 3 months may result in some tolerance.

Approved indication: Treatment of blepharospasm associated with dystonia in patients 12 years of age or older.

Usual Adult Dose for Strabismus:

OnabotulinumtoxinA (Botox):

OnabotulinumtoxinA is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle. Injection without surgical exposure or electromyographic guidance should not be attempted. Physicians should be familiar with electromyographic technique.

To prepare the eye for onabotulinumtoxinA injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection.

Initial dosage:

--Vertical muscles and/or horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units intramuscularly in any one muscle.

--Horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 units in any one muscle.

--Persistent VI nerve palsy of 1 month or longer duration: 1.25 to 2.5 units in the medial rectus muscle.
Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period. Overcorrections lasting more than 6 months have been rare. About one-half of patients will require subsequent doses because of inadequate paralytic response of the muscle to the initial dose, or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment.

Subsequent doses for residual or recurrent strabismus:

--The manufacturer recommends that patients be reexamined 7 to 14 days after each injection to assess the effect of that dose.

--Patients experiencing adequate paralysis of the target muscle that require subsequent injections should receive a dose comparable to the initial dose.

--Subsequent doses for patients experiencing incomplete paralysis of the target muscle may be increased up to 2-fold compared to the previously administered dose.

--Subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.

--The maximum recommended dose as a single injection for any one muscle is 25 Units.

Approved indication: Treatment of strabismus in patients 12 years of age or older.

Usual Adult Dose for Upper Limb Spasticity:

OnabotulinumtoxinA (Botox):

OnabotulinumtoxinA (Botox) is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).

Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to previous treatment, or adverse event history with onabotulinumtoxinA.

In clinical trials, doses of onabotulinumtoxinA ranging from 75 units to 360 units were divided among selected muscles at a given treatment session.

Recommended dose ranges per muscle:
Biceps Brachii: 100 to 200 units divided in 4 sites
Flexor Carpi Radialis: 12.5 to 50 units in 1 site
Flexor Carpi Ulnaris: 12.5 to 50 units in 1 site
Flexor Digitorum Profundus: 30 to 50 units in 1 site
Flexor Digitorum Sublimis: 30 to 50 units in 1 site

The lowest recommended starting dose should be used, and no more than 50 units per site should generally be administered. Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques is recommended.

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection. The degree and pattern of muscle spasticity at the time of reinjection may necessitate alterations in the dose and muscles to be injected.

Approved indication: Treatment of upper limb spasticity in adult patients (to decrease the severity of increased muscle tone in elbow flexors [biceps], wrist flexors [flexor carpi radialis and flexor carpi ulnaris] and finger flexors [flexor digitorum profundus and flexor digitorum sublimis]).

Usual Adult Dose for Cervical Dystonia:

For use in the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain:

OnabotulinumtoxinA (Botox):

In a phase 3 study of patients who had previously received and tolerated onabotulinumtoxinA, the mean dose administered was 236 units (25 th to 75 th percentile range 198 to 300 units) divided among the affected muscle groups. Limiting the total dose injected into the sternocleidomastoid muscles to 100 units or less may decrease the occurrence of dysphagia.

Clinical improvement generally begins within the first 2 weeks after injection with maximum clinical benefit at approximately 6 weeks postinjection. In the phase 3 study most subjects were observed to have returned to pretreatment status by 3 months posttreatment.

Approved indication: Treatment of cervical dystonia in adult patients (to reduce the severity of abnormal head position and neck pain).

Usual Adult Dose for Hyperhidrosis:

OnabotulinumtoxinA (Botox):

50 units (2 mL) injected intradermally in 0.1 to 0.2 mL aliquots to each axilla distributed evenly in multiple sites (10 to 15) 1 to 2 cm apart using a 30 gauge needle.

Inject each dose to a depth of approximately 2 mm and at a 45 degree angle to the skin surface with the bevel side up.

If injection sites are marked in ink do not inject directly through the ink mark to avoid a permanent tattoo mark.

Repeat injections for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes.

Approved indication: Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients.

Usual Adult Dose for Glabellar Lines:

OnabotulinumtoxinA (Botox (R) Cosmetic):

4 units IM into each of five sites, two in each corrugator muscle and one in the procerus muscle for a total of 20 units.

To reduce the complication of ptosis the following steps should be taken:

--Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.

--Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.

--Ensure the injected volume/dose is accurate and where feasible kept to a minimum.

--Do not inject toxin closer than 1 cm above the central eyebrow.

Approved indication: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Usual Adult Dose for Migraine Prophylaxis:

OnabotulinumtoxinA (Botox):

155 Units intramuscularly (IM) using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams provided in the manufacturer labeling. A 1 inch needle may be needed in the neck region for patients with thick neck muscles. With the exception of the procerus muscle, which should be injected at 1 site (midline), all muscles should be injected bilaterally with half the number of injection sites administered to the left, and half to the right side of the head and neck. The recommended retreatment schedule is every 12 weeks.

The manufacturer recommended dilution of Botox (R )is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL.

Botox (R) manufacturer recommended dosing by muscle for prophylaxis of chronic migraine:
Frontalis (bilaterally): 20 Units divided in 4 sites
Corrugator (bilaterally): 10 Units divided in 2 sites
Procerus: 5 Units in 1 site
Occipitalis (bilaterally): 30 Units divided in 6 sites
Temporalis (bilaterally): 40 Units divided in 8 sites
Trapezius (bilaterally): 30 Units divided in 6 sites
Cervical Paraspinal Muscle Group (bilaterally): 20 Units divided in 4 sites

Approved indication: Prophylaxis of headaches in adult patients with chronic migraine (15 days or more per month with headache lasting 4 hours a day or longer).

Usual Adult Dose for Urinary Incontinence:

OnabotulinumtoxinA (Botox):

Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the treatment day, and 1 to 3 days posttreatment.

Patients should discontinue antiplatelet therapy at least 3 days before the injection procedure. Patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

Overactive Bladder:
The recommended dose is 100 Units of onabotulinumtoxinA (Botox) per treatment. The reconstituted solution is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but overdistension should be avoided.

The injection needle should be primed with approximately 1 mL of reconstituted solution prior to the start of injections (depending on the needle length) to remove any air.

The needle should be inserted approximately 2 mm into the detrusor, and 20 injections of 0.5 mL (total volume of 10 mL) should be spaced approximately 1 cm apart. For the final injection, approximately 1 mL of sterile normal saline should be injected so the full dose is delivered. After the injections are given, the patient should void prior to leaving the clinic. The patient should be observed for at least 30 minutes postinjection and until a spontaneous void has occurred.

Patients should be considered for reinjection when the clinical effect of the previous injection diminishes (median time to qualification for retreatment is 42 to 48 weeks in clinical studies, but no sooner than 12 weeks from the prior bladder injection.

Detrusor Overactivity associated with a Neurologic Condition:
An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
The recommended dose is 200 Units per treatment, and should not be exceeded.

Approved indication:
-Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
-Treatment of urinary incontinence due to detrusor over activity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Urinary Frequency:

OnabotulinumtoxinA (Botox):

Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the treatment day, and 1 to 3 days posttreatment.

Patients should discontinue antiplatelet therapy at least 3 days before the injection procedure. Patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.

Overactive Bladder:
The recommended dose is 100 Units of onabotulinumtoxinA (Botox) per treatment. The reconstituted solution is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but overdistension should be avoided.

The injection needle should be primed with approximately 1 mL of reconstituted solution prior to the start of injections (depending on the needle length) to remove any air.

The needle should be inserted approximately 2 mm into the detrusor, and 20 injections of 0.5 mL (total volume of 10 mL) should be spaced approximately 1 cm apart. For the final injection, approximately 1 mL of sterile normal saline should be injected so the full dose is delivered. After the injections are given, the patient should void prior to leaving the clinic. The patient should be observed for at least 30 minutes postinjection and until a spontaneous void has occurred.

Patients should be considered for reinjection when the clinical effect of the previous injection diminishes (median time to qualification for retreatment is 42 to 48 weeks in clinical studies, but no sooner than 12 weeks from the prior bladder injection.

Detrusor Overactivity associated with a Neurologic Condition:
An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
The recommended dose is 200 Units per treatment, and should not be exceeded.

Approved indication:
-Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
-Treatment of urinary incontinence due to detrusor over activity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Orbicularis Oculi:

OnabotulinumtoxinA (Botox (R) Cosmetic):

4 units IM into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (12 Units per side). For complete information on placement of the injections and diagrams see the package insert.

Approved indication: For the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.

Usual Pediatric Dose for Strabismus:

OnabotulinumtoxinA (Botox):

The safety and efficacy of onabotulinumtoxinA for treatment of strabismus in children less than 12 years have not been established.

Vertical muscles and/or horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units in any one muscle.

Horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 units in any one muscle.

Persistent VI nerve palsy of one month or longer duration: 1.25 to 2.5 units in the medial rectus muscle.

Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period.

Approved indication: Treatment of strabismus in patients 12 years of age or older.

Usual Pediatric Dose for Blepharospasm:

OnabotulinumtoxinA (Botox):

The safety and efficacy of onabotulinumtoxinA for the treatment of blepharospasm in children less than 12 years have not been established.

1.25 to 2.5 units (0.05 to 0.1 mL) intramuscularly each into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. The cumulative dose of onabotulinumtoxinA in a 30 day period should not exceed 200 units.

Approved indication: Treatment of blepharospasm associated with dystonia in patients 12 years of age or older.

Usual Pediatric Dose for Cervical Dystonia:

OnabotulinumtoxinA (Botox):

The safety and efficacy of onabotulinumtoxinA for the treatment of cervical dystonia in children less than 16 years have not been established.

In a phase 3 study of patients who had previously received and tolerated botulinum toxin type A, the mean dose administered was 236 units (25th to 75th percentile range 198 to 300 units) divided among the affected muscle groups. Limiting the total dose injected into the sternocleidomastoid muscles to 100 units or less may decrease the occurrence of dysphagia.

Approved indication: Treatment of cervical dystonia in adult patients (to reduce the severity of abnormal head position and neck pain).

What other drugs will affect Botox?

Other medications such as cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines can increase some of the side effects of Botox. Tell your doctor if you regularly use any of these medications.

Other drugs may interact with Botox, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Botox (onabotulinumtoxinA).
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2013-10-14, 11:37:25 PM.

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