Pronunciation:

on-a-bot-ue-LYE-num-tox-in-ay

Brand Names:

• Botox
• Botox Cosmetic

Dosage Forms:

• Powder for Solution

Warnings:

Distant spread of toxin effects - 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 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms .

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Botulinum Toxin Type A

Uses of This Medicine:

OnabotulinumtoxinA is used to treat certain eye conditions, such as blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) or strabismus (a condition where the eyes do not line up properly).

OnabotulinumtoxinA is also used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck) and some types of axillary hyperhidrosis (severe sweating of the armpits).

OnabotulinumtoxinA is used to treat increased muscle stiffness in the elbow, wrist, and finger muscles or ankle and toe muscles in adults with upper or lower limb spasticity or in children 2 to 17 years of age with upper and lower limb spasticity.

OnabotulinumtoxinA is also used to prevent headaches in patients with chronic migraine (severe headaches for 15 or more days a month lasting 4 or more hours a day).

OnabotulinumtoxinA is used cosmetically to temporarily improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines), forehead lines, and crow's feet lines around the eyes (lateral canthal lines).

OnabotulinumtoxinA is also used to treat urinary incontinence (loss of bladder control) in patients with an overactive bladder caused by nervous system disorders (eg, multiple sclerosis, spinal cord injury). It is also used to treat an overactive bladder caused by a nervous system disorder or overactive bladder with symptoms, such as loss of bladder control, increased urge to urinate, and frequent need to urinate in patients who have failed treatment with other medicines (eg, anticholinergics).

OnabotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

OnabotulinumtoxinA is injected into the affected muscles. Depending on your condition, more than one treatment may be required.

This medicine is available only with your doctor's prescription and will be administered by your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 2 years of age for upper limb spasticity and lower limb spasticity (except spasms caused by cerebral palsy), in children younger than 5 years of age for overactive bladder caused by a nervous system disorder, in children younger than 12 years of age for blepharospasm or strabismus, in children younger than 16 years of age for cervical dystonia, or in children younger than 18 years of age for chronic migraine, hyperhidrosis, or overactive bladder with symptoms. Use of onabotulinumtoxinA to treat glabellar lines, forehead lines, and lateral canthal lines is not recommended in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of onabotulinumtoxinA in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving onabotulinumtoxinA.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• LetibotulinumtoxinA-wlbg

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
• Dermatochalasis (a skin problem) or
• Diabetes or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle or nerve problem) or
• Myasthenia gravis (severe muscle weakness) or
• Sebaceous skin, thick (oily or fatty skin) or
• Surgery on the face, history of—May increase risk for more serious side effects.

• Bleeding problems or
• Breathing problems (eg, asthma, emphysema) or
• Dysarthria (trouble with speaking) or
• Dysphagia (trouble with swallowing) or
• Dysphonia (voice problem) or
• Heart attack, recent or history of or
• Heart or blood vessel disease or
• Heart rhythm problems or
• Lung problems (eg, bronchitis) or
• Ptosis (droopy eyelid) or
• Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.

• Infection at the injection site or
• Urinary retention (not able to urinate) or
• Urinary tract infection—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Your doctor will give you this medicine in a medical facility. It is given as a shot under your skin or into one of your muscles.

You may be given medicine to numb the area where the shot will be injected. If you receive the medicine around your eyes, you may be given eye drops or ointment to numb the area. After your injection, you may need to wear a protective contact lens or eye patch.

If you are being treated for bladder problems, you may also receive medicine to help prevent urinary tract infection before, during, or after treatment with this medicine.

If you are treated for excessive sweating, shave your underarms but do not use deodorant for 24 hours before your injection. Avoid exercise, hot foods or liquids, or anything else that could make you sweat for 30 minutes before your injection.

This medicine works slowly. For neck disorders, you should have improvement within 2 to 6 weeks after your injection. For upper arm stiffness, you should have improvement within 4 to 6 weeks after your injection. Eyelid disorders should improve within 3 days to 2 weeks after your injection. Strabismus should improve within 1 or 2 days after the injection, and the improvement should last for 2 to 6 weeks. Once your condition has improved, the medicine will last about 3 months, then the effects of the medicine will slowly go away. You might need more injections when the effects of the medicine wear off. The recommended re-treatment schedule for chronic migraine is every 12 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use onabotulinumtoxinA (Botox® or Botox® Cosmetic) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require an immediate treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems (eg, bleeding inside the eye). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (eg, corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

After you have received this medicine and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.

This medicine may increase your chances of having bronchitis or upper respiratory tract infections when given for upper limb spasticity. Tell your doctor right away if you have trouble breathing, sneezing, sore throat, coughing, or a fever.

This medicine may cause a condition called autonomic dysreflexia in patients with nervous system disorders (eg, spinal cord injury). It can be a life-threatening condition and requires immediate medical attention. Call your doctor right away if you have headache, increased sweating, slow heartbeat, warmth or redness in your face, neck, or arm, or have problems in urinating while using this medicine.

This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

Check with your doctor right away if you have difficulty urinating or a burning sensation while urinating after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Difficulty with swallowing

Rare

Difficulty with breathing or speaking

muscle weakness

More common—for blepharospasm

Dryness of the eyes

inability to close the eyelids completely

More common—for upper limb spasticity

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

More common—for urinary incontinence caused by an overactive bladder

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

Less common—for blepharospasm

Decreased blinking

irritation of the cornea (colored portion) of the eyes

turning outward or inward of the edge of the eyelids

Less common—for forehead lines

Drooping of the brows and upper eyelids

Less common—for glabellar lines

Drooping of the upper eyelid

facial pain

muscle weakness

partial or slight paralysis of the face

Less common—for lateral canthal lines

Swelling of the eyelids

Less common—for upper limb spasticity

Cough producing mucus

difficulty breathing

muscle weakness

nausea

seizures

tightness in the chest

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—for blepharospasm

Blue or purplish bruise on the eyelids

drooping of the upper eyelids

irritation or watering of the eyes

sensitivity of the eyes to light

More common—for cervical dystonia

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

neck pain

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

More common—for chronic migraine

Neck pain

More common—for forehead lines

Headache

More common—for hyperhidrosis

Body aches or pain

chills

congestion

cough

diarrhea

dryness or soreness of the throat

fear

fever

general feeling of discomfort or illness

headache

heavy bleeding from the place where the shot was given

itching skin

joint pain

loss of appetite

nausea

nervousness

painful or difficult urination

runny nose

shivering

sweating

tender, swollen glands in the neck

trouble sleeping

trouble swallowing

voice changes

vomiting

More common—for strabismus

Drooping of the upper eyelid

eye pointing upward or downward instead of straight ahead

More common—for upper limb spasticity

Pain in the arms

Less common—for blepharospasm

Skin rash

swelling of the skin of the eyelid

Less common—for chronic migraine

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blurred vision

body aches or pain

cough producing mucus

difficulty with breathing

dizziness

drooping of the upper eyelid

headache

muscle aches and pains

nervousness

pounding in the ears

slow or fast heartbeat

tightness in the chest

Less common—for forehead lines

Skin tightness

Less common—for lower limb spasticity

Back pain

body aches or pain

chills

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy nose

unusual tiredness or weakness

Less common—for strabismus

Difficulty finding the location of objects

double vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.