Botox Cosmetic

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 Botox Cosmetic there are no specific foods that you must exclude from your diet when receiving Botox Cosmetic.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Botox Cosmetic is excreted in human breast milk or if it will harm your baby.

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of Botox Cosmetic 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.

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

Other medicines can increase certain side effects of Botox, especially: cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines. Tell your doctor about all your current medicines.

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.

In the U.S.

• Botox
• Botox Cosmetic

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: Botulinum Toxin Type A

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). This medicine 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). It is used for increased muscle stiffness in the elbow, wrist, and finger muscles in adults with upper limb spasticity. It is also used for increased muscle stiffness in the ankle and toe muscles in adults with lower limb spasticity. It 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 improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines) and crow's feet lines around the eyes (lateral canthal lines). It 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 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.

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

OnabotulinumtoxinA is injected into the muscles that are affected. 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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Botox Cosmetic is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Botox Cosmetic (onabotulinumtoxinA cosmetic injection) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Botox Cosmetic. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Botox Cosmetic is supplied in a single-use vial in the following sizes:

50 Units: NDC 0023-3919-50

100 Units: NDC 0023-9232-01

The top and bottom flaps of the Botox Cosmetic cartons have a tamper-evident seal that contains a translucent silver Allergan logo. Vials of Botox Cosmetic have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. In order to see the hologram, rotate the vial back and forth between your fingers under a desk lamp or fluorescent light source. (Note: the holographic film on the label is absent in the date/lot area.) Each Botox Cosmetic vial label and carton also contains the U.S. License number: 1145.

Do not use the product and contact Allergan for additional information at 1-800-890-4345 from 7:00 AM to 3:00 PM Pacific Time if:

• the horizontal lines of rainbow color or the name “Allergan” are not present on the vial label
• the tamper-evident seal is not intact and present on both ends of the carton
• the translucent silver Allergan logo on the seal is not clearly visible or has a black circle with a diagonal line through it (i.e., prohibition sign)
• the U.S. License number 1145 is not present on the vial label and carton

Storage

Unopened vials of Botox Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF). Do not use after the expiration date on the vial. Reconstituted Botox Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF) and administered within 24 hours.

Applies to onabotulinumtoxinA: powder for solution

Along with its needed effects, onabotulinumtoxinA (the active ingredient contained in Botox Cosmetic) 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 while taking onabotulinumtoxinA:

• Difficulty with swallowing

• Difficulty with breathing or speaking
• muscle weakness

• Dryness of the eyes
• inability to close the eyelids completely

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

• Decreased blinking
• irritation of the cornea (colored portion) of the eyes
• turning outward or inward of the edge of the eyelids

• Swelling of the eyelids

Some side effects of onabotulinumtoxinA 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:

• Blue or purplish bruise on the eyelids
• drooping of the upper eyelids
• irritation or watering of the eyes
• sensitivity of the eyes to light

• Body aches or pain
• chills
• cough, fever, sneezing, or sore throat
• ear congestion
• headache
• loss of voice
• nasal congestion
• neck pain
• runny nose
• unusual tiredness or weakness

• Neck pain

• 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 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

• Drooping of the upper eyelid
• eye pointing upward or downward instead of straight ahead

• Pain in the arms

• Skin rash
• swelling of the eyelid skin

• 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 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

• Difficulty finding the location of objects
• double vision

• Back pain
• body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• sneezing
• sore throat
• unusual tiredness or weakness

• Cough producing mucus
• difficulty breathing
• muscle weakness
• nausea
• tightness in the chest
• weakness

Applies to onabotulinumtoxinA: injectable powder for injection

Gastrointestinal

Common (1% to 10%): Constipation, nausea
Uncommon (0.1% to 1%): Dysphagia, oral dryness
Postmarketing reports: Abdominal pain, anorexia[Ref]

Nervous system

Common (1% to 10%): Headache, worsening migraine, facial paresis
Uncommon (0.1% to 1%): Vertigo
Frequency not reported: VII nerve disorder, new or recurrent seizures
Postmarketing reports: Brachial plexopathy
Nervous system side effects have included fatigue (2 to 3%), dizziness (2 to 10%), fever (2 to 10%), drowsiness (2 to 10%), and numbness (2 to 10%).[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cough, rhinitis, dyspnea, pharyngitis[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity, muscle weakness, asthenia, back pain, hypertonia, stiffness, fall, gait disturbance, muscle spasm, neck pain, musculoskeletal stiffness, myalgia
Uncommon (0.1% to 1%): Jaw pain
Postmarketing reports: Denervation/muscle atrophy[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Frequency not reported: Arrhythmia, myocardial infarction (sometimes fatal)[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Immunologic

Common (1% to 10%): Flu syndrome, infection
Frequency not reported: Immunogenicity (formation of neutralizing antibodies to botulinum toxin type A which may reduce the effectiveness of therapy)[Ref]

Ocular

Common (1% to 10%): Eyelid ptosis
Uncommon (0.1% to 1%): Dry eye, eyelid edema, eye infection, diplopia
Very rare (less than 0.01%): Corneal perforation
Frequency not reported: Superficial punctate keratitis, irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia, local swelling of the eyelid skin lasting for several days following eyelid injection, reduced blinking (from the injection of the orbicularis muscle which may lead to serious corneal exposure), persistent epithelial defect
Postmarketing reports: Visual disturbance[Ref]

Other

Common (1% to 10%): Fatigue, dizziness, hypertonia, asthenia, speech disorder, fever, stiffness, numbness, non-axillary sweating, sweating
Very rare (less than 0.01%): Brachial plexopathy
Frequency not reported: Focal facial paralysis, syncope, exacerbation of myasthenia gravis
Postmarketing reports: Hypoacusis, hypoesthesia, malaise, paresthesia, peripheral neuropathy, radiculopathy, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Frequency not reported: Diffuse skin rash
Postmarketing reports: Alopecia (including madarosis), erythema multiforme, dermatitis psoriasiform, psoriasiform eruption[Ref]

General

Adverse reactions usually occur within the first week following injection of this drug and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (26% in patients without diabetes and 31% in patients with diabetes), urinary retention (24%)
Common (1% to 10%): Dysuria, hematuria, bacteriuria, residual urine volume

Hematologic

Common (1% to 10%): Hemorrhage[Ref]

Psychiatric

Common (1% to 10%): Anxiety[Ref]

Some side effects of Botox Cosmetic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.