OnabotulinumtoxinA, Injection

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KEY POINTS

• This medicine is given by injections to treat neck pain and stiffness, bladder problems, muscle spasms, and other problems.
• This medicine may cause serious side effects that can be life-threatening. These symptoms may happen hours to weeks after an injection. This medicine may spread from the area of injection to other areas of the body. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: toxin

Generic and brand names: onabotulinumtoxinA, injection; Botox

What is this medicine used for?

This medicine is given by injections (shots) to treat:

• Severe spasms in the neck muscles, stiffness, and neck pain (cervical dystonia) in adults
• Increased muscle stiffness in elbow, wrist, and finger muscles in adults and muscle spasms in the arms and hands.
• Spasms of the eyelid, uncontrollable blinking (blepharospasm), and strabismus (a condition in which the eyes do not point in the same direction) in people 12 years and older.
• Overactive bladder symptoms such as leakage of urine (incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults when another type of medicine does not work well enough or cannot be taken.
• Severe underarm sweating in adults when other medicines do not work

It may also be given 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.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A nerve or muscle disorder such as ALS (Lou Gehrig's disease) or myasthenia gravis
• Bleeding problems
• Heart disease
• Lung or breathing problems such as asthma or COPD
• Trouble swallowing

Tell your healthcare provider if you have recently had:

• Any other botulinum injections (in the past 4 months)
• An infection
• Surgery (especially facial surgery)
• A urinary tract infection or trouble urinating

Also, tell your healthcare provider if you take aspirin, warfarin (Coumadin), or other medicines to treat or prevent blood clots.

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant while receiving these shots. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving these shots without your healthcare provider's approval.

How do I use it?

Read the Medication Guide when you start receiving this medicine and each time you receive an injection.

Your healthcare provider will inject the medicine into the sore or stiff muscles, skin, or bladder. Your provider may change your dose of this medicine to find the best dose for you, and tell you how often you will receive this medicine.

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

Ask your provider how soon you can expect results after treatment with this medicine. The benefits usually last for about 3 months. You may need more injections to treat your condition.

What should I watch out for?

The botulinum toxin may spread to other areas of your body from where it was injected and cause serious or life-threatening side effects. Call your healthcare provider right away if you have trouble breathing, talking, or swallowing; severe muscle weakness; vision problems or drooping eyelids; hoarse voice or loss of voice; or loss of bladder control. These effects can happen within hours, or weeks after an injection.

Treatment with this medicine may cause your body to form antibodies that may make future treatments less effective. You should receive the lowest effective dose, with at least 3 months between shots, as directed by your healthcare provider.

Injections in the muscles close to the eye may cause you to blink less. This may harm your eyes. Your healthcare provider may prescribe eyedrops, ointment, soft contact lenses, or an eye patch to protect your eyes until the medicine has worn off enough for you to be able to blink normally again.

Read the additional patient information sheet your healthcare provider will give you. Follow instructions carefully. Return to your normal activities slowly after your treatment.

There are several types, strengths, and brands of this medicine. Changing brands may be dangerous. Talk with your healthcare provider about this.

This medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

This medicine may cause muscle weakness and vision problems. Do not drive or operate machinery if you feel weak or cannot see clearly. This medicine may cause a dry mouth. Sucking on hard, sugar-free candy or chewing sugar-free gun may help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat), chest pain.

Serious (Report these to your healthcare provider right away.): Trouble swallowing or speaking, trouble breathing, severe muscle weakness, irregular heartbeat, eye infection or pain, blurred or double vision, inability to close your eye, drooping eyelids, hoarse voice, change or loss of voice, loss of bladder control or trouble urinating, painful urination, seizures.

Other: Dry mouth; sore throat; neck pain; headache; diarrhea; pain or numbness at the injection site; dizziness; drowsiness; nausea; fever; muscle or joint pain; dry eyes; sensitivity to light; muscle weakness; sweating; runny or stuffy nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as procainamide and quinidine
• Antibiotics such as amikacin, clindamycin (Cleocin), gentamicin, kanamycin, neomycin (Neo-Fradin), polymyxin, streptomycin, and tobramycin
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Cyclobenzaprine (Amrix)
• Magnesium supplements
• Other botulinum toxins

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.