onabotulinumtoxinA (Botox)

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

The botulinum toxin contained in this medicine can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

What is onabotulinumtoxinA (Botox)?

Botox is used in adults to treat cervical dystonia (abnormal head position and neck pain).

Botox is also used to treat muscle spasms and stiffness (spasticity) of the arms, hands, legs, and feet in adults and children at least 2 years old. This medicine will not treat spasticity caused by cerebral palsy.

Botox is also used to treat certain eye muscle conditions caused by nerve disorders in adults and children who are at least 12 years old. 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 in adults to treat overactive bladder and incontinence (urine leakage) that has not been helped by other medication. Botox may be used to treat incontinence caused by nerve disorders such as spinal cord injury or multiple sclerosis.

Botox is also used to treat overactive bladder caused by a neurologic disorder (such as multiple sclerosis or spinal cord injury) in children at least 5 years old when other medicines cannot be used or have not worked.

Botox is also used in adults to prevent chronic migraine headaches that occur more than 15 days per month and last 4 hours or longer. Botox should not be used to treat a common tension headache.

Botox is also used to treat severe underarm sweating (hyperhidrosis) in adults.

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

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

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

• 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.

Tell your doctor if you have ever had:

• other botulinum toxin injections such as Dysport or Myobloc (especially in the last 4 months);
• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a side effect after prior use of botulinum toxin;
• 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; or
• surgery (especially on your face).

Botox is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Tell your doctor if you are pregnant or breastfeeding.

How is Botox given?

This medicine is injected into a muscle by a healthcare provider. Botox injections should be spaced at least 3 months apart.

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

While receiving injections for 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 your injection. Do not apply antiperspirant or deodorant for 24 hours before or after 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 after 6 weeks.

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

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

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?

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?

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

What are the possible side effects of Botox?

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 botulinum toxin injections, even for cosmetic purposes.

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• loss of bladder control;
• hoarse voice, trouble talking or swallowing;
• drooping eyelids or eyebrows;
• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light);
• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats;
• pain or burning when you urinate, trouble emptying your bladder;
• sore throat, cough, chest tightness, shortness of breath; or
• eyelid swelling, crusting or drainage from your eyes, problems with vision.

Common side effects may include:

• painful or difficult urination;
• headache, neck pain, back pain, pain in your arms or legs;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• trouble swallowing;
• fever, chills, body aches, flu symptoms;
• increased sweating in areas other than the underarms; or
• bruising, bleeding, pain, redness, or swelling where the injection was given.

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.

What other drugs will affect Botox?

Tell your doctor about all your other medicines, especially:

• a muscle relaxer;
• cold or allergy medicine;
• sleep medicine;
• an injectable antibiotic; or
• a blood thinner --warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect Botox, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about Botox (onabotulinumtoxinA).