Drug Notes

Onabotulinumtoxina (By injection)

OnabotulinumtoxinA (on-a-bot-ue-LYE-num-tox-in-ay)

Treats muscle stiffness, muscle spasms, excessive sweating, overactive bladder, or loss of bladder control. Prevents chronic migraine headaches. Improves the appearance of wrinkles on the face.

Brand Name(s):

Botox, Botox Cosmetic

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given by a healthcare provider as a shot under your skin or into a muscle.
• 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 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.
• The recommended treatment schedule for chronic migraine is every 12 weeks.
• This medicine works slowly. Once your condition has improved, the medicine will last about 3 months, then the effects will slowly go away. You might need more injections to treat your condition.
  • Muscle spasms in the eyelids should improve within 3 to 10 days.
  • Eye muscle problems should improve 1 or 2 days after the injection, and the improvement should last for 2 to 6 weeks.
  • Neck pain should improve within 2 to 6 weeks.
  • Arm stiffness should improve within 4 to 6 weeks.
  • Facial lines or wrinkles should improve 1 or 2 days.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose :Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicine can affect how onabotulinumtoxinA works. Tell your doctor if you are using any of the following:
  • Aspirin or a blood thinner (such as ticlopidine, warfarin)
  • Muscle relaxer
  • Medicine for an infection (such as amikacin, gentamicin, streptomycin, tobramycin)
• Tell your doctor if you have received an injection of any botulinum toxin product within the past 4 months.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have breathing or lung problems, bleeding problems, heart or blood vessel disease, or nerve or muscle problems (such as myasthenia gravis). Tell your doctor if you have ever had face surgery or if you have a urinary tract infection or trouble urinating, diabetes, or multiple sclerosis.
• This medicine may cause the following problems:
  • Muscle weakness, loss of bladder control, trouble swallowing, speaking, or breathing (caused by the toxin spreading to other parts of your body)
• This medicine may make your muscles weak or cause vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• There are some warnings that only apply if you are receiving this medicine to treat the following:
  • Injections near the eye : This medicine may reduce blinking, which can raise the risk of eye problems such as corneal exposure and ulcers. Tell your doctor right away if you notice that you are blinking less than usual or your eyes feel dry.
  • Urinary incontinence : This medicine may cause autonomic dysreflexia, which can be a life-threatening condition.
  • Overactive bladder : Check with your doctor right away if you have trouble urinating or a burning sensation while urinating.
• This medicine contains products from donated human blood, so it may contain viruses, although the risk is low. Human donors and blood are always tested for viruses to keep the risk low. Talk with your doctor about this risk if you are concerned.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred or double vision, droopy eyelids
• Change in how much or how often you urinate, trouble urinating, or painful urination
• Chest pain, slow or uneven heartbeat
• Headache, increased sweating, warmth or redness in your face, neck, or arm
• Muscle weakness
• Trouble swallowing, talking, or breathing

If you notice these less serious side effects, talk with your doctor:

• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
• Pain in your neck, back, arms, or legs
• Redness, pain, tenderness, bruising, swelling, or weakness where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Last Updated: 1/27/2017