Onabotulinumtoxina (Injection)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you recently had a heart attack. Tell your doctor if you have breathing problems (such as asthma, bronchitis, or emphysema), bladder problems, bleeding problems, a droopy eyelid, heart disease, or heart rhythm problems. Tell your doctor if you have nerve or muscle problems, amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease), Lambert-Eaton syndrome (a nerve and muscle disorder), or myasthenia gravis (severe muscle weakness). Tell your doctor if you have trouble with speaking or swallowing, have a skin problem called dermatochalasis, or had face surgery in the past.
• One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.
• After you receive this medicine and your vision or muscle spasms are better, you may be 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 reduce blinking of the eye which can lead to an increased risk of eye problems (such as corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.
• Serious muscle reactions have been reported 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 immediate treatment in a hospital or clinic.
• This medicine may make your muscles weak and cause vision problems (such as bleeding inside the eye). Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.
• 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 fever.
• This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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 using this medicine.
• This medicine may cause a condition called autonomic dysreflexia in patients with nervous system disorders (such as 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.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to 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
• Bleeding, bruising, or swelling in or around your eye.
• Blistering, peeling, or red skin rash.
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs.
• Change in how much or how often you urinate, painful urination.
• Chest pain, shortness of breath, or uneven heartbeat.
• Eye pain, redness in the whites of your eyes.
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
• Loss of bladder control.
• Pain in the arms, neck, or face.
• Seizures.
• Severe trouble swallowing, breathing, or speaking.
• Unusual weakness in other muscles (not where the shot was given).

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

• Blurred or double vision.
• Change or loss of voice.
• Drooping or swelling of your eyelid, dry eyes, or watery eyes.
• Dry mouth.
• Headache.
• Increased body sweating.
• Mild skin rash.
• Nausea or stomach upset.
• Redness, pain, tenderness, bruising, swelling, or weakness where the shot was given.
• Tiredness.
• Trouble judging depth or distance.

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

Introduction

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

Treats the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). Treats uncontrolled muscle spasms in the eyelids (blepharospasm) or around the eyes (strabismus). Treats excessive underarm sweating (hyperhidrosis). Treats increased muscle stiffness in the elbow, wrist, and finger muscles from upper limb spasticity. Prevents headaches in patients with chronic migraine (severe headaches for 15 or more days a month lasting 4 or more hours a day). Also used to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines). Also used to treat urinary incontinence (loss of bladder control) in patients with an overactive bladder caused by nervous system disorders (such as multiple sclerosis, spinal cord injury). This is a botulinum toxin A product.

Brand Name(s)

Botox, Botox Cosmetic

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not receive this medicine if you have had an allergic reaction to onabotulinumtoxinA or any type of botulinum toxin product (such as abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB, Dysport®, Myobloc®, or Xeomin®). You should not receive this medicine if you have an infection in the skin where the shot will be given. Do not receive this medicine if you are not able to urinate or have a urinary tract infection.

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 as a shot under your skin or into one of your muscles.
• A nurse or other trained health professional will give you this medicine.
• 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 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.
• Your doctor will only use onabotulinumtoxinA (Botox® or Botox® Cosmetic) to treat your condition. Other botulinum toxin products may not work the same way.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• 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.

• Make sure your doctor knows if you are also using aspirin, dicycloverine (Bentyl®), glycopyrrolate (Robinul®), quinidine (Cardioquin®), magnesium sulfate, medicine for an infection (such as amikacin, clindamycin, gentamicin, lincomycin, neomycin, netilmicin, polymyxin B, streptomycin, tobramycin, Amikin®, Garamycin®, or Netromycin®), a muscle relaxant that would be used during surgery (such as atracurium, gallamine, pancuronium, succinylcholine, tubocurarine, vecuronium, Flaxedil®, Norcuron®, Pavulon®, Quelicin®, Tracrium®, or Tubarine®), or a blood thinner (such as warfarin, ticlopidine, Coumadin®, or Ticlid®).
• If you need to receive an injection of any botulinum toxin product within 4 months after receiving this medicine, tell the doctor when you last received a dose of onabotulinumtoxinA.