BOTOX Treatment for Chronic Migraine ® Botulinum Toxin Type A Information for patients and their families. Is Chronic Migraine the same as Migraine? Chronic Migraine is similar to migraine as sufferers experience the same type of symptoms: ■ Intense, sometimes throbbing or pulsing headache pain ■ Nausea and/or vomiting when headaches occur ■ Sensitivity to light and/or sound that increases the pain ■ Aggravated by routine physical activity, e.g. walking or climbing stairs Chronic Migraine sufferers, however, have a more serious condition as their headaches occur more frequently. As such, people are diagnosed as having Chronic Migraine if they experience: ■ 15 or more headaches per month (for more than 3 months) and ■ 8 of the headaches have migraine features (such as those mentioned above). Because sufferers have lived with severe headaches for so long, it is difficult for many of them to remember what not having a headache feels like. Even during their good days, sufferers are often consumed with worry about when the next headache will strike. As a result many Chronic Migraine sufferers are affected socially, economically and may also deal with depression, anxiety and other chronic pain. Although it is a common condition (more than 100 million people around the world), Chronic Migraine sufferers may take several months, years, or even decades, to be fully diagnosed. Although there is no cure for Chronic Migraine, there are treatments available that may help control the condition. What is the difference between acute and preventative medications? Acute medications can be either over-the-counter or prescription medications. They are taken as soon as the person feels the start of a migraine. Preventative medications (also known as prophylactic medications) are used to stop the migraines occurring before they even start and, therefore, need to be taken continually. These medications are not always totally effective in preventing Chronic Migraine and, like a lot of medicines, may have side effects in some people. BOTOX® is classified as a treatment for the prevention (prophylaxis) of headache in adults with Chronic Migraine. BOTOX® treatment can be combined with acute medications to treat breakthrough attacks. Patients should consult with their doctor to determine the optimal combination of medication. What is BOTOX® treatment and what is it used for? BOTOX® is a natural, purified protein. The active ingredient is botulinum toxin type A which is extracted from bacteria, under controlled laboratory conditions, in much the same way penicillin is produced from mould. BOTOX® is a prescription-only medicine and should only be administered for Chronic Migraine by either a Neurologist or Pain Specialist who have undergone extra training, specifically for the use of BOTOX® in Chronic Migraine. BOTOX® has been used therapeutically in Australia and New Zealand for over 20 years to treat many different neurological, pain and movement disorders, such as juvenile cerebral palsy, excessive sweating, cervical dystonia and now Chronic Migraine. How does BOTOX® treatment work? A person experiences a migraine when the trigeminal nerve is stimulated. This nerve sends impulses from the eyes, scalp, forehead, upper eyelids, mouth and jaw to the brain. When stimulated, the trigeminal nerve may release substances (neurotransmitters) that cause painful inflammation in the blood vessels of the brain and the layers of tissue that cover the brain. This inflammation accounts for the throbbing headache, nausea, vomiting and sensitivity to light and sound. Although the exact method of action in Chronic Migraine is not known, studies have shown that BOTOX® blocks the release of these neurotransmitters that signal the start and progression of pain in the brain. By limiting the release of these substances, BOTOX® reduces the number and severity of migraines that patients experience each month. What does BOTOX® treatment for Chronic Migraine involve? BOTOX® treatment consists of a series of superficial, low-volume injections, performed by a trained Neurologist or Pain Specialist, in seven muscle groups in the head and neck area. The total procedure time is about 15 minutes and the patient can go home immediately afterwards. Each BOTOX® treatment lasts up to 3 months What should I expect from my BOTOX® treatment? If you respond to BOTOX® treatment, you should expect to feel significant relief in the first month after treatment and further improvement after two treatments. BOTOX® should also be part of a treatment strategy. Other therapies are still important, including behavioural modifications (avoiding headache triggers, getting enough sleep, managing stress, etc). Patients should work closely with their doctors to set goals and determine a complete treatment strategy. Are there any side effects to BOTOX® treatment? In clinical studies, BOTOX® was found to be well tolerated by patients, and only 3.8% of the treated patients stopped their treatment because of side effects. The most common side effects reported were: loss of movement on the face, drooping of the eyelids, skin rash, itching, pain at the injection site, neck pain, muscle pain, tenderness or weakness, muscle spasms or tightness. Less commonly experienced were: pain of skin, pain of jaw and difficulty in swallowing. Headache, including worsening migraine, has also been reported, usually occurring within the first month after treatment; however, these reactions did not always reoccur with following treatments and the overall occurrence decreased with repeated treatments. Most BOTOX® side effects were temporary and mild to moderate in severity. The side effects noted in the clinical studies were consistent with what is already known about BOTOX®. Who should not have BOTOX® treatment? Persons should not undergo treatment with BOTOX® if they have: ■ Allergies to any of the following ingredients: clostridium botulinum toxin type A-haemagglutin complex, human albumin or sodium chloride ■ An infection in the muscles where it would normally be injected or ■ Any muscle disorders in other parts of their body, including myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis. You should also tell your doctor if you are, or have: ■ Taking, or are likely to take, antibiotics, especially aminoglycoside antibiotics ■ Pre-existing neuromuscular disorders ■ Pregnant or have the intention of becoming pregnant ■ Breast feeding or planning to start breast feeding ■ Problems with your heart or circulation ■ Taking medicines that may interfere with muscle function ■ Taking any other medicines, including those that you have bought at your pharmacy, supermarket or health food shop. Where can I get further information on BOTOX® treatment? This brochure has been given to you because your doctor has prescribed BOTOX® for you. If you have any further questions on BOTOX® treatment or Chronic Migraine, please ask your doctor. For New Zealand patients - Botox is not funded for the treatment of chronic migraine. You will need to pay for this medicine. Normal Doctors fees apply. For further information the Consumer Medicine Information can be accessed at www.medsafe.govt.nz or ask your doctor. Medicines have benefits and some may have risks. If symptoms persist or you have side effects, see your doctor. Allergan New Zealand Limited Cnr Manu Tapu Drive and Joseph Hammond Place Auckland International Airport, Mangere, Auckland DA0111CB TAPS PP1348 BOTOX® is a registered trademark of Allergan Inc. Allergan Australia Pty Ltd 810 Pacific Highway Gordon NSW 2072 ABN 85 000 612 831 AU/0137/2011a