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    Commonly Asked Questions About Treatment: Acthar For Infantile Spasms

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    WSET
    IS is a serious seizure disorder affecting children under 2 years old. Symptoms include spasms and abnormal brain waves. Acthar is approved to treat IS and in a study, most children treated with Acthar experienced no spasms or abnormal brain waves after 2 weeks. Common side effects include infections, increased appetite, and irritability.

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    Commonly Asked Questions About Treatment: Acthar For Infantile Spasms

    Uploaded by

    WSET
    1K views5 pages
    IS is a serious seizure disorder affecting children under 2 years old. Symptoms include spasms and abnormal brain waves. Acthar is approved to treat IS and in a study, most children treated with Acthar experienced no spasms or abnormal brain waves after 2 weeks. Common side effects include infections, increased appetite, and irritability.

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    Infantile Spasms

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    Infantile Spasms

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    IS is a serious seizure disorder affecting children under 2 years old. Symptoms include spasms and abnormal brain waves. Acthar is approved to treat IS and in a study, most children treated with Acthar experienced no spasms or abnormal brain waves after 2 weeks. Common side effects include infections, increased appetite, and irritability.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views5 pages

    Commonly Asked Questions About Treatment: Acthar For Infantile Spasms

    Uploaded by

    WSET
    IS is a serious seizure disorder affecting children under 2 years old. Symptoms include spasms and abnormal brain waves. Acthar is approved to treat IS and in a study, most children treated with Acthar experienced no spasms or abnormal brain waves after 2 weeks. Common side effects include infections, increased appetite, and irritability.

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    ACTHAR FOR INFANTILE SPASMS

    Commonly asked
    questions about treatment
    Acthar is a prescription medicine that is used to treat infantile
    spasms in infants and children under 2 years of age.

    IMPORTANT SAFETY INFORMATION


    Acthar is given as an injection into the muscle. Do not inject it under
    the skin or into a vein, or give it to your child by mouth. Inject Acthar exactly
    as your doctor tells you, and keep all of your childs follow-up appointments.

    Please see additional Important Safety Information


    throughout, as well as accompanying full Prescribing
    Information and Medication Guide.

    INFANTILE SPASMS
    What is infantile spasms (IS)?
    IS is a rare seizure disorder that affects approximately 2500 children
    in the United States every year.
    Children with IS generally have one or more of the following symptoms:

    A certain type of seizure (called spasms)


    A disorganized and chaotic brain-wave pattern called hypsarrhythmia
    (hips-a-rith-me-ya) as recorded on an EEG*

    Failure to meet developmental milestones


    IS typically begins in the first year of life, most commonly between 4 and
    8 months of age. Most of the time, IS is caused by an underlying disease or
    injury to the brain; however, in some children, no cause for IS can be found.
    IS is a serious condition that requires immediate attention. Multiple
    treatments for IS are available. Studies have shown that early
    intervention may lead to fewer long-term effects.

    Normal EEG pattern

    Guidelines created by the American Academy of Neurology and Child


    Neurology Society say that treatment for IS has been successful when
    2 conditions are met:

    The child no longer has spasms


    The childs brain-wave pattern no longer shows signs of hypsarrhythmia

    Chaotic EEG pattern (hypsarrhythmia)


    in a child with IS

    *An EEG, or electroencephalogram, is a test that measures and records the electrical activity
    of the brain.

    IMPORTANT SAFETY INFORMATION (CONTINUED)


    Your child should NOT use Acthar if they have:
    A skin condition called scleroderma, bone density loss or osteoporosis,
    any infections (including suspected congenital infections in children under
    2 years of age), eye problems, recent surgery, stomach ulcers or a history
    of ulcers, heart problems, high blood pressure, allergies to pig-derived
    proteins, been recently given a vaccine or are about to take one, certain
    adrenal conditions (such as Cushings or Addisons disease).

    Please see additional Important Safety Information throughout, as well


    as accompanying full Prescribing Information and Medication Guide.

    IS is a serious condition that


    requires immediate attention.

    ACTHAR FOR INFANTILE SPASMS


    What is Acthar?
    Acthar is an injectable prescription medicine approved by the FDA more
    than 5 years ago to treat IS in infants and children under 2 years of age.
    In a clinical study, 13 out of 15 children with IS had no spasms and no
    hypsarrhythmia after 2 weeks of treatment with Acthar.

    In a clinical study, 13 out of 15 children


    with IS had no spasms and no hypsarrhythmia
    after 2 weeks of treatment with Acthar.

    What are the side effects of Acthar?


    As with any medicine, your child may experience side effects during
    treatment with Acthar. These common side effects will likely go away
    as soon as treatment is over:

    Infections (like a cold)


    Change in behavior or mood (cranky or irritable)
    Change in appetite and weight gain
    Diarrhea and vomiting
    Increased blood pressure

    Visit www.ActharIS.com for more information

    IMPORTANT SAFETY INFORMATION (CONTINUED)

    IMPORTANT SAFETY INFORMATION (CONTINUED)

    Acthar can cause side effects similar to those with steroid


    treatments. The risk of getting side effects may increase the longer your
    child is treated with Acthar. Tell your doctor right away if your child has
    any of the following serious side effects:
    Increased risk of infections. Your child may be more likely to get new
    infections. Also, old infections may become active.While taking Acthar, your
    child should stay away from people who are sick or have infections. Signs of
    infection are fever, cough, vomiting, or diarrhea. Other signs may be open cuts
    or sores on your childs body

    Adrenal gland changes. Taking Acthar long term may cause symptoms

    Please see additional Important Safety Information throughout, as well


    as accompanying full Prescribing Information and Medication Guide.

    of Cushings syndrome, such as upper body fat, rounded moon face, bruising
    easily, or bone weakness. When stopping Acthar, your childs body may not
    produce enough cortisol on its own (adrenal insufficiency). Do not stop
    giving your child injections of Acthar without talking to your doctor
    first. Call your doctor right away if your child appears pale, weak, or tired; loses
    weight or appetite; has stomach pain; or appears sick or feverish

    INJECTION TRAINING AND SUPPORT


    How do I give Acthar to my child?
    Acthar is given as an intramuscular injection, which means Acthar is
    injected directly into a muscle, typically in the thigh. Acthar should
    not be injected under the skin or into a vein.
    Your doctor or nurse will provide you with exact instructions on how
    to give Acthar to your child.

    What if Ive never given an injection before?

    What support is available?


    The company that manufactures ActharMallinckrodtcreated the
    Acthar Support & Access Program (A.S.A.P.) to make timely information
    and a variety of helpful services available to you at no cost.

    A .S.A.P. representatives can work with you to evaluate your

    insurance benefits and help qualified patients get co-pay assistance*

    A .S.A.P. will make arrangements to have Acthar shipped to your


    home from the specialty pharmacy

    Expect a call. Someone from A.S.A.P. or the specialty pharmacy


    will call you to schedule the shipment of Acthar. It is important
    that you do not miss this call. Be sure to provide the best number
    at which to reach you.

    At first it may be scary to think about giving your child an injection.


    Thats completely normal; however, other parents and caregivers learn
    to do it and you can, too.

    For additional information, please


    visit the following websites:

    You will have a lot of help as you learn how to give your child an injection,
    beginning with one-on-one training from your doctor or a nurse before
    you give Acthar to your child for the first time. Ask your doctor or nurse
    about available step-by-step training, which may include the opportunity
    to practice on an anatomical model. A starter kit is also available to help
    you prepare to give your child Acthar.

    www.childneurologyfoundation.org/
    disorders/infantile-spasms
    www.infantilespasmscenter.org
    www.tsalliance.org

    *Most insurance plans cover Acthar for infantile spasms.


    

    To get started, you can find more information about


    Acthar and view injection-instruction videos on

    www.ActharInjectionTraining.com

    IMPORTANT SAFETY INFORMATION (CONTINUED)

    Increased blood pressure, too much water in the body, increased body
    salts, and low potassium in the blood. Your doctor may check your childs
    blood pressure during treatment and discuss treatment choices if your childs
    blood pressure increases. Follow your doctors instructions about if you need to
    decrease your childs salt intake or feed your child foods high in potassium
    Unpredictable response to vaccines. Talk to your doctor about which
    vaccines are safe for your child when taking Acthar

    Please see additional Important Safety Information throughout, as well


    as accompanying full Prescribing Information and Medication Guide.

    IMPORTANT SAFETY INFORMATION (CONTINUED)

    Masking other conditions. Tell your doctor if your child has any infections,

    changes in weight, bloody or black tarry stool, vomiting, stomach pain,


    excessive tiredness, increased thirst, fast heart rate, or difficulty breathing.
    Additionally, infantile spasms sometimes hide (mask) other seizures your
    child may have. Once treated with Acthar, the spasms may disappear and
    allow other seizures to become visible for the first time.Tell the doctor right
    away if you see a change in your childs seizures or spasms
    Stomach or intestinal problems. Acthar may put your child at increased
    risk for bleeding from the stomach or intestine.Tell your doctor if your child
    has any pain in the stomach area, vomits blood, or has bloody or black stools
    Changes in mood or behavior. Your child may be irritable, have mood
    swings, be depressed, or have trouble sleeping

    IMPORTANT SAFETY INFORMATION (CONTINUED)

    Worsening of other medical conditions, including diabetes


    Eye problems, such as cataracts, glaucoma, or optic nerve damage
    Allergic reactions. Tell your doctor if your child has a skin rash, swelling, or

    trouble breathing
    Changes in growth and physical development. Long-term use of Acthar may
    affect your childs growth and may weaken your childs bones
    Enlarged heart. Long-term use of Acthar may cause an increase in the size
    of your childs heart
    Bone density loss. Acthar may cause osteoporosis at any age
    Before your child takes Acthar, tell your doctor if he or she has:
     ad exposure to someone
    An infection
    H
    with tuberculosis (TB)
    Diabetes
     ad an allergic reaction to Acthar
    H
    Heart or kidney problems
    or to pork products
    Stomach or intestinal problems
    Had recent surgery
    Thyroid problems
    Had a recent vaccination or been
    Liver problems
    scheduled to receive a vaccination
    Neuromuscular problems
     family member who is receiving
    A
    vaccinations
    Convulsions or seizures
    Tell your doctor about all the medicines your child takes, including prescription and
    non-prescription medicines, vitamins, and herbal supplements. Do not start giving a
    new medicine to your child without first speaking to your doctor.
    The most common side effects include:
     hanges in appetite and weight
    Infections
    C
    Increased blood pressure
    Diarrhea
    Irritability and changes in behavior
    Vomiting
    These are not all of the possible side effects of Acthar.
    Tell your doctor if your child has any bothersome side effect or side effect
    that does not go away.
    You may report side effects to the FDA. Call 1-800-FDA-1088 or visit
    www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898.
    Please see additional Important Safety Information throughout, as well as
    accompanying full Prescribing Information and Medication Guide.

    Mallinckrodt, the M brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks
    of a Mallinckrodt company or their respective owners. 2016 Mallinckrodt. ARDUS/01-02/0216/0005 March 2016 Printed in USA.

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