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What is the most important information I should know about
natalizumab?
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Natalizumab increases the risk of a serious viral infection
of the brain that can lead to disability or death. This risk is higher
if you have a weak immune system or are receiving certain medicines. |
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Natalizumab is available only to select patients through a
restricted-use program called the TOUCH Prescribing Program. To receive
this medication, you must be enrolled in this program and meet all
requirements. You will be interviewed before receiving each dose of this
medicine to make sure you still meet these requirements. |
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During your natalizumab treatment, it is imperative that
your doctor check you every 3 to 6 months to make sure you are not
developing any signs of serious infection. Do not miss any scheduled
visits to your doctor. |
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Call your doctor at once if you develop any signs of
infection such as fever, chills, sore throat, cough, stuffy nose,
redness, pain, swelling, or painful urination. |
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Natalizumab is a monoclonal antibody that affects the
actions of the body's immune system. |
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Natalizumab is used in to treat relapsing forms of multiple
sclerosis. |
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Natalizumab may also be used for purposes other than those
listed in this medication guide. |
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What should I discuss with my healthcare provider before receiving
natalizumab?
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|
• |
Natalizumab increases the risk of a serious viral infection
of the brain that can lead to disability or death. This risk is higher
if you have a weak immune system or are receiving certain medicines. |
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• |
Natalizumab is available only to select patients through a
restricted-use program called the TOUCH Prescribing Program. To receive
this medication, you must be enrolled in this program and meet all
requirements. You will be interviewed before receiving each dose of this
medicine to make sure you still meet these requirements. |
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You should not receive natalizumab if you have ever had a
brain infection called progressive multifocal leukoencephalopathy. |
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Before receiving natalizumab, tell your doctor if you have: |
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if you have had a recent organ transplant; |
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if you are using any steroid medicines; or |
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if you are being treated with chemotherapy or radiation. |
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If you have any of these conditions, you may not be able to
receive natalizumab, or you may need a dosage adjustment or special
tests during treatment. |
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FDA pregnancy category C. This medication may be harmful to
an unborn baby. Tell your doctor if you are pregnant or plan to become
pregnant during treatment. |
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It is not known whether natalizumab passes into breast milk
or if it could harm a nursing baby. Do not receive this medication
without telling your doctor if you are breast-feeding a baby. |
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How is natalizumab given?
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Natalizumab is given as an injection through a needle placed
into a vein. You will receive this injection in a clinic or hospital
setting every 4 weeks. The medicine must be given slowly through an IV
infusion, and can take up to 1 hour to complete. |
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Before you receive your first dose of natalizumab, your
doctor may want you to have an MRI to make sure you do not have any
signs of a brain infection. |
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After you receive natalizumab, your caregivers may want to
watch you for at least 1 hour in case you have any type of reaction to
the medication. An allergic reaction can occur up to 2 hours after your
infusion. |
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During your treatment, it is imperative that your doctor
check you every 3 to 6 months to make sure you are not developing any
signs of serious infection. Do not miss any scheduled visits to your
doctor. |
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What happens if I miss a dose?
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Contact your doctor if you miss a dose of natalizumab. |
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What happens if I overdose?
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Seek emergency medical attention if you think you have received too
much of this medicine. Symptoms of a natalizumab overdose are unknown. |
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What should I avoid while receiving natalizumab?
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Natalizumab can lower the blood cells that help your body fight
infections. This can make it easier for you to bleed from an injury or
get sick from being around others who are ill. Avoid contact with people
who have colds, the flu, or other contagious illnesses. Contact your
doctor immediately if you develop signs of infection. |
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Do not receive a vaccine or flu shot while you are being treated
with natalizumab, unless your doctor has told you to. |
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What are the possible side effects of natalizumab?
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Get emergency medical help if you have any of these signs of an
allergic reaction: skin rash, hives, itching; dizziness, fever;
nausea, vomiting; feeling flushed; chest pain, difficulty breathing;
swelling of your face, lips, tongue, or throat; feeling light-headed or
fainting. |
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Call your doctor at once if you have any of these serious side
effects: |
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signs of infection such as fever, chills, body aches, flu symptoms,
sore throat, cough, redness, pain, swelling, or painful urination; |
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sudden change in your vision, balance, strength, or mental state; |
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easy bruising or bleeding, unusual weakness; |
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white patches or sores inside your mouth or on your lips; |
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vaginal itching or discharge; |
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tooth pain, gum pain or swelling; or |
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flare of herpes infection (cold sores, blisters or lesions of the
genital or anal area). |
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Other, less serious side effects are more likely to occur, such as: |
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painful menstrual cramps; or |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect natalizumab?
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Before receiving natalizumab, tell your doctor if you are taking any
other medicines, especially those that may affect the immune system such
as: |
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interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif,
Betaseron, or Actimmune); |
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cyclosporine (Neoral, Sandimmune, Gengraf); |
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sirolimus (Rapamune), tacrolimus (Prograf); |
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basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone); |
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mycophenolate mofetil (CellCept); |
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azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or |
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if you are receiving chemotherapy or radiation treatments. |
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If you are using any of these drugs, you may not be able to receive
natalizumab, or you may need dosage adjustments or special tests during
treatment. |
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There may be other drugs not listed that can affect natalizumab.
Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products,
and drugs prescribed by other doctors. Do not start using a new
medication without telling your doctor. |
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Where can I get more information?
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Your pharmacist has additional information about natalizumab written
for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision date: 6/
29/ 06. |