(nat ta LIZ yoo mab) Brand: Tysabri
• Natalizumab may reason 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 determined medicines. Call your doctor right away if you have any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.
• Natalizumab is accessible only to select patients through a restricted-use program called . To receive this medicine, you should be enrolled in this program and meet all requirements. You will be interviewed till receiving every doze of this medication to create certain you still meet these requirements.
• During your natalizumab treatment, it is extremely significant that your doctor check you each 3 to 6 months to create certain you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.
• Call your doctor at once if you develop any symptoms of liver hurt, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
• You must also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.
• Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only determined cells in the body. This may help to protect healthy cells from damage.
• Natalizumab is used in to treat relapsing forms of multiple sclerosis.
• Natalizumab is also used to treat temperate to severe Crohn's malady in adults. It is generally given after another Crohn's malady medications have been tried without successful treatment of this condition.
• Natalizumab may also be used for purposes not listed in this medicine guide.
• Natalizumab may reason 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 determined medicines.
• Natalizumab is accessible only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medicine, you should be enrolled in this program and meet all requirements. You will be interviewed till receiving every doze of this medication to create certain you still meet these requirements.
• You must not receive natalizumab if you are allergic to it, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.
• To create certain you can safely use natalizumab, speak your doctor if you have any of these another conditions:
· HIV or AIDS;
· herpes or shingles;
· leukemia, lymphoma;
· if you have ever tested positive for anti-JC virus (human polyomavirus) antibodies;
· if you have had a last organ transplant; or
· if you are being treated with chemotherapy or radiation.
• FDA pregnancy category C. It is not known whether natalizumab will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.
• Natalizumab can pass into breast milk and may harm a nursing child. You must not breast-feed while receiving natalizumab.
• Natalizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting each 4 weeks. Natalizumab should be given slowly, and the IV infusion can take up to 1 hour to complete.
• Till you receive your first doze of natalizumab, your doctor may want you to have an MRI to create certain you do not have any signs of a brain infection.
• 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 medicine. An allergic reaction can occur up to 2 hours after your infusion.
• Natalizumab can lower blood cells that help your body fight infections and help your blood to clot. This can create it easier for you to bleed from an injury or get sick from being near others who are ill.
• During your treatment, it is extremely significant that your doctor check you each 3 to 6 months to create certain you are not developing any signs of serious infection. Your doctor may also want to check you for different weeks after you stop using natalizumab. Do not miss any scheduled visits to your doctor.
• Contact your doctor if you miss an appointment for your natalizumab injection.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.
• Get abnormal 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 person, lips, tongue, or throat; feeling light-headed or fainting.
• Call your doctor at once if you have a serious side effect such as:
· change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
· pain or burning when you urinate;
· cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
· flu symptoms, sores or white patches in your mouth or on your lips;
· vaginal itching or discharge;
· tooth pain, gum pain or swelling; or
· flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).
• Smaller serious side effects may include:
· headache;
· weary feeling;
· joint or muscle pain;
· stomach pain, diarrhea;
· mild skin rash;
· depression;
· painful menstrual cramps; or
· cool symptoms such as stuffy nose, sneezing, sore throat.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Speak your doctor about all another medicines you use, especially drugs that may affect the immune system such as:
· drugs that weaken your immune system (such as cancer medication or steroids);
· cyclosporine (Neoral, Sandimmune, Gengraf);
· mercaptopurine (Purinethol);
· methotrexate (Rheumatrex, Trexall);
· mycophenolate mofetil (CellCept);
· azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);
· basiliximab (Simulect), muromonab-CD3 (Orthoclone);
· interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune); or
· sirolimus (Rapamune), tacrolimus (Prograf).
• This list is not complete and another drugs may interact with natalizumab. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.
• Your doctor or pharmacist can provide more information about natalizumab.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.