natalizumab IV

This medication is used to treat a type of multiple sclerosis that occurs when symptoms appear in cycles of worsening and improvement (relapsing/remitting multiple sclerosis-MS). It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.
Natalizumab is also used to treat a bowel condition called Crohn\'s disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels.
Natalizumab is a protein called a monoclonal antibody.

How to use natalizumab IV
This medicine comes with a Medication Guide. Read it carefully before you start using natalizumab and each time you receive another dose. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.
This medication is given by a health care professional in an infusion center, usually every 4 weeks or as directed by your doctor. This medication is mixed in a solution and injected slowly into a vein, usually over 1 hour. It should not be given as a rapid injection. You will be monitored for 1 hour after your treatment is finished to make sure you do not have a serious reaction to the medication. (See also Side Effects section.)
It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor\'s approval.
Tell your doctor if your condition worsens. When using this medication for Crohn\'s disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.

Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain.
Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, fast/pounding heartbeat, signs of infection (such as fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain.
This drug increases the risk of a possibly fatal brain infection (see Warning section for more details). In MS patients, the symptoms of PML can seem like an attack of worsening MS. Therefore, whether you are using this drug for MS or CD, tell your doctor immediately of any worsening symptoms that persist for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes.
This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, dark urine, yellowing eyes/skin, feeling tired/weak.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have ever had a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have ever had: a certain virus infection (progressive multifocal leukoencephalopathy-PML).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, history of certain virus infections that keep coming back (such as herpes, shingles), mental/mood disorders (such as depression).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
This drug should not be used with the following medications because very serious interactions may occur: long-term use of drugs that may weaken the immune system (such as azathioprine, cyclosporine, 6-mercaptopurine, methotrexate, TNF blockers such as adalimumab, etanercept, infliximab), immunomodulators (such as interferon beta).
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting natalizumab.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: short-term use of corticosteroids (such as prednisone).
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:
Laboratory and/or medical tests (such as MRI, liver function, anti-JCV antibody test) may be performed before you start treatment and repeated periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Examples of lifestyle changes include stress reduction programs and maintaining a healthy diet. A doctor-approved exercise program may also help MS patients maintain strength, balance, and muscle tone. Consult your doctor or pharmacist for more details.

MISSED DOSE:
It is very important to use this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to set up a new dosing schedule.

STORAGE:
Not applicable. This medication is given in an infusion center and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised January 2012. Copyright(c) 2012 First Databank, Inc.