Generic Name: natalizumab (nat ta LIZ yoo mab)Brand Names: Tysabri
Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain 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 moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition.
Natalizumab may also be used for other purposes not listed in this medication guide.
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.During your natalizumab treatment, it is extremely important 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.
Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
You should 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 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.You should not receive natalizumab if you have ever had a brain infection called progressive multifocal leukoencephalopathy.
Before receiving natalizumab, tell your doctor if you have:
HIV or AIDS;
herpes or shingles;
if you have had a recent organ transplant;
if you are using any steroid medicines; or
if you are being treated with chemotherapy or radiation.
If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.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. 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.
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.
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.
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.During your treatment, it is extremely important 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.
Contact your doctor if you miss an appointment for your natalizumab injection.
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.
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;
weakness on one side of the body, loss of balance or coordination;
change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
easy bruising or bleeding, unusual weakness;
white patches or sores inside 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).
Less serious side effects may include:
joint or muscle pain;
painful menstrual cramps; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Multiple Sclerosis:
300 mg IV, infused over approximately 1 hour, every 4 weeks
Usual Adult Dose for Crohn's Disease -- Maintenance:
300 mg IV, infused over approximately 1 hour, every 4 weeksIf the patient with Crohn's disease (CD) has not experienced therapeutic benefit by 12 weeks of induction therapy, natalizumab should be discontinued. For patients with CD that start natalizumab while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of natalizumab has occurred; if the patient cannot be tapered off of oral corticosteroids within 6 months of starting natalizumab, natalizumab should be discontinued. Other than the initial 6-month taper, prescribers should consider discontinuing natalizumab for patients who require additional steroid use that exceeds 3 months in a calendar year to control their CD.
Before receiving natalizumab, tell your doctor if you are taking any other medicines, especially those that may affect the immune system such as:
interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune);
cyclosporine (Neoral, Sandimmune, Gengraf);
sirolimus (Rapamune), tacrolimus (Prograf);
basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
mycophenolate mofetil (CellCept);
azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
if you are receiving chemotherapy or radiation treatments.
This list is not complete and there may be other drugs that can interact with 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.