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|BRAND NAME : Natalizumab Injection
FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of natalizumab (Tysabri) due to two serious adverse events reported with its use. FDA received reports of one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab for multiple sclerosis. Although the relationship between natalizumab and PML is not known at this time, because of the rare, serious and often fatal nature of PML, FDA announced the following, effective immediately: Biogen Idec is voluntarily suspending marketing of natalizumab.Biogen Idec is suspending dosing of natalizumab in clinical trials and is notifying patients and investigators of the possible association between natalizumab and PML.Patients being treated with natalizumab should contact their physician to discuss appropriate alternative treatments. At this time, there are no specific diagnostic or therapeutic interventions recommended for patients who have been taking natalizumab, other than to discontinue its use. Physicians should evaluate all patients who have received natalizumab and who have signs or symptoms suggestive of PML. Any suspect cases of PML should be reported immediately to Biogen Idec or to the FDA MedWatch program
Natalizumab is used to prevent episodes of symptoms in patients with relapsing forms (course of disease where symptoms flare up for a short time, then go away) of multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness; numbness; loss of muscle coordination; and problems with vision, speech, and bladder control). Natalizumab has not been shown to help patients with chronic progressive MS (a form of MS in which symptoms are always present and become more severe as time passes). Natalizumab is in a class of medications called immunomodulators. It works by preventing the damage to the brain and nerves that causes the symptoms of MS.
How should this medicine be used:
Natalizumab comes as a concentrated solution (liquid) to be diluted and infused (injected over a long time) into a vein by a doctor or nurse. It is usually given once every four weeks in a doctor's office. It will take about one hour for you to receive your entire dose of natalizumab, and you will have to stay in your doctor's office for one hour after your infusion is finished.
Natalizumab may cause serious allergic reactions that may happen within 2 hours after the beginning of an infusion. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse if you experience any of the following symptoms during or shortly after your infusion: hives; rash; itching; difficulty breathing or swallowing; dizziness; fainting; upset stomach; blurred vision; fever; chills; flushing; and chest pain.
Natalizumab controls the symptoms of MS, but does not cure it. Keep all appointments to receive natalizumab even if you feel well.
Other uses for this medicine:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking natalizumab,
tell your doctor and pharmacist if you are allergic to natalizumab, any medications made from murine (mouse) proteins, or any other medications. Ask your doctor or pharmacist if you don't know if a medication you are allergic to is made from murine proteins.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: glatiramer (Copaxone); interferon beta 1a (Avonex, Rebif); and medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Sandimmune, Neoral), methotrexate (Rheumatrex,Trexall), sirolimus (Rapamune), and tacrolimus (Prograf).Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had liver or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking natalizumab, call your doctor.
do not have any vaccinations (such as measles or flu shots) without talking to your doctor.
Special dietary instructions:
Unless your doctor tells you otherwise, continue your normal diet.
If I forget a dose:
If you miss an appointment to receive a natalizumab infusion, call your doctor as soon as possible.
What side effects:
Natalizumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
painful, irregular, or missed menstruation (period)
swelling, redness, burning, or itching of the vagina
white vaginal discharge
bleeding in the place where natalizumab was injected
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
sore throat, fever, chills, or other signs of infection
frequent or painful urination
sudden need to urinate right away
shaking hands that you cannot control
Natalizumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions:
Your doctor will store the medication in his or her office.
In case of overdose:
In case of overdose, call your local poison control center. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor.
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