Natalizumab is in a class of drug known as monoclonal antibody. This medicine affects the actions of the body's immune system. Natalizumab is used in to treat relapsing forms of multiple sclerosis, a demyelinating neurologic disease.
Natalizumab increases the risk of a serious viral infection of the brain known as encephalitis that can lead to disability or death. This risk is higher if your immune system is not competent or if you are receiving immunosuppressants. Natalizumab is only available in selected patients enrolled through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, the patients must meet all requirements including an interview prior to receipt of each dose of this medicine. You should not receive natalizumab if you have ever had a brain infection called progressive multifocal leukoencephalopathy.
Before commencing natalizumab treatment, inform your doctor if you have: HIV or AIDS; herpes zoster or shingles; leukemia, lymphoma; or if you have had a recent organ transplant; using any steroid medicines; or being treated with chemotherapy or radiation.
Natalizumab may be harmful to an unborn baby. Although it is not known whether it passes into breast milk or if it could harm a nursing baby, tell your doctor if you are pregnant, plan to become pregnant and breast-feeding during treatment. It is important to have regular follow up visits with your doctor every 3 to 6 months while under treatment with natalizumab to make sure you are not developing any signs of serious infection.
Natalizumab is given parenterally as an intravenous injection every 4 weeks. Intravenous infusion can take up to 1 hour to complete. Prior to the first dose, an MRI may be requested by your doctor to ensure that you do not have any signs of brain infection. After you receive natalizumab, you will be monitored for at least 1 hour in case you have any reaction to the drug which can actually occur up to 2 hours after IV infusion. If you miss a dose, contact your doctor.
There are no known symptoms of natalizumab overdose. However, if you suspect any symptom that may be attributed in taking too much of this medicine then seek emergency medical attention. Natalizumab can lower the white blood cells that help your body fight off infections. This medicine can also make it easier for you to bleed from an injury or get sick when exposed to others who are ill. Avoid close contact with people who have colds, flu, or other contagious illnesses. Do not receive a vaccine shot while you are being treated with natalizumab. If you develop any signs of infection, immediately seek consult.
Emergency medical help is needed if you develop any signs of an allergic reaction such as: 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.
The following are serious side effects of natalizumab: signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination; sudden change in your vision, balance, strength, or mental state; easy bruising or bleeding, unusual weakness; white patches or mouth and lip sores; vaginal itching or discharge; tooth pain, gum pain or swelling; or flare of herpes infection (cold sores, blisters or genital/anal lesions).
Less serious side effects are more likely to occur, such as: headache; joint or muscle pain; stomach pain; depression; painful menstrual cramps; or drowsiness, tiredness. For any other unusual side effect that you might experience while taking this medicine, tell your doctor.
Drugs that may interact with natalizumab include those medicines 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
To avoid any other drug interaction, always discuss with your doctor all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.
Natalizumab is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to a4-integrin. The molecular weight of natalizumab is 149 kilodaltons. TYSABRIÒ is supplied as a sterile, colorless, and clear to slightly opalescent concentrate for intravenous (IV) infusion. Each 15 mL dose contains 300 mg natalizumab; 123 mg sodium chloride, USP; 17.0 mg sodium phosphate, monobasic, monohydrate, USP; 7.24 mg sodium phosphate, dibasic, heptahydrate, USP; 3.0 mg polysorbate 80, USP/NF, in water for injection, USP at pH 6.1.
Brand name: Tysabri
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