Natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), which may lead to death or severe disability. Risk factors for PML include therapy duration, prior immunosuppressant use, and presence of anti-JC virus antibodies. Because of the risk of PML, natalizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH(R) Prescribing Program. Monitor patients for any new sign or symptom that may be suggestive of PML and interrupt therapy at the first sign or symptom suggestive of PML. For diagnosis, a gadolinium-enhanced MRI scan of the brain and, if indicated, cerebrospinal fluid analysis for JC viral DNA are recommended .
Natalizumab injection is used to treat patients with relapsing forms of multiple sclerosis (MS), and patients who have not been helped by other medicines. This medicine will not cure MS, but may delay physical disability and extend the time between relapses.
Natalizumab is also used to treat moderate to severely active Crohn's disease (CD) in patients who have not been helped by other medicines. This medicine will not cure CD, but may prevent it from occurring again.
This medicine is to be given only by or under the direct supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of natalizumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of natalizumab injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
You must enroll in a prescribing program called TOUCH® in order to begin receiving natalizumab. Your doctor will explain the program and have you sign an enrollment form. Be sure to ask your doctor if you have any questions about the TOUCH® prescribing program. It is very important that you understand and follow all of the instructions for the program.
Your doctor may need to check your brain before you start using this medicine. To do this, you may need to have a test known as a Magnetic Resonance Imaging (MRI) scan.
Natalizumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Your doctor will want to check your progress at 3 months and 6 months after the first injection, then every 6 months after that. Blood tests may be needed to check for unwanted effects.
Tell your doctor if you are currently taking interferon beta (Avonex®, Betaseron®, Rebif®), azathioprine (Imuran®), 6-mercaptopurine (Purinethol®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), or methotrexate (Rheumatrex® Trexall®). Natalizumab should not be given together with these medicines.
This medicine may increase your risk of developing infections, including a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: back pain, blurred vision, confusion, convulsions, difficulty with walking or other movements, dizziness, drowsiness, fever, headache, problems with vision or speaking, or unusual tiredness or weakness.
Natalizumab may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person who gets PML stops using the medicine. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.
Natalizumab may increase risk of developing encephalitis and meningitis caused by herpes and varicella viruses. Check with your doctor if you have a fever, headache, and confusion.
Liver problems may occur while you are using this medicine. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, hives, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the injection.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.