Natalizumab (Systemic)
Drug Information provided by: Micromedex
US Brand Names
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Description
Natalizumab (na-ta-LIZ-u-mab) is used to treat patients with relapsing-remitting forms of multiple sclerosis (MS). This medicine will not cure MS, but may delay physical disability and extend the time between relapses.
This medicine is available only with your doctor's prescription, in the following dosage forms:
Parenteral
· Injection
Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For natalizumab, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to natalizumab. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Natalizumab has not been studied in pregnant women. However, studies in animals have shown that natalizumab may cause unwanted effects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding
It is not known whether natalizumab passes into the breast milk. However, natalizumab is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.
Children
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of natalizumab in children with use in other age groups. This medicine is not indicated for use in children under 18 years of age.
Older adults
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of natalizumab in the elderly with use in other age groups.
Other medicines
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. When you are taking natalizumab, it is especially important that your health care professional knows if you are taking any of the following:
· Immunomodulators (azathioprine [e.g., Imuran]) or
· Immunosuppressive agents (cyclosporine, tacrolimus [e.g., Prograf], sirolimus [e.g., Rapamune]) or
· Interferon beta (e.g., Avonex, Betaseron, Rebif) or
· Other medicines that may weaken your immune system—You should NOT receive natalizumab if you are taking any of these medicines. Your risk of infections could be increased.
Other medical problems
The presence of other medical problems may affect the use of natalizumab. Make sure you tell your doctor if you have any other medical problems, especially:
· Kidney problems or
· Liver disease—Use with caution; natalizumab has not been studied in patients with these conditions.
· Progressive multifocal leukoencephalopathy (PML; rare viral brain infection that causes severe muscle disability)—People who have or who have ever had PML should not receive this medicine.
· Weakened immune system (e.g., HIV infection, AIDS, leukemia, lymphoma, or organ transplant)—This medicine is not recommended because people with these conditions may be more vulnerable to infections.
Proper Use of This Medicine
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.
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 its requirements.
Storage
To store this medicine:
· Keep out of the reach of children.
· Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
· Store in the refrigerator. However, keep the medicine from freezing.
· Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Your doctor will want to check your progress 3 months after the first injection, 6 months after the first injection, and every 6 months after that.
Other medicines—Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
Avoid immunizations unless approved by your doctor.
Side Effects of This Medicine
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 immediately if any of the following side effects occur:
More common
Body produces substance that can bind to drug making it less effective or cause side effects; cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing.
Rare
Abdominal fullness; blurred vision; changes in behavior; chest pain; confusion; difficult or labored breathing; faintness, or light-headedness when getting up from a lying or sitting position suddenly; feeling unusually cold; feeling of warmth; fever; gaseous abdominal pain; nausea; redness of the face, neck, arms and occasionally, upper chest; shivering; sneezing; sore throat; sweating; thoughts of killing oneself; troubled breathing; yellow eyes or skin.
Frequency unknown
Back pain; convulsions; drowsiness; headache.
Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.
More common
Bladder pain; blistering, crusting, irritation, itching, or reddening of skin; bloody or cloudy urine; cracked, dry, scaly skin; diarrhea; difficult, burning, or painful urination; difficulty in moving; discouragement; feeling sad or empty; frequent, strong or increased urge to urinate; headache; irregular menstruation; irritability; itching of the vagina or genital area; lab results that show problems with liver; lack of appetite; loss of appetite; loss of interest or pleasure; lower back or side pain; muscle pain or stiffness; nausea; pain, cramps, heavy bleeding; pain during sexual intercourse; pain in joints; passing urine more often; stomach pain; stomach soreness or discomfort; swelling; swollen glands; thick, white vaginal discharge with no odor or with a mild odor; trouble concentrating; trouble sleeping.
Less common
Absent, missed, or irregular menstrual periods; chest discomfort; fainting; local bleeding; shakiness in legs, arms, hands, feet; stopping of menstrual bleeding; trembling or shaking of hands or feet.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Source: Drug Information provided by: Micromedex
Original Article:http://www.mayoclinic.com/health/drug-information/DR500575