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Natalizumab (Intravenous route)

Pronunciation:

na-ta-LYE-zoo-mab

Brand Names:

  • Tysabri

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. 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 discontinue therapy at the first sign or symptom suggestive of PML .

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

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.

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding—

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.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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:

  • Liver disease—Use with caution. This medicine may make this condition worse.
  • Progressive multifocal leukoencephalopathy (PML; a rare virus infection of the brain that causes severe muscle disability)—People who have PML or who have ever had PML should not receive this medicine.
  • Weakened immune system (eg, HIV infection, AIDS, leukemia, lymphoma, or organ transplant recipient)—This medicine is not recommended, because people with these conditions may be more likely to get infections including PML.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

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 or nurse 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 with swallowing
dizziness
fast heartbeat
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash, hives, or itching
tightness in the chest
unusual tiredness or weakness
Rare
Abdominal or stomach fullness
blurred vision
changes in behavior
chest pain
confusion
difficult or labored breathing
faintness or lightheadedness when getting up suddenly from a lying or sitting position
feeling of warmth
feeling unusually cold
fever
gaseous abdominal or stomach pain
nausea
redness of the face, neck, arms, and occasionally, upper chest
shivering
sneezing
sore throat
sweating
thoughts of killing oneself
yellow eyes or skin
Incidence not known
Back pain
convulsions
drowsiness
headache

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:

More common
Bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
cracked, dry, scaly skin
diarrhea
difficult, burning, or painful urination
difficulty with moving
discouragement
feeling sad or empty
frequent, strong, or increased urge to urinate
irregular menstruation
irritability
itching of the vagina or genital area
loss of appetite
loss of interest or pleasure
lower back or side pain
muscle pain or stiffness
pain during sexual intercourse
pain in the joints
pain, cramps, or heavy bleeding
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 the legs, arms, hands, or feet
stopping of menstrual bleeding
trembling or shaking of the hands or feet

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.


Last Updated: 4/4/2014

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