Natalizumab (Intravenous route)
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 .
Uses of This Medicine:
Natalizumab injection is used to treat patients with relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of flare-ups (relapses) of the disease.
Natalizumab injection is also used to treat moderate to severely active Crohn's disease (CD) when other medicines or treatments did not work well. This medicine will not cure CD, but may prevent it from occurring again.
This medicine is available only under a restricted distribution program called the TOUCH® Prescribing program.
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:
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 performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of natalizumab injection in the elderly.
|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:
- Herpes infection—Use with caution. May increase the risk for more serious infections (eg, encephalitis, meningitis, retinal necrosis).
- Liver disease—Use with caution. This medicine may make this condition worse.
- Progressive multifocal leukoencephalopathy (PML, rare brain infection) or history of—Should not be used in patients with this condition.
- Weak immune system (caused by HIV infection, AIDS, leukemia, lymphoma, or organ transplant)—Use is not recommended. May increase risk of developing 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 into one of your veins. It must be injected slowly, so the needle will have to remain in place for about an hour.
It is very important that you understand the requirements of the TOUCH® Prescribing Program, and become familiar with the medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
Your doctor may need to check your brain before you start receiving this medicine. To do this, you may need to have a Magnetic Resonance Imaging (MRI) scan.
You will need to stay at the clinic or office for 1 hour after you receive this medicine to make sure you do not have any serious side effects.
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 have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.
Natalizumab may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. 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 the risk of developing encephalitis, meningitis, or acute retinal necrosis caused by herpes and varicella viruses. Check with your doctor if you have a fever, headache, eye pain or redness, sensitivity of the eyes to the sun, or confusion.
Check with your doctor right away if you pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
Side Effects of This Medicine:
- More common
- Body produces substance that can bind to drug making it less effective or cause side effects
- difficulty with swallowing
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- unusual tiredness or weakness
- Blurred vision
- changes in behavior
- chest pain
- difficult or labored breathing
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- feeling unusually cold
- gaseous abdominal or stomach pain
- redness of the face, neck, arms, and occasionally, upper chest
- sore throat
- stomach fullness
- thoughts of killing oneself
- yellow eyes or skin
- Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- dark urine
- general body swelling
- loss of appetite
- pale skin
- More common
- Bladder pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- cracked, dry, scaly skin
- difficult, burning, or painful urination
- difficulty with moving
- feeling sad or empty
- frequent, strong, or increased urge to urinate
- irregular menstruation
- itching of the vagina or genital area
- 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 soreness or discomfort
- 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
- local bleeding
- shakiness in the legs, arms, hands, or feet
- stopping of menstrual bleeding
- trembling or shaking of the hands or feet
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.
Last Updated: 9/4/2017