
Tysabri
Tysabri (natalizumab) is an injectable medication used to treat relapsing forms of multiple sclerosis (MS) in adults. It can also treat moderate-to-severe Crohn's disease (CD) in adults. It works as an integrin antagonist to help lower inflammation in the body. Tysabri (natalizumab) is given by a healthcare professional as an infusion into a vein once a month. Common side effects include headache and fatigue. Because it has a risk of serious infections, you must enroll in the Tysabri TOUCH Program before starting treatment.
What is Tysabri (natalizumab)?
What is Tysabri (natalizumab) used for?
- Relapsing forms of multiple sclerosis (MS)
- Moderate-to-severe Crohn's disease (CD) when other treatments haven't worked well
How Tysabri (natalizumab) works
Tysabri (natalizumab) is a type of monoclonal antibody called an integrin antagonist. It attaches to a protein on immune cells called integrin. This blocks signals that cause inflammation in your body.
Researchers don't fully understand how Tysabri (natalizumab) treats MS and Crohn's disease (CD). But they think it helps keep inflammation from damaging your nerves in MS and your gut in CD.
Drug facts
| Common Brands | Tysabri |
|---|---|
| Drug Class | Integrin receptor antagonist |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Tysabri (natalizumab) essentials
Side effects of Tysabri (natalizumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (38%)
- Fatigue or feeling very tired (27%)
- Urinary tract infection (21%)
- Joint pain (19%)
- Depression (19%)
- Lower respiratory tract infection (17%)
- Pain in arm or leg (16%)
- Rash or other skin irritation (up to 12%)
- Stomach discomfort (11%)
- Diarrhea (10%)
Less Common Side Effects
- Chest discomfort
- Muscle cramps
- Trouble keeping your balance
- Frequent need to urinate or sudden urges to urinate
- Inflamed tonsil (tonsillitis)
- Tooth infections
- Herpes infection
- Itching and pain in the vagina (vaginitis)
- Irregular menstruation
- Abnormal liver enzyme levels
Note: Side effects were from people with MS. Side effects might differ for people with Crohn's disease.
Tysabri (natalizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious brain infection: weakness on one side of your body, clumsiness, confusion, changes in personality, changes in vision, trouble remembering, trouble thinking, headache, stiff neck, light sensitivity, seizures
- Other infection: fever, trouble breathing, cough, stomach pain, diarrhea, sweating, weakness, chills
- Liver damage: nausea, vomiting, pain in the upper right side of your stomach, poor appetite, dark urine, yellowing of your skin or whites of your eyes
- Allergic reaction or infusion reaction: hives, rash, itching, flushing, dizziness, fever, shaking, nausea, trouble breathing, tightness in the throat, chest pain
More on Tysabri (natalizumab) side effects
The following Tysabri (natalizumab) side effects have also been reported
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
Bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
body produces substance that can bind to drug making it less effective or cause side effects
difficult, burning, or painful urination
difficulty with swallowing
dizziness
fast heartbeat
frequent, strong, or increased urge to urinate
itching of the vagina or genital area
lower back or side pain
pain during sexual intercourse
passing urine more often
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
thick, white vaginal discharge with no odor or with a mild odor
tightness in the chest
unusual tiredness or weakness
Rare
Blurred vision
changes in behavior
confusion
difficult or labored breathing
fainting 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
shivering
stomach fullness
sweating
thoughts of killing oneself
yellow eyes or skin
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
Cracked, dry, scaly skin
difficulty with moving
discouragement
feeling sad or empty
irritability
loss of interest or pleasure
muscle pain or stiffness
pain, cramps, or heavy bleeding
pain in the joints
stomach soreness or discomfort
swollen glands
trouble concentrating
trouble sleeping
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.
Pros and cons of Tysabri (natalizumab)
Pros
- Infusions are once every month
- Can help reduce relapses in MS
- An option for Crohn's disease when other treatments haven't worked well
Cons
- Must be given by a healthcare professional in a healthcare setting
- Raises your risk of serious infection
- Only FDA approved for adults
Pharmacist tips for Tysabri (natalizumab)
- Be sure to plan ahead for your Tysabri (natalizumab) infusion appointments. Each infusion takes about 1 hour. After your infusion, you might need to stay for another hour so your care team can watch for allergic reactions. Tell your nurse right away if you feel dizzy, have chills, itching, flushing, trouble breathing, or chest pain during or after your infusion.
- Write down your Tysabri (natalizumab) infusion dates on your calendar to help you stay on schedule. This medication is given about once a month. Staying on schedule helps make sure the medication can work the best it can for you. If you can't make an appointment, call your care team about rescheduling.
- When you first start Tysabri (natalizumab), you'll see your prescriber every 3 months. After that, you'll have follow-ups every 6 months. These visits help your prescriber watch for serious infections and make sure the medication is still safe for you.
- Tell your care team right away if you have signs of infection. This can include fever, chills, sweating, cough, trouble breathing, or feeling unwell. Tysabri (natalizumab) can make it harder for your body to fight infections, so it's important to get any infections treated early.
- Get medical help right away if you have weakness on one side of your body, changes in your vision or personality, or trouble remembering or thinking. Tysabri (natalizumab) can raise the risk of complications from a rare but serious brain infection. Keep watching for these symptoms for at least 6 months after you stop taking the medication. This infection can happen even after treatment ends.
- Tell your prescriber if you're taking a corticosteroid (also called a steroid). Steroids and Tysabri (natalizumab) can both make it harder for your body to fight infections. Your prescriber might recommend to slowly lower your steroid dose. Or, they might recommend to use a different medication than Tysabri (natalizumab). This might help lower your risk of infection.
- Share your medication list with your care team. Taking some medications with Tysabri (natalizumab) can raise your risk of serious infections even more. These include other medications that weaken your immune system (such as TNF blockers). Your care team can check for interactions and make sure your medications are safe to take together. They might recommend some treatment changes to keep you safe.
- Don't stop taking Tysabri (natalizumab) without talking to your prescriber first. Stopping treatment can cause more MS relapses. And for Crohn's disease, it might make your symptoms worse. Your prescriber can help decide if you should stop Tysabri (natalizumab) or switch to a different medication for your condition.
- If you're pregnant or thinking of becoming pregnant: Talk to your prescriber about the risks and benefits of taking Tysabri (natalizumab) during pregnancy. There have been cases of low platelet levels and anemia in newborns. Your prescriber can help you decide what's the safest treatment for you.
- If you plan to breastfeed: Talk to your prescriber about the risks and benefits of breastfeeding while taking Tysabri (natalizumab). Small amounts of the medication can pass into breast milk. But it's not known how it might affect a breastfed baby. Your prescriber or a lactation consultant can help you choose a safe feeding option.
Risks and warnings for Tysabri (natalizumab)
Tysabri (natalizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of a brain infection leading to progressive multifocal leukoencephalopathy (PML)
- Risk factors: Having antibodies against the JC virus in the body | Taking Tysabri (natalizumab) for a long time (longer than 2 years) | Taking or have taken medications that weaken your immune system
In rare cases, people taking Tysabri (natalizumab) have developed a rare but serious brain infection. This infection can cause progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or even death.
Get medical help right away if you have weakness on one side of your body, clumsiness, or changes in your personality, vision, memory, or thinking skills. Keep watching for these signs for at least 6 months after you stop taking Tysabri (natalizumab). This is because PML can happen even after treatment ends. It's important to get help right away and get tested for PML since symptoms can worsen over days to weeks.
Because of the risk of PML, you must enroll in the Tysabri TOUCH Prescribing Program. Your prescriber, the pharmacy, and infusion center must also be enrolled. This Risk Evaluation and Mitigation Strategies (REMS) program makes sure everyone understands the risks and watches for signs of PML.
Risk of other infections
- Risk factors: Having a medical condition that weakens your immune system | Taking medications that weaken your immune system
Tysabri (natalizumab) can make it harder for you body to fight infections. This can raise your risk of bacterial, viral, or fungal infections. They can sometimes be serious. Some infections can affect the brain, eyes, lungs, stomach, urinary tract, or other parts of the body.
Let your care team know if you don't feel well or have signs of an infection. This can include fever, chills, confusion, trouble breathing, cough, stomach pain, or eye pain. If you have a serious infection, you might need to stop taking Tysabri (natalizumab) to get treated.
Liver problems
Some people taking Tysabri (natalizumab) have had liver damage. Signs can include higher liver enzyme levels in the blood days. This can happen within a few days after the first dose or after many doses. This liver damage can sometimes be serious or life-threatening.
Get medical care right away if you have unusual tiredness, poor appetite, pain in the upper right side of your stomach, dark urine, or yellowing of your skin or the whites of your eyes. These can be symptoms of liver damage. Your prescriber might check your liver with blood tests. If you develop liver problems, you might need to stop taking Tysabri (natalizumab).
Allergic reaction or infusion reaction
- Risk factors: Having antibodies to Tysabri (natalizumab) in the body | Restarting Tysabri (natalizumab) after a long break
It's possible for Tysabri (natalizumab) to cause allergic reactions, including infusion reactions. In rare cases, they can be serious or life-threatening, like with anaphylaxis. Having antibodies against the medication can raise your risk of an allergic reaction. Your prescriber might order blood tests every few months to check for these antibodies.
Allergic reactions usually happen within 2 hours after the Tysabri (natalizumab) infusion starts. Your care team will watch you during the infusion and for 1 hour after it ends to make sure you're okay.
Tell your care team right away if you have signs of an allergic reaction or an infusion reaction. They can include hives, rash, itching, flushing, fever, dizziness, shivering, shortness of breath, chest pain, or nausea. Your care team will stop the infusion and help manage your symptoms. Depending on how serious the reaction is, you might need to stop taking Tysabri (natalizumab).
Low platelet levels
Some people who took Tysabri (natalizumab) developed low platelet levels during treatment. Platelets help stop bleeding when you get injured, like when you get a cut. Having low platelet levels can put you at risk of bleeding.
Tell your care team right away if you notice any bleeding that's hard to stop, easy bruising, or red or purple pinpoint spots on your skin. They can see what's going on and help prevent it from becoming serious. If your platelets are too low, you might need to stop Tysabri (natalizumab).
Other lab changes
Tysabri (natalizumab) might cause changes in your blood cell counts. These changes usually go away within a few months after you stop taking the medication. Some people might also have a small drop in their hemoglobin levels, but this is often temporary. Your prescriber might check on these with blood tests during treatment.
Tysabri (natalizumab) dosage
Typical dosage for Tysabri (natalizumab)
The typical dose is 300 mg infused into the vein (IV) once a month. The IV infusion is given by a healthcare professional at a medical office, infusion center, or hospital.
More on Tysabri (natalizumab) dosage
Interactions between Tysabri (natalizumab) and other drugs
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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Tysabri (natalizumab) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Tysabri (natalizumab) will not be safe for you to take.
- Currently have or have had progressive multifocal leukoencephalopathy (a serious illness from a rare viral brain infection)
What are alternatives to Tysabri (natalizumab)?
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