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Tysabri Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tysabri (natalizumab) is used in to treat relapsing forms of multiple sclerosis. It is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition. It is a monoclonal antibody. Common side effects include headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle.
The recommended dose of Tysabri for multiple sclerosis or Crohn's disease is 300 mg intravenous infusion over one hour every four weeks. Tysabri may interact with other medicines, especially those that may affect the immune system such as: interferon, cyclosporine, sirolimus, tacrolimus, basiliximab, efalizumab, muromonab-CD3, mycophenolate mofetil, azathioprine, leflunomide, etanercept, or chemotherapy or radiation treatments. Tell your doctor all medications you use. During pregnancy, Tysabri should be used only when prescribed. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug.
Our Tysabri (natalizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tysabri in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.
Call your doctor at once if you have a serious side effect such as:
- change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- pain or burning when you urinate;
- cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
- flu symptoms, sores or white patches in your mouth or on your lips;
- vaginal itching or discharge;
- tooth pain, gum pain or swelling; or
- flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).
Less serious side effects may include:
- tired feeling;
- joint or muscle pain;
- stomach pain, diarrhea;
- mild skin rash;
- painful menstrual cramps; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Read the entire detailed patient monograph for Tysabri (Natalizumab) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tysabri Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain.
Tell your doctor immediately if any of these unlikely but serious side effects occur: severe/persistent headache, stiff/painful neck, fast/pounding heartbeat, signs of infection (such as fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain.
This drug increases the risk of a rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during treatment or, in some cases, after treatment has stopped. In MS patients, the symptoms of PML can seem like an attack of worsening MS. Therefore, whether you are using this drug or have stopped using it within the last 6 months, tell your doctor right away of any new or worsening symptoms that have lasted for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes.
This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, dark urine, yellowing eyes/skin, feeling tired/weak.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tysabri (Natalizumab)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tysabri FDA Prescribing Information: Side Effects
The most serious adverse reactions were [see WARNINGS AND PRECAUTIONS]:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions (incidence ≥ 10%) were headache and fatigue in both the multiple sclerosis (MS) and Crohn's disease (CD) studies. Other common adverse reactions (incidence ≥ 10%) in the MS population were arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash. Other common adverse reactions (incidence ≥ 10%) in the CD population were upper respiratory tract infections and nausea.
The most frequently reported adverse reactions resulting in clinical intervention (i.e., discontinuation of TYSABRI), in the MS studies were urticaria (1%) and other hypersensitivity reactions (1%), and in the CD studies (Studies CD1 and CD2) were the exacerbation of Crohn's disease (4.2%) and acute hypersensitivity reactions (1.5%) [see WARNINGS AND PRECAUTIONS].
A total of 1617 multiple sclerosis patients in controlled studies received TYSABRI, with a median duration of exposure of 28 months. A total of 1563 patients received TYSABRI in all CD studies for a median exposure of 5 months; of these patients, 33% (n=518) received at least one year of treatment and 19% (n=297) received at least two years of treatment.
Multiple Sclerosis Clinical Studies
The most frequently reported serious adverse reactions in Study MS1 [see Clinical Studies] with TYSABRI were infections (3.2% versus 2.6% in placebo, including urinary tract infection [0.8% versus 0.3%] and pneumonia [0.6% versus 0%]), acute hypersensitivity reactions (1.1% versus 0.3%, including anaphylaxis/anaphylactoid reaction [0.8% versus 0%]), depression (1.0% versus 1.0%, including suicidal ideation or attempt [0.6% versus 0.3%]), and cholelithiasis (1.0% versus 0.3%). In Study MS2, serious adverse reactions of appendicitis were also more common in patients who received TYSABRI (0.8% versus 0.2% in placebo).
Table 2 enumerates adverse reactions and selected laboratory abnormalities that occurred in Study MS1 at an incidence of at least 1 percentage point higher in TYSABRI-treated patients than was observed in placebo-treated patients.
Table 2: Adverse Reactions in Study MS1 (Monotherapy
|Adverse Reactions (Preferred Term)||TYSABRI
|Acute hypersensitivity reactions**||4%||< 1%|
|Other hypersensitivity reactions**||5%||2%|
|Weight increased||2%||< 1%|
|Weight decreased||2%||< 1%|
|Urinary tract infection||21%||17%|
|Lower respiratory tract infection||17%||16%|
|Musculoskeletal/Connective Tissue Disorders|
|Pain in extremity||16%||14%|
|Abnormal liver function test||5%||4%|
|Ovarian cyst||2%||< 1%|
|Renal and Urinary Disorders|
|Limb injury NOS||3%||2%|
|Skin laceration||2%||< 1%|
|Thermal burn||1%||< 1%|
|*Percentage based on female patients only.
** Acute versus other hypersensitivity reactions are defined as occurring within 2 hours post-infusion versus more than 2 hours.
In Study MS2, peripheral edema was more common in patients who received TYSABRI (5% versus 1% in placebo).
Crohn's Disease Clinical Studies
The following serious adverse events in the induction Studies CD1 and CD2 [see Clinical Studies] were reported more commonly with TYSABRI than placebo and occurred at an incidence of at least 0.3%: intestinal obstruction or stenosis (2% vs. 1% in placebo), acute hypersensitivity reactions (0.5% vs. 0%), abdominal adhesions (0.3% vs. 0%), and cholelithiasis (0.3% vs. 0%). Similar serious adverse events were seen in the maintenance Study CD3. Table 3 enumerates adverse drug reactions that occurred in Studies CD1 and CD2 (median exposure of 2.8 months). Table 4 enumerates adverse drug reactions that occurred in Study CD3 (median exposure of 11.0 months).
Table 3: Adverse Reactions
in Studies CD1 and CD2(Induction Studies)
|Acute hypersensitivity reactions||2%||< 1%|
|Upper respiratory tract infection||22%||16%|
|Urinary tract infection||3%||1%|
|Aphthous stomatitis||2%||< 1%|
|* Occurred at an incidence of
at least 1% higher in TYSABRI-treated patients than placebo-treated patients.
** Percentage based on female patients only.
Table 4: Adverse Reactions
in Study CD3 (Maintenance Study)
|Vaginal infections**||8%||< 1%|
|Lower abdominal pain||4%||2%|
|Musculoskeletal and Connective Tissue|
|* Occurred at an incidence of
at least 2% higher in TYSABRI-treated patients than placebo-treated patients.
** Percentage based on female patients only.
Progressive Multifocal Leukoencephalopathy (PML) occurred in three patients who received TYSABRI in clinical trials [see WARNINGS AND PRECAUTIONS]. Two cases of PML were observed in the 1869 patients with multiple sclerosis who were treated for a median of 120 weeks. These two patients had received TYSABRI in addition to interferon beta-1a [see WARNINGS AND PRECAUTIONS]. The third case occurred after eight doses in one of the 1043 patients with Crohn's disease who were evaluated for PML. In the postmarketing setting, additional cases of PML have been reported in TYSABRI-treated multiple sclerosis and Crohn's disease patients who were not receiving concomitant immunomodulatory therapy.
In Studies MS1 and MS2 [see Clinical Studies], the rate of any type of infection was approximately 1.5 per patient-year in both TYSABRI-treated patients and placebo-treated patients. The infections were predominately upper respiratory tract infections, influenza, and urinary tract infections. In Study MS1, the incidence of serious infection was approximately 3% in TYSABRI-treated patients and placebo-treated patients. Most patients did not interrupt treatment with TYSABRI during infections. The only opportunistic infection in the multiple sclerosis clinical trials was a case of cryptosporidial gastroenteritis with a prolonged course.
In Studies CD1 and CD2 [see Clinical Studies], the rate of any type of infection was 1.7 per patient-year in TYSABRI-treated patients and 1.4 per patient-year in placebo-treated patients. In Study CD3, the incidence of any type of infection was 1.7 per patient-year in TYSABRI-treated patients and was similar in placebo-treated patients. The most common infections were nasopharyngitis, upper respiratory tract infection, and influenza. The majority of patients did not interrupt TYSABRI therapy during infections and recovery occurred with appropriate treatment. Concurrent use of TYSABRI in CD clinical trials with chronic steroids and/or methotrexate, 6-MP, and azathioprine did not result in an increase in overall infections compared to TYSABRI alone; however, the concomitant use of such agents could lead to an increased risk of serious infections.
In Studies CD1 and CD2, the incidence of serious infection was approximately 2.1% in both TYSABRI-treated patients and placebo-treated patients. In Study CD3, the incidence of serious infection was approximately 3.3% in TYSABRI-treated patients and approximately 2.8% in placebo-treated patients.
In clinical studies for CD, opportunistic infections (pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and burkholderia cepacia) have been observed in < 1% of TYSABRI-treated patients; some of these patients were receiving concurrent immunosuppressants [see WARNINGS AND PRECAUTIONS]. Two serious non-bacterial meningitides occurred in TYSABRI-treated patients compared to none in placebo-treated patients.
An infusion-related reaction was defined in clinical trials as any adverse event occurring within two hours of the start of an infusion. In MS clinical trials, approximately 24% of TYSABRI-treated multiple sclerosis patients experienced an infusion-related reaction, compared to 18% of placebo-treated patients. In the controlled CD clinical trials, infusion-related reactions occurred in approximately 11% of patients treated with TYSABRI compared to 7% of placebo-treated patients. Reactions more common in the TYSABRI-treated MS patients compared to the placebo-treated MS patients included headache, dizziness, fatigue, urticaria, pruritus, and rigors. Acute urticaria was observed in approximately 2% of patients. Other hypersensitivity reactions were observed in 1% of patients receiving TYSABRI. Serious systemic hypersensitivity infusion reactions occurred in < 1% of patients [see WARNINGS AND PRECAUTIONS]. All patients recovered with treatment and/or discontinuation of the infusion.
Infusion-related reactions more common in CD patients receiving TYSABRI than those receiving placebo included headache, nausea, urticaria, pruritus, and flushing. Serious infusion reactions occurred in Studies CD1, CD2, and CD3 at an incidence of < 1% in TYSABRI-treated patients.
MS and CD patients who became persistently positive for antibodies to TYSABRI were more likely to have an infusion-related reaction than those who were antibody-negative.
Patients in Study MS1 [see Clinical Studies] were tested for antibodies to natalizumab every 12 weeks. The assays used were unable to detect low to moderate levels of antibodies to natalizumab. Approximately 9% of patients receiving TYSABRI developed detectable antibodies at least once during treatment. Approximately 6% of patients had positive antibodies on more than one occasion. Approximately 82% of patients who became persistently antibody-positive developed detectable antibodies by 12 weeks. Anti-natalizumab antibodies were neutralizing in vitro.
The presence of anti-natalizumab antibodies was correlated with a reduction in serum natalizumab levels. In Study MS1, the Week 12 pre-infusion mean natalizumab serum concentration in antibody-negative patients was 15 mcg/mL compared to 1.3 mcg/mL in antibody-positive patients. Persistent antibody-positivity resulted in a substantial decrease in the effectiveness of TYSABRI. The risk of increased disability and the annualized relapse rate were similar in persistently antibody-positive TYSABRI-treated patients and patients who received placebo. A similar phenomenon was also observed in Study MS2.
Infusion-related reactions most often associated with persistent antibody-positivity included urticaria, rigors, nausea, vomiting, headache, flushing, dizziness, pruritus, tremor, feeling cold, and pyrexia. Additional adverse reactions more common in persistently antibody-positive patients included myalgia, hypertension, dyspnea, anxiety, and tachycardia.
Patients in CD studies [see Clinical Studies] were first tested for antibodies at Week 12, and in a substantial proportion of patients, this was the only test performed given the 12-week duration of placebo-controlled studies. Approximately 10% of patients were found to have antinatalizumab antibodies on at least one occasion. Five percent (5%) of patients had positive antibodies on more than one occasion. Persistent antibodies resulted in reduced efficacy and an increase in infusion-related reactions with symptoms that include urticaria, pruritus, nausea, flushing, and dyspnea.
The long-term immunogenicity of TYSABRI and the effects of low to moderate levels of antibody to natalizumab are unknown [see WARNINGS AND PRECAUTIONS].
Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody-positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to TYSABRI with the incidence of antibodies to other products may be misleading.
Read the entire FDA prescribing information for Tysabri (Natalizumab) »
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