Tysabri

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  • Colorectal disorders
  • Multiple sclerosis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tysabri Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Natalizumab 300mg/15mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Immunomodulator (integrin receptor antagonist).

    How Supplied

    Single-use vial—1

    How Supplied

    Tysabri (natalizumab) injection, a sterile, preservative-free, colorless and clear to slightly opalescent solution for dilution prior to intravenous infusion, is supplied as one 300 mg/15 mL (20 mg/mL) single-dose vial per carton.

    Tysabri is available only through registered infusion centers participating in the TOUCH® Prescribing Program. To locate these infusion centers, contact Biogen at 1-800-456-2255. 

    Storage

    Tysabri single-dose vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the carton and vial label. Do not shake or freeze. Protect from light.

    Store diluted Tysabri solution refrigerated at 2°C to 8°C (36°F to 46°F). 

    Manufacturer

    Biogen

    Generic Availability

    NO

    Mechanism of Action

    Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s). Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue.

    Tysabri Indications

    Indications

    In moderately to severely active Crohn's disease: to induce and maintain clinical response and remission in adult patients with evidence of inflammation who have had inadequate response to or are intolerant to conventional therapy and TNF-α inhibitors.

    Tysabri Dosage and Administration

    Adult

    ≥18yrs: Give by IV infusion over 1hr; monitor during and for 1hr post-infusion. 300mg every 4 weeks. Discontinue after 12 weeks of induction therapy if no therapeutic response, or if unable to taper off chronic concomitant steroids within 6 months of starting therapy. May continue with aminosalicylates.

    Children

    <18yrs: not established.

    Tysabri Contraindications

    Contraindications

    Progressive multifocal leukoencephalopathy (PML).

    Tysabri Boxed Warnings

    Boxed Warning

    Progressive multifocal leukoencephalopathy.

    Boxed Warning

    Progressive multifocal leukoencephalopathy (PML)

    • Increased risk of PML. 

    • Risk factors for development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants.

    • Monitor for any new sign or symptom that may be suggestive of PML. Withhold Tysabri immediately at the first sign of symptom of PML.

    • For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

    • Because of the risk of PML, Tysabri is available only through the REMS program called the TOUCH Prescribing Program.

    Tysabri Warnings/Precautions

    Warnings/Precautions

    Increased risk of PML with longer treatment duration (>2yrs), prior treatment with immunosuppressants, and/or presence of anti-JCV antibodies. Monitor for signs/symptoms of PML; withhold if develops. Test patients for anti-JCV antibody status prior to or during treatment if status unknown; patients with negative status should be retested periodically. Reevaluate periodically (at 3 months and 6 months post-infusion, every 6 months thereafter, and for at least 6 months after discontinuation). MS: obtain MRI scan prior to initiating therapy. Risk of JCV granule cell neuronopathy; manage similarly to PML if develops. Monitor for herpes encephalitis and meningitis; discontinue and treat if occurs. Refer for retinal screening if eye symptoms develop; consider discontinuing therapy if acute retinal necrosis is confirmed. Discontinue if jaundice or liver injury occurs, or if thrombocytopenia is suspected. Immunosuppression. Monitor for infections. Vaccinations. Elderly. Neonates. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Progressive Multifocal Leukoencephalopathy 

    • Increased risk of PML in Tysabri-treated patients with the following 3 factors:

      • Presence of anti-JCV antibodies.

      • Longer treatment duration, especially beyond 2 years.

      • Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil).

    • Patients with negative anti-JCV antibody test result should be retested periodically.

    • Assess anti-JCV antibody status using an analytically and clinically validated immunoassay.

    • Wait at least 2 weeks to test for anti-JCV antibodies after plasma exchange to avoid false negative test results caused by the removal of serum antibodies.

    • Wait at least 6 months (5 half-lives) for the IVIG to clear after infusion of IVIG to avoid false positive anti-JCV antibody test results.

    • Monitor for new sign or symptom suggestive of PML. Monitoring with MRI for signs may be useful and any suspicious findings could lead to further investigation to allow for an early diagnosis of PML (if present). 

    • Consider monitoring more frequently in patients at high risk for PML. After discontinuing Tysabri, continue monitoring for signs or symptoms suggestive of PML for at least 6 months.

    • In MS patients, obtain an MRI scan prior to initiation. In CD patients, a baseline brain MRI may be helpful to distinguish pre-existent lesions from newly developed lesions.

    • For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

    • Withhold Tysabri dosing immediately and perform diagnostic evaluation at the first sign or symptom suggestive of PML. 

    • Immune reconstitution inflammatory syndrome (IRIS) has been reported. Monitor for IRIS development and appropriate treatment should be taken.

    Herpes Infections  

    • Herpes Encephalitis and Meningitis: Monitor for signs and symptoms. Discontinue if herpes encephalitis or meningitis occurs, and treat appropriately.

    • Acute Retinal Necrosis: Refer for retinal screening if eye symptoms develop (including decreased visual acuity, redness, or eye pain). Consider discontinuing therapy if acute retinal necrosis is confirmed.

    Hepatotoxicity

    • Discontinue if jaundice or other evidence of significant liver injury occurs.

    Hypersensitivity/Antibody Formation

    • Discontinue and initiate appropriate therapy if hypersensitivity reaction occurs.

    • Do not retreat patients who experience a hypersensitivity reaction. Consider the possibility of antibodies in patients who have hypersensitivity reactions.

    • Test for antibodies if the presence of persistent antibodies is suspected. Testing is recommended to be repeated 3 months after an initial positive result to confirm that antibodies are persistent. Higher risk of developing antibodies in patients who receive Tysabri for a short exposure (1 to 2 infusions) followed by an extended period.

    Immunosuppression/Infections 

    • Concurrent use of antineoplastic, immunosuppressant, or immunomodulating agents may further increase the risk of infections, including PML and other opportunistic infections, over the risk observed with use of Tysabri alone.

    • The safety and efficacy of Tysabri in combination with antineoplastic, immunosuppressant, or immunomodulating agents have not been established.

    • Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not ordinarily be treated with Tysabri.

    • For patients with Crohn’s disease who start Tysabri while on chronic corticosteroids, commence steroid withdrawal as soon as a therapeutic benefit has occurred. If the patient cannot discontinue systemic corticosteroids within six months, discontinue Tysabri. 

    Laboratory Test Abnormalities 

    • In clinical trials, Tysabri was observed to induce increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. 

    • Observed changes persisted during Tysabri exposure, but were reversible, returning to baseline levels usually within 16 weeks after the last dose.

    Thrombocytopenia

    • Discontinue if thrombocytopenia is suspected.

    • Obtain CBC in neonates who were exposed to Tysabri in utero.

    Immunizations

    • No data are available on the effects of vaccination in patients receiving Tysabri. No data are available on the secondary transmission of infection by live vaccines in patients receiving Tysabri.

    Pregnancy Considerations

    Risk Summary 

    • No adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of Tysabri in pregnant women.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Obtain CBC in neonates who were exposed to Tysabri in utero.

    Nursing Mother Considerations

    Risk Summary 

    • No data on the effects of this exposure on the breastfed infant or the effects of the drug on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Tysabri and any potential adverse effects on the breastfed infant from Tysabri or from the underlying maternal condition. 

    Pediatric Considerations

    Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn’s disease below the age of 18 years have not been established. 

    REMS

    YES

    Tysabri Pharmacokinetics

    Distribution

    Volume of distribution: 5.7 ± 1.9 L (MS patients); 5.2 ± 2.8 L (CD patients).

    Elimination

    Half-life: 11 ± 4 days (MS patients); 10 ± 7 days (CD patients).

    Clearance: 16 ± 5 mL/hour (MS patients); 22 ± 22 mL/hour (CD patients).

    Tysabri Interactions

    Interactions

    Concomitant other immunosuppressants or TNF-α inhibitors: not recommended.

    Tysabri Adverse Reactions

    Adverse Reactions

    Headache, fatigue, arthralgia, infections, depression, pain in extremity, abdominal discomfort, diarrhea NOS, nausea, rash; immune reconstitution syndrome (monitor), hypersensitivity reactions (discontinue if occurs; do not restart), hepatotoxicity, inj site reactions, antibody formation (if persistent, may substantially reduce efficacy), changes in blood cell counts.

    Tysabri Clinical Trials

    Clinical Trials

    Crohn’s Disease

    • The approval was based on 3 randomized, double-blind, placebo-controlled trials that evaluated Tysabri in 1414 adults with moderately to severe active Crohn’s disease (CDAI ≥220 and ≤450). Concomitant inhibitors of TNF-α were not permitted. Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunosuppressants (e.g., 6-mercatopurine, azathioprine, or methotrexate) were permitted, and 89% of patients continued to receive at least one of these medications.

    • In Study CD1, 896 patients were randomly assigned 4:1 to receive 3 monthly infusions of either Tysabri 300 mg or placebo. At week 10, results showed that 56% of the 717 patients receiving Tysabri were in response compared to 49% of the 179 patients receiving placebo (treatment effect: 7%; 95% CI, -1%, 16%; P =.067). In a post hoc analysis of the subset of 653 patients with elevated baseline C-reactive protein (CRP), indicative of active inflammation, 57% of Tysabri patients were in response compared to 45% of those receiving placebo (treatment effect: 12%; 95% CI: [3%, 22%]; nominal P =.01).

    • In Study CD2, 509 patients were randomly assigned 1:1 to receive 3 monthly infusions of either Tysabri 300 mg or placebo. Induction with Tysabri achieved the following clinical response and remission at weeks 8 and 12 compared with placebo, respectively:

      • Clinical Response at week 8: 56% vs 40% (treatment difference, 16%; 95% CI, 8-26)

      • Clinical Response at week 12: 60% vs 44% (treatment difference, 16%; 95% CI, 7-25)

      • Clinical Response at both weeks 8 & 12: 48% vs 32% (treatment difference, 16%; 95% CI, 7-24)

      • Clinical Remission at week 8: 32% vs 21% (treatment difference, 11%; 95% CI, 3-19)

      • Clinical Remission at week 12: 37% vs 25% (treatment difference, 12%; 95% CI, 4-21)

      • Clinical Remission at both weeks 8 & 12: 26% vs 16% (treatment difference, 10%; 95% CI, 3-18)

    • In Study CD3, maintenance therapy was evaluated in 331 patients who had a clinical response to Tysabri at both Weeks 10 and 12. Patients were re-randomly assigned 1:1 to continue receiving monthly infusions of either Tysabri 300 mg or placebo. Maintenance treatment with Tysabri achieved the following clinical response and remission at Months 9 and 15 compared with placebo, respectively:

      • Clinical Response through Month 9: 61% vs 29% (treatment difference, 32%; 95% CI, 21-43)

      • Clinical Response through Month 15: 54% vs 20% (treatment difference, 34%; 95% CI, 23-44)

      • Clinical Remission through Month 9: 45% vs 26% (treatment difference, 19%; 95% CI, 6-31)

      • Clinical Remission through Month 15: 40% vs 15% (treatment difference, 25%; 95% CI, 13-36)

    Tysabri Note

    Notes

    This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255.

    Tysabri Patient Counseling

    Patient Counseling

    Progressive Multifocal Leukoencephalopathy (PML)

    • Inform patients that PML has occurred. Instruct patients that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Instruct patients to continue to look for new signs and symptoms suggestive of PML for approximately 6 months following discontinuation of Tysabri.

    Tysabri TOUCH® Prescribing Program

    • Advise the patient that Tysabri is only available through a restricted program called the TOUCH® Prescribing Program. 

    Herpes Infections 

    • Inform patients that Tysabri increases the risk of developing encephalitis, and meningitis, which could be fatal, and acute retinal necrosis, which could lead to blindness, caused by the family of herpes viruses (e.g., herpes simplex and varicella zoster viruses).

    Hepatotoxicity

    • Inform patients that Tysabri may cause liver injury.

    Hypersensitivity Reactions

    • Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction (e.g., urticaria with or without associated symptoms) during or following an infusion of Tysabri. 

    Immunosuppression/Infections

    • Inform patients that Tysabri may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection.

    Thrombocytopenia  

    • Inform patients that Tysabri may cause a low platelet count, which can cause severe bleeding that may be life-threatening.

    Pregnancy

    • Instruct patients that if they become pregnant or plan to become pregnant while taking Tysabri they should inform their healthcare provider.

    Cost Savings Program

    Tysabri Patient Support

    Tysabri Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Natalizumab 300mg/15mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Immunomodulator (integrin receptor antagonist).

    How Supplied

    Single-use vial—1

    How Supplied

    Tysabri (natalizumab) injection, a sterile, preservative-free, colorless and clear to slightly opalescent solution for dilution prior to intravenous infusion, is supplied as one 300 mg/15 mL (20 mg/mL) single-dose vial per carton.

    Tysabri is available only through registered infusion centers participating in the TOUCH® Prescribing Program. To locate these infusion centers, contact Biogen at 1-800-456-2255. 

    Storage

    Tysabri single-dose vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the carton and vial label. Do not shake or freeze. Protect from light.

    Store diluted Tysabri solution refrigerated at 2°C to 8°C (36°F to 46°F). 

    Manufacturer

    Biogen

    Generic Availability

    NO

    Mechanism of Action

    Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s). Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue.

    Tysabri Indications

    Indications

    Monotherapy for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Tysabri Dosage and Administration

    Adult

    ≥18yrs: Give by IV infusion over 1hr; monitor during and for 1hr post-infusion. 300mg every 4 weeks.

    Children

    <18yrs: not established.

    Tysabri Contraindications

    Contraindications

    Progressive multifocal leukoencephalopathy (PML).

    Tysabri Boxed Warnings

    Boxed Warning

    Progressive multifocal leukoencephalopathy.

    Boxed Warning

    Progressive multifocal leukoencephalopathy (PML)

    • Increased risk of PML. 

    • Risk factors for development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants.

    • Monitor for any new sign or symptom that may be suggestive of PML. Withhold Tysabri immediately at the first sign of symptom of PML.

    • For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

    • Because of the risk of PML, Tysabri is available only through the REMS program called the TOUCH Prescribing Program.

    Tysabri Warnings/Precautions

    Warnings/Precautions

    Increased risk of PML with longer treatment duration (>2yrs), prior treatment with immunosuppressants, and/or presence of anti-JCV antibodies. Monitor for signs/symptoms of PML; withhold if develops. Test patients for anti-JCV antibody status prior to or during treatment if status unknown; patients with negative status should be retested periodically. Reevaluate periodically (at 3 months and 6 months post-infusion, every 6 months thereafter, and for at least 6 months after discontinuation). MS: obtain MRI scan prior to initiating therapy. Risk of JCV granule cell neuronopathy; manage similarly to PML if develops. Monitor for herpes encephalitis and meningitis; discontinue and treat if occurs. Refer for retinal screening if eye symptoms develop; consider discontinuing therapy if acute retinal necrosis is confirmed. Discontinue if jaundice or liver injury occurs, or if thrombocytopenia is suspected. Immunosuppression. Monitor for infections. Vaccinations. Elderly. Neonates. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Progressive Multifocal Leukoencephalopathy 

    • Increased risk of PML in Tysabri-treated patients with the following 3 factors:

      • Presence of anti-JCV antibodies.

      • Longer treatment duration, especially beyond 2 years.

      • Prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil).

    • Patients with negative anti-JCV antibody test result should be retested periodically.

    • Assess anti-JCV antibody status using an analytically and clinically validated immunoassay.

    • Wait at least 2 weeks to test for anti-JCV antibodies after plasma exchange to avoid false negative test results caused by the removal of serum antibodies.

    • Wait at least 6 months (5 half-lives) for the IVIG to clear after infusion of IVIG to avoid false positive anti-JCV antibody test results.

    • Monitor for new sign or symptom suggestive of PML. Monitoring with MRI for signs may be useful and any suspicious findings could lead to further investigation to allow for an early diagnosis of PML (if present). 

    • Consider monitoring more frequently in patients at high risk for PML. After discontinuing Tysabri, continue monitoring for signs or symptoms suggestive of PML for at least 6 months.

    • In MS patients, obtain an MRI scan prior to initiation. In CD patients, a baseline brain MRI may be helpful to distinguish pre-existent lesions from newly developed lesions.

    • For diagnosis, an evaluation that includes a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

    • Withhold Tysabri dosing immediately and perform diagnostic evaluation at the first sign or symptom suggestive of PML. 

    • Immune reconstitution inflammatory syndrome (IRIS) has been reported. Monitor for IRIS development and appropriate treatment should be taken.

    Herpes Infections  

    • Herpes Encephalitis and Meningitis: Monitor for signs and symptoms. Discontinue if herpes encephalitis or meningitis occurs, and treat appropriately.

    • Acute Retinal Necrosis: Refer for retinal screening if eye symptoms develop (including decreased visual acuity, redness, or eye pain). Consider discontinuing therapy if acute retinal necrosis is confirmed.

    Hepatotoxicity

    • Discontinue if jaundice or other evidence of significant liver injury occurs.

    Hypersensitivity/Antibody Formation

    • Discontinue and initiate appropriate therapy if hypersensitivity reaction occurs.

    • Do not retreat patients who experience a hypersensitivity reaction. Consider the possibility of antibodies in patients who have hypersensitivity reactions.

    • Test for antibodies if the presence of persistent antibodies is suspected. Testing is recommended to be repeated 3 months after an initial positive result to confirm that antibodies are persistent. Higher risk of developing antibodies in patients who receive Tysabri for a short exposure (1 to 2 infusions) followed by an extended period.

    Immunosuppression/Infections 

    • Concurrent use of antineoplastic, immunosuppressant, or immunomodulating agents may further increase the risk of infections, including PML and other opportunistic infections, over the risk observed with use of Tysabri alone.

    • The safety and efficacy of Tysabri in combination with antineoplastic, immunosuppressant, or immunomodulating agents have not been established.

    • Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not ordinarily be treated with Tysabri.

    • For patients with Crohn’s disease who start Tysabri while on chronic corticosteroids, commence steroid withdrawal as soon as a therapeutic benefit has occurred. If the patient cannot discontinue systemic corticosteroids within six months, discontinue Tysabri. 

    Laboratory Test Abnormalities 

    • In clinical trials, Tysabri was observed to induce increases in circulating lymphocytes, monocytes, eosinophils, basophils, and nucleated red blood cells. 

    • Observed changes persisted during Tysabri exposure, but were reversible, returning to baseline levels usually within 16 weeks after the last dose.

    Thrombocytopenia

    • Discontinue if thrombocytopenia is suspected.

    • Obtain CBC in neonates who were exposed to Tysabri in utero.

    Immunizations

    • No data are available on the effects of vaccination in patients receiving Tysabri. No data are available on the secondary transmission of infection by live vaccines in patients receiving Tysabri.

    Pregnancy Considerations

    Risk Summary 

    • No adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of Tysabri in pregnant women.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Obtain CBC in neonates who were exposed to Tysabri in utero.

    Nursing Mother Considerations

    Risk Summary 

    • No data on the effects of this exposure on the breastfed infant or the effects of the drug on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Tysabri and any potential adverse effects on the breastfed infant from Tysabri or from the underlying maternal condition. 

    Pediatric Considerations

    Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn’s disease below the age of 18 years have not been established. 

    REMS

    YES

    Tysabri Pharmacokinetics

    Distribution

    Volume of distribution: 5.7 ± 1.9 L (MS patients); 5.2 ± 2.8 L (CD patients).

    Elimination

    Half-life: 11 ± 4 days (MS patients); 10 ± 7 days (CD patients).

    Clearance: 16 ± 5 mL/hour (MS patients); 22 ± 22 mL/hour (CD patients).

    Tysabri Interactions

    Interactions

    Concomitant other immunosuppressants: not recommended.

    Tysabri Adverse Reactions

    Adverse Reactions

    Headache, fatigue, arthralgia, infections, depression, pain in extremity, abdominal discomfort, diarrhea NOS, nausea, rash; immune reconstitution syndrome (monitor), hypersensitivity reactions (discontinue if occurs; do not restart), hepatotoxicity, inj site reactions, antibody formation (if persistent, may substantially reduce efficacy), changes in blood cell counts.

    Tysabri Clinical Trials

    Clinical Trials

    Multiple Sclerosis

    • The approval was based on 2 randomized, double-blind, placebo-controlled trials (Study MS1 and MS2) that evaluated Tysabri in patients with MS who experienced at least 1 clinical relapse during the prior year and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.0. In both studies, neurological evaluations were performed every 12 weeks and at times of suspected relapse. MRI evaluations for T1-weighted Gd-enhancing lesions and T2-hyperintense lesions were performed annually.

    • Study MS1 included patients who had not received any interferon-beta or glatiramer acetate for at least the previous 6 months. Patients were randomly assigned 2:1 to receive Tysabri 300mg IV infusion (n=627) or placebo (n=315) every 4 weeks for up to 28 months (30 infusions).

    • Study MS2 included patients who had experienced one or more relapses while on treatment with Avonex (Interferon beta-1a) 30mcg intramuscularly (IM) once weekly during the year prior to study entry. Patients were randomly assigned to receive Tysabri 300mg (n=589) or placebo (n=582) every 4 weeks for up to 28 months (30 infusions). All patients received Avonex 30mcg IM once weekly.

    • The primary endpoint at 2 years was time to onset of sustained increase in disability, defined as an increase of at least 1 point on the EDSS from baseline EDSS ≥ 1.0 that was sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS=0 that was sustained for 12 weeks.

    • In Study MS1, treatment with Tysabri achieved the following results at 2 years compared with placebo, respectively:

      • Percentage with sustained increase in disability: 17% vs 29% (relative risk reduction, 42%; 95% CI, 23-57)

      • Annualized relapse rate: 0.22 vs 0.67 (relative reduction, 67%)

      • Percentage of patients remaining relapse-free: 67% vs 41%

      • New or newly enlarging T2-hyperintense lesions (median): 0.0 vs 5.0

      • Gd-enhancing lesions (median): 0.0 vs 0.0

    • In Study MS2, treatment with Tysabri achieved the following results at 2 years compared with placebo, respectively:

      • Percentage with sustained increase in disability: 23% vs 29% (relative risk reduction, 24%; 95% CI, 4-39)

      • Annualized relapse rate: 0.33 vs 0.75 (relative reduction, 56%)

      • Percentage of patients remaining relapse-free: 54% vs 32%

      • New or newly enlarging T2-hyperintense lesions (median): 0.0 vs 3.0

      • Gd-enhancing lesions (median): 0.0 vs 0.0

    Tysabri Note

    Notes

    This product is only available through the TOUCH prescribing program. For more information call (800) 456-2255.

    Tysabri Patient Counseling

    Patient Counseling

    Progressive Multifocal Leukoencephalopathy (PML)

    • Inform patients that PML has occurred. Instruct patients that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Instruct patients to continue to look for new signs and symptoms suggestive of PML for approximately 6 months following discontinuation of Tysabri.

    Tysabri TOUCH® Prescribing Program

    • Advise the patient that Tysabri is only available through a restricted program called the TOUCH® Prescribing Program. 

    Herpes Infections 

    • Inform patients that Tysabri increases the risk of developing encephalitis, and meningitis, which could be fatal, and acute retinal necrosis, which could lead to blindness, caused by the family of herpes viruses (e.g., herpes simplex and varicella zoster viruses).

    Hepatotoxicity

    • Inform patients that Tysabri may cause liver injury.

    Hypersensitivity Reactions

    • Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction (e.g., urticaria with or without associated symptoms) during or following an infusion of Tysabri. 

    Immunosuppression/Infections

    • Inform patients that Tysabri may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection.

    Thrombocytopenia  

    • Inform patients that Tysabri may cause a low platelet count, which can cause severe bleeding that may be life-threatening.

    Pregnancy

    • Instruct patients that if they become pregnant or plan to become pregnant while taking Tysabri they should inform their healthcare provider.

    Cost Savings Program

    Tysabri Patient Support

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