Natalizumab — Membership Pricing

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What Natalizumab is approved for (FDA label)

TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Source: Read the full FDA label on DailyMed. Label effective date: March 21, 2025.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Natalizumab (FDA label)

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants.

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Natalizumab (FDA label)

Injection: 300 mg /15 mL (20 mg/mL) colorless and clear to slightly opalescent solution in a single-dose vial for dilution prior to infusion. Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial for dilution prior to infusion ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Natalizumab (FDA label)

The following serious adverse reactions are described below and elsewhere in the labeling: Progressive Multifocal Leukoencephalopathy (PML) [see Warnings and Precautions ( 5.1 )] Herpes Infections [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Hypersensitivity/Antibody Formation [see Warnings and Precautions ( 5.5 )] Immunosuppression/Infections [see Warnings and Precautions ( 5.6 )] Hematological Abnormalities [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥ 10%): MS - headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash ( 6.1 ) CD - headache, upper respiratory tract infections, nausea, and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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.

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Natalizumab (FDA label)

TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [ see Warnings and Precautions ( 5.1 ) ]. TYSABRI is contraindicated in patients who have had a hypersensitivity reaction to TYSABRI. Observed reactions range from urticaria to anaphylaxis [ see Warnings and Precautions ( 5.5 ) ]. Patients who have or have had PML ( 4 ) Patients who have had a hypersensitivity reaction to TYSABRI ( 4 , 5.3 )

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Natalizumab (FDA label)

Herpes infections: Life-threatening and fatal cases have occurred with herpes encephalitis and meningitis infections. Blindness has occurred in patients developing acute retinal necrosis. Discontinue TYSABRI if these infections occur and treat appropriately ( 5.3 ) Hepatotoxicity: Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue TYSABRI in patients with evidence of liver injury ( 5.4 ) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue TYSABRI if such a reaction occurs ( 5.5 ) Immunosuppression/Infections: TYSABRI may increase the risk for certain infections. Monitor patients for development of infections due to increased risk with use of TYSABRI ( 5.6 ) Hematological Abnormalities: TYSABRI may cause thrombocytopenia. Monitor patients for bleeding abnormalities. Discontinue TYSABRI in patients with thrombocytopenia. Neonatal thrombocytopenia and anemia have also occurred.

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Natalizumab (FDA label)

Because of the potential for increased risk of PML and other infections, Crohn's disease patients receiving TYSABRI should not be treated with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be tapered in those patients with Crohn's disease who are on chronic corticosteroids when they start TYSABRI therapy [ see Indications and Usage ( 1.2 ), Warnings and Precautions ( 5.1 , 5.6 ) ]. Ordinarily, MS patients receiving chronic immunosuppressant or immunomodulatory therapy should not be treated with TYSABRI [ see Indications and Usage ( 1.1 ), Warnings and Precautions ( 5.1 , 5.6 ) ].

Source: FDA prescribing information (DailyMed). Set ID: c5fdde91-1989-4dd2-9129-4f3323ea2962. SPL document ID: 119c87a9-d153-4796-9525-694afdcdc1d6. Label effective date: March 21, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.