Natalizumab-sztn
Generic Name: natalizumab-sztn
Brand Names:
Tyruko
11 DESCRIPTION Natalizumab-sztn is a recombinant humanized IgG4ĸ monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell expression system. Natalizumab-sztn contains human framework regions and the complementarity-determining regions of an antibody that binds to α4-integrin. The molecular weight of natalizumab-sztn is 149 kilodaltons.
Overview
11 DESCRIPTION Natalizumab-sztn is a recombinant humanized IgG4ĸ monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell expression system. Natalizumab-sztn contains human framework regions and the complementarity-determining regions of an antibody that binds to α4-integrin. The molecular weight of natalizumab-sztn is 149 kilodaltons.
Uses
1 INDICATIONS AND USAGE TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO 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. Natalizumab products increase the risk of PML [see Warnings and Precautions ( 5.1 )] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk.
Dosage
2 DOSAGE AND ADMINISTRATION • 300 mg infused intravenously over one hour, every four weeks. Do not give as an intravenous push or bolus. ( 2.1 , 2.2 ) • TYRUKO solution must be administered within 4 hours of preparation. ( 2.3 ) • Observe patients during all infusions. Post-infusion, for the first 12 infusions, observe patients for one hour after the infusion is complete. For patients who have received 12 infusions without evidence of a hypersensitivity reaction, observe patients post-infusion for the 13th and subsequent infusions according to clinical judgment. ( 2.4 ) • In CD, discontinue in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy.
Side Effects
6 ADVERSE REACTIONS 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 - he...
Interactions
7 DRUG INTERACTIONS Because of the potential for increased risk of PML and other infections, Crohn’s disease patients receiving natalizumab products 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 TYRUKO therapy [see Indications and Usage ( 1.2 ) and Warnings and Precautions ( 5.1 , 5.6 )] . Ordinarily, MS patients receiving chronic immunosuppressant or immunomodulatory therapy should not be treated with TYRUKO [see Indications and Usage ( 1.1 ) and Warnings and Precautions ( 5.1 , 5.6 )] .
Warnings
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase 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. 5 WARNINGS AND PRECAUTIONS • 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 TYRUKO if these infections occur and treat appropriately. ( 5.3 ) • Hepatotoxicity: Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue TYRUKO in patients with evidence of liver injury. ( 5.4 ) • Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue TYRUKO if such a reaction occurs. ( 5.5 ) • Immunosuppression/Infections: Natalizumab products may increase the risk for certain infections. 4 CONTRAINDICATIONS • TYRUKO is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see Warnings and Precautions ( 5.1 )] . • TYRUKO is contraindicated in patients who have had a hypersensitivity reaction to natalizumab products or any of the ingredients in TYRUKO.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of natalizumab products in pregnant women. Adverse fetal outcomes of neonatal thrombocytopenia and anemia have been reported (see Clinical Considerations ) . In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING TYRUKO (natalizumab-sztn) 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 (NDC 61314-543-94). TYRUKO is available only through registered infusion centers participating in the TYRUKO REMS Program.
Frequently Asked Questions
What is Natalizumab-sztn used for?▼
1 INDICATIONS AND USAGE TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO 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. Natalizumab products increase the risk of PML [see Warnings and Precautions ( 5.1 )] . When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk.
What are the side effects of Natalizumab-sztn?▼
6 ADVERSE REACTIONS 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 - he...
Can I take Natalizumab-sztn during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of natalizumab products in pregnant women. Adverse fetal outcomes of neonatal thrombocytopenia and anemia have been reported (see Clinical Considerations ) . In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose.
What are the important warnings for Natalizumab-sztn?▼
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase 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. 5 WARNINGS AND PRECAUTIONS • 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 TYRUKO if these infections occur and treat appropriately. ( 5.3 ) • Hepatotoxicity: Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue TYRUKO in patients with evidence of liver injury. ( 5.4 ) • Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue TYRUKO if such a reaction occurs. ( 5.5 ) • Immunosuppression/Infections: Natalizumab products may increase the risk for certain infections. 4 CONTRAINDICATIONS • TYRUKO is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see Warnings and Precautions ( 5.1 )] . • TYRUKO is contraindicated in patients who have had a hypersensitivity reaction to natalizumab products or any of the ingredients in TYRUKO.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.