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TYSABRI is a brand name for Natalizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TYSABRI (natalizumab) is indicated: • as monotherapy (i.e. single disease-modifying agent) for the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations TYSABRI (natalizumab) should be administered by a healthcare professional. • Patients should be observed during the infusion and for 1 hour after the infusion is complete for signs and symptoms of infusion reactions.
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction (see 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity Reactions). 9% Sodium Chloride Injection, USP.
• TYSABRI contains 52 mg sodium per vial. 9% Sodium Chloride Injection, USP, TYSABRI contains 406 mg sodium per dose. This should be taken into consideration by patients on a controlled sodium diet. 2 Recommended Dose and Dosage Adjustment The recommended dose of TYSABRI is 300 mg IV infusion every 4 weeks.
Do not administer TYSABRI as an IV push or bolus injection. 1 Pediatrics). Pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency have not been studied. 6 mg Intravenous infusion: If not used immediately, store the TYSABRI solution for infusion at 2°-8°C.
TYSABRI solution for infusion must be administered within 72 hours of preparation. DO NOT FREEZE. See 11 STORAGE, STABILITY AND DISPOSAL. 4 Administration Dilution: Parenteral Products: Use aseptic technique when preparing TYSABRI solution for IV infusion.
Each vial contains a single dose and is intended for single patient use only. TYSABRI is a colourless, clear to slightly opalescent concentrate. Inspect the TYSABRI vial for particulate material prior to dilution and administration. If visible particulates are observed and/or the liquid in the vial is discoloured, the vial must not be used.
Do not use TYSABRI beyond the expiration date on the carton or vial. To prepare the solution, withdraw 15 mL of TYSABRI concentrate from the vial using a sterile needle and syringe. 9% Sodium Chloride Injection, USP. No other IV diluents may be used to prepare the TYSABRI solution.
Gently invert the TYSABRI solution to mix completely. Do not shake. Inspect for particulate material prior to administration. Infuse over approximately 1 hour. Observe patients during the infusion and for 1 hour after the infusion is completed for signs and symptoms of infusion reactions.
After the first 12 TYSABRI doses, patients should continue to be observed during infusion. If patients have not experienced any infusion reactions including hypersensitivity, the post dose observation time may be adjusted for the 13th and subsequent infusions according to clinical judgement.
• Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML and/or JCV GCN. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of either PML or JCV GCN.
Diagnosis and management of GCN should follow guidance provided for PML. 1 Dosing Considerations TYSABRI (natalizumab) should be administered by a healthcare professional. • Patients should be observed during the infusion and for 1 hour after the infusion is complete for signs and symptoms of infusion reactions.
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction (see 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity Reactions). 9% Sodium Chloride Injection, USP.
• TYSABRI contains 52 mg sodium per vial. 9% Sodium Chloride Injection, USP, TYSABRI contains 406 mg sodium per dose. This should be taken into consideration by patients on a controlled sodium diet. 2 Recommended Dose and Dosage Adjustment The recommended dose of TYSABRI is 300 mg IV infusion every 4 weeks.
Do not administer TYSABRI as an IV push or bolus injection. 1 Pediatrics). Pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency have not been studied. 6 mg Intravenous infusion: If not used immediately, store the TYSABRI solution for infusion at 2°-8°C.
TYSABRI solution for infusion must be administered within 72 hours of preparation. DO NOT FREEZE. See 11 STORAGE, STABILITY AND DISPOSAL. 4 Administration Dilution: Parenteral Products: Use aseptic technique when preparing TYSABRI solution for IV infusion.
Each vial contains a single dose and is intended for single patient use only. TYSABRI is a colourless, clear to slightly opalescent concentrate. Inspect the TYSABRI vial for particulate material prior to dilution and administration. If visible particulates are observed and/or the liquid in the vial is discoloured, the vial must not be used.
). See 7 WARNINGS AND TYSABRI natalizumab for injection Page 5 of 49 Unclassified / Non classifié PRECAUTIONS. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Treatment with TYSABRI (natalizumab) has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML) and/or granule cell neuronopathy (GCN) secondary to opportunistic infection caused by John Cunningham virus (JC virus).
Both PML and JCV GCN can cause disability or death. See 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, Infections, and
• TYSABRI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). See 7 WARNINGS AND PRECAUTIONS. ). See 7 WARNINGS AND TYSABRI natalizumab for injection Page 5 of 49 Unclassified / Non classifié PRECAUTIONS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Natalizumab in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
9% Sodium Chloride Injection, USP. Other medications should not be injected into infusion set side ports or mixed with TYSABRI. 5 Missed Dose If a dose of TYSABRI is missed, TYSABRI should be administered as soon as possible, and dosing should continue at the prescribed frequency.
Do not use TYSABRI beyond the expiration date on the carton or vial. To prepare the solution, withdraw 15 mL of TYSABRI concentrate from the vial using a sterile needle and syringe. 9% Sodium Chloride Injection, USP. No other IV diluents may be used to prepare the TYSABRI solution.
Gently invert the TYSABRI solution to mix completely. Do not shake. Inspect for particulate material prior to administration. Infuse over approximately 1 hour. Observe patients during the infusion and for 1 hour after the infusion is completed for signs and symptoms of infusion reactions.
After the first 12 TYSABRI doses, patients should continue to be observed during infusion. If patients have not experienced any infusion reactions including hypersensitivity, the post dose observation time may be adjusted for the 13th and subsequent infusions according to clinical judgement.
9% Sodium Chloride Injection, USP. Other medications should not be injected into infusion set side ports or mixed with TYSABRI. 5 Missed Dose If a dose of TYSABRI is missed, TYSABRI should be administered as soon as possible, and dosing should continue at the prescribed frequency.
5 OVERDOSAGE Safety of doses higher than 300 mg has not been adequately evaluated. The maximum amount of TYSABRI (natalizumab) that can be safely administered has not been determined. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 2 – Dosage Forms, Strengths, Composition and Packaging TYSABRI (natalizumab) concentrate is supplied as 300 mg natalizumab in a sterile, single-use vial free of preservatives. Each package contains one vial. Eur Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Concentrate for solution / 300 mg per 15 mL polysorbate 80; sodium chloride; sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, monohydrate; water for injection TYSABRI natalizumab for injection Page 8 of 49 Unclassified / Non classifié 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Before initiation of treatment with TYSABRI (natalizumab), a recent magnetic resonance image (MRI) should be available. This MRI may be helpful in differentiating subsequent MS symptoms from PML. For diagnosis of PML, an evaluation that includes a magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
See 7 WARNINGS AND PRECAUTIONS, Infections). Patients who are prescribed TYSABRI are to be enrolled in the Biogen ONETM Support Program – a registry of Canadian patients. To enroll, physicians fax an enrollment form to 1-855-676- 6301.
Biogen ONETM Support Program is a comprehensive program […]