Tysabri

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Natalizumab 20 mg/mL;  

Available from:

Biogen NZ Biopharma Ltd

INN (International Name):

Natalizumab 20 mg/mL

Dosage:

300 mg/15mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Natalizumab 20 mg/mL   Excipient: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Units in package:

Vial, glass, 1 x 15mL vial, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Biogen Denmark Manufacturing ApS

Therapeutic indications:

Indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse. The safety and efficacy of TYSABRI beyond two years are unknown

Product summary:

Package - Contents - Shelf Life: Vial, glass, 15mL vial - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2006-06-27

Patient Information leaflet

TYSABRI
1
TYSABRI®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING TYSABRI?
TYSABRI contains the active ingredient natalizumab. TYSABRI is used to
treat relapsing remitting Multiple Sclerosis (MS).
For more information, see Section 1. Why am I using TYSABRI? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TYSABRI?
Do not use if you have ever had an allergic reaction to Tysabri or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TYSABRI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TYSABRI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TYSABRI?
•
The recommended dose of TYSABRI is 300 mg given once every 4 weeks.
•
TYSABRI will be prepared and given to you by a doctor or nurse.
More instructions can be found in Section 4. How do I use TYSABRI? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TYSABRI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, nurse or pharmacist you visit that you are
using Tysabri.
•
Call your doctor straight away if you or your partner or caregiver
notice any new or worsening
medical problems (fever or infection, new or sudden change in your
thinking, eyesight, balance or
strength)
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine without checking with your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how TYSABRI affects you.
•
TYSABRI may cause dizziness in some people.
DRINKING
AL

Summary of Product characteristics

d_tysabij_181223
1 of 25
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
TYSABRI
®
(natalizumab, rmc) 300 mg/15 mL solution for infusion
TYSABRI
®
(natalizumab, rmc) 150 mg/1 mL solution for injection
WARNING
TYSABRI
®
IS
ASSOCIATED
WITH
AN
INCREASED
RISK
OF
PROGRESSIVE
MULTIFOCAL
LEUKOENCEPHALOPATHY (PML), AN OPPORTUNISTIC VIRAL INFECTION OF THE
BRAIN THAT MAY LEAD
TO DEATH OR SEVERE DISABILITY. HEALTHCARE PROFESSIONALS SHOULD CLOSELY
MONITOR PATIENTS
ON TYSABRI FOR ANY NEW OR WORSENING SIGNS OR SYMPTOMS THAT MAY BE
SUGGESTIVE OF
PML. TYSABRI DOSING SHOULD BE WITHHELD IMMEDIATELY AT THE FIRST SIGNS
OR SYMPTOMS
SUGGESTIVE OF PML. FOR DIAGNOSIS, AN EVALUATION THAT INCLUDES A
GADOLINIUM-ENHANCED
MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE BRAIN, NEUROLOGICAL
ASSESSMENT, AND
CEREBROSPINAL
FLUID
ANALYSIS
FOR
JC
VIRAL
DNA
IS
RECOMMENDED
(SEE
SECTION
4.3
CONTRAINDICATIONS
AND
SECTION
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE,
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution for intravenous infusion
Each 15 mL dose contains 300 mg natalizumab.
Solution for subcutaneous injection *
Each dose contains 300 mg natalizumab (two injections of 150mg/1 mL
prefilled syringes).
TYSABRI (natalizumab) is a recombinant humanised IgG4 monoclonal
antibody produced in
murine myeloma cells. Natalizumab (rmc) contains human framework
regions and the
complementarity-determining regions of a murine antibody that binds to

4-integrin. The
molecular weight of natalizumab is 149 kilodaltons.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
TYSABRI (natalizumab) is supplied as:
•
a sterile, colourless, clear to slightly opalescent concentrated
solution for intravenous
infusion
•
a sterile, colourless to slightly yellow, slightly opalescent to
opalescent solution for
subcutaneous injection.
4. CLINICAL PARTICULARS
d_tysabij_181223
2 of 25
4.1
THERAPEUTIC INDICATIONS
TYSABRI is indicated as monotherapy for the treatment of patients with
relapsing remitting
multiple scl