REVESTIVE teduglutide 5 mg powder for solution for injection vial with diluent pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 0.5 mL

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

teduglutide,water for injections

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients:

Administration route:

Subcutaneous

Units in package:

28's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

REVESTIVE is indicated for the treatment of adult and paediatric patients 2 years of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.,Patients should be stable for at least 4 weeks on their parenteral support regimen before initiating teduglutide therapy

Product summary:

Visual Identification: Clear liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2017-05-19

Patient Information leaflet

REVESTIVE
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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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING REVESTIVE?
REVESTIVE contains the active ingredient teduglutide. REVESTIVE is
used to treat adults and children 2 years of age and above
with Short Bowel Syndrome who need additional nutrition or fluids from
intravenous feeding (parenteral support).
For more information, see Section 1. Why am I using REVESTIVE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE REVESTIVE?
Do not use if you have ever had an allergic reaction to REVESTIVE 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
REVESTIVE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with REVESTIVE 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 REVESTIVE?
•
The recommended daily dose is 0.05 mg per kg body weight once per day,
given under the skin. The dose will be prescribed as
mL of solution. Your doctor will choose the dose that is right for you
depending on your body weight
•
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use REVESTIVE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING REVESTIVE?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using REVESTIVE.
If you become pregnant while
using this medicine, tell your doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using REVESTIVE or change the dosage without checking w

Summary of Product characteristics

REVESTIVE PI V3.0. (CCDS V6).
1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION REVESTIVE
® (TEDUGLUTIDE)
1
NAME
OF
THE
MEDICINE
Teduglutide.
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
REVESTIVE contains teduglutide powder and solvent for solution for
injection. Each single-
use vial contains 5 mg of teduglutide as a white lyophilised powder.
The solvent is water for
injections. After reconstitution, each vial contains 5 mg teduglutide
in 0.5 mL of solution,
corresponding to a concentration of 10 mg/mL.
The active ingredient teduglutide (rDNA origin) is a 33 amino acid
glucagon-like peptide-2
(GLP-2) analogue manufactured using a strain of Escherichia coli
modified by recombinant
DNA technology.
See Section 6.7 PHYSICOCHEMICAL PROPERTIES for the chemical
composition and
structural formula.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REVESTIVE is indicated for the treatment of adult and paediatric
patients 2 years of age and
above with Short Bowel Syndrome (SBS) who are dependent on parenteral
support.
Patients should be stable for at least 4 weeks on their parenteral
support regimen before
initiating teduglutide therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a medical
professional with experience
in the treatment of SBS. REVESTIVE may be self-administered or
administered by a
caregiver only after training in subcutaneous injection technique by a
healthcare professional.
Paediatric (2 years of age and above)
See also general instructions for adults in this section.
REVESTIVE should not be administered to children weighing less than 10
kg. Treatment
should be evaluated after 6 months. If no overall imp