LETYBO (letibotulinumtoxinA) 100 U, Powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letibotulinumtoxinA, Quantity: 100 U

Available from:

CROMA Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium chloride; Albumin

Administration route:

Intramuscular

Units in package:

1 vial each

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.

Product summary:

Visual Identification: White freeze-dried powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-11-28

Patient Information leaflet

LETYBO®
1
LETYBO®
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 RECEIVING LETYBO?
LETYBO contains the active ingredient LetibotulinumtoxinA. It is used
to temporarily improve glabellar frown lines in adults,
which are the vertical frown lines between your eyebrows.
For more information, see Section 1. Why am I receiving LETYBO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN LETYBO?
Do not receive this medicine if you have ever had an allergic reaction
to LETYBO or any of the ingredients listed at the end of
the CMI, if you have muscle activity disorders or if you have an
infection or inflammation at the proposed injection sites.
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 am
given LETYBO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LETYBO 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 WILL I BE GIVEN LETYBO?
LETYBO therapy can only be initiated by a doctor with experience in
handling this medicine. Your doctor will determine the
dose you need.
Further details can be found in Section 4. How will I be given LETYBO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING LETYBO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are being
treated with LETYBO.
•
Keep your appointments with your doctor and check for any side
effects.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how LETYBO affects you.
LOOKING AFTER
YOUR MEDICINE
•
LETYBO is administered by your d

Summary of Product characteristics

LETYBO AU PI
Version 1.0 – December 2022
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 https://www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION – LETYBO
®
(
LETIBOTULINUMTOXINA
)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
LetibotulinumtoxinA
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of LETYBO powder for injection contains 50 or 100 units (U)
of
letibotulinumtoxinA, albumin (0.25 or 0.5 mg) and sodium chloride
(0.45 or 0.9 mg) in a
sterile, freeze-dried form without a preservative.
LetibotulinumtoxinA is a 900 kD molecular weight complex consisting of
the
_Clostridium _
_botulinum _
type A neurotoxin
and several accessory
proteins.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
LETYBO 50 U or 100 U is a white freeze-dried powder for injection in a
clear glass vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LETYBO is indicated for the temporary improvement in the appearance of
moderate to severe
glabellar frown lines in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
LETYBO should only be administered by medical practitioners with
suitable qualifications and
proven experience in the application of botulinum toxin and in the use
of the necessary
equipment.
RECONSTITUTION
Product is for single use in one patient only. Discard any residue.
▼
LETYBO AU PI
Version 1.0 – December 2022
2
LETYBO is reconstituted prior to use with preservative-free sodium
chloride 9 mg/mL (0.9%)
solution for injection. A suitable sterile needle should be used for
administration.
It is good practice to reconstitute the vial content and prepare the
syringe over plastic-lined
paper towels to catch any spillage. Sodium chloride 9 mg/mL (0.9%)
solution for injection is
drawn up into a syringe and must be injected gently into the vial (to
avoid foam/bubble
formation or vigorous agitation wh