TECVAYLI teclistamab 10mg/mL solution for injection vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

teclistamab, Quantity: 30 mg

Dostępny od:

Janssen-Cilag Pty Ltd

Forma farmaceutyczna:

Injection, solution

Skład:

Excipient Ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections

Droga podania:

Subcutaneous

Sztuk w opakowaniu:

1

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

TECVAYLI as monotherapy has provisional approval in Australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.,The decision to approve this indication has been made on the basis of the overall response rate in a single arm study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Podsumowanie produktu:

Visual Identification: Colourless to light yellow preservative-free solution for injection in a vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered (Provisional)

Data autoryzacji:

2023-06-14

Ulotka dla pacjenta

Tecvayli(230614)ACMI
1
TECVAYLI®
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. Please report side effects. See the full CMI for
further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING TECVAYLI?
TECVAYLI is a cancer medicine that contains the active ingredient
teclistamab.
TECVAYLI is used to treat adults with cancer of the bone marrow called
multiple myeloma. It is used for patients who have had at
least three other kinds of treatment which have not worked or have
stopped working.
For more information, see Section 1. Why am I using TECVAYLI?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TECVAYLI?
Do not use if you have ever had an allergic reaction to teclistamab or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have had a stroke or seizure within the
past 6 months or have had a recent vaccination or are going to
have a vaccination. Tell your doctor if you are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
TECVAYLI?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TECVAYLI 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 IS TECVAYLI GIVEN?
Your doctor or other healthcare professional will give the injection
under the skin (called subcutaneous injection) in the stomach
area or thigh. More information can be found in Section 4. How is
TECVAYLI given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TECVAYLI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TECVAYLI.
•
Look out for serious side effects such as signs of a condition known
as ‘cytokine release syndrome’
(CRS), infe

Charakterystyka produktu

3.230113
Page 1 of 21
TECVAYLI (230614)API
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
TECVAYLI
TECLISTAMAB SOLUTION FOR INJECTION
1. NAME OF THE MEDICINE
teclistamab
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TECVAYLI (teclistamab) is a humanised immunoglobulin G4-proline,
alanine, alanine (IgG4-PAA)
bispecific antibody targeting the B cell maturation antigen (BCMA) and
CD3 receptors, produced in
a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant
DNA technology.
TECVAYLI is available in the following presentations:
•
Each 3 mL vial contains 30 mg of teclistamab (10 mg of teclistamab per
mL)
•
Each 1.7 mL vial contains 153 mg of teclistamab (90 mg of teclistamab
per mL)
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
TECVAYLI is a colourless to light yellow preservative-free solution
for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TECVAYLI as monotherapy has PROVISIONAL APPROVAL in Australia and is
indicated for the treatment
of adult patients with relapsed or refractory multiple myeloma who
have received at least three prior
therapies,
including
a
proteasome
inhibitor,
an
immunomodulatory
agent
and
an
anti-CD38
monoclonal antibody.
The decision to approve this indication has been made on the basis of
the overall response rate in
a single arm study. Continued approval of this indication depends on
verification and description of
benefit in confirmatory trials.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with TECVAYLI should be initiated and supervised by
physicians experienced in the
treatment of multiple myeloma.
DOSAGE – ADULTS (18 YEARS OF AGE AND OLDER)
TECVAYLI should be administered by subcutaneous injection only.
▼
WARNING: CYTOKINE RELEASE SYNDROME
Cytokine release syndrome (CRS)