TIBSOVO ivosidenib 250 mg film-coated tablet bottle

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

ivosidenib, Quantity: 250 mg

Disponibbli minn:

Servier Laboratories (Aust) Pty Ltd

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake; hypromellose acetate succinate; lactose monohydrate

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

60 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Cholangiocarcinoma,TIBSOVO is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.,Acute myeloid leukaemia,TIBSOVO is indicated for the treatment of acute myeloid leukaemia (AML) that carries an IDH1 R132 mutation:,? as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or,? as monotherapy in patients whose AML is relapsed and/or refractory to prior therapy.

Sommarju tal-prodott:

Visual Identification: Oval shape, blue, film-coated tablets debossed with "IVO" on one side and "250" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2023-04-05

Fuljett ta 'informazzjoni

TIBSOVO
®
T
I
B
S
O
V
O
®
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 TIBSOVO?
TIBSOVO contains the active ingredient ivosidenib. TIBSOVO is used to
treat specific cancers (including bile duct cancer) that
contain a mutated (abnormal) form of the isocitrate dehydrogenase 1
(IDH1) enzyme.
For more information, see Section 1. Why am I using TIBSOVO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TIBSOVO?
Do not use if you have ever had an allergic reaction to TIBSOVO 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
TIBSOVO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TIBSOVO 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 TIBSOVO?
The usual dose of TIBSOVO is two tablets to be taken once daily at
approximately the same time each day. In some cases your
doctor may tell you to take a reduced dose if you are taking some
other medicines or to help you better tolerate some possible side
effects. It is important to follow the instructions provided and use
TIBSOVO until your doctor tells you to stop.
More instructions can be found in Section 4. How do I use TIBSOVO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TIBSOVO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are using
TIBSOVO.
•
Continue regular monitoring (e.g. echocardiogram and/or blood tests)
as directed by your doctor.
THINGS YOU
SHOULD NOT DO
•
Do not take TIBSOVO along with a high-fa

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION – TIBSOVO
® (IVOSIDENIB)
Version: 1
1/15
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 PI – TIBSOVO
® (IVOSIDENIB)
1
NAME OF THE MEDICINE
TIBSOVO
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of ivosidenib.
Excipient with known effect: contains lactose. For the full list of
excipients, see _section 6.1 - List of _
_excipients_.
3
PHARMACEUTICAL FORM
Blue, oval shaped, film-coated tablets approximately 18 mm in length,
debossed with ‘IVO’ on one side and
‘250’ on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TIBSOVO is indicated for the treatment of adult patients with locally
advanced or metastatic
cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132
mutation after at least one prior line
of systemic therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the use of
anti-cancer therapies. Before taking
TIBSOVO , patients must have confirmation of an IDH1 mutation using an
appropriate diagnostic test, and
an electrocardiogram (ECG) to assess heart rate-corrected QT (QTc)
interval.
Dose
The recommended dose of ivosidenib is 500 mg orally once daily until
disease progression or unacceptable
toxicity.
Method of administration
TIBSOVO should be taken at about the same time each day, with or
without food, but not with a high fat
meal (see _section 4.5 - Interactions with other medicines and other
forms of interactions_ and_ 5.2 - _
_Pharmacokinetic properties_). Do not split, crush or chew the
tablets.
Two doses should not be taken within 12 hours. If a dose of TIBSOVO is
missed or not taken at the usual
time, administer the dose as soon as possible within 12 hours after it
was missed. Administer the following
day’s dose at the usual time.