Tibsovo TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: ivosidenib
Pack: Tibsovo 250 mg tablet, 60, bottle
Brand name
(ARTG)
: TIBSOVO ivosidenib 250 mg film-coated tablet bottleDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
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.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet, film coated
- Oral
- Oval shape, blue, film-coated tablets debossed with "IVO" on one side and "250" on the other side
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Keep Container Tightly Closed/Airtight
- Protect from Moisture
- Shelf lifetime is 60 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 60 tablets pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient ivosidenib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
