Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
ivosidenib, Quantity: 250 mg
Servier Laboratories (Aust) Pty Ltd
Tablet, film coated
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
Oral
60 tablets
(S4) Prescription Only Medicine
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.
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
Registered
2023-04-05
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 Przeczytaj cały dokument
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. Przeczytaj cały dokument