Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
pralsetinib, Quantity: 100 mg
Roche Products Pty Ltd
Capsule, hard
Excipient Ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue FCF; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide
Oral
90 CAPSULES, 60 CAPSULES, 120 CAPSULES
(S4) Prescription Only Medicine
Non-Small Cell Lung Cancer (NSCLC),Gavreto has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR) in single-arm trials. Continued approval of this indication depends on verification and description of benefit in confirmatory trials. RET-Fusion Positive Thyroid Cancer,Gavreto has provisional approval in Australia for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Visual Identification: Size 0 light blue opaque HPMC capsule, printed in white ink with 'BLU-667' on the capsule shell body and '100 mg' on the capsule shell cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered (Provisional)
2023-03-29
GAVRETO ® G A V R E T 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 GAVRETO? GAVRETO contains the active ingredient pralsetinib. GAVRETO is used to treat patients who have certain types of cancer - known as rearranged during transfection (RET)-fusion positive lung cancer or thyroid cancer. For more information, see Section 1. Why am I using GAVRETO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GAVRETO? Do not use if you have ever had an allergic reaction to GAVRETO 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. IT IS IMPORTANT TO TELL YOU DOCTOR IF YOU HAVE A HISTORY OF LUNG AND/OR BREATHING PROBLEMS, HIGH BLOOD PRESSURE, LIVER PROBLEMS OR BLEEDING PROBLEMS. For more information, see Section 2. What should I know before I use GAVRETO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GAVRETO 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 GAVRETO? • The recommended dose is 400 mg (4 capsules) taken by mouth once daily. GAVRETO capsules should be swallowed whole with a glass of water and must not be opened or chewed. If you get side effects, your doctor may change your dose, temporarily stop, or permanently stop treatment. • Take GAVRETO on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking GAVRETO. More instructions can be found in Section 4. How do I use GAVRETO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GAVRETO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are t Prečítajte si celý dokument
GAVRETO 20230406 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 www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION GAVRETO ® (PRALSETINIB) 1. GAVRETO Pralsetinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg pralsetinib. Gavreto (pralsetinib) 100 mg, light blue, opaque, immediate release, hydroxypropyl methylcellulose (HPMC) hard capsule printed with “BLU-667” on the capsule shell body and “100 mg” on the capsule shell cap. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Hard capsule. Gavreto is a size 0 capsule with light blue body and cap and BLU-667 imprinted in white on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER (NSCLC) Gavreto has PROVISIONAL APPROVAL in Australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR) in single-arm trials. Continued approval of this indication depends on verification and description of benefit in confirmatory trials. RET-FUSION POSITIVE THYROID CANCER Gavreto has PROVISIONAL APPROVAL in Australia for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Method of administrati Prečítajte si celý dokument