Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
trifluridine, Quantity: 20 mg; tipiracil hydrochloride, Quantity: 9.42 mg
Servier Laboratories (Aust) Pty Ltd
tipiracil hydrochloride,trifluridine
Tablet, film coated
Excipient Ingredients: purified talc; stearic acid; macrogol 8000; titanium dioxide; hypromellose; indigo carmine aluminium lake; iron oxide yellow; Carnauba Wax; magnesium stearate; lactose monohydrate; iron oxide red; Shellac; pregelatinised maize starch
Oral
60 film-coated tablets, 20 film-coated tablets
(S4) Prescription Only Medicine
Colorectal cancer LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.,Gastric cancer LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Visual Identification: Pale red, round, biconvex, immediate-release film-coated tablet imprinted with "20" on one side, and "102" and "20 mg" on the other side in grey ink.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-05-23
LONSURF ® _Trifluridine/Tipiracil Hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LONSURF. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking LONSURF against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LONSURF IS USED FOR LONSURF is a medicine used to treat cancer by slowing down the growth and spread of cancer cells. LONSURF is used to treat adults with colon or rectal cancer - sometimes called 'colorectal' cancer. It is also used to treat gastric cancer- sometimes called 'stomach' cancer. • It is used when the cancer has spread to other parts of the body. • It is used when other treatments have not worked - or when other treatments are not suitable for you. LONSURF is a type of cancer chemotherapy which belongs to a group of medicines called 'cytostatic antimetabolite medicines'. LONSURF contains two different active substances trifluridine and tipiracil • Trifluridine stops the growth of cancer cells. • Tipiracil stops the trifluridine from being broken down by the body, helping trifluridine to work longer. This medicine is available only with a doctor's prescription. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that LONSURF is addictive. BEFORE YOU TAKE LONSURF _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE LONSURF IF YOU HAVE AN ALLERGY TO: • TIPIRACIL AND/OR TRIFLURIDINE (THE ACTIVE INGREDIENTS IN LONSURF) • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to LONSURF may include: • shortness of breath, wheezing or difficulty breathing • sw Read the complete document
AUSTRALIAN PRODUCT INFORMATION – LONSURF (TRIFLURIDINE/TIPIRACIL) Version: 10 1/28 AUSTRALIAN PI – LONSURF (TRIFLURIDINE/TIPIRACIL) 1 NAME OF THE MEDICINE Trifluridine / tipiracil hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each LONSURF 15/6.14 film-coated tablet contains 15 mg of trifluridine and tipiracil hydrochloride 7.065 mg (equivalent to tipiracil 6.14 mg). Each LONSURF 20/8.19 film-coated tablet contains 20 mg of trifluridine and tipiracil hydrochloride 9.420 mg (equivalent to tipiracil 8.19 mg). The active components of LONSURF are trifluridine and tipiracil hydrochloride. Excipients with known effect: Each LONSURF 15/6.14 tablet contains 90.735 mg of lactose. Each LONSURF 20/8.19 tablet contains 120.980 mg of lactose. For the full list of excipients, see _section 6.1 - List of excipients_. 3 PHARMACEUTICAL FORM LONSURF 15/6.14: white, biconvex, round, film-coated tablet, imprinted with ‘15’ on one side, and ‘102’ and ’15 mg’ on the other side, in grey ink. LONSURF 20/8.19: pale red, biconvex, round, film-coated tablet, imprinted with ‘20’ on one side, and ‘102’ and ‘20 mg’ on the other side, in grey ink. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS COLORECTAL CANCER LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. GASTRIC CANCER LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu- targeted therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION AUSTRALIAN PRODUCT INFORMATION – LONSURF (TRIFLURIDINE/TIPIRACIL) Version: 10 2/28 DOSAGE (DOSE AND INTERVAL) LONSURF must be administered by doctors w Read the complete document