ORCANTAS 15/6.14 trifluridine 15 mg/ tipiracil hydrochloride 7.065 mg (equivalent to tipiracil 6.14 mg) film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tipiracil hydrochloride, Quantity: 7.065 mg; trifluridine, Quantity: 15 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

tipiracil hydrochloride,trifluridine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 8000; lactose monohydrate; indigo carmine aluminium lake; pregelatinised maize starch; Shellac; magnesium stearate; titanium dioxide; iron oxide red; stearic acid; iron oxide yellow; hypromellose; Carnauba Wax; purified water

Administration route:

Oral

Units in package:

60 film-coated tablets, 20 film-coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Colorectal cancer ORCANTAS 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 ORCANTAS 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.

Product summary:

Visual Identification: White, round, biconvex, immediate-release film-coated tablet imprinted with "15" on one side, and "102" and "15 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

Authorization status:

Licence status A

Authorization date:

2017-05-23