VINORELBINE ALVOGEN SOFT CAPSULES 20MG

LOTUS INTERNATIONAL PTE. LTD.

LOTUS INTERNATIONAL PTE. LTD.

Therapeutic

Prescription Only

CAPSULE, LIQUID FILLED

**4.2 Posology and method of administration** Posology - **As a single agent:** Adult patients The recommended regimen is: _First three administrations_ 60 mg/m2 of body surface area, administered once weekly _Subsequent administrations_ After the third administration, it is recommended to increase the dose of vinorelbine to 80 mg/m2 once weekly except in those patients for whom the neutrophil count dropped once <500/mm3 or more than once between 500 and 1,000/mm3 during the first three administrations at 60 mg/m2.  - **Dose modification** For any administration planned to be given at 80 mg/m2, if the neutrophil count is below 500/mm3, the administration should be delayed until recovery and the dose reduced from 80 to 60 mg/m2 per week during the 3 following administrations.  It is possible to re-escalate the dose from 60 to 80 mg/m2 per week if the neutrophil count did not drop below 500/mm3 or more than once between 500 and 1,000/mm3 during 3 administrations given at 60 mg/m2 according to the rules previously defined for the first 3 administrations. - **For combination regimens, the dose and schedule will be adapted to the treatment protocol.** Based on clinical studies, the oral dose of 80 mg/m2 was demonstrated to correspond to 30 mg/m2 of the IV form and 60 mg/m2 to 25 mg/m2. This has been the base for combination regimens alternating IV and oral forms improving patient convenience. _For combination regimens_, the dose and schedule will be adapted to the treatment protocol. The following table gives the dose required for appropriate ranges of body surface area (BSA).  Even for patients with BSA≥ 2 m2 the total dose should never exceed 120 mg per week at 60 mg/m2 and 160 mg per week at 80 mg/m2. _Elderly_ Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ Safety and efficacy in children have not been established and administration is therefore not recommended. (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic insufficiency_ Vinorelbine can be administered at the standard dose of 60 mg/m2/week in patients with mild liver impairment (bilirubin < 1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN). In patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT), vinorelbine should be administered at a dose of 50 mg/m2/week. The administration of vinorelbine in patients with severe hepatic impairment is not recommended as there is insufficient data to determine the pharmacokinetics, efficacy and safety of vinorelbine in this population (see sections 4.3, 4.4, 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal insufficiency_ Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of vinorelbine in patients with serious renal insufficiency (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration Vinorelbine must be given strictly by the oral route. Vinorelbine must be swallowed whole with water, without chewing, sucking or dissolving the capsule. It is recommended to administer the capsule with some food.