70

80

80

90

100

100

110

110

120
 80

90

100

100

110

120

130

140

140

150

160
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.
Administration
Navelbine must be given strictly by the oral route.
Navelbine must be swallowed whole with water, without chewing, sucking or dissolving the capsule.
It is recommended to administer the capsule with some food.
Administration in the 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.
Administration in children
Safety and efficacy in children have not been established and administration is therefore not recommended.
Administration in patients with liver insufficiency
Navelbine 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), Navelbine should be administered at a dose of 50 mg/m²/week. The administration of Navelbine in patients with severe hepatic impairment is contra-indicated: see sections 4.3, 4.4, 5.2.
Administration in patients with renal insufficiency
Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Navelbine in patients with serious renal insufficiency: see sections 4.4, 5.2.
Specific instructions must be observed for handling Navelbine: see section 6.6
4.3 Contraindications
- Known hypersensitivity to vinorelbine or other vinca-alkaloids or to any of the constituents.
- Disease significantly affecting absorption
- Previous significant surgical resection of stomach or small bowel.
- Neutrophil count < 1500/mm3 or severe infection current or recent (within 2 weeks).
- Platelet count < 100000/mm3
- Severe hepatic insufficiency
- Pregnancy: see section 4.6
- Lactation: see section 4.6
- Patients requiring long-term oxygen therapy
- In combination with yellow fever vaccine: see section 4.5
4.4 Special warnings and precautions for use
Special warnings
Navelbine should be prescribed by a physician who is experienced in the use of chemotherapy with facilities for monitoring cytotoxic drugs.
If the patient chews or sucks the capsule by error, the liquid is an irritant. Proceed to mouth rinses with water or preferably a normal saline solution.
In the event of the capsule being cut or damaged, the liquid content is an irritant, and so may cause damage if in contact with skin, mucosa or eyes. Damaged capsules should not be swallowed and should be returned to the pharmacy or to the doctor in order to be properly destroyed. If any contact occurs, immediate thorough washing with water or preferably with normal saline solution should be undertaken.
In the case of vomiting within a few hours after drug intake, do not re-administer. Supportive treatment such as metoclopramide or 5HT3 antagonists (e.g. ondansetron, granisetro