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Special care should be taken when prescribing for patients with: history of ischemic heart disease (see Adverse Reactions); poor performance status.
Vinorelbine Alvogen should not be given concomitantly with radiotherapy if the treatment field includes the liver.
This product is specifically contra-indicated with yellow fever vaccine and its concomitant use with other live attenuated vaccines is not recommended (see Contraindications).
Caution must be exercised when combining Vinorelbine Alvogen and strong inhibitors or inducers of CYP3A4 (see Interactions), and its combination with phenytoin (like all cytotoxics) and with itraconazole (like all vinca alkaloids) is not recommended.
Oral Vinorelbine Alvogen has been studied in patients with hepatic impairment at the following dosages: 60 mg/m2 in 7 patients with mild hepatic impairment (bilirubin <1.5 x ULN, and ALAT and/or ASAT between 1.5 and 2.5 x ULN); 50 mg/m2 in 6 patients with moderate hepatic impairment (bilirubin between 1.5 and 3 x ULN, independent of ALAT and ASAT level).
Total clearance of vinorelbine was neither modified between mild and moderate liver impairment nor was it altered in hepatically impaired patients when compared with clearance in patients with normal liver function.
Oral Vinorelbine Alvogen was not studied in patients with severe hepatic impairment, therefore its use is contra-indicated in these patients (see Dosage & Administration, Contraindications and Pharmacology: Pharmacokinetics under Actions).
As there is a low level of renal excretion there is no pharmacokinetic rationale for reducing the dose of Vinorelbine Alvogen in patients with impaired kidney function (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions.).
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed but on the basis of the pharmacodynamic profile vinorelbine does not affect the ability to drive and use machines. However, caution is necessary in patients treated with vinorelbine considering some adverse effects of the drug: see Adverse Reactions.
