Navelbine Special Precautions

Special warnings: Vinorelbine soft-gelatin capsules must be prescribed only by a physician who is qualified and experienced in the use of chemotherapy with facilities for monitoring cytotoxic drugs.
The liquid content is irritant if the patient chews or sucks the capsule in error. Rinse the mouth with water or preferably physiological saline solution.
If a capsule being cut or damaged, its liquid content which has irritating properties may have adverse reactions if it comes into contact with the skin, mucosal membranes or eyes.
Damaged capsules must not be swallowed and should be returned to the pharmacist or physician in order to be destroyed appropriately.
In the event of contact, immediately wash thoroughly with water or preferably physiological saline solution.
If vomiting occurs during the hours after taking the medicine, never repeat administration of the dose. Symptomatic treatment such as 5HT3 antagonists (for example: ondansetrons, granisetrons) may reduce the occurrence of vomiting.
Vinorelbine soft-gelatin capsule is associated with a higher incidence of nausea or vomiting than the injectable form.
Prophylactic antiemetic treatment is recommended.
As it contains sorbitol, patients with rare hereditary problems of fructose intolerance should not take vinorelbine soft-gelatin capsule.
Treatment must be administered under strict haematological monitoring (blood haemoglobin, leukocyte, neutrophil and platelet count should be checked each day the substance is administered).
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
The dose administered should be determined according to the haematology profile: If the neutrophil count is under 1500/mm³ and/or the platelet count is under 100000/mm³, treatment should be deferred until these parameters have returned to normal and the patient should be monitored.
Refer to Dosage & Administration for increasing the 60 mg/m² dose to 80 mg/m² per week after the third dose has been administered.
For administrations at the 80 mg/m² dose, if the neutrophil count is under 500/mm³ or between 500 and 1000/mm³ on more than one occasion, administration should not only be delayed but the dose should be reduced to 60 mg/m² per week. The 60 mg/m² dose can be increased again to 80 mg/m² per week.
In clinical trials in which treatments were started at a dose of 80 mg/m², a few patients developed complications involving excessive neutropenia. This included patients with a poor performance status.
It is therefore recommended that treatment be started at the dose of 60 mg/m² and then increased to 80 mg/m² if the initial dose is well tolerated, as described in Dosage & Administration.
Further investigations should be performed without delay if patients have signs or symptoms suggestive of infection.
Use of this medicinal product in combination with a live attenuated vaccine is not recommended (for the yellow fever vaccine, see Contraindications).
Caution is recommended when vinorelbine is used at the same time as potent cytochrome CYP3A4 inhibitors or inducers. Hence, taking this medicinal product with phenytoin, fosphenytoin, itraconazole, ketoconazole or posaconazole is not recommended.
Special precautions for use: Special precautions are recommended in patients with: History of ischaemic heart disease; Poor performance status.
Vinorelbine soft-gelatin capsule should not be given concomitantly with radiotherapy if the treatment fields include the liver.
Vinorelbine soft-gelatin capsule has been studied in patients suffering from hepatic disorder at the following doses: 60 mg/m²/week in patients suffering from mild hepatic disorder (bilirubin <1.5 x ULN, ALT and/or AST 1.5 to 2.5 x ULN).
50 mg/m²/week in patients suffering from moderate hepatic disorder (bilirubin 1.5 to 3 x ULN, regardless of the ALT or AST level). The safety and pharmacokinetics of vinorelbine were not changed in these patients at the doses tested.
Vinorelbine soft-gelatin capsule has not been studied in patients suffering from severe hepatic disorder and its use is therefore not recommended in these patients.
As renal excretion is low, there is no pharmacokinetic justification to reduce the dose of vinorelbine in patients with impaired kidney function.
Effects on ability to drive and use machines: No studies on the ability to drive or use machines have been conducted although, based on its pharmacodynamic profile, vinorelbine does not affect these activities. Caution, however, is required in patients treated with vinorelbine because of the adverse effects due to this medicinal product.