Navelbine Injection Special Precautions

Navelbine injection should be administered under the supervision of a physician experienced in the use of chemotherapy. The product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death.
Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥1500 cells/mm³. Prior to the administration of Navevlbine, the dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.
Navelbine must only be administered by the intravenous route.
It is extremely important that the intravenous needle or catheter be properly positioned before any Navelbine is injected. Leakage into surrounding tissue during intravenous administration of Navelbine may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasations occur, the injection should be discontinued immediately, and any remaining of the dose should then be introduced into another vein.
Since there are no established guidelines for the treatment of extravasations injuries with Navelbine, institutional guidelines may be used. The ONS chemotherapy guidelines provide additional recommendations for the prevention of extravasations injuries.
Since inhibition of the hematopoietic system is the main risk associated with Navelbine, close haematological monitoring should be undertaken during treatment (determination of hemoglobin level and the leukocyte, neutrophil and platelet counts on the day of each new administration).
The dose limiting adverse reaction is mainly neutropenia. This effect is non-cumulative, having its nadir between 7 and 14 days after the administration and is rapidly reversible within 5 to 7 days.
If the neutrophil count is below 1500/mm³ and/or the platelet count is below 100000/mm³, then the treatment should be delayed until recovery.
The pharmacokinetics of Navelbine is not modified in patients presenting moderate or severe liver impairment. For dosage adjustment in this specific patient group, see "Dose modifications" under Dosage & Administration.
As there is a low level of renal excretion there is no pharmacokinetic rationale for reducing the dose of Navelbine in patients with impaired kidney function.
Navelbine should not be given concomitantly with radiotherapy if the treatment field includes the liver.
All contact with the eyes should be strictly avoided: there is a risk of severe irritation and even corneal ulceration if the drug is sprayed under pressure. Immediate washing of the eye with sodium chloride 9 mg/ml (0.9%) solution for injection should be undertaken if any contact occurs.
Special care should be taken when prescribing for patients with history of ischemic cardiac disease.
If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out.
Use of this medicine with live attenuated vaccines is not recommended (for yellow fever vaccine, see Contraindications).
Caution is recommended when Navelbine is used with strong inhibitors or inducers of cytochrome CYP3A4. Hence, the use of this medicine with phenytoïn, fosphenytoïn, itraconazole or posaconazole is not recommended.
Patients treated with Navelbine should be frequently monitored for myelosuppression both during and after therapy.
Reported cases of interstitial pulmonary changes and ARDS occurred in patients treated with Navelbine, in combination with mitomycin. The mean time to onset of these symptoms after vinorelbine administration was 1 week (range 3 to 8 days). Patients with alterations in their baseline pulmonary symptoms or with new onset of dyspnoea, cough, hypoxia, or other symptoms should be evaluated promptly.
Navelbine has been reported to cause severe constipation (e.g. grade 3-4) such as paralytic ileus.
If severe adverse events occur, Navelbine should be reduced in dosage or discontinued and appropriate corrective measures taken. Reinstitution of therapy with Navelbine should be carried out with caution and alertness as to possible recurrence of toxicity.
Navelbine should be used in extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from the effects of previous chemotherapy.
Patients with a prior history of pre-existing neuropathy, regardless of etiology, should be monitored for new or worsening signs and symptoms of neuropathy while receiving Navelbine.
Effects on ability to drive and use machines: Navelbine is unlikely to impair the ability of patients to drive or to operate machinery. Nevertheless patients should be advised that their ability to drive and operate machinery may be affected.
Use in children: Safety and efficacy in children have not been established and administration is therefore not recommended.
Use in elderly: Clinical experience has not identified relevant 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.