Relubin Special Precautions

Vinorelbine Tartrate must only be administered by the intravenous route.
lt is extremely important that the intravenous needle or catheter be properly positioned before any Vinorelbine Tartrate is injected. Leakage into surrounding tissue during intravenous administration of Vinorelbine Tartrate 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 Vinorelbine, institutional guidelines may be used. The ONS chemotherapy guidelines provide additional recommendations for the prevention of extravasations injuries.
Treatment should be undertaken with close haematological monitoring (determination of haemoglobin level and number of leukocytes, granulocytes and platelets before each new injection); if the neutrophil count is below 1,500/mm³ and/or the platelet count is below 75,000/mm³, then the treatment should be delayed until recovery.
If there is severe hepatic impairment the dose should be reduced.
In case of renal impairment, no dose modification is necessary because of the low level of renal excretion.
Vinorelbine Tartrate should not be given concomitantly with radiotherapy if the treatment field includes the liver.
All contact with the eyes should be strictly avoided: risk of severe irritation and even corneal ulceration if the drug is sprayed under pressure. Immediate abundant rinsing of the eye with normal saline solution is recommended in case of contact.
Special core should be taken for patients with history of ischemic cardiac disease.
lf patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out.
Patients treated with Vinorelbine Tartrate should be frequently monitored for myelosuppression both during and after therapy.
Reported cases of interstitial pulmonary changes and ARDS occurred in patients treated with Vinorelbine Tartrate, in combination with Mitomycin. The meantime to onset of these symptoms after Vinorelbine Tartrate 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.
Vinorelbine Tartrate has been reported to cause severe constipation (e.g. grade 3-4) such as paralytic ileus.
If severe adverse events occur, Vinorelbine Tartrate should be reduced in dosage or discontinued and appropriate corrective measures taken. Reinstitution of therapy with Vinorelbine Tartrate should be carried out with caution and alertness as to possible recurrence of toxicity.
Vinorelbine Tartrate should be used with 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 or pre-existing neuropathy, regardless of etiology, should be monitored for new or worsening signs and symptoms of neuropathy while receiving Vinorelbine Tartrate.
Effects on ability to drive and use machines: Vinorelbine Tartrate 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.