VINORELBINE Concentrate for solution for infusion Ref.[9077] Active ingredients: Vinorelbine

Vinorelbine must be administered under the supervision of a doctor experienced in the use of chemotherapy.

Posology

Non-small cell lung cancer

In monotherapy the usual dose given is 25-30 mg/m² once weekly. In combination chemotherapy the usual dose (25-30 mg/m²) is usually maintained, while the frequency of administration is reduced e.g. day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol.

Metastatic breast cancer

The usual dose given is 25-30 mg/m² once weekly."

Maximum tolerated dose per administration: 35.4 mg/m² of body surface area.

Maximum total dose per administration: 60 mg.

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)

Dose adjustment

Vinorelbine metabolism and clearance are mostly hepatic: only 18.5% is excreted unchanged in the urine. No prospective study relating altered metabolism of the active substance to its pharmacodynamic effects is available in order to establish guidelines for vinorelbine dose reduction in patients with impaired liver or kidney function.

Patient with liver impairment

The pharmacokinetics of vinorelbine is not modified in patients presenting with moderate or severe liver impairment. Nevertheless as a precautionary measure a reduced dose of 20mg/m² and close monitoring of haematological parameters is recommended in patients with severe liver impairment (see sections 4.4 and 5.2).

Patient with renal impairment There is no pharmacokinetic basis for reducing the vinorelbine dose in patients with renal dysfunction.

Paediatric population

The safety and efficacy in children and adolescents have not been demonstrated and administration is therefore not recommended.

Method of administration

For intravenous use only. Strictly by intravenous injection through an infusion line, after appropriate dilution.

Use of the intrathecal route is contraindicated.

For instructions on dilution of the product before administration and other handling, see section 6.6.

Vinorelbine solution may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution.

Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.

Symptoms

A Vinorelbine solution overdose can cause bone marrow hypoplasia, which is sometimes accompanied by infection, fever and paralytic ileus.

Emergency procedures

General supportive measures should be taken in conjunction with a blood transfusion and broad spectrum antibiotic therapy, according to the doctor’s criterion.

Antidote

There is no known antidote for a Vinorelbine solution overdose.

Shelf life

Unopened packaging: 2 years.

Shelf-life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not freeze.

Store in a refrigerator (2°C-8°C). Do not freeze.

Store in the original package in order to protect from light.

Storage conditions for the diluted medicinal product, see section 6.3.

Vinorelbine solution is packaged in Type I clear glass vial with bromobutyl rubber stopper and aluminium flip off blue seal.

Vinorelbine solution is available in:

Vial – 1 unit(s) - 1 ml
Vial – 1 unit(s) - 5 ml

Not all pack sizes may be marketed.

Only trained staff should carry out the preparation and administration of Vinorelbine solution. Precautions should be taken into account to avoid exposing staff during pregnancy.

Suitable safety equipment, eye protection, disposable gloves, facemask and disposable apron should be worn. Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended). Excreta and vomit must be handled with care.

Spills and leakages must be wiped up. All contact with the eye must be strictly avoided. Immediate washing of the eye with normal saline solution should be undertaken if any contact occurs. On completion, any exposed surface should be thoroughly cleaned and hands and face washed. There is no incompatibility between Vinorelbine solution and clear glass vials, PVC or vinyl acetate bags, or infusion sets with PVC tubing. Vinorelbine solution may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution. Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.

Vinorelbine solution should only be given intravenously. It is very important to make sure that the cannula is accurately placed in the vein before the injection is commenced. If Vinorelbine solution infiltrates the surrounding tissue during intravenous administration, a substantial irritation may occur. In this case, the injection should be stopped, the vein flushed with normal saline solution and the rest of the dose should be administered in another vein. In the event of extravasation, glucocorticoids could be given intravenously to reduce the risk of phlebitis.

Any unused product or waste material should be disposed of in accordance with local requirements.