Vinorelbine (single agent)
Cumbria, Northumberland, Tyne & Wear Area Team
DRUG ADMINISTRATION SCHEDULE
Day
Day 1
and
Day 8
Drug
Sodium Chloride 0.9%
Daily Dose
500ml
Metoclopramide
10mg
Vinorelbine
Route
Infusion
Diluent
Oral
25 to 30mg/m² IV Infusion
Rate
Fast Running
NA
NA
50ml Sodium
Chloride 0.9%
Very Slow
(5 mins)
CYCLE LENGTH AND NUMBER OF DAYS
21 day cycle Day 1 & Day 8, rest Day15
APPROVED INDICATIONS
As a single agent or in combination with trastuzumab for the treatment of advanced
breast cancer stage 3/4 relapsing after or refractory to an anthracycline containing
regimen.
EXCLUSION CRITERIA
Patients suffering pain on administration must be offered oral vinorelbine.
PREMEDICATION
As above
RECOMMENDED TAKE HOME MEDICATION
Metoclopramide 10 mg three times daily as required
INVESTIGATIONS / MONITORING REQUIRED
FBC, U&E and LFT’s prior to each cycle
FBC Day 8
ASSESSMENT OF RESPONSE
Metastatic: Tumour size and patient symptomatic response
REVIEW BY CLINICIAN
To be reviewed by either a Nurse, Pharmacist or Clinician before every cycle.
NURSE / PHARMACIST LED REVIEW
On day 8 each cycle
ADMINISTRATION NOTES
•
•
•
Vinorelbine IV may cause pain and venous irritation therefore the oral version is
preferred.
Vinorelbine is for intravenous administration only. Administration by other routes
may be fatal.
Prior to starting Vinorelbine ensure the venous access device is sufficiently
patent by flushing well with Sodium Chloride 0.9%. If there is doubt about the
patency of the access device it must not be used.
BOO1-Vinorelbine-IV-protocol-CRP09-v1.3
Issued 29 May 2014
Page 1 of 3
Expiry Date: 29 May 2016
Vinorelbine (single agent)
Cumbria, Northumberland, Tyne & Wear Area Team
•
•
•
Vinorelbine is highly vesicant –during administration a nurse should remain with
the patient and observe the infusion site carefully for signs of extravasation. If
extravasation is suspected the infusion must immediately be stopped and
appropriate treatment started (see extravasation policy).
Following administration of vinorelbine flush well with Sodium Chloride 0.9%
Maximum total dose of vinorelbine per administration is 60mg
EXTRAVASATION
See NECN/ Local Policy Vinorelbine is a vesicant
TOXICITIES
•
•
•
•
•
•
•
•
Rare anaphylaxis
Severe venous irritation, discoloration and/or pain during injection
Nausea & Vomiting
Constipation
Peripheral Neuropathy
Fatigue, Myalgia
Alopecia (Rare/mild)
Myelosuppression (Neutropenia common)
DOSE MODIFICATION / TREATMENT DELAYS
Haematological Toxicity:
Day One:
Proceed if neutrophil count > 1.5, WBC > 3.0, plts >100, unless directed by an
Oncology specialist.
Delay 1 week on DAY 1 if:WCC
< 3.0
PLT
<100
ANC
< 1.5
Day Eight
Proceed on if neutrophil count > 1.0, plts >100, unless directed by an Oncology
specialist.
Omit treatment On DAY 8 if:PLT
< 100
ANC
< 1.0
NB On Day 8 of the cycle patients whose bloods are not at the required level will
miss that dose and proceed to the next cycle of treatment as planned
•
•
•
If WCC, Platelets or ANC still below required levels for treatment at after one
week delay , delay treatment again and patient will need assessed and
chemotherapy dose reduced by Oncologist
If Hb < 10 & patient symptomatic will need blood transfusion, but may proceed
with chemotherapy as planned if performance status (PS) stable.
If pre-treatment U&E’s & LFT’s abnormal, delay treatment 1 week and discuss
with Oncologist as may need dose reduction, patient will miss that dose and
proceed to next dose of chemotherapy as planned.
BOO1-Vinorelbine-IV-protocol-CRP09-v1.3
Issued 29 May 2014
Page 2 of 3
Expiry Date: 29 May 2016
Vinorelbine (single agent)
Cumbria, Northumberland, Tyne & Wear Area Team
Non- Haematological Toxicity:
If PS deteriorates to 3 or 4 and on assessment patient is more symptomatic withhold
treatment and discuss with Oncologist
TREATMENT LOCATION
Can be given at Cancer Centre or Cancer Unit
REFERENCES:
• Jones S, Winer E, Vogel C et al. (1995) Randomized comparison of vinorelbine
and melphalan in anthracycline-refractory advanced breast cancer. J Clin Oncol.
13: 2567-74.
• Tresca P, Fumoleau P, Roche H et al. (1990) Vinorelbine: a new active drug in
breast carcinoma. Results of an Artac phase ll trial. Breast Cancer Res Treat. 16:
161 (abstract).
• Zelek L, Barthier S, Riofrio M et al. (2001) Weekly vinorelbine is an effective
palliative regimen after failure with anthracyclines and taxanes in metastatic
breast carcinoma. Cancer. 92: 2267
• National Patient Safety Agency. NPSA RRR004 Using Vinca Alkaloid Minibags
(Adult/Adolescent Units) August 2008
Document Control
Document Title:
Vinorelbine IV NECN protocol CRP09 B001
Document No:
CRP09 B001
Author:
Approved by:
Current
Version:
Steve Williamson, Consultant Pharmacist
Approval
Signature*
Calum Polwart, Cancer Pharmacist
Alison Humphreys, Consultant Oncologist
Date
Approved:
1.3
29 May 2014
Due for Review:
29 May 2016
Summary of
Changes
1.1
Reformatted from old NCN/CCA version
1.2
Typing errors corrected and protocol reviewed
1.3
Protocol reviewed and reissued, Antiemetic advice updated
BOO1-Vinorelbine-IV-protocol-CRP09-v1.3
Issued 29 May 2014
Page 3 of 3
Expiry Date: 29 May 2016