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DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special
(Storage Prior to Use, With: Stability Precautions/Notes
Manufacturer, Preservative
Status)
Leucovorin
1 3 3
50 mg/5 mL N/A 10 mg/mL 5 mL vial: discard syringe 7 d F,
2 3,4
500 mg/50 mL unused portion 48 h RT
(Hospira)
1
(F)(PFL) 50 mL vial: 8 h
1
no preservative 0.05-10 mg/mL 24 h RT in NS, D5W,
NS, D5W, Ringer’s, Lactated Ringer’s,
1
Lactated Ringer’s, Ringer’s
1,2
D10W, D5NS
8 h RT in D10W, D5-
1
(e.g., 50-250 mL*) NS
5
0.06 - 0.4 mg/mL NS, 24 h RT in NS
5
D5W
5
12 h RT in D5W
Melphalan
12 12
50 mg 10mL supplied 5 mg/mL 2 h RT 0.1 – 0.45 mg/mL in complete
12 12
(GSK) diluent NS only administration within
(RT)(PFL) do NOT 60 min from time of
12
no preservative immediately after refrigerate (e.g., greater than 45 initial reconstitution at
10
adding diluent, mg and less than or RT
12
shake vigorously equal to 110 mg in
250 mL NS)*
record time of
reconstitution
Methotrexate
14 10,15,16
50 mg/2mL N/A 25 mg/mL 50mg: discard syringe 2 d F, RT - for high-dose
14
500 mg/20mL unused portion regimens (e.g., 1-
2
1 g/40mL 12 g/m as a single
22 22 17-21
5 g/200mL 500mg, 1 g, 5 g: 0.4–2 mg/mL 24 h RT dose) : use
14
(Hospira) 8 h F, RT 100 mL* NS, D5W preservative-free
10
(RT)(PFL) methotrexate
14
no preservative - do not use for IT
injection
2,22,23
high dose (e.g., 1-12 24 h RT
2
g/m as a single
17-21
dose) : 1000 mL*
NS
Methotrexate
14 14 26
IT Injection : N/A 25 mg/mL discard unused qs to 6 mL with use within 4 h of initial - auxiliary label :
14 25 7,10
Only preservative free portion preservative free NS puncture “IT”
methotrexate may be - label to include
administered by the route in full (i.e.,
14
intrathecal route INTRATHECAL
24
50 mg/2mL injection) attached
(Hospira) to both syringe and
26
(RT)(PFL) outer ziplock bag
14
no preservative
Mitomycin
29 29 29 29
20 mg 40 mL SWI 0.5 mg/mL 6 h RT, 72 h F syringe 6 h RT, 72 h F
(Teva)
29 29 29
(RT)(PFL) shake well **(PFL) **(PFL)
29
no preservative
Mitomycin
29 29 29 29
intravesical 40 mL SWI 0.5 mg/mL 6 h RT, 72 h F syringe 6 h RT, 72 h F
20 mg
29 29 29
(Teva) shake well **(PFL) **(PFL)
(RT)(PFL)
29
no preservative
30 30
10 mL SWI 2 mg/mL use immediately syringe use immediately after - may precipitate
after preparation preparation to prevent due to low
29 31 31,32
shake well to prevent precipitation solubility
31
precipitation - do NOT
31
refrigerate
mitoXANTRONE
33 33 33
20 mg/10 mL N/A 2 mg/mL discard unused NS, D5W 24 h RT
33
(Fresenius Kabi) portion
(RT) Greater than or equal
33 33
no preservative to *50 mL
mitoXANTRONE
34 34 34
20 mg/10 mL N/A 2 mg/mL discard unused 0.2-0.6 mg/mL NS: 24 h F, RT
34
25 mg/12.5 mL portion
34 34
(Hospira) NS, D5W **(PFL)
(RT)(PFL)
34
no preservative Greater than or equal
34
to *50 mL
mitoXANTRONE
35 35 35
20 mg/10 mL N/A 2 mg/mL discard unused NS, D5W 24 h RT
35
(Teva/Novopharm) portion
36
(RT)(PFL) Greater than or equal **(PFL)
35 35
no preservative to *50 mL
oBINutuzumab
39 39,40
1000 mg/40 mL N/A 25 mg/mL discard unused 100 mg: 24 h F, 48 h RT -once removed
2 39
(Hoffman-La Roche) portion in 100 mL NS from the fridge,
**
(F)(PFL) diluted product is
do not shake 900 mg: stable for an
39 39
no preservative in 250 mL NS additional 48 h
39,40
RT
39
1000 mg: - do NOT shake
39
in 250 mL NS - do NOT use
dextrose containing
39
solutions
multidose vial:
41 41 41 41
1000 mcg/5 mL 200 mcg/mL 15 d F NS 24 h RT
(Omega)
(F)(PFL) volume adjusted to
41
preservative ensure a continuous
infusion of octreotide
41
at 25 mcg/hour
Octreotide
42
50 mcg/mL N/A 50 mcg/mL discard unused SC syringe single use vials: use
42
100 mcg/mL 100 mcg/mL portion within 4 h
42
500 mcg/mL 500 mcg/mL
(Teva/Novopharm) multidose vials: use
28,42
(F)(PFL) within 14 d F
42
no preservative
Octreotide
10,46 45
(SANDOSTATIN®) N/A 50 mcg/mL discard unused 50-100 mL 24 h RT
45
50 mcg/1 mL 100 mcg/mL portion
43 45
100 mcg/1 mL 500 mcg/mL NS
500 mcg/1 mL
(Novartis) SC infusion: adjust
(F)(PFL) volume to ensure
43
no preservative infusion rate of 25
45
mcg/h
Octreotide
(SANDOSTATIN LAR®) 2 mL supplied 10 mg: 5 mg/mL discard unused deep intragluteal use within 4 h of initial - do NOT shake
45 45 7,45
10 mg diluent portion administration only reconstitution
20 mg 20 mg: 10 mg/mL
30 mg gently run 2 mL
45
(Novartis) down sides of the 30 mg: 15 mg/mL
(F)(PFL) vial; do NOT disturb
44
no preservative for 2–5 min, then
45
swirl moderately
record time of
reconstitution
Olaratumab
48 48
500 mg/50 mL N/A 10 mg/mL discard unused dilute to a final complete - do NOT shake
2,48
(Lilly) portion volume of 250 mL administration within
48
(F)(PFL) NS 24 h F, plus an
48
do not shake additional 12 h RT
48
no preservative do NOT use D5W or
other dextrose
48
containing solutions
48
gently invert to mix
do NOT use
aluminum-containing
49
needle and syringe
Oxaliplatin
50
50 mg/10 mL N/A 5 mg/mL discard unused 250-500 mL D5W 0.2-0.4 mg/mL: - do NOT use
50 50
100 mg/20 mL portion (0.2-0.7 mg/mL 24 h RT aluminum-
200 mg/40 mL or containing needle,
50
(Hospira/Pfizer) do NOT use NS or 5 d F plus an syringe or tubing
50,52
(RT) other chloride- additional 8 h RT
50 51
no preservative containing solutions
0.5–2 mg/mL:
do NOT use 24 h RT
aluminum-containing or
51
needle and syringe 14 d F plus an
50,52
additional 8 h RT
do NOT use
aluminum-containing
53
needle and syringe
Oxaliplatin
51 2,56 51
50 mg/10 mL N/A 5 mg/mL 2 d F, RT 0.2-0.7 mg/mL 0.2-2 mg/mL:
51
100 mg/20 mL 24 h RT, 48 h F
51
150 mg/30 mL 250-500 mL D5W
200 mg/40 mL
(Sandoz) do NOT use NS or
(RT)(PFL) other chloride-
51 51
no preservative containing solution
do NOT use
aluminum-containing
51
needle and syringe
do NOT use
aluminum-containing
57
needle and syringe
PACLitaxel
58
30 mg/5 mL N/A 6 mg/ mL 30 mg/5 mL or 0.3-1.2 mg/mL in NS, complete - use non-DEHP
58
100 mg/16.7 mL 100 mg/16.7 mL D5W, D5NS, D5LR administration within bag and tubing with
58
300 mg/50 mL vial: 27 h RT 0.22 micron in-line
2,58 58
(Accord) 48 h RT (e.g., 100-1000 mL)* filter
(RT)(PFL) - avoid excessive
58 58
no preservative 300 mg/50 mL shaking
vial:
58
24 h RT
62
0.012-0.12 mg/mL in 16 h RT
64
NS
PACLitaxel
67 2,67,68
30 mg/5 mL N/A 6 mg/mL 48 h RT 0.3-1.2 mg/mL in NS, complete - use non-DEHP
67
100 mg/16.7 mL D5W, D5NS, D5LR administration within bag and tubing with
67
150 mg/25 mL 27 h RT 0.22 micron in-line
67
300 mg/50 mL (e.g., 100-1000 mL)* filter
(Hospira)
(RT)(PFL)
66
preservative
Pamidronate
30 mg/10 mL N/A 3 mg/mL discard unused 0.06–0.36 mg/mL NS, 24 h F followed by 24 h - do NOT mix with
73 73 73
60 mg/10 mL portion D5W RT (total 48 h) calcium containing
90 mg/10 mL 6 mg/mL solution (e.g.,
73 73
(Hospira) **(PFL) Ringer’s)
73 74
(RT) 9 mg/mL (e.g., 250 mL* NS)
73
no preservative
Pamidronate
76 76 76
30 mg/10 mL N/A 3 mg/mL discard unused NS; D5W 24 h RT - do NOT mix with
76
60 mg/10 mL portion calcium containing
76
90 mg/10 mL 6 mg/mL Less than or equal to solutions
76
(Fresenius Kabi) 0.36 mg/mL
76
(RT) 9 mg/mL
76
no preservative
Pamidronate
77 77 77
30 mg/10 mL N/A 3 mg/mL discard unused NS; D5W 24 h RT - do NOT mix with
77,28
60mg/10 mL portion calcium containing
90 mg/10 mL 6 mg/mL solution (e.g.,
77
(Sandoz Canada) Ringer’s)
77
RT 9 mg/mL
77
no preservative
pegaspargase
80
(PEG-asparaginase) N/A 750 units/mL discard unused IM: syringe: - discard cloudy
80 80
(pegylated portion max volume: discard at end of solution
2,80 80
asparaginase E. coli) 2 mL in children and day - do not shake
3750 units/5 mL adolescents; - do not use if
(Baxalta) 3 mL in adults stored out of
(F)(PFL) refrigerator for
80 81
no preservative if volume greater than greater than 48 h
above, use multiple - do not use if
80 81
sites previously frozen
IV: bag:
80
100 mL NS, D5W complete
administration within
81
48 h F
Pembrolizumab
82 82 82
50 mg 2.3 mL SWI 25 mg/mL 6 h RT, 24 h F 1-10 mg/mL NS, complete - use 0.2 to 5
82
(Merck) D5W administration within 6 micron in-line
82 83
(F) direct diluent against h RT, 24 h F filter
82
no preservative side of vial during mix by gentle - allow
82
reconstitution to inversion reconstituted vials
82
avoid foaming and diluted
solutions to come
82
allow up to 5 to RT prior to use
minutes for bubbles - vials can be at RT
82
to clear for up to 24 h prior
82
to use
82
do NOT shake - vials contain 20%
82
overfill
Plerixafor
87 87 28,88
24 mg/1.2 mL N/A 20 mg/mL discard unused SC syringe 48 hours RT
87
(sanofi-aventis) portion
(RT)
87
no preservative
Porfimer
89 89
15 mg 15 mg: 6.6 mL D5W 2.5 mg/mL 24 h F syringe use within 4 h of initial - avoid contact with
7,90
75 mg reconstitution skin and eyes;
89
(Axcan) 75 mg: 31.8 mL **(PFL) protect exposed
89 89 89
(RT)(PFL) D5W **(PFL) area from light
89
no preservative
record time of
reconstitution
Ramucirumab
92 92 92
100 mg/10 mL N/A 10 mg/mL discard unused 250 mL* NS 4 h RT, 24 h F - use 0.22 micron
92 92
500 mg/50 mL portion filter
93
(Eli Lilly) (0.4 – 4 mg/mL) - do NOT use
(F)(PFL) dextrose containing
92 92
(do not shake) gently invert to mix solutions
92
no preservative
92
do NOT shake
riTUXimab
94 95,96
100 mg/10 mL N/A 10 mg/mL discard unused 1-4 mg/mL NS, 24 h F, 12 h RT - once removed
94 94
500 mg/50 mL portion D5W from the fridge,
(Roche) compounded
(F)(PFL) (e.g., 250-500 mL)* product is stable
94 95,96
no preservative for 12h RT
riTUXimab
97 97 97
subcutaneous N/A 120 mg/mL discard unused SC syringe 48 h F plus 8 h RT - contains
97 97
1400 mg/11.7 mL portion hyaluronidase
(Roche)
(F)(PFL)
97
no preservative
Siltuximab
101 101 101
100 mg 100 mg: 20 mg/mL 2 h RT 250 mL D5W complete - use 0.2 micron in-
101 101
400 mg 5.2 mL SWI administration within line filter
101
(Janssen) dilute to 250 mL final 6 h RT
(F)(PFL) 400 mg: volume by
101 101
no preservative 20 mL SWI withdrawing volume
from bag equal to
allow vial to come to volume of drug to be
101
room temperature added
prior to use (~30
101
minutes)
Temsirolimus
103,104 103,104 103,104
30 mg/1.2 mL 1.8 mL supplied 10 mg/mL 24 h RT 250 mL NS complete - use non-DEHP
103,104
(Wyeth) diluent administration within 6 bag and tubing with
103,104 103 103,104 103,104
(F)(PFL) **(PFL) h in-line filter
105
no preservative
Teniposide
106
50 mg/5 mL N/A 10 mg/mL discard unused 50 – 500 mL NS or 0.1-0.4 mg/mL: 24 h - do not refrigerate
106
(BMS) portion D5W for a final RT - use non-DEHP
106
(RT) concentration of 0.1-1 bag and tubing
106 106
preservative mg/mL 1 mg/mL: complete - do not use if
106,107
administration within 4 precipitates
h of preparation - contains DMA***
106,107
RT - excessive
agitation may
cause
106
precipitation
Thiotepa
108 108 25
IT injection diluents containing 10 mg/mL 8hF qs to 6 mL with use within 4 h of initial - auxiliary label :
108,109
15 mg preservatives should preservative free reconstitution “IT”
112
(Bedford) NOT be used for NS - label to include
108,110
(F)(PFL) intrathecal **(PFL) route in full (i.e.,
108
no preservative administration INTRATHECAL
injection) attached
108
1.5 mL SWI to both syringe and
25
outer ziplock bag
filter through 0.22 - do not use if
108
micron filter precipitates or
108
remains opaque
record time of
reconstitution
Topotecan
114 114 114 114
4 mg N/A 1 mg/mL discard unused 0.02–0.5 mg/mL 24 h F, RT
115
(Hospira) portion
(F)(PFL) 50-100 mL NS,
114 115
no preservative D5W
Topotecan
116 116 116 116 116
4 mg 4 mL SWI 1 mg/mL 24 h F, RT 0.02 – 0.5 mg/mL 24 h F, RT
(Mylan)
(RT)(PFL) 50-100 mL NS,
116 116
no preservative D5W
Topotecan
117 117
4 mg/4 mL N/A 1 mg/mL discard unused 0.02-0.5 mg/mL 24 h F
117
(Sandoz) portion
117
(F)(PFL) 50-100 mL NS, **(PFL)
117 117
no preservative D5W
vinBLAStine
130
10 mg/10 mL N/A 1 mg/mL discard unused 25-50 mL NS, use within 4 h of initial - auxiliary label:
130 125,131 2
(Teva) portion D5W puncture WARNING: FOR
(F)(PFL) INTRAVENOUS
130
no preservative USE ONLY –
FATAL IF GIVEN
BY OTHER
128,129
ROUTES
Vinorelbine
135 135 135
10 mg/1 mL N/A 10 mg/mL discard unused 0.5-2.0 mg/mL 24 h F, RT - auxiliary label:
135
50 mg/5mL portion WARNING: FOR
(Fresenius Kabi) NS, D5W, ½NS, INTRAVENOUS
(F)(PFL) D5½NS, Ringer’s, USE ONLY –
135 135
no preservative Ringer’s Lactate FATAL IF GIVEN
BY OTHER
128,129
ROUTES
Vinorelbine
137 137 137
10 mg/1 mL N/A 10 mg/mL discard unused 0.5–2.0 mg/mL 24 h F, RT - auxiliary label:
137
50 mg/5 mL portion WARNING: FOR
(Teva) 50 mL* NS, D5W, INTRAVENOUS
(F)(PFL) ½NS, D5½NS, USE ONLY –
137
no preservative Ringer’s, Ringer’s FATAL IF GIVEN
137
Lactate BY OTHER
128,129
ROUTES
Zoledronic acid
139 139 139
(ZOMETA) N/A 0.8 mg/ mL discard unused 100 mL NS, D5W complete infusion - do NOT mix with
2
4 mg/ 5 mL portion within 24 h of calcium containing
139 139
(Novartis) preparation solutions
(RT)
139
no preservative Refrigerate diluted
product if not used
immediately after
preparation; bring to
RT prior to
139
administration
* Suggested volume based on usual dose range and any concentration range of stability data
** Protect from light means minimizing exposure to direct sunlight over a storage period. More specific information on protection from light (eg, protecting container and tubing during
administration) will be indicated in the Under the Special Precautions/Notes column.
*** Contains DMA (N,N dimethylacetamide). Product may be incompatible with closed system transfer devices such as ChemoLock.
Centres are not to change the content locally but should forward suggestions to the Cancer Drug Manual staff.
Explanatory Notes
Stability data assumes products prepared using standard aseptic technique in biological safety cabinet at low risk for contamination according to the classification
141,142
outlined in USP 797.
Vial stability: Stability of solution after first puncture or reconstituted solution.
Storage temperature: If information states same stability with refrigerator and room temperature storage, then fridge stability is bolded as preferred (ie, to minimize
growth of micro-organisms).
Discard unused portion: Unused portion from single use vials should be discarded at the end of the day.
“overfill known” is stated if the manufacturer states overfill that is present is within acceptable limits.
“Complete administration within __” is stated if the manufacturer specifies that the infusion must be completed in a specific time frame following preparation,
usually including entire time required for preparation (from first puncture), storage, and administration of infusion.
References
1. Hospira Healthcare Corporation. LEUCOVORIN CALCIUM INJECTION® product monograph. Saint-Laurent, Quebec; 7 June 2007.
2. BC Cancer Agency. Pharmacy Policy Number II-20: Guiding Principles for Chemotherapy Preparation Chart. Vancouver, British Columbia: BC Cancer Agency; 19 September 2007.
3. John Korontzis. Personal communication. Regulatory Affairs Associate, Leucovorin Calcium, Mayne Pharma Canada; February 2005.
4. The United States Pharmacopeial Convention, Inc. General Chapter 797: Pharmaceutical compounding - sterile preparations. USP 27-NF 22. Rockville, Maryland: The United
States Pharmacopeial Convention, Inc.; 2003.
5. Teva Canada Limited. Leucovorin calcium injection® product monograph. Toronto, Ontario; 5 May 2014.
6. Novopharm Limited (Teva). LEUCOVORIN CALCIUM® Injection product information package. Toronto, Ontario; undated.
7. BC Cancer Agency. Pharmacy Policy Number II-20: Guiding Principles for Chemotherapy Preparation Chart. Vancouver, British Columbia: BC Cancer Agency; 6 January 2006.
8. Jenny Yeung. Personal communication. Medical Information Specialist, Teva Canada; 12 April 2017.
9. Ovation Pharmaceuticals Inc. MUSTARGEN® Package Insert. Deerfield, Illinois; October 2005.
10. Trissel LA. Handbook on Injectable Drugs. 13th ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc.; 2005.
11. Trissel LA. Handbook on Injectable Drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc.; 2003.
12. GlaxoSmithKline Inc. Alkeran Package Insert. Mississauga, Ontario; Montreal, Quebec; 2004.
13. Pharmaceutical Partners of Canada Inc. Mesna Package Insert. Richmond Hill, Ontario; November 2001.
14. Mayne Pharma Canada. Methotrexate Product Monograph. Montreal, Quebec; December 2003.
15. John Korontzis. Personal communication. Regulatory Affairs Associate, Methotrexate, Mayne Pharma Canada; February 2005.
16. John Korontzis. Personal communication. Regulatory Affairs Associate, Fluorouracil, Methotrexate, Vincristine, Mayne Pharma Canada; 14 March 2005.
17. BC Cancer Agency Miscellaneous Origins Tumour Group. (MOHDMTX) BCCA Protocol Summary for Treatment of Meningeal Disease (Miscellaneous Tumour Origins) using High
Dose Methotrexate with Leucovorin Rescue. Vancouver, British Columbia: BC Cancer Agency; 1 Jan 2013.
18. BC Cancer Agency Sarcoma Tumour Group. (SAHDMTX) BCCA Protocol Summary for Treatment of Osteosarcoma Using High Dose Methotrexate with Leucovorin Rescue.
Vancouver, British Columbia: BC Cancer Agency; 1 Nov 2012.
19. BC Cancer Agency Lymphoma Tumour Group. (LYHDMRP) BCCA Protocol Summary for Treatment of Primary Intracerebral Lymphoma with High Dose Methotrexate and
riTUXimab. Vancouver, British Columbia: BC Cancer Agency; 1 Jun 2014.
20. BC Cancer Agency Lymphoma Tumour Group. (LYHDMTXP) BCCA Protocol Summary for Treatment of Primary Intracerebral Lymphoma with High Dose Methotrexate.
Vancouver, British Columbia: BC Cancer Agency; 1 Jun 2014.
21. BC Cancer Agency Lymphoma Tumour Group. (LYHDMTXR) BCCA Protocol Summary for Treatment of Leptomeningeal Lymphoma or Recurrent Intracerebral Lymphoma with
High Dose Methotrexate. Vancouver, British Columbia: BC Cancer Agency; 1 Jun 2014.
22. Hospira Healthcare Corporation. Methotrexate Injection USP® product monograph. Saint-Laurent, Quebec; 27 June 2012.