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Detail-Document #241014

−This Detail-Document accompanies the related article published in−


PHARMACIST’S LETTER / PRESCRIBER’S LETTER
October 2008 ~ Volume 24 ~ Number 241014

Stability of Refrigerated and Frozen Drugs


(Last modified November 2008)
(Based on Canadian Product Monographs and relevant studies)
Failure to follow storage recommendations of pharmaceutical products can result in subpotent products and potentially, therapeutic failure.1-3 In
addition, hundreds of thousands of medications are discarded each year because of improper storage conditions resulting in millions of dollars
wasted.1,2 This can occur for a variety of reasons including improper shipping, failure to refrigerate or freeze a product upon receipt or after use, and
in the event of a power failure. It is important to recognize when pharmaceutical products have not been stored according to the manufacturer’s
specifications and take appropriate action. Depending on the product, lot number and expiration date, time of exposure to temperatures outside of the
recommended range and actual temperature of exposure, some medications may be deemed suitable for administration while others should be
discarded. The following chart provides general guidelines for the room temperature stability of common medications and vaccines which are stored
in the refrigerator or freezer. However, if a pharmaceutical product has not been stored according to the recommended conditions, it is important to
contact the manufacturer and provide the specifics (lot number, expiration date, exposure temperature, length of time) to determine if the product is
viable. Health Canada provides guidelines for the proper storage and transportation of drug products that can be accessed on their website at
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069_temp_control_dproducts_storage_transportation_ltr-doc-eng.php.
Continue to the end of this chart for helpful tips on what to do during a power failure or when there is a potential for flooding.

• For a listing of Anti-infective Suspensions and their stability after reconstitution, see Detail-Document #231122

• For a listing of Insulin Products and their storage/stability information, see Detail-Document #220217

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Adalimumab Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Abbott Laboratories
(Humira) Keep in original carton until time of 1-866-8HUMIRA
administration. (1-866-848-6472)

Alprostadil injection Unreconstituted lyophilized sterile powder Manufacturer has no additional Pfizer Canada Inc.
(Caverject) (20 µg vials) should be stored at recommendations. 1-800-463-6001
2°C to 30°C. Do not freeze.

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 2 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Alprostadil injection Store in a refrigerator at 2ºC to 8°C. Contact manufacturer.*** Pfizer Canada Inc.
(Prostin VR) Prepare fresh dilutions every 24 hours. 1-800-463-6001
Discard any dilution more than 24 hours
old.
Alprostadil urethral Refrigerate unopened foil pouches at May be kept at room temperature Paladin
suppository 2ºC to 8°C. Do not expose to (below 30°C) for up to 14 days prior to 1-888-550-6060
(Muse) temperatures above 30°C. use.

Amphotericin B Refrigerate at 2ºC to 8ºC before May be stored in the dark at room Bristol-Myers Squibb
(Fungizone and others) reconstitution (lyophilized powder). temperature for 24 hours (reconstituted 1-866-463-6267
After reconstitution, refrigerated solution solution at concentration of 5 mg/mL,
(5 mg/mL concentration, diluted with diluted with Sterile Water for
Sterile Water for Injection) stable for one Injection).
week at 2ºC to 8ºC.
Becaplermin Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Janssen-Ortho
(Regranex) Off-label§ information indicates can be 1-800-567-3331
stored at room temperature (below
30ºC) for up to 6 days. Can be left for
short periods up to 20 minutes
repeatedly as long as it is put back in
the fridge as soon as possible.4

Calcitonin nasal Refrigerate at 2ºC to 8ºC. Stable for 2 weeks at room temperature Sanofi-Aventis
(Calcimar) (15°C to 30°C). 1-800-265-7927

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Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 3 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Calcitonin nasal Refrigerate unopened nasal spray at 2ºC to Store primed bottle at room Apotex (Apo-Calcitonin)
(Apo-Calcitonin, Miacalcin 8ºC. Protect from freezing. temperature (below 25°C) and use 1-800-667-4708
NS, Sandoz Calcitonin NS) within 4 weeks.
Novartis Pharmaceuticals
Canada Inc. (Miacalcin NS)
1-800-363-8883

Sandoz Canada Inc.


1-800-343-8839 ext 4636
Calcitonin injectable Refrigerate 100 IU/mL glass ampuls at Contact manufacturer.*** Ferring Inc.
(Caltine) 2ºC to 8ºC. Off-label§ information indicates stable 1-800-263-4057
at room temperature (25ºC) for 3
days.5
Chlorambucil Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** GlaxoSmithKline
(Leukeran) Off-label§ information indicates stable 1-800-387-7374
when maintained at up to 30oC for up
to one week.6

Darbepoetin alfa Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Amgen
(Aranesp) Discard if left at room temperature (up to Off-label§ information indicates 1-866-502-6436
25°C) for longer than 24 hours. unopened, prefilled syringe in original
cardboard packaging remains stable at
30oC for up to one week.7

Desmopressin Acetate Refrigerate at about 4°C. Do not freeze. Contact manufacturer.*** Ferring Inc.
(DDAVP Injection) Off-label§ information indicates that it 1-800-263-4057
is stable at 30°C up to 5 days.5

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 4 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Desmopressin Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** Ferring Inc.


(DDAVP Rhinyle Nasal Off-label§ information indicates that it 1-800-263-4057
Solution) is stable at 30°C up to 5 days.5

Dinoprostone cervical gel Refrigerate at 4°C. Do not freeze. Contact manufacturer.*** Paladin
(Prepidil Gel) 1-888-550-6060

Dinoprostone vaginal gel Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** Paladin


(Prostin E2 vaginal gel) 1-888-550-6060

Dinoprostone Refrigerate at 2ºC to 8ºC. Once bottle is Contact manufacturer.*** Paladin


(Prostin E2 tablets) opened, use tablets within 90 days. 1-888-550-6060
Dornase alfa recombinant Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** Hoffman-La Roche
(Pulmozyme) Should not be exposed to room 1-888-762-4388
temperatures for more than 24 hours
total. The solution should be discarded
if it is cloudy or discoloured.

Dronabinol Refrigerate at 2ºC to 8ºC in high density Contact manufacturer.*** Solvay Pharma
(Marinol) polyethylene containers. 1-800-268-4276

Epoetin alfa Refrigerate at 2ºC to 8ºC. Do not freeze or Contact manufacturer.*** Janssen-Ortho
(Eprex) shake. 1-800-567-3331

Estradiol/norethindrone Prior to dispensing, refrigerate at 2ºC to After dispensing, patches may be Novartis Pharmaceuticals
acetate transdermal system 8ºC. Patches stored in the refrigerator stored unrefrigerated at 20°C to 25°C 1-800-363-8883
(Estalis, Estalis-Sequi) after dispensing are good to the expiry and used within 6 months or before the
date. expiry date (whichever comes first).

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 5 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Estradiol-17-beta Store at 2ºC to 30ºC. Do not freeze. Contact manufacturer.*** Novartis Pharmaceuticals
(Estradot) 1-800-363-8883

Etonogestrel/ethinyl Prior to dispensing, refrigerate at 2ºC to After dispensing to the user, store for Organon
estradiol vaginal ring 8ºC. up to 4 months at 2°C to 30°C. 1-800-463-5442
(NuvaRing)
Estramustine Store at 2ºC to 25°C. Contact manufacturer.*** Pfizer Canada Inc.
(Emcyt) 1-800-463-6001

Etanercept injection Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Amgen
(Enbrel) Reconstituted solutions of Enbrel Off-label§ information indicates: 1-866-502-6436
§
prepared with the supplied Sterile Vial: 10 days out of fridge.7
§
Bacteriostatic Water for Injection, USP Pre-filled syringe: 4 days out of
(0.9% benzyl alcohol) may be stored in fridge.7
the original vial for up to 14 days at 2°C §
Auto-injector: 4 days out of fridge.7
to 8°C.
Filgrastim Refrigerate at 2ºC to 8ºC. Stable up to 24 hours at room Amgen
(Neupogen) temperature. 1-866-502-6436
Off-label§ information indicates that
stability is maintained during one time
exposure of the intact vials in the
cardboard box at a temperature of up
to 30ºC for up to 168 hours (1 week).
This is not a storage recommendation.7

Glatiramer acetate injection Refrigerate at 2°C to 8°C immediately Prefilled syringes can be stored at Teva Neuroscience
(Copaxone) upon receipt. Do not freeze. room temperature (15°C to 30°C) for 1-800-283-0034
up to 1 month.

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 6 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Hepatitis B Immune Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** Talecris (HyperHEP B S/D)
Globulin 1-877-252-8510
(HyperHEP B S/D, Cangene (HepaGam B)
HepaGam B) 1-877-CANGENE (226-4363)
Interferon alfa-2b Store Lyophilized Powder, Ready-to-Use Lyophilized Powder: Can be stored at Schering-Plough
(Intron A) Solution, and Multi-dose Pen at room temperature (up to 25°C) for up 1-800-463-5442
2°C to 8°C. Intron A Ready-to-Use to 4 weeks before use. If the product is
Solution should not be frozen. left at room temperature and is not
reconstituted during the 4-week period,
it should be discarded.

Ready-to-Use Solution: When


transporting, the solution can be kept
at room temperature (up to 25°C) for
up to 7 days before use. Ready-to-Use
Solution can be put back in the
refrigerator at any time during this 7-
day period. If the product is not used
during the 7-day period, it should be
discarded.

Multi-dose Pen: A maximum total of


48 hours (2 days) of exposure at room
temperature (15°C to 25°C) is
permitted over the 4-week use period.

For other stability instructions, see


product monograph.

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 7 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Interferon beta-1a Refrigerate vials at 2°C to 8°C. Lyophilized powder vial: Biogen Idec
(Avonex) Refrigerate prefilled syringes at 2°C to Up to 25°C for 30 days 1-866-477-3462
8°C. Once removed from the refrigerator,
the prefilled syringe should be allowed to
warm to room temperature and used
within 12 hours.
Interferon beta-1a Refrigerate at 2ºC to 8ºC. Do not freeze. Prefilled syringes: Up to 25°C for one EMD Serono
(Rebif) month. 1-888-737-6668

Latanoprost Refrigerate unopened bottles prior to Opened, bottle may be stored at room Pfizer Canada Inc.
(Xalatan) dispensing at 2°C to 8°C. temperature up to 25°C, for up to 1-800-463-6001
6 weeks.
Off-label§ information indicates
unopened bottle stable at 25oC for 12
months.8

Lopinavir/ritonavir solution Refrigerate at 2ºC to 8ºC until dispensed. 42 days at 25°C. Abbott Laboratories
(Kaletra) 1-800-361-7852

Melphalan tablets Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** GlaxoSmithKline


(Alkeran) Off-label§ information indicates stable 1-800-387-7374
when maintained at up to 30oC for up
to one week.6

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 8 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Octreotide Refrigerate at 2ºC to 8ºC. Ampoules and Vials: For day-to-day Novartis Pharmaceuticals
(Sandostatin, Sandostatin use, may be stored at room 1-800-363-8883
LAR) temperature for up to 2 weeks.

Undiluted LAR vials: May remain at


room temperature on the day of the
injection but must be used immediately
following reconstitution.

Peginterferon alfa-2a Refrigerate at 2°C to 8ºC. Do not freeze. Contact manufacturer.*** Hoffman-La Roche
(Pegasys) 1-888-762-4388
Peginterferon alfa-2b Pegetron vials: Refrigerate at 2°C to 8°C. Contact manufacturer.*** Schering-Plough
(Pegetron) Administer within 3 hours of 1-800-463-5442
reconstitution or within 24 hours when
prepared under aseptic conditions.
Pegetron Redipen: Refrigerate at 2°C to
8ºC. After reconstitution, the solution
should be used immediately, but may be
stored up to 24 hours at 2°C to 8°C.
Proparacaine ophthalmic Refrigerate at 2ºC to 8ºC. Contact manufacturer.*** Alcon
solution (Alcaine) §
Off-label information indicates stable 1-800-613-2245
for 12 hours at room temperature. Do
not use if solution is darker than a pale
yellow.9

Ritonavir capsules Refrigerate at 2°C to 8ºC until dispensed. 30 days at temperatures up to 25°C. Abbott Laboratories
(Norvir SEC) Stable until expiration date if stored in 1-800-361-7852
refrigerator.

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Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 9 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Sirolimus oral solution Refrigerate at 2°C to 8ºC. Do not freeze. Opened bottles at room temperature Wyeth Pharmaceuticals
(Rapamune) (15°C to 30°C) for up to 5 days. 1-800-734-5001

Teriparatide Refrigerate at 2°C to 8ºC. Minimize time Contact manufacturer.*** Eli Lilly
(Forteo) out of refrigerator during use. Discard if 1-800-545-5979
frozen.

Trifluridine Refrigerate at 2°C to 8ºC. Contact manufacturer.*** Theramed Corporation


(Viroptic) 1-800-305-4441

Vaccines
Bacillus Calmette-Guérin Refrigerate at 2ºC to 8ºC. Discard if Contact manufacturer.*** Sanofi Pasteur
Connaught substrain, exposed to freezing. Reconstituted 1-888-621-1146
attenuated strain of vaccine should be kept at 2ºC to 8ºC. Any
Mycobacterium bovis reconstituted vaccine not used within
(BCG Vaccine, freeze- 8 hours must be discarded.
dried)

Cholera, oral, inactivated Refrigerate at 2ºC to 8ºC. Do not freeze. Store at room temperature (<27°C) for Sanofi Pasteur
and travellers' diarrhea After reconstitution the vaccine should be up to two weeks on one occasion only. 1-888-621-1146
vaccine used within 2 hours. The sodium hydrogen carbonate sachet
(Dukoral) may be stored separately at room
temperature (<27°C).

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 10 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Haemophilus b conjugate Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Merck Frosst
vaccine (meningococcal Maintain at 2ºC to 8ºC during shipment to 1-800-567-2594
protein conjugate) ensure potency.
(Liquid PedvaxHIB)
Haemophilus b conjugate Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
vaccine (tetanus protein- if exposed to freezing. Use immediately 1-888-621-1146
conjugate) after reconstitution.
(Act-HIB)
Haemophilus b conjugate Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
vaccine (tetanus protein if exposed to freezing. 1-888-621-1146
conjugate), diphtheria,
tetanus toxoids, acellular
pertussis vaccine adsorbed,
and inactivated
poliomyelitis vaccine
(Pediacel)

Haemophilus b conjugate Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
vaccine (tetanus protein- if exposed to freezing. Use immediately 1-888-621-1146
conjugate) reconstituted after reconstitution.
with component pertussis
vaccine, diphtheria, tetanus
toxoids adsorbed, and
inactivated poliomyelitis
vaccine
(Pentacel)

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 11 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Hepatitis A Vaccine, Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
Inactivated if exposed to freezing. 1-888-621-1146
(Avaxim, Avaxim Pediatric)

Hepatitis A Vaccine, Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** GlaxoSmithKline
Inactivated if it has been frozen. Off-label§ information indicates stable 1-800-387-7374
(Havrix, Havrix Junior) for 72 hours at temperatures between
8ºC to 25ºC.6
(Note: Older product monographs
stated potency of unopened vaccine is
not significantly affected after
exposure at 37°C for up to 3 weeks.
This information was based on
stability studies from the time of
manufacture and was not intended for
the dispensed product. Statement no
longer appears in 2008 monograph.)
Hepatitis A vaccine Refrigerate at 2ºC to 8ºC. Discard product Stability studies show that the potency Merck Frosst
purified, inactivated if exposed to freezing. of unopened vaccine is not 1-800-567-2594
(Vaqta, Vaqta Pediatric significantly affected after exposure at
and Adolescent) 37°C for up to 6 months. This is not a
storage recommendation.

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Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 12 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Hepatitis B Recombinant Ship under refrigeration. Store at 2ºC to Contact manufacturer.*** GlaxoSmithKline
Vaccine 8ºC. Discard if frozen. Monodose Off-label§ information indicates stable 1-800-387-7374
(Engerix-B, Engerix-B- container must be used immediately upon for 72 hours at temperatures between
Pediatric) withdrawal. Contents of multidose 8ºC to 25ºC.6
vaccine should be discarded within (Note: 2003 product monograph made
24 hours after first puncture. a statement that the potency of the
unopened 10 mL multidose vial is not
significantly affected after exposure at
37°C [up to 7 days]. This statement is
being re-evaluated in the next
monograph.)

Hepatitis B Recombinant Refrigerate unopened and opened vials at Contact manufacturer.*** Merck Frosst
Vaccine 2ºC to 8ºC. Storage above or below the 1-800-567-2594
(Recombivax HB) recommended temperature may reduce
potency. Do not freeze.
Hepatitis A and hepatitis B Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** GlaxoSmithKline
vaccine if exposed to freezing. Off-label§ information indicates stable 1-800-387-7374
(Twinrix, Twinrix Junior) for 72 hours at temperatures between
8ºC to 25ºC.6

Influenza vaccine, split Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
virion, inactivated, trivalent if exposed to freezing. 1-888-621-1146
(Vaxigrip 2008-2009) Multidose vials should be discarded 7
days after entry into the vial.

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www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 13 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Influenza vaccine, split Refrigerate at 2°C to 8ºC. Discard Contact manufacturer.*** ID Biomedical
virion, inactivated, trivalent product if exposed to freezing. 1-800-387-7374
(Fluviral 2008-2009) Once entered, the multidose vial should be
discarded after 28 days.
Influenza vaccine, surface Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Solvay Pharma
antigen, inactivated, 1-800-268-4276
trivalent
(Influvac 2008-2009)
Japanese encephalitis virus Refrigerate at 2º to 8ºC. Discard if Contact manufacturer.*** Sanofi Pasteur
vaccine (inactivated) exposed to freezing. Reconstituted 1-888-621-1146
(JE-VAX) vaccine should be stored at 2ºC to 8°C and
used within 8 hours. Do not freeze
reconstituted vaccine.

Measles, mumps, and Refrigerate at 2ºC to 8ºC or colder. The Contact manufacturer.*** Merck Frosst
rubella virus vaccine, live, diluent may be stored in the refrigerator 1-800-567-2594
attenuated1 with the lyophilized vaccine or separately
(M-M-R II) at room temperature. Do not freeze the
diluent. Combination pack containing
lyophilized vaccine and diluent together
should be stored at 2ºC to 8ºC.
During shipment vaccine must be
maintained at a temperature of 10°C or
colder. Freezing during shipment will not
affect potency of the vaccine but diluent
should not be frozen.

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 14 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Measles, mumps, and Refrigerate at 2ºC to 8ºC. Diluent may be Contact manufacturer.*** GlaxoSmithKline
rubella vaccine, live, stored at room temperature to conserve Off-label§ information indicates 1-800-387-7374
attenuated refrigerator space. Use reconstituted unreconstituted lyophilized powder is
(Priorix) vaccine as soon as possible (may store up stable for 12 hours at temperatures
to 8 hours in the refrigerator). above 8ºC to 25ºC.6

Off-label§ information indicates


lyophilized vaccine is not affected by
freezing; however, this is not the
recommended storage condition.
Measles, mumps, rubella, Refrigerate at 2ºC to 8ºC. Use Contact manufacturer.*** GlaxoSmithKline
and varicella vaccine, live, reconstituted vaccine as soon as possible Off-label§ information indicates 1-800-387-7374
attenuated (may store up to 8 hours in the unreconstituted lyophilized powder is
(Priorix-Tetra) refrigerator). stable for 12 hours at temperatures
Off-label§ information indicates above 8ºC to 25ºC.6
lyophilized vaccine is not affected by
freezing; however, this is not the
recommended storage condition.
Meningococcal group C Refrigerate at 2ºC to 8ºC. Do not freeze. Alternative Storage Condition (Before Merck Frosst
conjugate vaccine Lyophilized product has a shelf life of 36 Reconstitution): Do not store above 1-800-567-2594
(diphtheria CRM197 protein) months. Vaccine vials and the vials or 25°C. Do not freeze. Use or discard
(Menjugate) syringes of diluent may have different within 6 months of the date of removal
expiry dates. Outer carton bears the from the refrigerator (2ºC to 8°C) or
earlier of the two dates. The carton and upon reaching the outer carton expiry
all its contents should be discarded on date (whichever comes first).
reaching the outer carton expiry date.
Meningococcal group C Refrigerate at 2ºC to 8ºC. Discard if Contact manufacturer.*** Wyeth Canada
conjugate vaccine exposed to freezing. 1-800-268-1946
(Meningitec)

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Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 15 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Meningococcal group C-TT Refrigerate at 2ºC to 8ºC. Do not freeze. Within the indicated shelf life, the GlaxoSmithKline
conjugate vaccine, vaccine may be stored at room 1-800-387-7374
adsorbed temperature (up to 25°C) for a single
(NeisVac-C) period of no more than 9 months.
Record the period of storage at room
temperature on the product package.
Discard after this period.
Meningococcal (Groups A, Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Sanofi Pasteur
C, Y and W-135) Discard if exposed to freezing. 1-888-621-1146
Polysaccharide Diphtheria
Toxoid Conjugate Vaccine
(Menactra)
Meningococcal Store freeze-dried vaccine and Contact manufacturer.*** Sanofi Pasteur
polysaccharide vaccine, reconstituted vaccine, when not in use, at 1-888-621-1146
groups A, C, Y and W-135 2ºC to 8ºC. Do not freeze. The single dose
combined vial should be used within 24 hours of
(Menomune-A/C/Y/W-135) reconstitution. Discard remainder of
multi-dose vials within 35 days after
reconstitution. Discard product if exposed
to freezing.
Quadrivalent human Refrigerate at 2ºC to 8ºC. Do not freeze. Contact manufacturer.*** Merck Frosst
papillomavirus (types 6, 11, Administer as soon as possible after being Stable at up to 25°C for 72 hours. 1-800-567-2594
16, 18) recombinant removed from refrigeration.
vaccine
(Gardasil)

Pertussis vaccine and Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
diphtheria and tetanus if exposed to freezing. 1-888-621-1146
toxoids adsorbed combined
with inactivated
poliomyelitis vaccine
(Quadracel)
More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 16 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Pneumococcal 7-valent Refrigerate between 2ºC to 8ºC. Discard if Stability studies indicate that potency Wyeth Canada
conjugate vaccine the vaccine has been frozen. of unopened vaccine is not 1-800-268-1946
(diphtheria CRM197 protein) significantly affected by exposure to
(Prevnar) temperatures between 8°C and 37°C
for up to one week; however, this is
not a storage or shipping
recommendation.
Pneumococcal 23- Refrigerate at 2ºC to 8ºC. Discard product Contact manufacturer.*** Sanofi Pasteur
valentpolysaccharide if exposed to freezing. 1-888-621-1146
vaccine
(Pneumo 23)
Pneumococcal 23-valent Refrigerate unopened and opened vials at Contact manufacturer.*** Merck Frosst
polysaccharide vaccine 2°C to 8°C. 1-800-567-2594
(Pneumovax 23)

Poliomyelitis vaccine, Refrigerate at 2°C to 8°C. Discard product Contact manufacturer. *** Sanofi Pasteur
inactivated (Vero cell if exposed to freezing. 1-888-621-1146
origin)
(Imovax Polio)
Rabies Vaccine, inactivated Refrigerate at 2°C to 8°C. Discard Contact manufacturer.*** Sanofi Pasteur
(human diploid-cell product if exposed to freezing. If not 1-888-621-1146
culture) administered promptly after
(Imovax Rabies) reconstitution, discard contents.
Rabies Vaccine (purified Refrigerate at 2°C to 8°C. Use Contact manufacturer.*** Distributed by Merck Frosst
chick embryo cell) immediately after reconstitution. 1-800-567-2594
(RabAvert)

Ragweed tyrosine Refrigerate at 2°C to 8°C. Contact manufacturer.*** AllerPharma


adsorbate vaccine 1-866-404-2332
(Pollinex-R)

More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 17 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Rotavirus Gastroenteritis Refrigerate at 2°C to 8°C. Give soon after When out of refrigeration, do not Merck Frosst
Vaccine, live, oral, removal from the refrigeration unit. expose to freezing temperatures. Store 1-800-567-2594
pentavalent at temperatures at or below 25°C. If
(Rotateq) these conditions are met,
administration may be delayed for up
to 4 hours.
Salmonella Typhi VI Refrigerate at 2°C to 8°C. Discard if Off-label§ information indicates it is GlaxoSmithKline
Capsular Polysaccharide vaccine has been frozen. stable for 72 hours at temperatures 1-800-387-7374
Vaccine between 8ºC to 25ºC. 6
(Typherix)

Salmonella Typhi VI Refrigerate at 2°C to 8°C. Discard Contact manufacturer.*** Sanofi Pasteur
Capsular Polysaccharide product if exposed to freezing. 1-888-621-1146
Vaccine
(Typhim VI)
Tetanus and diphtheria Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** Sanofi Pasteur
toxoids adsorbed exposed to freezing. 1-888-621-1146
(Td Adsorbed)
Tetanus and diphtheria Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** Sanofi Pasteur
toxoids adsorbed and exposed to freezing. 1-888-621-1146
inactivated poliomyelitis
vaccine
(Td Polio Adsorbed)
Tetanus and diphtheria Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** Sanofi Pasteur
toxoids and acellular exposed to freezing. 1-888-621-1146
pertussis vaccine, adsorbed
(Adacel)

More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 18 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Combined diphtheria, Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** GlaxoSmithKline


tetanus, acellular pertussis exposed to freezing. Off-label§ information indicates it is 1-800-387-7374
(adsorbed) vaccine stable for 72 hours at 8ºC to 25ºC. 6
(Boostrix)

Tick-borne Encephalitis Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** Baxter FSME-Immun Program
Vaccine (Purified, vaccine has been frozen. 1-877-211-3582
Inactivated, strain Off-label§ information indicates it is
Neudörfl)(FSME-IMMUN) stable for 7 days at room temperature
(up to 25°C).10
Typhoid (purified Vi Refrigerate at 2°C to 8°C. Discard if Contact manufacturer.*** Sanofi Pasteur
polysaccharide) and exposed to freezing. Administer 1-888-621-1146
Inactivated Hepatitis A immediately after reconstitution.
Vaccine (Vivaxim)
Typhoid (Salmonella Typhi Refrigerate at 2°C to 8°C. Vaccine Vaccine may be left unrefrigerated Berna Biotech Ltd.
TY21A) capsules should be stored in the during transit home but only if the 1-305-443-2900
(Vivotif) refrigerator between doses. While it will duration is reasonable. Capsules can
not affect the viability of the vaccine, it is be left at room temperature (25°C) for
not recommended for capsules to be up to 12 hours on a one-time only
frozen. Protect from moisture by storing occasion without affecting product
in a dry place. quality.
Varicella Virus Vaccine, Refrigerate at 2°C to 8°C. The diluent Contact manufacturer.*** GlaxoSmithKline
live attenuated OKA- may be stored in the refrigerator or at Off-label§ information indicates 1-800-387-7374
STRAIN 2000 UNIT ambient temperature (maximum 25°C). unreconstituted lyophilized powder is
/0.5ML Vaccine is not affected by freezing; stable for 12 hours at temperatures
(Varilrix) however this is not a recommended above 8ºC to 25ºC.6
storage condition.
Reconstituted vaccine may be kept for up
to 90 minutes at room temperature (25°C)
and up to 8 hours in the refrigerator (2°C
to 8°C); thereafter, discard reconstituted
product.
More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 19 of 22)

Generic name (Brand Recommended Storage** Stability at Room Temperature** Manufacturer Contact
Name)* FOR SPECIFIC INFORMATION, Information (Quality
CONTACT MANUFACTURER Control)

Varicella Virus Vaccine, Refrigerate at 2°C to 8°C or colder. May Contact manufacturer.*** Merck Frosst
live attenuated OKA- also be stored in freezer. Once transferred Before reconstitution, shelf-life of 1-800-567-2594
STRAIN to refrigerator, do not refreeze. Diluent product is 24 months.
1350UNIT / 0.5ML should be stored separately at room
(Varivax III) temperature (20°C to 25°C), or in the
refrigerator.

Yellow Fever Vaccine Refrigerate vaccine and diluent at 2°C to Contact manufacturer.*** Sanofi Pasteur
(YF-VAX) 8°C. Do not freeze. Reconstituted vaccine 1-888-621-1146
must be kept in refrigerator and used
within 1 hour following reconstitution.
All reconstituted vaccine and containers
which remain unused after one hour must
be disposed of properly (e.g., sterilized or
disposed of in hazardous waste
containers).

* This table includes commonly used medications and vaccines. For those products not listed, consult the product monograph or
pharmaceutical manufacturer for stability information at room temperature.

** Data based on information provided by product monograph unless otherwise indicated. The following PMs were used for this chart:
Humira (January 2008), Caverject (September 2003), Prostin VR (September 2003), Muse (March 2006), Fungizone (July 2008), Regranex (May
2008), Calcimar (February 2007), Miacalcin NS (February 2008), Apo-Calcitonin (September 2003), Sandoz Calcitonin NS (November 2004),
Caltine,11 Leukeran (August 2007), Aranesp (April 2007), DDAVP Injection (March 1991), DDAVP Rhinyle NS (June 2008), Prepidil (September
2003), Prostin E2 vaginal gel,11 Prostin E2 tablets,11 Pulmozyme (August 2006), Marinol (May 2007), Eprex (2007), Estalis (December 2003),
Estalis-Sequi (December 2003), Estradot (June 2004), NuvaRing (October 2006), Emcyt (October 2006), Enbrel (July 2007), Neupogen (September
2006), Copaxone (July 2007), HyperHEP B S/D (February 2006), HepaGam B (May 2007), Intron A,11 Avonex (August 2006), Rebif (February 2006),
Xalatan (June 2004), Kaletra (June 2008), Alkeran (December 2007), Sandostatin (March 2008), Sandostatin LAR (March 2008), Pegasys (April
2008), Pegetron (eCPS), Unitron (January 2005), Alcaine,11 Norvir SEC (January 2005), Rapamune (November 2007), Forteo (June 2004),
Viroptic,11 BCG Vaccine (October 2005), Dukoral (November 2007), Pedvax HIB, liquid (August 2005), Act-Hib (July 2006), Pediacel (November
2007), Pentacel (April 2007), Avaxim (October 2005), Avaxim Pediatric (November 2005), Havrix (July 2008), Havrix Junior (July 2008), Vaqta
More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 20 of 22)

(May 2006), Vaqta Pediatric/Adolescent (May 2006), Engerix-B (July 2005), Engerix-B Pediatric (July 2005), Recombivax HB (February 2008),
Twinrix (February 2008), Twinrix Junior (February 2008), Vaxigrip (June 2008), Fluviral (June 2008), Influvac (May 2008), JE-VAX (December
2006), MMR II (June 2007), Priorix (December 2007), Priorix-Tetra (July 2007), Menjugate (September 2006), Meningitec (December 2003),
NeisVac-C (December 2006), Menactra (September 2007), Menomune (October 2005), Gardasil (March 2008), Quadracel (April 2007), Prevnar
(May 2007), Pneumo 23 (October 2005), Pneumovax 23 (March 2008), Imovax Polio (October 2007), Imovax Rabies (March 2006), RabAvert (April
2006), Pollinex-R,11 Rotateq (March 2008), Typherix (November 2006), Typhim VI (November 2005), Td Adsorbed (January 2006), Td Polio
Adsorbed (April 2006), Adacel (November 2007), Boostrix (February 2008), FSME-IMMUN (February 2005), Vivaxim (November 2005), Vivotif
(June 2007), Varilrix (January 2007), Varivax III (September 2007), YF-VAX (July 2008).

*** Room temperature stability determined on a case-by-case basis. Contact manufacturer and provide lot number and expiration date,
length of time exposed to room temperature, and maximum exposure temperature.

§ Off-label information is not reviewed or approved by Health Canada

Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical
judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and Internet links in this article were current as of the date of publication.

More. . .
Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 21 of 22)

Safeguarding Pharmaceutical Products During Power Outages or Flooding


In the event of a power outage, there are a Project Leaders in preparation of this Detail-
number of steps to take to minimize damage to Document: Margaret Wong BScPhm and Neeta
pharmaceutical products. If the power goes out, the Bahal O’Mara, Pharm.D., BCPS
time of the power outage should be noted. During
the power outage, refrigerator and freezer doors References
should not be opened. For products which are 1. Cohen V, Jellinek SP, Teperikidis L, et al. Room-
stored in the freezer, if the power outage continues temperature storage of medications labeled for
for more than 24 hours, the products should be refrigeration. Am J Health Syst Pharm 2007;64:1711-
5.
removed from the freezer and packed in dry ice. 2. Welte MS. Vaccines ruined by poor refrigeration.
When the power is restored, the temperature in Washington Post, December 4, 2007.
the refrigerator and freezer should be recorded, and http://www.washingtonpost.com/wp-
monitored until the temperature has returned to the dyn/content/article/2007/12/04/AR2007120400983.ht
ml. (Accessed December 5, 2007).
desired temperature. This allows the calculation of 3. Food and Drug Administration. Impact of severe
the duration of time the product was stored at a weather conditions on biological products.
temperature outside of the product labelling and http://www.fda.gov/cber/weatherimpact.htm.
may enable calculations to be made by the product (Accessed September 2, 2008).
manufacturer, in consultation with Health Canada 4. Personal communication. Medical Information.
Janssen-Ortho. Toronto, ON M3C 1L9. September
as necessary, about the continued potency of the 23, 2008.
involved products.3 5. Personal communication. Medical Information.
When a flood is anticipated, if possible, Ferring. Toronto, ON M2J 5C1. September 23, 2008.
pharmaceutical products should be moved out of 6. Personal communication. Medical Information.
GlaxoSmithKline. Mississauga, ON L5N 6L4.
areas which could accumulate flood water. If September 23, 2008.
possible, elevate products stored on warehouse 7. Personal Communication. Medical Information.
floors off the ground (e.g., on pallets). For those Amgen. Mississauga, ON L5N 0A4. September
items on shelves, securely anchor the shelves to 24,2008.
keep products dry. For refrigerated products, raise 8. Personal communication. Medical Information. Pfizer
Canada Inc. Kirkland, QC H9J 2M5. September
refrigerators onto platforms, if possible.3 2008.
If flooding occurs, any product which was not 9. Personal Communication. Medical Information. Alcon
sealed in airtight, waterproof bags should be Canada Inc. Mississauga, ON L5N 8C7. September
considered contaminated and should be discarded.3 25, 2008.
10. Personal Communication. Baxter FSME Immun
Program. Mississauga, ON L4Z 3Y4. June 2008.
11. Compendium of Pharmaceuticals and Specialties
Users of this document are cautioned to use their own (online, eCPS). Canadian Pharmacists
professional judgment and consult any other necessary Association. http://www.e-therapeutics.ca. (Accessed
or appropriate sources prior to making clinical September 2008).
judgments based on the content of this document. Our
editors have researched the information with input from
experts, government agencies, and national
organizations. Information and Internet links in this
article were current as of the date of publication.

Cite this Detail-Document as follows: Stability of refrigerated and frozen drugs. Pharmacist’s Letter/Prescriber’s
Letter 2008;24(10):241014.

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Copyright © 2008 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #241014: Page 22 of 22)

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