My Tasigna came the other day, not packed in a cooler with ice packs. Last summer, I was told by CVS Specialty Pharmacy that the medication is packed in a cooler with ice packs each time it is shipped to an area that had a hotter climate. On that same phone call, I requested that my Tasigna be shipped each time, regardless of season, because no one really knows what temperature extremes (high or low) the medication undergoes if it is shipped as cargo in a plane. Also, each time I re-order the medication, the pharmacy asks if I want a signature to be required or not. Each time I tell them no signature because I work and no one will be home to sign for the medication at delivery.
On the day of delivery, our area was under a heat advisory with the heat index ranging from 104-109 degrees F. This meant that the medication was exposed to the above temperatures, at least from the time it was delivered to my front door step (not sure if UPS trucks are air-conditioned or not).
I wrote Novartis asking if the medication would be safe to take and still be stable in order to provide the desired effect. I haven't heard back from Novartis.
CVS Caremark Specialty Pharmacy contacted Novartis and received the information:
This letter is in follow up to your recent request for information regarding Tasigna® (nilotinib).
The Novartis Medical Information department provides responses to unsolicited requests for
information from health care professionals. This response is for your medical information
purposes only and should not be regarded as a recommendation by Novartis Pharmaceuticals
For marketed products, the information provided herein may be outside of the approved product
labeling. Please refer to the package insert for full prescribing information. However, if the
information you requested pertains to a compound in development, please note that the
compound is not currently FDA approved for use in the United States.
In this document, please find the response(s) to your question:
· TASIGNA - Storage and Stability
For marketed products, the end of this document includes the FDA-approved indication(s) and
general safety information for the product(s) referenced above.
Novartis Medical Information is Available on the Web, 24/7
The newly redesigned Medical Information website and mobile applications are now available to
get access to Novartis product information. The advanced functionality of both of these offer
simple navigation, robust search features, bookmarking, prescribing information and the ability to
directly submit inquiries to our Medical Information Department - all tailored to meet your needs
in a timely manner. For information about Novartis products, please
visit https://medinfo.nova...maceuticals.comor search for Novartis at your mobile
applications store (available for iPhone, iPad, Android and Windows Phone devices).
Please contact us if you have additional questions at 1-(888)-NOW-NOVA. Full prescribing
information on Novartis marketed products is available on our website
[name removed by this poster for privacy purposes]
Medical Information Physician
Inquiry Number(s): I-01873956
Page 1 of 5
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080
Storage and Stability
Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. This letter summarizes how the
product is supplied, the storage, and stability information for Tasigna. (Tasigna PI; Data on File)
Tasigna (nilotinib) 150 mg capsules are red opaque hard gelatin capsules, size 1 with black axial
imprint "NVR/BCR". Tasigna (nilotinib) 200 mg capsules are light yellow opaque hard gelatin
capsules, size 0 with the red axial imprint "NVR/TKI." Tasigna capsules are supplied in blister
Carton of 4 blister packs of (4x28)................................................NDC 0078-0592-87
Blisters of 28 capsules..................................................................NDC 0078-0592-51
Carton of 4 blister packs of (4x28) .........................................NDC 0078-0526-87
Blisters of 28 capsules.........................................................NDC 0078-0526-51
Each blister pack contains one folded blister card of 28 capsules each, for dosing two in the
morning and two in the evening at 12 hour intervals over a 7 day period.
Tasigna (nilotinib) capsules, 150 mg and 200 mg, should be stored at 25°C (77°F); excursions
permitted between 15°-30°C (59°-86°F) (Tasigna PI).
Please note that Novartis Pharmaceuticals Corporation does not recommend the use of Tasigna
capsules stored outside of the aforementioned conditions. Summarized below is results of an in
vitro evaluation of capsules stored outside of blister packs and the stability of nilotinib capsules
under various temperature extremes beyond the permitted excursions (Data on File).
The shelf life of nilotinib capsules is 36 months (Data on File). The capsules have been studied in
the following storage materials:
· HDPE Bottles: White, square, high density polyethylene bottles (325 ml) with aluminum
induction seal and child resistant polypropylene screw cap closure.
· Blister Packs: PVC blister packs backed with a heat-sealable lacquered aluminum foil.
Novartis Pharmaceuticals Corporation has not studied the stability of Tasigna capsules stored in
bottles made of other materials.
Stability outside Excursion Temperatures
Extreme Cold Storage Conditions
No significant change in assay of AMN107 (nilotinib) capsules, or dissolution results were
observed for the AMN107 150 mg capsules packaged in HDPE bottles, PVC bottles, duplex film
(DPX) and ALU blisters after storage for 6 months at -20°C (-4°F). Also, no significant change in
assay or dissolution results in AMN107 150mg capsules packaged in HDPE bottles, DPX and
ALU blisters after storage for up to 36 months (PVC only up to 18 months) at 5°C (41°F) were
observed (Data on File).
Page 2 of 5
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080
Accelerated Storage Conditions
No significant change in assay value or specified degradation products of AMN107 (nilotinib)
capsules, or dissolution results were observed for the AMN107 150 mg capsules packaged in
HDPE bottles, PVC bottles, duplex film (DPX) and ALU blisters after storage for 6 months at 40°C
(104°F) and 75% relative humidity and up to 3 months at 50°C (122°F) (Data on File).
It is important to note that while no significant changes in assay value or degradation products
were reported overall in this in vitro evaluation; some batches tested did not meet acceptable
criteria for stability at various time points. Novartis Pharmaceutical Corporation does not
recommend that Tasigna (nilotinib) capsules, 150 mg and 200 mg, should be stored under any
conditions other than 25°C (77°F); with excursions permitted between 15°-30°C (59°-86°F)
My specialty care pharmacy's response is that the medication can be replaced, but with my having to incur another $95 copay. I'm unsure of if this means the "Plan" would also incur another $28,019.27 charge.
My health insurance case manager inquired of the specialty pharmacy regarding this matter and the response I got from the case manager was that the specialty care pharmacy maintains that the medication could be replace, but with the patient incurring an additional $95 copay.
Honestly, I don't have another $95. I only have five-days-worth of Tasigna left before I have to decide whether to take the recently shipped medication.