32 replies to this topic

[Widgeonus]

Last year, my Gleevec was shipped in a cooled container due to hot temperatures in SE Texas. Yesterday, my script arrived at my home in a FedEX envelope and the temps were well over 95 degrees.

 

I contacted my pharmacy, and was told that Novartis provided information that Gleevec is heat tolerant to 104 degrees for 6 months. The documentation on the Novartis website, as well as a representative at Novartis, says that the medication should not be stored above 86 degrees Fahrenheit. Now, the pharmacy has denied my request for replacement due to the information that they supposedly received from Novartis.

 

Should I be concerned and continue to fight the pharmacy, or should I just take the meds?

[Trey]

The key is the word "stored" which means for long periods of time.  The TKI drugs are very stable chemically, so no problem for short term exposure.  Long term storage in high heat can be a relatively small issue.

[rcase13]

My Tasigna comes in a huge 14" x 14" Styrofoam cooler with frozen gel packs inside. I keep the gel packs and use them in my regular cooler. They work great and I have a seemingly endless supply.

[Trey]

Special Promotional Offer!!!!!

 

Buy a 30 day supply of Tasigna for only $3000 and get a styrofoam cooler AND gel packs ABSOLUTELY FREE!!!!!!!! 

 

HURRY, SUPPLY IS LIMITED*

 

MUST USE PROMOTIONAL CODE: "SILLYSHARTS"

 

*Offer Void in Australia since the 'Roos eat the gel packs. 

[Widgeonus]

My Tasigna comes in a huge 14" x 14" Styrofoam cooler with frozen gel packs inside. I keep the gel packs and use them in my regular cooler. They work great and I have a seemingly endless supply.

 

That's the way Gleevec was shipped to me last summer. This year, the pharmacy said that Gleevec was no longer on their list for special packaging and shipment.

[tiredblood]

Special Promotional Offer!!!!!

 

Buy a 30 day supply of Tasigna for only $3000 and get a styrofoam cooler AND gel packs ABSOLUTELY FREE!!!!!!!! 

 

HURRY, SUPPLY IS LIMITED*

 

MUST USE PROMOTIONAL CODE: "SILLYSHARTS"

 

*Offer Void in Australia since the 'Roos eat the gel packs. 

 

LOL.  My Tasigna package is due to arrive tomorrow. I'm in the Southeast too with heat index up in to the 100s. I assume they will ship it in my freebie Styrofoam and gel pack cooler.

[gerry]

Special Promotional Offer!!!!!

 

Buy a 30 day supply of Tasigna for only $3000 and get a styrofoam cooler AND gel packs ABSOLUTELY FREE!!!!!!!! 

 

HURRY, SUPPLY IS LIMITED*

 

MUST USE PROMOTIONAL CODE: "SILLYSHARTS"

 

*Offer Void in Australia since the 'Roos eat the gel packs. 

 

Offer void in Australia since the mother kangaroos were making their joeys get out and hop while they carried the Gleevec in their pouches to keep it cool.

[Trey]

There is an additional warning from the manufacturer which I feel compelled to pass on:

 

"WARNING: Do NOT use free gel packs for DIY breast enhancement or butt lift purposes."

[Busa]

Too late...

 

 

But, my butt has never looked better

[Trey]

I won't argue with you....Just sayin'

[Antilogical]

There is an additional warning from the manufacturer which I feel compelled to pass on:

 

"WARNING: Do NOT use free gel packs for DIY breast enhancement or butt lift purposes."

 

I feel compelled to add some clarification to Trey's warning:

 

Those gel packs have been in close proximity to tyrosine kinase INHIBITORS.

If recycling for implant purposes, this may result in something shockingly OPPOSITE to the intended outcome.

 

Need I say more?

[tiredblood]

Received my Tasigna in the mail today with no cooler or ice packs.  The heat index was 104-109 degrees F today and it set out on the front porch all day, not to mention wherever it was since it was shipped last night at  9PM.  You'd think for $26,000 +/-, they'd  chill it.

[tiredblood]

On the Tasigna box, "Store at 77degrees F; excursions permitted to (59-86 degrees F)."

[Buzzm1]

Received my Tasigna in the mail today with no cooler or ice packs.  The heat index was 104-109 degrees F today and it set out on the front porch all day, not to mention wherever it was since it was shipped last night at  9PM.  You'd think for $26,000 +/-, they'd  chill it.

 

You're lucky tired blood, Kaiser doesn't ship, or allow 90-day Rx's of, expensive meds; I have to go to their pharmacy every month to pick Gleevec up.  It's a pain.

[tiredblood]

You're lucky tired blood, Kaiser doesn't ship, or allow 90-day Rx's of, expensive meds; I have to go to their pharmacy every month to pick Gleevec up.  It's a pain.

How far do you have to go?  I have another med that I get in a 30-day supply. Seems like those thirty days pass by quickly.

[tiredblood]

I feel compelled to add some clarification to Trey's warning:

 

Those gel packs have been in close proximity to tyrosine kinase INHIBITORS.

If recycling for implant purposes, this may result in something shockingly OPPOSITE to the intended outcome.

 

Need I say more?

So, how do you guys dispose of your empty TKI packaging?  Mine just gets tossed with the regular trash.

[Buzzm1]

How far do you have to go?  I have another med that I get in a 30-day supply. Seems like those thirty days pass by quickly.

Only around 7 miles each way; it's the necessity of showering, shaving, and having to get dressed, that adds to the drag.  

Being retired is mostly about the freedom to not have to do those things.   

[tiredblood]

Only around 7 miles each way; it's the necessity of showering, shaving, and having to get dressed, that adds to the drag.  

Being retired is mostly about the freedom to not have to do those things.   

I can appreciate that Buzzm1. : )  At least you shower, shave, and get dressed at least q30 days.

[tiredblood]

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

Corporation.

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

at http://www.pharma.us...s/bybrand.shtml

Sincerely,

[name removed by this poster for privacy purposes]

Medical Information Physician

MIC Oncology

Inquiry Number(s): I-01873956

Page 1 of 5

 

,

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080

Storage and Stability

Overview

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)

Prescribing Information

How Supplied/Storage

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

packs.

150 mg

Carton of 4 blister packs of (4x28)................................................NDC 0078-0592-87

Blisters of 28 capsules..................................................................NDC 0078-0592-51

200 mg

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).

Additional Data

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).

Storage

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.

(ALU)

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)

(Tasigna PI).

 

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.

[hannibellemo]

I wanted to weigh in because I have never been the beneficiary of free coolers or ice packs! I feel terribly neglected. My pills have always come in a plain brown box, with plain brown paper inside to keep the bottle from rattling around.

 

I did have a bad moment last winter when my drug delivery was delayed and the pills sat outside in minus many degrees below zero over the weekend. They survived and so did I.

 

Now, about those freebies the rest of you are getting and excursions our drugs are allowed....If I weren't taking these drugs I could probably go on more excursions, too...just sayin.