Should I refrigerate Ibrutinb?

[freddog]

For miscallaneous reasons, I now have an extra month's supply of Imbruvica. Should I refrigerate it in this warm weather? Thanks!

[Docpacman]

Recommend speaking to your doctor or pharmacist they would know this information

[Jm954 Administrator]

Hi freddog,

no don't refrigerate. Storage is quoted as room temperature, between 20 and 25 degrees centigrade.

More useful info on Ibrutinib here: medicines.org.uk/emc/medici...

All the best

Jackie

[kohsamui0 in reply to Jm954]

yes sure, but if its around 30 celcius what to do ?

[Cllcanada Top Poster CURE Hero]

The drug label clearly states...

IMBRUVICA:

- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

- Store in original container

So, what you do in 95 degree F weather, I don't know. Perhaps a chill pack? I have had IV antibiotics packaged in these. They are cool to the touch, for about 24 hours, then you put them in the refrigerator again to chill... they aren't the freezer type.

My pharmacy refrigerated a bottle ibrutinib in error when it first came to market, and I was advised to return it.

Best check with your specialty pharmacy that sends you the Imbruvica (ibrutinib).

~chris

[starsafta]

The answer to refrigerating Imbruvica is an emphatic NO!

When the temperature in New England reached 85-90 F (29-32 C) for a stretch, I called Pharmacyclics for an official response. They have done temperature studies, and refrigerating can negatively affect the efficacy of the drug.

Apparently, there is more wiggle room at higher temps. He said there is some stability at 90 F for up to 3 months. Since we are given only a one month supply at a time, he felt that the drug can hold up. I suggested that this information be included in the fact sheet.

Yet, he pushed for maintaining as close to the ideal temp as possible.

I heightened his awareness to the fact that people who take Imbruvica are scattered in varying climates all around the world. It is naive to think that all are able to maintain the ideal temp.

While I do have central air conditioning in my house, I rarely turn it on because I hate the stale air. I'm an open window or outdoors being. I tend to run air conditioning when I am at my drawing board and the humidity is unbearable, since sweaty arms and dripping perspiration affect the paper. Im not going to run it just for Imbruvica.

So when we have a stretch of high temperature, like right now, I have taken to storing my Imbruvica in the basement, where the thermometer tends to read a few degrees cooler than in the house proper. I do the same with my Synthroid, which also has an ideal temperature range. Of course, not all houses have a basement either, so I guess we just have to find the coolest spot in the house and hope for the best.

[freddog in reply to starsafta]

Thanks to everyone who replied! Very helpful indeed, and I feel reassured that I'm not damaging the efficacy of my Imbruvica by not refrigerating it.

[kimiD]

Due to Ibrutinib's hefty price tag, I store mine in our safe!

[starsafta in reply to kimiD]

You should check the temperature in your safe. If it warmer or colder than room temperature, it may be safer elsewhere.

[kimiD in reply to starsafta]

It's about the same as room temperature. I worry if I accidentally drop or spill some, I'm sure my insurance company would not pay to replace it.

[starsafta]

The Pharmacyclics rep was emphatic. Imbruvica should NOT be refrigerated because the colder temp destroys the viability.

Try to store it as close to range as possible. He did say they have found it can hold up for as long as 90 days in high heat if there is no alternative, though it is not as ideal as the preferred range.

I usually order my next dose a couple of days before running out of the current bottle. This ensures that it doesn't hang around too long in my environment.

He was surprised to learn that even my winter house temp is slightly below the stated ideal range. I like it cool, and maintain a 64-66 F house in winter, and am happy as can be. I'm glad to say that imbruvica is still being good to me after 12 months.

[cook4650 in reply to starsafta]

I believe that if ANY drug requires refrigeration, the pharmacist is required to put that on the label. I am on more medications than you can shake a stick at, and the only time in my life I had to put anything in the frig was when my kids were little and had infections. BTW, I had to smile at kimiD's remark above about keeping hers in a safe. If we ever have a disaster such as a tornado or such, I will be grabbing my Imbruvica first, even BEFORE my cat or my laptop!

[AussieNeil Administrator]

I've just checked what should be reputable sources and it appears Ibrutinib might be able to be stored between minus 20 C (i.e. in a freezer - which I wouldn't do due to the responses @starsafta received from Pharmacyclics) and 30C.

From the FDA approval process document section 3. CMC/Device : accessdata.fda.gov/drugsatf...

Based on the available stability data an 24-month expiry dating is granted for

Imbruvica® ibrutinib capsules stored at temperature of 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (between 59°F and 86°F).

starsafta , I think this is why the Pharmacyclics rep was so insistent about not storing it at lower temperatures - that would involve storage below the FDA approved range.

The Janssen data sheet just states 'Store below 30ºC. Keep capsules

in the original container. Do not store it or any medicines in the bathroom or near a sink.' : janssen.com/australia/sites...

As to how cold it can be stored, would you believe minus 20C?pubchem.ncbi.nlm.nih.gov/co... (In other words according to section 10.4.1 Storage Conditions, you could keep it in your freezer! Note that I would want this very low temperature confirmed before actually risking it!)

(During my career, I evaluated failure mechanisms for electronic components typically in the range -40C to +125C. Below freezing, failures can be caused by water turning to ice, with the ice crystal expansion causing damage. Higher temperatures cause substances to degrade, provided the temperature is high enough to activate the degradation process. (Chemical reactions may require sufficient energy, i.e. a high enough 'activation' temperature, for a chemical action to occur.) This is what goes into determining the shelf life time. So it didn't make sense to me that Ibrutinib shouldn't be stored in the fridge, particularly when I read that it sometimes gets shipped with ice packs! I haven't had experience with pharmaceutical product storage lifetime determinations, but I would love to know what degradation mechanisms happen between 0C and 15C that don't occur between 15C and 30C - and how is that compatible with sometimes shipping the product with ice packs!)

healthunlocked.com/cllsuppo...

Neil

[starsafta]

Hard to know what to do with conflicting advice. I think I will call Pharmacyclics and my oncology pharmacy again. Maybe it depends on who you talk to. Will let you know.

How hot do you get in Australia, Neil? Do you get heat streaks of 26-35 C or are you blessed with more reasonable temps? Fortunately, we're down to 80sF as summer wanes in New England. Tonight it's also rainy and humid as the remnants of Irma makes its way through our area.

[AussieNeil Administrator in reply to starsafta]

I suspect you won't get a definitive answer until whoever you talk to takes the time to follow-up with the relevant specialist in the company. Otherwise, they will just reiterate the temperature range approved by the FDA. Point out the -20C storage in the reputable site here for some action! pubchem.ncbi.nlm.nih.gov/co...

As to temperatures in Australia (which is almost as big as the continental USA, so there's a great variation in climate) - I wish it were as cool as you thought, because in the places I've lived, we get heat streaks (we call them hot spells or heat waves) that can be over 10C above that. We are experiencing more summer days over 40C, with some places approaching 50C. Of particular concern is when we get strong hot North winds from our desert inland. In those conditions, we can lose electric power and not have it restored for up to a day or more in more remote locations. Then we have no option but to use a refrigerator to store medications and minimise access to the fridge so that the food doesn't spoil. Overnight temperatures can stay over 30C for a week or so in summer too and air conditioning isn't run continuously and in older homes, may not include the kitchen.

So if you are able to get official sanction for storing Ibrutinib in the fridge, you'll be helping people world-wide!

Neil

[Mkhait]

Hi everybody, want to share an official reply from Diplomat pharmacy - our Imbruvica supplier. We're in NY - very cold at the moment , asked for temperature requirements:

- As part of product development for IMBRUVICA, the capsules have been exposed to high and low temperatures. These temperature studies are performed in highly controlled equipment so the exact temperature/humidity conditions and duration are known.

After exposure to the following conditions, the capsules are thoroughly tested and found to continue to meet requirements for newly manufactured capsules.

40 o C (104 o F) for 6 months

60 o C (140 0 F) for 6 days

2 - 8 o C (36 - 46 o F) for 12 months

-20 o C (-4 o F) for 6 days

============================

Hopefully it would be useful

M

[country76]

It should say on the container. I keep it in a dresser drawer.