Sanofi-Aventis has problems with their Apidra production.
In Finland pharmacies will not receive new shipments of Apidra insulin from mid-October.
Big warnings in the UK, too:
Hopefully the supply problems are solved by January 2012 or so. Let’s see.
(In Finland doctors start to write rx:s for Humalog and NovoRapid(=Novolog), so we diabetic citizens still get rapid-acting insulin during the supply problems.
Googled more info. Spillage in factory in Frankfurt, Germany. It seems that the supply problem impacts mostly EU countries.
Shortage of Apidra (insulin glulisine) cartridges
The European Medicines Agency is aware of a shortage of Apidra, a medicine for treating diabetes,
affecting the supply of Apidra 3 ml cartridges and Apidra prefilled disposable pens (OptiSet and
SoloStar) in several EU Member States. The Agency’s Committee for Medicinal Products for Human Use
(CHMP) has made several recommendations to manage the situation and ensure patients continue to
receive appropriate treatment during the temporary supply shortage.
What is Apidra?
Apidra is a solution for injection that contains the active substance insulin glulisine. It is used to treat
patients aged six years or over with diabetes, when they need insulin.
Apidra is supplied in vials, cartridges and prefilled disposable pens (called OptiSet and SoloStar).
Apidra is given by injection under the skin or by continuous infusion with an insulin pump. The vials are
used together with an insulin syringe to inject the medicine, or with an insulin pump. The cartridges
are used together with a pen device1 to inject the medicine. The prefilled pens are used alone to inject
Apidra is a rapid-acting insulin analogue (chemically modified insulin) that is used in combination with
intermediate- or long-acting insulins or insulin analogues. It may also be used in combination with
other (oral) medicines to treat diabetes.
What is the cause of the supply problem and how long will it last?
The company that markets Apidra, Sanofi-Aventis Deutschland GmbH, informed the Agency that an
accidental spillage occurred on 11 July 2011 at the plant where the medicine is manufactured in
Frankfurt, Germany. Manufacturing has been temporarily suspended while internal investigations are
taking place. This will result in a continued delay in the release of batches of Apidra cartridges onto the
EU market. The shortage affects Apidra cartridges and Apidra prefilled disposable pens, OptiSet and
SoloStar. It does not affect Apidra vials or any other Sanofi insulin product (Lantus and Insuman).
1 Cartridges are suitable for use with OptiPen, ClikSTAR, Tactipen or Autopen 24, and specific cartridges are suitable for use
Normal supply is expected to resume in early 2012. Supply shortages are expected in most EU Member
States until normal supply resumes.
What are the recommendations of the CHMP to cope with the shortage?
Apidra cartridges and prefilled disposable pens currently on the market are safe to use.
The Committee has agreed that the company should provide a letter to the healthcare professionals,
health authorities and wholesalers explaining the specific supply situation in their countries together
with recommendations to manage the situation. During the supply shortage, if cartridges or prefilled
pens are not available, the main recommendations are as follows taking account of national guidance
and the needs of individual patients:
Patients may be switched to an alternative rapid-acting insulin analogue – i.e. Humalog (insulin
lispro) or NovoRapid (insulin aspart) under the supervision of a healthcare professional and with
close monitoring of blood glucose levels.
Where rapid-acting insulin analogues are not available or not appropriate, patients may need to be
switched to regular (standard) short-acting human insulin such as Insuman, Humulin, Novolin or
equivalent. As these insulins have a slower onset and a longer duration of action than Apidra, this
must be done under the direct supervision of a healthcare professional with more frequent
monitoring of blood glucose levels and adjusted dose as required.
Patients for whom vials and syringes are an acceptable alternative to a pen device may be
switched to Apidra vials and syringes if available. No dose adjustment is required.
The company is providing a program of support for healthcare professionals and patients during the
supply shortage, including a demonstration video and educational materials on switching to using vials
and syringes, rapid-acting insulin analogues or regular short-acting human insulin. The company will
also provide a national helpline for patients and healthcare professionals in the countries concerned.
The Committee is working closely with Sanofi-Aventis Deutschland GmbH to ensure that normal supply
is resumed as soon as possible in the interest of patients.
The current European public assessment report for Apidra can be found on the Agency’s website:
ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
That isn’t good! Thank you for posting this.
We just received this information from Sanofi, the makers of Apidra:
"We wanted to pass along some more information on the Apidra SoloSTAR shortage. We wanted to clarify that this is actually a temporary shortage of Apidra SoloSTAR and not Apidra vials, which will still be available. We have a website explaining this in more detail: http://www.ApidraSupplyNews.com."
That’s a US website. So the supply problems affect the US, too.
(Maybe all the Apidra SoloStar pens are manufactured in the Frankfurt facility, who knows…)
I am trying to find out , if same story in Canada .
I fully agree with your comment. I am an Apidra user along with a pump. I am happy to know of what may be impending with it.
Brian, if you read the link that Manny posted, it says that the Apidra vials are not affected, just the pens. You should be safe.
I used pens before getting my pump. My pharmacy had trouble getting them and I started getting vials and using a syringe. I don’t know if that shortage had anything to do with this issue, as it was some months ago, or if it was a local thing, but I am told that pens have been is short supply.
Ironically I went today to the same pharmacy to pick up a prescription for another vial of Apidra, and the prescription was prepared in pen format. I told them that pens don’t work to fill the pump and they told me that I would have to contact my doctor to get the prescription changed. This is turning out to be a real hassle.
I have already decided I will switch to Novolog before getting vials. Apidra goes bad too fast and I was throwing vials away after 10 days on the pump. I only use about half of a vial a month on MDI and I am not throwing away 2 1/2 vials of insulin a month to keep using Apidra. Hopefully my pharmacy has some in their fridge that I can get before switching!
I just read Kelly’s blog post - and this is scary stuff! I don’t perseonally use Apidra pens - but if I did - I would not be happy. It sort of gives me a scare thinking about what happens if this starts to occur with other insulin manufacturers - especially with the demand of insulin users rising. I didn’t realise until now - from Kelly’s blog - that Apidra doesn’t have a long shelf life.
Nel - I haven’t found anything here in Canada for shortages (Sanofi-Aventis Canada is a 10 minute drive from my house here in Montreal).
I am sorry you are having trouble with Apidra going bad. I have not experienced such a problem. I have used it when it has not been refrigerated and been out for over 30 days without a bit of problem.
I will keep that in mind. My endo is kind of a Novolog person.
Hi Anna. I use Apidra for MDI and part-time on the MM522. I keep my Apidra vial in the fridge between all uses, including MDI, and it lasts for 24 days all year. I found out early that it’s was more temperature sensitive than other types of inslin. I trust my pharmacy to keep it refrigerated, but I have to wonder if there are storage problems or traveling problems before the Apidra gets to my pharmacy that contributes to causing its shorter life.
Trudy, I have wondered the same thing about the traveling thoughts. I never had a problem until last Dec and I started Apidra in 2008. I switched from pens to vials last June when I started the pump. I also had to change pharmacies. The vial problem started in Dec and it took me awhile to even figure that out because I had been using it for a week and it was fine. I always kept my vials in the fridge and in Dec, I wasn’t even letting them sit out to warm up before filling up the cartridge. This summer, I started having a problem with my pens. Those I keep out of the fridge once I start using them and they were dying after about 7 days. I keep my place on the cold site with AC running constantly and the insulin rarely goes outside. I had to get the insulin for my pump at a different pharmacy & the two are about 40 miles apart.
When I originally had the problem, I was getting a lot of searches to my blog with “Apidra problems.” I know that could mean anything, but when I Googled the same term, I came up with another blogger up in NY (I am in Western PA) that was having the same problem.
Not sure what is causing it, but it is very hit & miss and very annoying when you end up throwing a lot of insulin away.
Your post was spotted by John Fitzgerald, in Project Services at Sanofi-Aventis, who asked me to post this answer:
Yes, in fact, the Apidra SoloSTAR pen cartridges are manufactured at the Frankfurt plant. Again, this temporary shortage affects only Apidra SoloSTAR. No other Apidra products were affected.
Sanfi Aventis is a joke. They bought the rights to Curedm’s (Pancreate which could have turned out to be a regeneration therapy for type 1’s ) almost 2 years ago and they haven’t done jack ■■■■ with it. A complete insult to the diabetes community.
Gary- Can you say for a certainty what Sanofi has done with Pancreate? Could they have had a team of scientist conlude that in it’s current form it is not feasible but with slight modifications it could work with them working on the modifications now? How can you know for sure?
(Pancreate which could have turned out to be a regeneration therapy for type 1’s )
I bolded the key word in you statement. The simple fact of the matter is could does not always mean a company should continue to invest in a solutiuon to a problem no matter how much we all hate this disease and wish it were gone.
I simply don’t buy the argument that all the insulin manufactuer’s want to stop promising curative research. After all, once they develop it they get to set the price as there would be no competition. Seems like a money maker to me. Just because you cure a person with type 1 dosen’t mean there won’t be another who will be diagnosed in short order. Also, who is to say these therapies won’t be needed on a consistent basis?
I am by no means a supporter of big pharma. I think patients, in particualr USA patients, have been getting the shaft from these companies. But making statements of fact when you can’t know exactly what they are or are not doing is unproductive.
So wow. My son uses Apidra in pump. First reading this I thought that it doesnt concern us as vials are not affected. Then later on I realised they dont sell vials for pump-users in Finland, only cartridges (which we use).
Today we received information from Sanofi-Aventis that they have made available this offer to patients in the US:
"From now until April 30, 2012, Apidra® vials are free for patients with commercial insurance..."