Apidra supply problems

Taken from: Link ... 1_psum.htm </a

Apidra supply problem (glulisine insulin) Injectable solution in preloaded pen
Publication date: September 29, 2011

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Category: Human use medications, supply problems
Reference: SGICM (cont) psum, 5/2011

Apidra supply problems 100 units/ml Injectable solution in preloaded pen.
It is expected that the normal supply will resume in early 2012.
Apidra® preloaded feathers currently in the market can be used with total safety.
Sanofi Aventis Deutschland GmbH, head of the Marketing Authorization, has informed the European Medicines Agency (EMA) of an Apidra supply problem, medication for the treatment of diabetes mellitus, which affects in Spain the supply of the following medications:

Apidra 100 units/ml, Optiset Injectable solution in preloaded pen (CN: 651458) and
Apidra 100 units/ml, solostar injectable solution in preloaded pen (CN: 656073).
Apidra is a rapid action insulin analog (chemically modified insulin) that is used in combination with intermediate or prolonged action insulins, or other analogs of insulin.It can also be used in combination with other medications (oral route) to treat diabetes.

Sanofi-Aventis Deutschland GmbH, informed the European drug agency for an accidental discharge that occurred on July 11, 2011 at the plant where the medicine is manufactured in Frankfurt, Germany.The manufacture has been temporarily suspended while the corresponding internal investigations are carried out.This situation will result in a delay in the release of Apidra's lots in the European Union market.The problem of supply in Spain affects preloaded feathers, Optiset and Solostar.It does not affect Apidra vials or any other Sanofi insulin (Lantus).

The normal supply is expected to resume in early 2012. Until then supply problems are expected.

The preloaded feathers of Apidra currently in the market can be used with total safety.

The Committee of Human Use Medicines of EMA (CHMP) has developed recommendations for the management of this situation and ensure that patients continue to receive appropriate treatment during this temporary supply problem.Therefore, it has agreed that the company must send a letter to health professionals explaining the specific supply situation that will occur in each country, together with recommendations to handle the situation.

In Spain, taking into account the needs of each patient, the main recommendations, while this supply problem lasts, are the following:

Patients can move on to an alternative rapid insulin analogue treatment - for example, Insulina Lispr.blood.
In the event that the use of fast insulin action analogues is not appropriate, patient treatments could change to regular human insulin (standard) short action (Actrapid).As these insulins have a slower start of action and a longer duration of action that apidra, this change should be made under the direct supervision of a healthcare professional, with a more frequent control of blood glucose levels and dose adjustment,If it is considerednecessary.
At the hospital level, Apidra roads will continue to be available.
CHMP and national agencies are working in close collaboration with the company to guarantee the restoration of the normal supply as soon as possible for the benefit of patients.

Both the European Public Report on Apidra evaluation and the questions and answers published by the EMA on this matter, "Shortage of Apidra (Insuline Glulisine) Cartridges", can be consulted on your website www.ema.europa.eu .

Cagüentoloquesemenea.

Do you know if the vials will be available in pharmacy or will they only for hospitals?Celia uses Apidra with the bomb.

Well, I also used it and went for recipes earlier this month and I had no problems, they gave me three boxes, I hope they get to December:-/:-/

When I changed to Apidra, vials were not sold in the pharmacy, now I don't know ......

The vials no idea, tomorrow I will ask in my hospital because I have learned via Mail of the AEMPS.

In any case, the simplest thing is to go to Novorapid, so it can happen and it would be seen in 2012

Hallucino with which they recommend replacing it with actrapid: shock ::-/

We will have to wait to see what is the specific situation of supply in each country because there are countries that do not affect them.

I would be surprised that a pharmaceutics like Sanofi Aventis (which has other important products that are sold worldwide such as Lantus) only had a single factory to supply the rest of the world.

It is fine that they inform what happened and take the measures they are taking (paralyze the production, that they do not go to the market possible affected lots, ... etc) but I hope that there is no excessive alarm if it is not necessary since ifFor example, alarmism occurred in a country that in principle does not affect the supply problem could occur precisely the problem.

Yes, transparency (forced, I don't know if at the legal level) of Sanofi Aventis ... let's not forget touched by the past information about Lantus.

Having simple alternatives such as Novorapid or Humalog, health managers should go in the line that TNT points out, avoid unnecessary alarmism that would only accelerate shortage much faster yet.

As for production, an unprepmed event of this type is hardly rectible in short space of time.
I don't know exactly the number of factories produced by Apidra, but I don't think there are many more than 4 or 5 worldwide.

But if it is only Apidra that has supply problems, why this phrase?

"... the problem of supply in Spain affects pre -scaled feathers, Optiset and Solostar. It does not affect Apidra roads or any other Sanofi insulin (Lantus) ..."

I don't understand anything.According to that also affects Lantus !!(Optiset and Solostar).

Optiset and Solostar are only different presentations that use Sanofi-Aventis in their preloaded insulin feathers (there is at least another one called Opticlik).

Photos of the Apidra insulin presentations that can be affected by the problem:

• * Apidra Solostar :

  
  

Are there other insulins that use those same Optiset and Solostar presentations?Yes, Sanofi-Aventis with the Lantus insulin uses the same presentations (there are Lantus optiset and lantus solostar) but that uses the same presentation does not mean that it is affected.

The Lantus is not affected by the problem and of the Apidra only those two presentations (Optiset and Solostar) can be affected by the problem.

TNT has already explained it, Sanofi Aventis must have patented those 3 injection devices: Solostar, Optiset and Opticlick ... in addition to the vials.

Glulisin insulin (Apidra in its commercial name) is the one that has generated problems in its manufacture.

What I do not understand is why Apidra's commercialization has not been affected.
Maybe it is because they do it in a different factory.

Sanofi's official note is clear: Link ... 9sep11.pdf
The incidence is worldwide and hope to resume production at the beginning of 2012: Shock:

In my hospital they had no more information than we commented yesterday.Neither in pharmacy nor in endocrine I have been able to have more information.

In my opinion, those that are affected, when you need insulin, go to any of the other 2 ultra fast insulins because the duration of shortage is not known.

On the other hand, this is another hard blow for Sanofi Aventis (today has fallen by 1% in the Madrid Stock Exchange), other areas of the group go through problems and the entire Affaire Lantus-Cancer made it lose a lot of market share.
In the medium and long term it is not good for patients that companies lose a lot of money ... research investments are reduced, among other problems.

The Official note of healthy> aimed at health professionals seems like a tract of the Informative note of the Spanish Agency for Medicine and Health Products (Aemps), come on ... that the AEMPS was already confirmation ... as in the note ofThe AEMPS appeared at least one reference that the company had to send a statement explaining the specific situation of each country, the matter was a bit in the air but it seems not, it was already confirmation.

Anyway, things remain in the air:

>
Publication date: September 29, 2011

(...)

Sanofi Aventis Deutschland GmbH, head of the marketing authorization, has reported to the European Medicines Agency (EMA) of an Apidra supply problem

Apidra 100 units/ml, Optiset Injectable solution in preloaded pen (CN: 651458) and
Apidra 100 units/ml, solostar injectable solution in preloaded pen (CN: 656073).

Apidra is a rapid action insulin analog (chemically modified insulin) that is used in combination with intermediate or prolonged action insulins, or other analogs of insulin.It can also be used in combination with other medications (oral route) to treat diabetes.

Sanofi-Aventis Deutschland GmbH, informed the European drug agency for an accidental discharge that occurred on July 11, 2011 at the plant where the medicine is manufactured in Frankfurt, Germany.The manufacture has been temporarily suspended while the corresponding internal investigations are carried out. This situation will result in a delay in the release of Apidra's lots in the European Union market.The problem of supply in Spain affects preloaded feathers, Optiset and Solostar.

The normal supply is expected to resume in early 2012. Until then supply problems are expected.

The preloaded feathers of Apidra currently in the market can be used with total safety.

(...)

>
September 29, 2011

Estimated health professional,

Direct communication to the health professional on temporary supply problems of Apidraml injectable solution in preloaded pen
Sanofi-Aventis addresses you to inform you of a Temporary Reduction of the Apidra 3ML supply that affect the following presentations in Spain.Apidra Optiset 100 IU/ML Injectable solution in preloaded pen.

Supply reduction is due to a technical incident in the manufacturing plant that has led to temporary interruption in production.We are doing everything possible so that at the beginning of 2012 the normal supply resumes.

This supply reduction will occur in most European Union countries over the coming months and will affect many patients. In Spain, the shortage is expected to begin the second week of October.

The preloaded feathers of Apidra currently in the market areThey can use sure.None of the other Sanofi insulins marketed in Spain (Lantus) have been affected.

(...)

There is no certainty that all of us who use Apidra in the Optiset or Solostarwhen one can begin to have the problem or how long it will last).

With current data it is very difficult to make decisions about what to make ...

Among the recommendations that give (if you suffer the problem) personally I think it is better to replace a rapid action insulin analog (Apidra) with another (Humalog or Novorapid) than changing regular insulin (Actrapid).

Insulin analogues (whether fast or prolonged action) are used in basal-bolus thermos that are the terápia that the majority currently have, regular insulin is used in what is called biphasic terápia.
It is not the same:

If I am affected by this movie I have it clear: Humalog or Novorapid, but I hope not to be affected, every insulin change implies being more on the subject doing among other things more blood glucose controls and the problem would be double (insulin and insulin change andmore strips of the normal that continue to ration).

Obviously any change that you are going to do should agree with the endocrine.

In my opinion it is nonsense to mention Actrapid or other regular insulins in the press release of both the AEMPS and the Sanofi Aventis itself, although much more serious it seems to me about the AEMPS.

As I put before, if I used Apidra, when my stock was over, I would immediately happen to Novorapid or Humalog, the insecurity about the restoration of the supply is great and I would not play it to endure a long time (3 or 4 months asThe manufacturer himself points are many).

Extracted from Apidra's prospect:

In one patient the change to another type or insulin brand should be performed under strict medical supervision.Changes in concentration, brand (manufacturer), type (regular, neutral protamine hageden nph, slow, prolonged action, etc.), origin (animal, human, analogous of human insulin) and/or manufacturing method could lead to theneed for a dose change.

As for Apidra vials, in Spain they are authorized for commercialization, their National Code is 652001

The differences between the 3 ultrarapid insulins can be significant, an example is that of excipients.
Excipient comparison of the 3 ultra -upstyle insulins:
Apidra
Metacresol, sodium chloride, trometamol, polysorbate 20, hydrochloric acid, sodium hydroxide concentrate, water for injected preparations

Novorapid
Glycerol, phenol, metacresol, zinc chloride, dysóic phosphate dihydrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injectable preparations

Humalog
M-Cresol [3.15 mg/ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injectable preparations may have used hydrochloric acid and sodium hydroxide to adjust the pH to 7.0-7.8.

Today we have commented with the endo the issue of Apidra, and he has told me that in vials there is no problem, so we will not change insulin, because for the bomb it is worth the same.

Health

The differences between the 3 ultrarapid insulins can be significant, an example is that of excipients.
Excipient comparison of the 3 ultra -upstyle insulins:
Apidra
Metacresol, sodium chloride, trometamol, polysorbate 20, hydrochloric acid, sodium hydroxide concentrate, water for injected preparations

Novorapid
Glycerol, phenol, metacresol, zinc chloride, dysóic phosphate dihydrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injectable preparations

Humalog
M-Cresol [3.15 mg/ml] Glycerol Dibasic sodium phosphate.7H2O Zinc oxide Water for injectable preparations may have used hydrochloric acid and sodium hydroxide to adjust the pH to 7.0-7.8.

: Shock :: Shock :: Shock :: Shock :: Shock:
In addition to this one, what does it do for what is for ... it takes some insulin?

Today I have gone to the hospital to make a glycosylated hemoglobin and I have taken the opportunity to ask about this subject, they were aware and in the event that there are Apidra supply problems the recommendation is to change to novorapid (and to have to make the change to do it withSupervision) But come on ... that it is no confirmation that there will be the problem, it is only what they are going to do in that (Central University Hospital of Asturias) if patients with the problem arrive.

On the other hand and continuing with the subject ...

On the Spanish page of Sanofi Aventis ( Link ) also have a note that is basically equal to the aforementioned notes of the AEMPS and the one aimed at health professionals:

Link

Important Information: Temporary Problems for the Supply of Pre -Argated Feathers of 3 ml of Apidra®

We report a temporary problem of the supply of preloaded feathers for Apidra® 3 ml injection (glulisine insulin) [ADNR origin], which affects: Apidra® Solostar ™ 100 UI/ml, injectable solution in preloaded pen and apidra optiset 100 UI/ml injectable solution in preloaded pen.This situation is due to a technical incident in a manufacturing line that has led to a temporary interruption of production.We are working to restore the supply before the end of 2011 and be at full capacity in early 2012. The preloaded feathers of Apidra currently in the market can be used safely.None of the other Sanofi insulins marketed in Spain (Lantus) have been affected.

Our priority is patient safety.Sanofi has notified the health authorities and is contacting health professionals to explain the specific supply situation that will occur, together with recommendations to handle the situation.()

What you should know about the change options during the temporal interruption of the Apidra® 3 ml supply:

In Spain, taking into account the needs of each patient, the main recommendations, while this supply problem lasts, are the following:

Patients could be changed to an alternative fast insulin analogue such as Humalog (Insulina Lispr.

Other rapid insulin analogues are not available or not appropriate, patients may require change to regular human insulin of rapid action such as Actrapid.As these insulins have a slower start and a longer action duration than Apidra, the direct supervision of a health professional as well as a more frequent review of blood glucose in order to supervise the necessary dose adjustment will be necessary.>

Hospitals continue to have Apidra vials available.In this case, no dose adjustment is required.

In order to be informed about when the supply will resume in Spain, patients, doctors and pharmacists, can contact the Sanofi subsidiary in Spain, through the medical information service in Sanofi.Telephone: 93 485 91 00

Sanofi puts the patient's well -being and safety as the highest priority and undertakes to provide high quality insulins and help patients control their diabetes.

The change of insulin must be done with caution andonly under medical supervision.

If someone is encouraged, they can call that phone number to see what they say.

Well, I'm quite fly.

This morning we have gone to the header, to look for apidra recipes in vials.He told us that they did not go on the computer.I called the Endo consultation and they told me to make the recipe by hand and that's it.He did so, but when they arrived at the pharmacy they told us there wasn't.I called the educator again and told me to try another pharmacy and that if the problem persisted, I returned to the endo to change the insulin to Humalog or Novorapid.

A pain: Evil:

Anyway, we will do pharmaceutical tourism this afternoon: Mrgreen:

Health

Alea, Apidra's roads are marketed throughout Spain ... in the pharmacy, all they should have done is to look for the code on the computer and request it, in less than 4 hours you should have it in your pharmacy ... if IHurry the next day.

Above I have put the National Code ... Let's see if it serves them.

And if not, do not complicate yourself ... to change to Humalog or Novorapid and Apañao.

Nothing, Owash, I have taken the code and gets out that it is marketed, but when I go to ask for it, it does not exist.They have also looked on a ministry website and does not appear either.That is, yes but no.I have gone to several pharmacies and in all the same.They are told that they are not provided by the laboratory.