Counterfeit Herceptin (trastuzumab)
Situation in Austria (as of 04/16/2014): Currently, onlyItalian Herceptin of the two parallel distributors "HAEMATO PHARM GmbH" and "INOPHA GmbH" is affected (see paragraph Situation in Austria).
The drug Herceptin is approved throughout Europe for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. It is used primarily in hospitals, contains the active ingredient trastuzumab and is available as 150 mg powder for the preparation of an infusion solution concentrate for intravenous administration or as 600 mg/5 ml injection solution for subcutaneous administration.
Suspicions of counterfeiting are currently limited to the intravenous dosage form only.
Measures at EU level
The European Medicines Agency (EMA) received information that vials of Herceptin (trastuzumab), a drug used to treat cancer, were adulterated and introduced into the legal distribution chain. Herceptin is believed to have been stolen in Italy, including from Italian hospitals. Italian law enforcement authorities are currently investigating both this theft and other products that may have been counterfeited. At the moment, suspicions are limited to "Herceptin 150 mg powder for the preparation of an infusion solution concentrate." At this time, no affected product has been detected in hospitals, nor have there been any reports that a patient has been harmed. Users and pharmacists should check Herceptin for the following characteristics to detect potentially counterfeit vials:
- Lot number and expiration date on the vials do not match the information on the outer packaging.
- Some vials contained a liquid (Herceptin is a white to faint yellow lyophilized powder)
- Tampered with rubber stoppers, crimp caps and caps.
- The counterfeit vials are circulating as Italian Herceptin 150 mg
These statements are based on information currently available. If users and pharmacists notice suspicious Herceptin vials with characteristics other than those listed above, BASG / AGES Medizinmarktaufsicht should be contacted. Counterfeit medicinal products should not be used under any circumstances! Appropriate measures are currently being taken to exclude any health risk to patients.
The following Italian Herceptin batches have been observed with counterfeit vials to date:
| affected batches (as of 04/16/2014). |
|---|
| H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, H4303B01. |
Only a small number of vials are believed to be counterfeit, but the marketing authorization holder of Herceptin - Roche Registration Limited - is conducting a precautionary recall of the Italian batches. In addition, all parallel distributors operating in the EU have been informed. As Herceptin is a centrally approved medicine, the EMA is coordinating the further course of action with the competent authorities in the EU Member States. It is anticipated that the recall of Herceptin will not result in any restriction of distribution. The EMA is monitoring this case and will issue new information if necessary.
Situation in Austria The following medicinal products are approved in Austria:
- Herceptin 150 mg powder for the preparation of an infusion solution concentrate.
- Herceptin 600 mg/5 ml solution for injection
Please note that counterfeits have currently only been identified for "Herceptin 150 mg powder for the preparation of an infusion solution concentrate"!
In Austria, Italian Herceptin has been distributed exclusively by the two parallel distributors "HAEMATO PHARM GmbH" and "INOPHA GmbH". A recall of the affected batches (H4196B01, H4271B01, H4284B04, H4303B01, H4301B09, H4324B03, H4329B01) has been initiated.
The BASG has received a total of 26 adverse event reports from Austria in the period from January 2013 to April 2014. However, no conclusion can be drawn regarding a connection with the use of adulterated "Herceptin 150 mg powder for the preparation of an infusion concentrate".
Recommendations of the BASG Recommendations for users and pharmacists:
- Before using/preparing Herceptin, please check the counterfeit characteristics listed above.
- In case of detection of a possible counterfeit, please report to the Medical Market Surveillance of the Institute Surveillance of BASG / AGES Medical Market Surveillance at enforcement@ages.at.
- Please check your stock for Italian Herceptin with the batch numbers listed above and stop using it
Recommendations for patients:
- If you have any questions, please contact your physician
More information: European Medicines Agency press release (04/16/2014):
BASG safety release (04/16/2014):
Queries (technical): Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
