07 September 2017

[Reminder] Add Instructions And Warnings On The Drug Kyprolis 60Mg(Carfilzomib)- Amgen

Reference: CIR-2017-SHN0758

To: All Healthcare Facilities - Private Sector

In accordance with the recommendations of the Ministry of Health and Prevention and the Keenness of community and public health safety, we would like to draw your attention to the fact that the manufacturer has added guidelines and warnings about the use of the above-mentioned drug used to treat cancer, which may cause bleeding, pneumonia, sinusitis and cough with sputum. In addition, the dosage should be reduced and used with caution for all patients with liver and kidney disease.

Since the product is registered with the Department of Medicine of the Ministry of Health and Prevention, we recommend that:

1.     The pharmaceutical Manufacturer Company of the product shall amend the warnings, side effects and dosages in the medicine leaflet to include the risks mentioned above.

2.     Healthcare Professionals should take the necessary precautions mentioned above when administering medication to their patients

  3.     Using a 21-gauge or larger gauge needle and add a 100 ml bag as an option to reduce the dose.

4.     In case of Adverse Drug Reaction or event of any side effects kindly fill out the form of the ADR of the drug available at:

http://www.cpd-pharma.ae
Or contact the following addresses: 

Tel: 04-2301448 or fax 04-2301947 or Email address: pv@moh.gov.ae    

  §  All health facilities must adhere to this circular in accordance with the instructions in this regard.

§  Kindly adhere to the above details in order to avoid any penalties that might be taken as a result.       

    §  For more information or inquiries and submitting the required data, kindly call the support office on :    

          04- 5022901/ 5022996Email address:  regulation@dha.gov.ae     

             Your co-operation is highly appreciated,   

For full access on the circular # 108, please refer to the following link:

   https://www.dha.gov.ae/Documents/Kyprolis%2060mg%20(carfilzomib)%20Circular%20%D8%AA%D8%B9%D9%85%D9%8A%D9%85%20%D8%B1%D9%82%D9%85%20(108)%20%D8%A5%D8%B6%D8%A7%D9%81%D8%A9%20%D8%A5%D8%B1%D8%B4%D8%A7%D8%AF%D8%A7%D8%AA%20%D9%88%D8%AA%D8%AD%D8%B0%D9%8A%D8%B1%D8%A7%D8%AA%20%D9%84%D9%85%D8%B3%D8%AA%D8%AD%D8%B6%D8%B1%20%D8%AF%D9%88%D8%A7%D8%A6%D9%8A.pdf

 

  

Supporting Documents:

Kyprolis 60mg (carfilzomib) Circular تعميم رقم (108) إضافة إرشادات وتحذيرات لمستحضر دوائي.pdf:

View Document