關於zoledronic acid (Aclasta®, Zometa®)和carbocisteine安全性的最新資訊 Latest safety updates on zoledronic acid (Aclasta®, Zometa®) and carbocisteine

  • 靜脈輸注zoledronic acid有可能引起腎功能損傷

        總結近期所收到的藥物上市後不良反應通報, 藥廠Novartis表示, 靜脈輸注zoledronic acid可引起腎功能障礙, 甚至出現急性腎功能衰竭的罕有個案。影響腎功能的因素包括年齡大﹑併用腎毒性藥物或利尿藥﹑以及於輸注zoledronic acid後缺水等。為了減少腎功能不良反應的出現, 藥物監測暨管理處通知醫生﹑藥劑師及其他衛生專業人士

1.     不要使用zoledronic acid於嚴重腎功能受損(肌酐清除率小於30mL/min)的病人。

2.     當併用zoledronic acid與其他可影響腎功能的藥物時, 須謹慎使用。

3.     對於具有上述危險因素的病人, 於開始使用zoledronic acid治療前, 應計算肌酐清除率, 並定期監測病人血清肌酐。

4.     病人於輸注zoledronic acid前後, 應適當地補充水份, 特別是年老及同時使用利尿藥的病人

5.     單次使用zoledronic acid不應超過5 毫克, 輸注時間不應少於15分鐘。

 

  • Rhinathiol® 2% 糖漿禁用於2歲以下小孩

        法國藥物監管機構(Afssaps)在研究最近的藥物監測數據後指出, 對於2歲以下的小孩, 使用化痰藥物控制支氣管分泌時, 可能會加重這類病人呼吸道方面的症狀。基於此, Sanofi-Aventis公司決定在Rhinathiol®的說明書中加入禁用於2歲以下小孩的資訊。

        目前文獻並沒有明確指出carbocisteine禁用於2歲以下的小孩, 然而, 基於該藥使用於2歲以下小孩的安全性尚未確定, 藥物監測暨管理處提醒醫生﹑藥劑師及其他衛生專業人士, 對於2歲以下的小孩, 應謹慎使用carbocisteine, 本處將密切監測該藥的安全性, 衛生專業人士如發現由該類藥物引致的不良反應, 請向藥物事務廳藥物監測暨管理處通報。

                                                                                                                                                                                                                    

  • Intravenous infusion of Zoledronic acid and renal dysfunction

After reviewing submitted post-marketing ADR reports, Novartis indicated that intravenous infusion of zoledronic acid may be associated with renal dysfunction and, in rare cases, with acute renal failure. Advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy or dehydration, may further compromise the renal function of the patients. In order to minimize such renal adverse reactions, Division of Pharmacovigilance and Pharmacoeconomics(DFF) recommends the followings to physicians, pharmacists and other health professionals:

1.     zoledronic acid should not be used in patients with severe renal impairment (creatinine clearance <30 mL/min).

2.     cautionly use zoledronic acid when other drugs that could impact renal function are concomitantly used.

3.     creatinine clearance should be calculated before each treatment with zoledronic acid followed by periodic monitoring of serum creatinine in patients with the above risk factors.

4.     patients should be appropriately hydrated prior to and following administration of zoledronic acid, especially elderly patients and those receiving diuretic therapy.

5.     A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be no less than 15 minutes.

 

  • Rhinathiol® 2% Syrup contraindicated in children below 2 years old

The French Drug Regulator (Afssaps) revealed that recent pharmacovigilance data concerning the use of mucolytic products to treat bronchial secretion in children below 2 years old may, in fact, aggravate and worsen the respiratory symptoms on this group of patients. Upon adoption of the above decision Sanofi-Aventis announced her action to revise package insert to include a new contraindication restricting the use of Rhinathiol® in children younger than 2 years of age.

Carbocisteine contraindicated in children below 2 years old is not well documented. However, due to safety not established in children 2 years of age and younger, DFF reminds physicians, pharmacists and other healthcare professionals cautionly use carbocisteine in children below 2 years old.  DFF will continue to monitor the safety of carbocisteine. Should health professionals encounter any ADR caused by mucolytics, please notify DAF/DFF.

 

 

參考資料/References and websites:

https://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/aclasta_hpc-cps-eng.php

https://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information


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