The Spanish Agency for Medicines and Health Products (Aemps) has issued a series of recommendations to alleviate the supply problems of the different presentations of Metalyse and Actilyse, fibrinolytic drugs.
As reported by Aemps in a statement, there is an increase in the demand for Metalyse 8,000 units. Powder and solvent for injectable solution. 1 vial + 1 pre-filled syringe of solvent; Metalyse 10,000 units. Powder and solvent for solution for injection, 1 vial + 1 pre-filled syringe of solvent; Actilyse powder and solvent for solution for injection and infusion, 1 vial 20 mg + vial of solvent; and Actilyse powder and solvent for solution for injection and infusion, 1 vial 50 mg + vial of solvent.
Because its production capacity is “limited”, the company is conducting a “controlled distribution” of the available units of thiss medications until it can increase its manufacture, as Aemps, dependent on the Ministry of Health, has detailed.
Meanwhile, and with the aim of reaching a greater number of patients, the company has prioritized the manufacture of Actilyse, which covers a greater number of indications, instead of Metalyse. Within Actilyse, the manufacture of the 20 mg presentation has been prioritized over the 50 mg presentation in order to be able to adjust dose and thus avoid unnecessary product losses.
The Aemps, for its part, has consulted with the scientific societies directly involved in the use of fibrinolytics to optimize the use of available units.
Limit the use of alteplase
Together with the Spanish Society of Neurology (SEN), the Spanish Society of Intensive, Critical Medicine and Coronary Units (Semicyuc) and the Spanish Society of Nephrology (SEN), Aemps has agreed on some recommendations on the use of fibrinolytics given the current shortage of alteplase and tenecteplase.
Specifically, they have established that the use of alteplasa should be limited to its authorized indications: ischemic stroke, myocardial infarction y pulmonary embolism (TEP) of high risk. In addition, tenecteplase must be limited to its authorized indication: myocardial infarction.
The Aemps details that the use of urokinase it should be considered as an alternative to alteplase for high-risk PTE and also for unblocking catheters (preferably over other fibrinolytics). Alteplase or tenecteplase should not be used off-label. In particular, its off-label use is discouraged for the unblocking catheters.
In any case, Aemps reminds that it is possible to have reteplasa, a drug not marketed in Spain, as a bolus alternative to tenecteplase (eg in mobile ICUs). To do this, it is necessary to assess the specific needs and contact the Aemps Medicines in Special Situations Service (MSE), which will be in charge of informing regarding the availability of the medicine and the conditions of acquisition.
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