ACTILYSE®
Side effects and safety
Contraindications
ACTILYSE® should not be administered to:
- Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients.
- Patients with high risk of hemorrhage such as:
- significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
- receiving effective oral anticoagulant treatment, e.g. warfarin sodium (international normalized ratio [INR] > 1.3)
- any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- suspected or confirmed or history of intracranial hemorrhage, including subarachnoid hemorrhage
- severe uncontrolled arterial hypertension
- major surgery or trauma (including any damage from recent acute myocardial infarction) within less than 10 days, recent head or intracranial trauma
- prolonged or traumatic external heart massage (over 2 minutes), obstetrical delivery, recent (less than 10 days) puncture of a non-compressible blood vessel (e.g. subclavian or jugular vein puncture)
- severe liver disease, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis
- bacterial endocarditis, pericarditis
- acute pancreatitis
- ulcerative gastrointestinal disease during the last 3 months
- arterial aneurysm, arterial/venous malformations
- neoplasm with increased bleeding risk
Additional contraindications in acute myocardial infarction and acute massive pulmonary embolism:
- any known history of hemorrhagic stroke or stroke of unknown origin
- known history of ischemic stroke or transient ischemic attack (TIA) in the preceding 6 months except current acute ischemic stroke within 4.5 hours
Additional contraindications in acute ischemic stroke:
- symptoms of ischemic attack beginning more than 4.5 hours prior to infusion start or symptoms for which the onset time is unknown
- minor neurological deficit or symptoms rapidly improving before start of infusion
- severe stroke as assessed clinically (e.g.National Institute of Health Stroke Scale [NIHSS] >25) and/or by appropriate imaging techniques
- seizure at onset of stroke
- prior stroke or severe head trauma within the last 3 months
- any history of prior stroke and concomitant diabetes
- administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
- platelet count of below 100,000/mm3
- active internal bleeding
- systolic blood pressure 85 mm Hg or diastolic BP 110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits
- blood glucose 50 mg/dl or 400 mg/dl
ACTILYSE® is not indicated for the treatment of acute ischemic stroke in children or teenagers under 18 years of age.
Adverse reactions
The most frequent adverse reactions associated with ACTILYSE® is bleeding (≥1/100 to 1/10: major bleeding; ≥1/10: any forms of bleeding) resulting in a fall in hematocrit and/or hemoglobin values. Any bleeding occurring in any site or body cavity may lead to life-threatening, permanent disability or death.
Bleeding caused by thrombolytic treatments can be divided as the following:
- Bleeding on the surface, which usually occurs at the site of a vascular puncture or injury.
- Bleeding in any site or body cavity
Any neurologic symptoms related to intracranial bleeding (such as drowsiness, aphasia, limb weakness, or seizure).
Footnotes:
-
INR, international normalized ratio; NHISS, National Institute of Health Stroke Scale; TIA, transient ischemic attack.
References:
-
ACTILYSE® Injection, approved package insert. Updated April 2019. Approved September 2019.
![[BI Medical] NOAC於AF併有CAD在真實世界的臨床效益](/tw/sites/default/files/2023-05/8-SC-TW-00435.png "[BI Medical] NOAC於AF併有CAD在真實世界的臨床效益")
![[BI Medical] NOAC於AF併有CAD在真實世界的臨床效益](/tw/sites/default/files/styles/bi_gds_medium/public/2023-02/arrow.png "[BI Medical] NOAC於AF併有CAD在真實世界的臨床效益"){kind=icon}
