Alteplase

Tissue-type plasminogen activator precursor tPA t-PA t-plasminogen activator

Therapeutic Indications

Alteplase is indicated for:

Acute ischaemic stroke

Irrespective of gender only Adults (18 - 65 years old)

Alteplase is indicated for the fibrinolytic treatment of acute ischaemic stroke. Treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 0.9 mg/kg body weight

Acute massive pulmonary embolism with haemodynamic instability

Irrespective of gender only Adults (18 years old or older)

Alteplase is indicated for the thrombolytic treatment in acute massive pulmonary embolism with haemodynamic instability. The diagnosis should be confirmed whenever possible by objective means such as pulmonary angiography or non-invasive procedures such as lung scanning. There is no evidence for positive effects on mortality and late morbidity related to pulmonary embolism.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 100 mg in 2 hours

Acute myocardial infarction

Irrespective of gender only Adults (18 years old or older)

Alteplase is indicated for thrombolytic treatment in acute myocardial infarction.

90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h after symptom onset

3 h dose regimen: for patients in whom treatment can be started between 6-12 h after symptom onset provided that the diagnosis has been clearly confirmed.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 90 minutes administration

Treatment 2: Intravenous - 3 h dose regimen

Contraindications

Active ingredient Alteplase is contraindicated in the following cases:

Haemorrhage

No gender/age discrimination

Alteplase is contraindicated in cases where there is a high risk of haemorrhage such as:

  • significant bleeding disorder at present or within the past 6 months
  • known haemorrhagic diathesis
  • patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (see section 4.4)
  • manifest or recent severe or dangerous bleeding
  • known history of or suspected intracranial haemorrhage
  • suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
  • any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a noncompressible blood-vessel (e.g. subclavian or jugular vein puncture)

Severe uncontrolled arterial hypertension

No gender/age discrimination

Alteplase is contraindicated in cases of severe uncontrolled arterial hypertension.

Ulcerative gastrointestinal disease, oesophageal varices, arterial-aneurysm, arterial/venous malformations

No gender/age discrimination

Alteplase is contraindicated in cases of documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations.

Severe liver disease, hepatic failure, cirrhosis, portal hypertension, active hepatitis

No gender/age discrimination

Alteplase is contraindicated in cases of severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.

Neoplasm with increased bleeding risk

No gender/age discrimination

Alteplase is contraindicated in cases of neoplasm with increased bleeding risk.

Αcute pancreatitis

No gender/age discrimination

Alteplase is contraindicated in cases of acute pancreatitis.

Bacterial endocarditis, pericarditis

No gender/age discrimination

Alteplase is contraindicated in cases of bacterial endocarditis, pericarditis.