
Actilyse50 mg/vial
Radiant Pharmaceuticals Ltd.
Alteplase is a recombinant tissue plasminogen activator (tPA) indicated for the emergency treatment of specific thromboembolic conditions.
Alteplase is a recombinant tissue plasminogen activator (tPA) indicated for the emergency treatment of specific thromboembolic conditions. It must only be administered in a hospital setting by clinicians experienced in thrombolytic therapy.
Alteplase is a time-critical, specialist-administered emergency medicine and is not intended for outpatient, elective, or self-administered use.
Alteplase is administered only in a hospital/emergency setting under close monitoring, with dosing individualized by indication and patient weight. The maximum total dose must never be exceeded regardless of patient weight. See Dosage for exact per-indication amounts and Administration for infusion technique.
| Indication | Typical Regimen |
|---|---|
| Acute Ischemic Stroke | 0.9 mg/kg IV (max 90 mg total); 10% as bolus, remainder infused over 60 minutes |
| Acute Myocardial Infarction | Weight-based accelerated infusion over 90 minutes, or 3-hour infusion regimen, max 100 mg total |
| Acute Massive Pulmonary Embolism | 100 mg IV infused over 2 hours |
| Occluded Central Venous Access Device | 2 mg/2 mL instilled into the catheter lumen (weight-based in children) |
The most common and most serious adverse reaction associated with Alteplase is bleeding.
Alteplase is contraindicated in patients with any of the following, because of an unacceptably high risk of serious or fatal bleeding:
Additional indication-specific exclusion criteria (e.g., precise stroke-onset time windows, recent major surgery, active peptic ulcer disease) apply per detailed clinical protocols and must be reviewed by the treating physician before Alteplase is used; these function as careful patient-selection criteria rather than universal absolute contraindications. See Precautions and Warnings.
Disclaimer
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