Recombinant Tissue Plasminogen Activator (Thrombolytic) Pregnancy: Limited data in pregnant women; not considered teratogenic but nonclinical studies at higher-than-human doses showed fetal immaturity/embryotoxicity. In acute life-threatening disease, weigh benefit against risk. Consider discontinuing breast-feeding for first 24 hours after use.

Alteplase

Brand names: Actilyse

Used in: Venous Thromboembolism (DVT & PE) Stroke & TIA

Alteplase is a recombinant tissue plasminogen activator used as a thrombolytic in acute ischaemic stroke, ST-elevation myocardial infarction, and massive pulmonary embolism.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Regimen depends on indication. Acute MI (accelerated 90-min regimen, treatment started within 6 h of symptom onset, body weight >=65 kg): 15 mg IV bolus, then 50 mg IV infusion over first 30 min, then 35 mg IV infusion over 60 min (maximum total dose 100 mg)

Route: intravenous

Frequency: single treatment course per indication

Max: 100 mg total (acute MI); 100 mg total (acute massive PE)

Prescribe only by physicians experienced in thrombolytic treatment; give as early as possible after symptom onset. ACUTE MI, accelerated 90-min regimen, body weight <65 kg: 15 mg IV bolus, then 0.75 mg/kg over first 30 min, then 0.5 mg/kg over 60 min. ACUTE MI, 3-hour regimen (treatment started 6-12 h after onset), body weight >=65 kg: 10 mg IV bolus, then 50 mg over first hour, then 40 mg over 2 hours (maximum total 100 mg); body weight <65 kg: 10 mg IV bolus, then IV infusion over 3 hours up to a maximum total dose of 1.5 mg/kg. ACUTE MASSIVE PULMONARY EMBOLISM, body weight >=65 kg: total dose 100 mg administered over 2 hours. Only 10 mg, 20 mg or 50 mg vials are indicated for these indications (2 mg vials not indicated - risk of massive underdosing). Antithrombotic adjunctive therapy per current international guidelines for STEMI. (Acute ischaemic stroke regimen truncated in fetched SPC posology text; clinician to confirm stroke dosing from full SPC.)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to alteplase or any excipient
Significant bleeding disorder at present or within the past 6 months; known haemorrhagic diathesis
Manifest or recent severe or dangerous bleeding
Any history of CNS damage (neoplasm, aneurysm, intracranial or spinal surgery)
Severe uncontrolled arterial hypertension; bacterial endocarditis, pericarditis; acute pancreatitis; severe liver disease
Major surgery or significant trauma in past 3 months; recent (<10 days) obstetrical delivery or puncture of a non-compressible vessel
MI/PE: any history of haemorrhagic stroke or stroke of unknown origin; oral anticoagulation with INR >1.3; ischaemic stroke/TIA in preceding 6 months (except current acute ischaemic stroke within 4.5 h)
Stroke: intracranial haemorrhage (known, suspected or on CT); severe stroke (NIHSS >25); BP >185/110 mmHg uncontrolled; platelets <100000/mm3; blood glucose <50 or >400 mg/dL

Side effects

Haemorrhage in various forms with fall in haematocrit/haemoglobin (very common)
Intracerebral haemorrhage (very common in acute ischaemic stroke)
Recurrent ischaemia / angina pectoris, hypotension, heart failure / pulmonary oedema (very common in MI)
Reperfusion arrhythmias (uncommon in MI)
Hypersensitivity reactions e.g. rash, urticaria, bronchospasm, angio-oedema, hypotension, shock (rare)

Interactions

Other substances affecting coagulation or platelet function (e.g. heparin, oral anticoagulants) may contribute to bleeding
ACE inhibitors may enhance risk of angio-oedema (especially in acute ischaemic stroke)

Clinical monograph

How it works

It binds fibrin within a thrombus and converts entrapped plasminogen to plasmin, which degrades fibrin and dissolves the clot.

Prescribing in practice

The principal hazard is major haemorrhage, especially intracranial bleeding, so strict contraindication screening and adherence to the treatment time window are essential before administration.
In acute ischaemic stroke, intracranial haemorrhage must be excluded by imaging and blood pressure controlled before treatment.
It should not be combined indiscriminately with other agents that increase bleeding risk, and facilities to manage bleeding must be available.

Monitoring

Monitor neurological status, blood pressure, and for signs of bleeding closely during and after infusion, with urgent reassessment if deterioration suggests haemorrhage.

Counselling the patient

Explain that the treatment dissolves a clot but carries a risk of serious bleeding.
Advise the patient and team to report any new headache, weakness, or signs of bleeding immediately.
Note that blood pressure and neurological observations are monitored intensively after treatment.

Evidence & guidelines

Alteplase is recommended by NICE for thrombolysis in eligible acute ischaemic stroke within the approved time window, supported by landmark trials such as NINDS and ECASS III.

Reference: NICE NG128 (Stroke and transient ischaemic attack in over 16s, 2022); NICE NG185 (Acute coronary syndromes, 2020); ESC Guidelines on STEMI (2023); ESC Guidelines on acute PE (2019); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways