Alteplase 12.5micrograms/0.1ml solution for injection pre-filled syringes
Requires a prescription from a doctor or prescriber
Alteplase is a recombinant tissue plasminogen activator (rt-PA) used as a thrombolytic agent.[L43125] It cleaves plasminogen to form plasmin, an enzyme involved in the degradation of fibrin clots.
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Alteplase
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Alteplase
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(6)
Alteplase for treating acute ischaemic stroke (TA264)
Tenecteplase for treating acute ischaemic stroke (TA990)
Guidance on the use of drugs for early thrombolysis in the treatment of acute myocardial infarction (TA52)
Therapeutic hypothermia for acute ischaemic stroke (HTG511)
Stroke and transient ischaemic attack in over 16s: diagnosis and initial management (NG128)
Mechanical thrombectomy devices for acute ischaemic stroke (MIB153)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 27 · Randomised trials: 23 · 1990–2026
Showing the 50 most relevant studies, sorted by most relevant.
William Whiteley, Jonathan Emberson, Kennedy R. Lees, et al.
The Lancet Neurology, 2016
- Age Factors
- Cerebral Hemorrhage
- Brain Ischemia
Götz Thomalla, Florent Boutitie, Henry Ma, et al.
The Lancet, 2020
- Time-to-Treatment
- Ischemic Stroke
- Fibrinolytic Agents
Yongjun Wang, Yongjun Wang, Shuya Li, et al.
The Lancet, 2023
- Tenecteplase
- Ischemic Stroke
- Brain Ischemia
Kennedy R. Lees, Erich Bluhmki, Rüdiger von Kummer, et al.
The Lancet, 2010
- Fibrinolytic Agents
- Infusions, Intravenous
- Injections, Intravenous
Jonathan Emberson, Kennedy R. Lees, Patrick D. Lyden, et al.
The Lancet, 2014
- Acute Disease
- Age Factors
- Fibrinolytic Agents
Natalie E. LeCouffe, Manon Kappelhof, Kilian M. Treurniet, et al.
New England Journal of Medicine, 2021
- Thrombectomy
- Ischemic Stroke
- Combined Modality Therapy
Bijoy K. Menon, Brian Buck, Nishita Singh, et al.
The Lancet, 2022
- Ischemic Stroke
- Brain Ischemia
- Tenecteplase
Urs Fischer, Johannes Kaesmacher, Daniel Strbian, et al.
The Lancet, 2022
- Tissue Plasminogen Activator
- Thrombectomy
- Stroke
Christopher Elnan Kvistad, Halvor Næss, Bernt Harald Helleberg, et al.
The Lancet Neurology, 2022
- Ischemic Stroke
- Brain Ischemia
- Stroke
Serge Bracard, Xavier Ducrocq, J.‐L. Mas, et al.
The Lancet Neurology, 2016
- Outcome Assessment, Health Care
- Brain Ischemia
- Combined Modality Therapy
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
156 found
Half-life
5 minutes
Mechanism
Alteplase is a recombinant tissue plasminogen activator (rt-PA) that converts pl…
Food interactions
1 warning
Human targets
4 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3.3 ng/ml
Half-life
5 minutes
Protein binding
Volume of distribution
3.9 to 4.3 L
[L43125]…
Metabolism
[A252270]…
Elimination
80%
[A252270]
Clearance
570 mL/min
[L43125]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[L43125]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 706 interactions
[L43125]
Symptomatic and supportive measures are recommended. The carcinogenic potential of alteplase or its effect on fertility have not been evaluated. In vivo studies evaluating tumorigenicity and in vitro studies evaluating mutagenicity were negative.
[L43125]
It has been estimated that the acute oral and dermal toxicity of alteplase is above 5,000 mg/kg.
[L43175]
In patients with acute myocardial infarction, alteplase reduces fibrinogen levels 3 to 6 hours after treatment. In patients with acute ischemic stroke, patients treated with alteplase have a significantly higher resolution of hyperdense artery sign, a marker of clot formation in the proximal middle cerebral artery, compared to those treated with placebo.[A252330] The use of alteplase increases the risk of bleeding and thromboembolic events. Rare cases of cholesterol embolism have also been reported.[L43125]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A252270]
Acute myocardial infarction patients (n=12) given 10 mg of alteplase in a 2-minute infusion reached a peak plasma concentration of 3310 ng/ml. This was followed by 50 mg of alteplase in 1 h and 30 mg in 1.5 h, resulting in steady-state plasma levels of 2210 ng/ml and 930 ng/ml, respectively.
[A252285]
[L43125]
[L43125]
The average volume of distribution of the central compartment goes from 3.9 to 4.3 L, and the volume of distribution at steady state goes from 7.2 to 12 L.
[A252270]
[A252270]
In vivo studies suggest that alteplase follows zero-order kinetics, meaning that its metabolism is saturable at higher plasma concentrations.
[A252270]
[A252270]
[L43125]
Proteins and enzymes this drug interacts with in the body
PMID:6447255
Cleavage of fibronectin and laminin leads to cell detachment and apoptosis.
Also cleaves fibrin, thrombospondin and von Willebrand factor. Its role in tissue remodeling and tumor invasion may be modulated by CSPG4. Binds to cells
Was originally thought to be essential for platelet aggregation, based on in vitro studies using anticoagulated blood. However, subsequent studies have shown that it is not absolutely required for thrombus formation in vivo. Enhances expression of SELP in activated platelets via an ITGB3-dependent pathway.
Maternal fibrinogen is essential for successful pregnancy. Fibrin deposition is also associated with infection, where it protects against IFNG-mediated hemorrhage. May also facilitate the immune response via both innate and T-cell mediated pathways
Was originally thought to be essential for platelet aggregation, based on in vitro studies using anticoagulated blood. However, subsequent studies have shown that it is not absolutely required for thrombus formation in vivo. Enhances expression of SELP in activated platelets via an ITGB3-dependent pathway.
Maternal fibrinogen is essential for successful pregnancy. Fibrin deposition is also associated with infection, where it protects against IFNG-mediated hemorrhage. May also facilitate the antibacterial immune response via both innate and T-cell mediated pathways
PMID:15853774
Is a primary inhibitor of tissue-type plasminogen activator (PLAT) and urokinase-type plasminogen activator (PLAU). As PLAT inhibitor, it is required for fibrinolysis down-regulation and is responsible for the controlled degradation of blood clots .
PMID:17912461 PMID:8481516 PMID:9207454 PMID:21925150
As PLAU inhibitor, it is involved in the regulation of cell adhesion and spreading .
PMID:9175705
Acts as a regulator of cell migration, independently of its role as protease inhibitor .
PMID:15001579 PMID:9168821
It is required for stimulation of keratinocyte migration during cutaneous injury repair .
PMID:18386027
It is involved in cellular and replicative senescence .
PMID:16862142
Plays a role in alveolar type 2 cells senescence in the lung (By similarity).
Is involved in the regulation of cementogenic differentiation of periodontal ligament stem cells, and regulates odontoblast differentiation and dentin formation during odontogenesis PMID:25808697 PMID:27046084
Involved compounds
ATC B01AD02
ATC S01XA13
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Alteplase
Additional database identifiers
Drugs Product Database (DPD)
7297
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9071
GenAtlas
PLG
GeneCards
PLG
GenBank Gene Database
X05199
GenBank Protein Database
387026
Guide to Pharmacology
2394
UniProt Accession
PLMN_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3661
GenAtlas
FGA
GeneCards
FGA
GenBank Gene Database
AF361104
GenBank Protein Database
13591824
UniProt Accession
FIBA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3694
GenAtlas
FGG
GeneCards
FGG
GenBank Gene Database
M10014
GenBank Protein Database
182439
UniProt Accession
FIBG_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8583
GenAtlas
SERPINE1
GeneCards
SERPINE1
GenBank Gene Database
X04429
GenBank Protein Database
35272
UniProt Accession
PAI1_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q45769835), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.