Alteplase is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units (IU). Activase (alteplase) is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP. Table 6 Quantitative Composition of the Lyophilized Product 100 mg Vial 50 mg Vial Alteplase 100 mg (58 million IU) 50 mg (29 million IU) L-Arginine 3.5 g 1.7 g Phosphoric Acid 1 g 0.5 g Polysorbate 80 10 mg 5 mg Vacuum No Yes The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3. The osmolality of this solution is approximately 215 mOsm/kg.

Can you take alteplase with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run alteplase against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is alteplase sold under?

We track 2 alteplase-containing products in the U.S.: Activase and Cathflo Activase. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does alteplase come in?

Across the brands we track, alteplase is currently marketed as kit and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic alteplase?

We do not currently list a generic-labelled alteplase product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has alteplase been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions alteplase. The most recent: Cathflo activase (ALTEPLASE) (May 20, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Alteplase: uses, dosing, side effects & brands

Alteplase is a medicine sold in the U.S. under 2 brand and generic names, for arterial occlusive diseases, intracranial embolism and thrombosis and myocardial infarction. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Treats: Arterial Occlusive Diseases, Intracranial Embolism and Thrombosis and Myocardial Infarction
Available as: Kit · Injectable
Sold as: 2 products — Activase and Cathflo Activase
Prescription?: Prescription only
Generic available?: Not in our catalog

How alteplase is dosed

From the FDA label for Activase (application BLA103172). Other alteplase products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Acute Ischemic Stroke : The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose) infused intravenously over 60 minutes with 10% of the total dose administered as an initial bolus over 1 minute. ( 2.1 ) Acute Myocardial Infarction : The recommended total dose is based on patient weight, not to exceed 100 mg. ( 2.2 ) Acute Massive Pulmonary Embolism : The recommended dose is 100 mg administered by IV infusion over 2 hours. ( 2.3 ) Do not add other medications to infusions containing Activase. ( 2.5 ) 2.1 Acute Ischemic Stroke Administer Activase as soon as possible but within 3 hours after onset of symptoms. The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose), with 10% of the total dose administered as an initial intravenous bolus over 1 minute and the remainder infused over 60 minutes. During and following Activase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure. In patients without recent use of oral anticoagulants or heparin, Activase treatment can be initiated prior to the availability of coagulation study results. Discontinue Activase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated [see Contraindications (4.1) ] . 2.2 Acute Myocardial Infarction Administer Activase as soon as possible after the onset…

Alteplase side effects

The following adverse reactions are discussed in greater detail in the other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.2) ] Thromboembolism [see Warnings and Precautions (5.3) ] Cholesterol Embolization [see Warnings and Precautions (5.4) ] The most frequently occurring adverse reaction ( > 5%) is bleeding. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most frequent adverse reaction associated with Activase in all approved indications is bleeding. Bleeding Acute Ischemic Stroke (AIS) In clinical studies in patients with AIS (Studies 1 and 2) the incidence of intracranial hemorrhage, especially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients. A dose-finding study of Activase suggested that doses greater than 0.9 mg/kg may be associated with an increased incidence of intracranial hemorrhage. The incidence of all-cause 90-day mortality,…

Every alteplase product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Alteplase products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Activase	68/100	Prescription	Kit	—	—	View →
2	Cathflo Activase	68/100	Prescription	Injectable	—	—

Alteplase recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Cathflo activase (ALTEPLASE)
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Genentech, Inc. · May 20, 2024

Frequently asked questions

What is alteplase?: Alteplase is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units (IU). Activase (alteplase) is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP. Table 6 Quantitative Composition of the Lyophilized Product 100 mg Vial 50 mg Vial Alteplase 100 mg (58 million IU) 50 mg (29 million IU) L-Arginine 3.5 g 1.7 g Phosphoric Acid 1 g 0.5 g Polysorbate 80 10 mg 5 mg Vacuum No Yes The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3. The osmolality of this solution is approximately 215 mOsm/kg.
Can you take alteplase with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run alteplase against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is alteplase sold under?: We track 2 alteplase-containing products in the U.S.: Activase and Cathflo Activase. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does alteplase come in?: Across the brands we track, alteplase is currently marketed as kit and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic alteplase?: We do not currently list a generic-labelled alteplase product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Who shouldn’t take alteplase

General Active internal bleeding. ( 4.1 , 4.2 ) Recent intracranial or intraspinal surgery or serious head trauma. ( 4.1 , 4.2 ) Intracranial conditions that may increase the risk of bleeding. ( 4.1 , 4.2 ) Bleeding diathesis. ( 4.1 , 4.2 ) Current severe uncontrolled hypertension. ( 4.1 , 4.2 ) Acute Ischemic Stroke Current intracranial hemorrhage. ( 4.1 ) Subarachnoid hemorrhage. ( 4.1 ) Acute Myocardial Infarction or Pulmonary Embolism History of recent stroke. ( 4.2 ) 4.1 Acute Ischemic Stroke Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1) ] : Current intracranial hemorrhage Subarachnoid hemorrhage Active internal bleeding Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma Presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms) Bleeding diathesis Current severe uncontrolled hypertension. 4.2 Acute Myocardial Infarction or Pulmonary Embolism Do not administer Activase for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1) ]: Active internal bleeding History of recent stroke Recent (within 3 months) intracranial or…