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Generic Name
Alteplase
Brand Names
Activase, Cathflo Activase
FDA approval date: November 13, 1987
Form: Injection, Kit
What is Activase (Alteplase)?
Activase is a tissue plasminogen activator indicated for the treatment of: Acute Ischemic Stroke .
Approved To Treat
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Brand Information
Activase (Alteplase)
1DOSAGE FORMS AND STRENGTHS
- 50 mg lyophilized powder in single-dose vial with 50 mL SWFI USP for reconstitution
- 100 mg lyophilized powder in single-dose vial with 100 mL SWFI USP for reconstitution
2ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the other sections of the label:
- Bleeding
- Hypersensitivity
- Thromboembolism
- Cholesterol Embolization
2.1Clinical 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.
2.2Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Activase. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions are frequent sequelae of the underlying disease, and the effect of Activase on the incidence of these events is unknown.
3DRUG INTERACTIONS
The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy.
In the post-marketing setting, there have been reports of angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors.
4DESCRIPTION
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.
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.
5PATIENT COUNSELING INFORMATION
Following Activase administration, patients are at increased risk of bleeding internally or externally. Advise patients to contact a health-care professional if they experience symptoms or signs consistent with bleeding (e.g., unusual bruising, pink or brown urine, red or black or tarry stools, coughing up blood, vomiting blood or blood that looks like coffee grounds), headache, or stroke symptoms.
6INSTRUCTIONS FOR USE
Activase®
(alteplase) for injection
for intravenous use
(alteplase) for injection
for intravenous use
100 mg (58 million IU)
Read before preparing Activase®
See also enclosed, full prescribing information
Instructions for Use should accompany reconstituted Activase to patient bedside.
Prescribing Information
Also Required
(not included in kit)
1 Luer syringe for removing bolus dose, as needed
1 Luer syringe for removing excess volume, as needed
2 large bore needles
2 Alcohol swabs
IV infusion set
Administration Notes
- Activase is for intravenous administration only.
- Do not add any other medication to infusion solutions containing Activase.
- Extravasation of Activase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that IV site and apply local therapy.
- See full prescribing information for alternative dilution instructions.
Storage & Stability
- Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration at 2° to 8° C (36° to 46° F). Protect the lyophilized material during extended storage from excessive exposure to light.
- Activase contains no antibacterial preservatives and must be used within 8 hours following reconstitution (when stored at 2-30°C).
Manufactured by:
U.S. License No. 1048
Activase® (alteplase) is a registered trademark of Genentech, Inc.
©2025 Genentech, Inc. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: February/2025
Representative sample of labeling (see the
7PRINCIPAL DISPLAY PANEL - Kit Carton - 50 mg
NDC 50242-044-13
Activase
50 mg per vial
For Intravenous Use
a tissue plasminogen activator
10243242
Genentech
8PRINCIPAL DISPLAY PANEL - Kit Carton - 100 mg
NDC 50242-085-27
Activase
100 mg per vial
For Intravenous Use
a tissue plasminogen activator
10236862
Genentech
