Claims for Patent: 9,023,346

Summary for Patent: 9,023,346

Title:	Method of treating stroke with tenecteplase
Abstract:	A method for treating acute ischemic stroke in a human comprises administering tenecteplase to the human in a total dose of about 0.05 to 0.5 mg/kg, given as (a) an initial bolus dose of about 0.015 to 0.15 mg/kg, followed by infusion of an amount equaling the total dose minus the initial dose over a period of about 50-90 minutes, or (b) a bolus. Also described are kits for carrying out this method.
Inventor(s):	Kuebler; Peter (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	13/189,413
Patent Claims:	1. A method for treating acute ischemic stroke in a human comprising administering tenecteplase to the human in a total dose of about 0.05 to 0.5 mg/kg, given as an initial bolus dose of about 0.05 to 0.15 mg/kg, followed by infusion of an amount equaling the total dose minus the initial dose over a period of about 50-90 minutes. 2. The method of claim 1 wherein the total dose is about 0.2 to 0.3 mg/kg. 3. The method of claim 1 wherein the total dose is about 0.25 mg/kg. 4. The method of claim 1 wherein the initial dose is about 0.08 to 0.12 mg/kg bolus. 5. The method of claim 1 wherein the initial dose is about 0.1 mg/kg bolus. 6. The method of claim 1 wherein the period of infusion is about 55-70 minutes. 7. The method of claim 1 wherein the period of infusion is about 60 minutes. 8. The method of claim 1 wherein the total dose is about 0.25 mg/kg, given as an initial bolus of about 0.1 mg/kg, followed by infusion of about 0.15 mg/kg over about 60 minutes. 9. The method of claim 1 wherein the tenecteplase is administered to the human at a time between about 15 minutes and 20 hours from the onset of acute ischemic stroke. 10. The method of claim 1 wherein the tenecteplase is administered to the human at a time between about 30 minutes and 6 hours from the onset of acute ischemic stroke. 11. The method of claim 1 wherein the tenecteplase is administered to the human at a time between about 30 minutes and 3 hours from the onset of acute ischemic stroke. 12. The method of claim 1 wherein the bolus is intravenous. 13. The method of claim 1 further comprising administering to the human an effective amount of a second medicament, wherein the first medicament is tenecteplase. 14. The method of claim 13 wherein the second medicament is a neuroprotective agent, a thrombolytic agent, a glycoprotein IIb IIIa antagonist, or an anti-CD18 antibody.

Details for Patent 9,023,346

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	TNKASE	tenecteplase	For Injection	103909	06/02/2000		2039-02-26