TNKase Product Return and Replacement

Genentech will provide credit or replacement for a product return only if it is authorized and after the actual physical product has been received and identified by Inmar RX Solutions.

Expired Returnable Products

Product Returns will be accepted from direct (wholesaler) and non-direct (wholesaler's customers, ie, pharmacies) accounts under the following conditions:

  • Product returned within 2 months prior to and 6 months past expiration date
  • Product in its original container and bearing its original label

Non-Returnable Products

The following products are non-returnable, regardless of expiration date:

  • Products damaged by improper storage or handling, fire, flood, or catastrophe
  • Repackaged products
  • Products that had been sold expressly on a non-returnable basis
  • Products obtained illegally or from an unauthorized source
  • Products purchased on the "secondary source" market or from a distributor who is not a direct purchasing account with Genentech
  • Partially filled vials
  • Products with no lot numbers, expiration dates, or with unreadable labels
  • Products in their original containers but with prescription labels attached
  • Products that Genentech determines, in its sole discretion, are otherwise adulterated, misbranded, or counterfeit

Procedure for Returning Products

The procedure for returning products depends on the condition of the product.

Expired Product

  • Unless requested, all TNKase expired returns will be replaced. If you would like a credit for your return, please contact Genentech Customer Service at (800) 551-2231 to obtain authorization and return box label. Shipping and transportation charges are prepaid by the customer.

Damaged Product

  • To return damaged product, please contact Genentech Customer Service at (800) 551-2231

Spoiled Product

When Genentech product is prescribed for a labeled indication is spoiled and unable to be administered, the product might be eligible for replacement through the Genentech Spoilage Replacement Program.*

  • You may complete your request for spoilage replacement online at www.spoilage.gene.com or by calling Genentech Customer Service at (800) 551-2231.

Please be sure to retain intact vials and all product. Unless the vial is broken, all product must be returned. If the vial is broken, a completed Certification of Destruction form is required.

*Subject to certain limitations and conditions

Additional Information

  • Genentech will continue to process credits
  • All products returned, including unauthorized returns, will be destroyed
  • Returns for reasons related to product quality (for example, solution is cloudy, etc.) will continue to be processed by Genentech—Please contact Genentech's Quality Department at (800) 334-0290
  • Customers are liable for the product until Inmar RX Solutions or Genentech identifies it as an appropriate product return, which may be up to ten business days after receiving the product
  • Products covered by this policy include TNKase and Activase

Genentech Patient Foundation

The Genentech Patient Foundation gives free Genentech medicine to people who meet certain income criteria and don't have insurance coverage or have financial concerns.

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    • TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

      TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

    • O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

      O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

    • Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

      Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

    • Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.

      Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.

    • Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

      Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

    • Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.

      Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.

    Important Safety Information

    Indication

    TNKase® (tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.

    Important Safety Information

    Contraindications

    TNKase therapy in patients with AMI is contraindicated in the following situations because of an increased risk of bleeding: active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension.

    Warnings

    Bleeding

    The most common complication encountered during TNKase therapy is bleeding. Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately and treated appropriately.

    In clinical studies of TNKase, patients were treated with both aspirin and heparin. Heparin may contribute to the bleeding risks associated with TNKase. The safety of the use of TNKase with other antiplatelet agents has not been adequately studied. Intramuscular injections and nonessential handling of the patient should be avoided for the first few hours following treatment with TNKase.

    The risk of bleeding may be increased in the following conditions and should be weighed against the anticipated benefits: recent major surgery, cerebrovascular disease, recent gastrointestinal or genitourinary bleeding, recent trauma, hypertension, acute pericarditis, subacute bacterial endocarditis, hemostatic defects, severe hepatic dysfunction, pregnancy, diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions, septic thrombophlebitis or occluded AV cannula at seriously infected site, advanced age, patients currently receiving oral anticoagulants, recent administration of GP IIb/IIIa inhibitors, and any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

    Thromboembolism

    The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation.

    Cholesterol Embolization

    Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown. This serious condition, which can be lethal, is also associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.

    Arrhythmias

    Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered.

    Use with Percutaneous Coronary Intervention (PCI)

    In patients with large ST-segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion.

    Precautions

    Standard management of myocardial infarction should be implemented concomitantly with TNKase treatment. In the event of serious bleeding, heparin and antiplatelet agents should be discontinued immediately.

    Hypersensitivity

    Anaphylactoid reactions associated with the administration of TNKase are rare and can be caused by hypersensitivity to the active substance tenecteplase or to any of the excipients. If symptoms of hypersensitivity occur, appropriate therapy should be initiated.

    Drug and Drug/Laboratory Test Interactions

    Formal interaction studies of TNKase with other drugs have not been performed. Patients studied in clinical trials of TNKase were routinely treated with heparin and aspirin.

    During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts. Tenecteplase is an enzyme that, when present in blood in pharmacologic concentrations, remains active under in vitro conditions. This can lead to degradation of fibrinogen in blood samples removed for analysis.

    Adverse Reactions

    The most frequent adverse reaction associated with TNKase is bleeding.

    Should serious bleeding occur, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes. For TNKase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9% and incidence of any stroke was 1.8%. The incidence of all strokes, including intracranial bleeding, increases with advancing age.

    Please see full Prescribing Information for additional Important Safety Information.

      • TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

        TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

      • O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

        O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

      • Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

        Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

      • Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.

        Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.

      • Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

        Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

      • Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.

        Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.