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.

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

    • 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.

    • 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.

    • 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.

    Important Safety Information & Indication

    Indication

    TNKase® (tenecteplase) is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).

    Important Safety Information

    Contraindications

    TNKase is contraindicated in patients with: 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 and Precautions

    Bleeding

    TNKase can cause bleeding, including intracranial hemorrhage and fatal bleeding.  Concomitant use of other drugs that impair hemostasis increases the risk of bleeding.

    Should serious bleeding that is not controlled by local pressure occur, discontinue any concomitant heparin or antiplatelet agents immediately and treat appropriately.

    Avoid intramuscular injections and nonessential handling of the patient for the first few hours following treatment with TNKase.  Perform arterial and venous punctures carefully and only as required. To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures.  If an arterial puncture is necessary during TNKase infusion, use an upper extremity vessel that is accessible to manual compression. Apply pressure for at least 30 minutes.

    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 in patients treated with thrombolytic agents. Investigate cause of any new embolic event and treat appropriately.

    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.

    Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI

    In a trial of patients with STEMI there were trends toward worse outcomes in the individual components of the primary endpoint between TNKase plus PCI versus PCI alone (mortality 6.7% vs. 4.9%, respectively; cardiogenic shock 6.3% vs. 4.8%, respectively; and CHF 12% vs. 9.2%, respectively).  In addition, there were trends towards worse outcomes in recurrent MI (6.1% vs. 3.7%, respectively; p = 0.03) and repeat target vessel revascularization (6.6% vs. 3.4%, respectively; p = 0.0045) in patients receiving TNKase plus PCI versus PCI alone. In patients with large ST-segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate; however, the optimal use of adjunctive antithrombotic and antiplatelet therapies in this setting is unknown.

    Hypersensitivity

    Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of TNKase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with TNKase during and for several hours after infusion. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids).

    Adverse Reactions

    The most frequent adverse reactions associated with TNKase are bleeding and hypersensitivity.

    Drug/Laboratory Test Interactions

    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.

    You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

    Please see full Prescribing Information for additional Important Safety Information.

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

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

      • 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.

      • 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.

      • 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.