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Prescribing Information

  

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Genentech offers a comprehensive product replacement program that, under specific circumstances, allows physicians to return certain Genentech products for 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 GENCO Supply Chain Solutions. Return authorization is required for all returns except those in which replacements are provided for expired products.

Wasted Product

The TNKase wastage replacement program replaces reconstituted TNKase not administered, billed, or reimbursed, or usable due to the following circumstances:


Contraindicated/Misdiagnosed

Patient Expired/Coded

Delivery System Failure

Dropped and Broken

Duplicate Reconstitution

Admixture Error

Physician Preference

Patient Transferred

Please contact your local Clinical Specialist or Customer Service at 800-551-2231 for more details.

Expired Product

In the event that TNKase in stock at your institution is past its expiration date, you may get a replacement or a credit.

If you would like a replacement only, no return authorization is required—you may ship the expired product directly to GENCO Supply Chain Solutions at the address provided below:

GENCO Supply Chain Solutions
6101 North 64th Street
Milwaukee, WI 53218
Phone: (800) 950-5479

If you would like credit for your return, please contact Genentech Customer Service at (800) 551-2231 to obtain a return authorization.


After receiving a return authorization from a Customer Service representative, enclose a copy of the return authorization with the product you are returning.

Information required for processing all returns includes contact name, phone number and DEA number of sender, product name, expiration date of each item returned. Please also indicate whether you would prefer to receive credit or replacement; if credit is requested, indicate your wholesaler's name and zip code where applicable.

Shipping and transportation charges are prepaid by the customer.

Additional Information


Genentech (not GENCO Supply Chain Solutions) 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 GENCO Supply Chain Solutions or Genentech identifies it as an appropriate product return, which may be up to ten business days after receiving the product.

Genentech Access to Care Foundation

If you have patients who are uninsured or deemed uninsured due to payer denial, your patients may qualify for the Genentech Access to Care Foundation, a separate 501(c)(3) nonprofit organization dedicated to helping patients receive the Genentech therapies they need.

View Access to Care Foundation forms


Statement of Medical Necessity (SMN)

Patient Authorization and Notice of Release of Information (PAN) - English

Patient Authorization and Notice of Release of Information (PAN) - Spanish

Confirmation of Infusion Injection

Patient Financial Attestation


Indication
For use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.

Important Safety Information
TNKase therapy in patients with acute myocardial infarction is contraindicated in the following certain situations (eg, active internal bleeding, history of cerebrovascular accident, known bleeding diathesis, severe uncontrolled hypertension) because of an increased risk of bleeding [See CONTRAINDICATIONS in full prescribing information].

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.

In certain conditions (eg, recent major surgery, cerebrovascular disease, hypertension) the risk of TNKase therapy may be increased and should be weighed against the anticipated benefits. [See WARNINGS in full prescribing information].

Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown.

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.

Please see full Prescribing Information for additional important safety information.





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Please see TNKase full Prescribing Information. TNKase® (Tenecteplase). Activase® (Alteplase, recombinant).

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