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.
The TNKase wastage replacement program replaces reconstituted TNKase not administered, billed, or reimbursed, or usable due to the following circumstances:
||Delivery System Failure
||Dropped and Broken
Please contact your local Clinical Specialist or Customer Service at 800-551-2231 for more details.
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.
||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
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
Important Safety Information
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.
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
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, high likelihood of left
heart thrombus, 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.
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.
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
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.
Standard management of myocardial infarction should be
implemented concomitantly with TNKase treatment.
Pregnancy (Category C)
There are no adequate and well-controlled studies in
pregnant women. TNKase should be given to pregnant women only if the potential
benefits justify the potential risk to the fetus.
It is not known if TNKase is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when TNKase
is administered to a nursing woman.
In elderly patients, the benefits of TNKase on mortality
should be carefully weighed against the risk of increased adverse events,
The most frequent adverse reaction associated with TNKase
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
Allergic-type reactions (e.g., anaphylaxis, angioedema,
laryngeal edema, rash, and urticaria) have rarely (<1%) been reported in
patients treated with TNKase. Anaphylaxis was reported in <0.1% of patients
treated with TNKase; however, causality was not established.
The following adverse reactions have been reported among
patients receiving TNKase in clinical trials: cardiogenic shock, arrhythmias,
atrioventricular block, pulmonary edema, heart failure, cardiac arrest,
recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture,
cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation,
thrombosis, embolism, and electromechanical dissociation. These events can be
life-threatening and may lead to death. Nausea and/or vomiting, hypotension,
and fever have also been reported.
Please see full Prescribing Information for additional
Important Safety Information.