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TNKase Product Return and Replacement
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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.

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


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

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, and 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

Damaged product or overstock


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

Spoiled product

When Genentech medicine 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.*

To request replacement for spoiled product, please contact Genentech Customer Operations directly: (800) 551-2231


Complete the Genentech Spoilage Replacement Program form (will be provided by Genentech Customer Operations)

Fax the form to (877) 329-6737

The request may take up to 1 business day to review. If approved, instructions for how to return the spoiled product or verify spoilage are provided at this time

Replacement product ships within 11 business days following receipt of the spoiled product or Certification of Destruction form

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 (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 Services 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 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

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.

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 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.

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.

Nursing Mothers

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.

Geriatric Use

In elderly patients, the benefits of TNKase on mortality should be carefully weighed against the risk of increased adverse events, including bleeding.

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.

Allergic Reactions

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.





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

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