Alteplase prescribing information pdf


















The chest ports were treated with 2 mg 2 mL of alteplase per dose, to a maximum of two doses. Injections were delivered through a Huber needle.

The indwell time for the first dose was 30 min. If at this time the port remained dysfunctional the inability to freely withdraw at least 5 mL of blood from it , then a second 2 mg dose of alteplase was administered and the chest port was reassessed after an additional 30 min 60 min from the time of administration of the first dose.

This was considered a secondary outcome measure. A third dose was not part of the study and was not used. The safety end points included all minor or major hemorrhagic events, such as intracranial hemorrhage, and sepsis.

For the present study, it was assumed that each port was independent. The patient population included 21 men The ages ranged from 27 to 81 years. The mean age was Body weight varied from The average body weight was The length of time the chest ports were in place at the time of treatment ranged from 0.

The average length of time the chest ports were in place was The majority of patients had chest ports placed for chemotherapy The population also included patients with sickle cell disease and bilateral lung transplants Table 1. A port was considered patent if 5 mL or more of blood could be withdrawn freely following lytic instillation. The success rate for one dose of alteplase 2 mg was An average of 1.

There were no adverse effects cited. High efficacy and safety rates can be obtained in restoring the function of occluded chest ports with a 2 mg or 4 mg dose of alteplase. Part of this high efficacy rate may be due to the gentle push and pull technique used by the interventionalists in the present study.

In this technique, 2 mg of alteplase is reconstituted with 2. The Huber needle is then inserted into the chest port Figure 2. A 10 mL syringe is then aspirated until the plunger is at the 8 mL or 9 mL mark to create negative pressure; the stopcock is then turned off Figure 4. This step may be repeated to create greater negative pressure. In our experience, the placement of a 10 mL syringe in this location facilitates the production of negative pressure in a stable and safe manner. A 3 mL syringe with 2 mg alteplase is attached to the top port of the three-way stopcock.

Using a gentle push and pull technique, alteplase is instilled into the port. A small amount between 0. After instillation, the stopcock to the port is turned off, allowing the alteplase to dwell in the port for 30 min without interruption Figure 6. The top port of the stopcock is turned off, and the port is aspirated with a 10 mL syringe to check for at least 5 mL of blood return Figure 7.

If there is no blood return, an additional 2 mg alteplase is instilled into the port. After an additional 30 min, patency is once again assessed. If patency is restored, 5 mL of blood is aspirated to clear the port of alteplase. The port is then flushed with 10 mL of normal saline using a pulsing method.

This is followed by units of heparin 5 mL. The syringe is detached while infusing the last 1 mL of heparin and applying continuous positive pressure. Reconstitution of recombinant tissue plasminogen activator 2 mg with 2.

A Attachment of a three-way stopcock into the Huber needle hub with the stopcock to the port turned off. B Attachment of an empty 10 mL syringe to the remaining stopcock port opposite the chest port. The top port is then turned off.

Aspiration with a 10 mL syringe until the plunger is at the 8 mL or 9 mL mark. Attachment of the 3 mL syringe with the recombinant tissue plasminogen activator rt-PA to the top port of the three-way stopcock.

Using a gentle push and pull technique, rt-PA is instilled into the port. A small amount 0. After instillation of the recombinant tissue plasminogen activator rt-PA , the stopcock to the port is turned off, allowing the rt-PA to dwell in the port for 30 min without interruption. The stopcock to the top port is turned off and the line is aspirated to check for at least 5 mL of blood return.

Steps 5 to 7 are repeated if there is no return of blood, or return is sluggish. If patency is restored, 5 mL of blood are aspirated to clear the line of recombinant tissue plasminogen activator. The line is then flushed with 10 mL of 0. The flush is followed with units 5 mL heparin. We believe that the administration of alteplase into the chest port with a gentle pull and push technique is responsible for the high efficacy rates seen in our study.

The efficacy may be the result of the negative pressure created that allows a small amount of lytic agent into the port to start lysis. Since the present study, we have restored the function of several occluded chest ports that had failed alteplase treatment attempted by the nurses from our chemotherapy clinic.

In our study, patients received either 2 mg or 4 mg of alteplase in the port and catheter. A small amount of alteplase may have been administered into the systemic circulation. If alteplase is administered according to the study protocol, the circulating plasma level is not expected to reach pharmacological concentrations 8. The most frequent complication of systemic thrombolysis is bleeding.

There was no incidence of bleeding with 2 mg or 4 mg of alteplase in our study, which only included patients with a low risk of bleeding. Thus, one or two doses 2 mg per dose of alteplase are highly effective and safe in restoring the function of occluded chest ports when administered using a gentle push and pull technique.

The authors thank Ed Peterson for help with the statistics, and Rajiv and Nitin Sharma for the preparation of the manuscript. The authors have no financial disclosures to make. National Center for Biotechnology Information , U. Journal List Int J Angiol v. Int J Angiol. Be sure to insert the needle into the keyhole port of the vial top, away from the puncture site made by the transfer device, and do not prime the syringe.

Prepare it one of the following ways, using a syringe and needle:. Remove the treatment dose from the Y-site injection port on the infusion line after the infusion set is primed. Remove the treatment dose before the vial is attached to the infusion set. Be sure to insert the needle away from the puncture site made by the transfer device.

Insert the spike end of an infusion set through the center of the stopper of the vial of reconstituted Activase, using the same puncture site made by the transfer device.

Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop. Administer remainder. The infusion should begin immediately following the bolus treatment dose. Activase bolus and the remainder of the treatment dose can also be administered using an infusion pump. Make sure to prime the pump tubing with Activase solution so that the infusion begins immediately following the bolus treatment dose. One example may be to spike a small bag for example, mL of 0.

Program an infusion pump to flush the IV tubing following administration of treatment dose. Activase is for intravenous administration only. Extravasation of Activase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that IV site and apply local therapy. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment.

Initiate treatment as soon as possible but within 3 hours after symptom onset. Activase is indicated for use in acute myocardial infarction AMI for the reduction of mortality and reduction of the incidence of heart failure. Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage ICH ; subarachnoid hemorrhage; active internal bleeding; recent within 3 months intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding e. Do not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent within 3 months intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Perform venipunctures carefully and only as required.

Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Aspirin and heparin have been administered concomitantly with and following infusion with Activase in the management of acute myocardial infarction and pulmonary embolism. The concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during the first 24 hours after symptom onset has not been investigated.

Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. If serious bleeding occurs, terminate the Activase infusion, and treat appropriately. In the following conditions, the risks of bleeding with Activase are increased and should be weighed against the anticipated benefits: recent major surgery or procedure; cerebrovascular disease; recent intracranial hemorrhage; recent gastrointestinal or genitourinary bleeding; recent trauma; hypertension; acute pericarditis; subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; significant hepatic dysfunction; pregnancy; diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions; septic thrombophlebitis or occluded AV cannula at seriously infected site; advanced age; and patients currently receiving oral anticoagulants, or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

Rare fatal outcome for hypersensitivity was reported. Angioedema has been observed during and up to 2 hours after Activase infusion in patients treated for acute ischemic stroke and acute myocardial infarction. In many cases, patients received concomitant angiotensin-converting enzyme inhibitors. Monitor patients treated with Activase during and for several hours after infusion for hypersensitivity.

If signs of hypersensitivity occur, e. 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.

Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of re-embolization due to the lysis of underlying deep venous thrombi in this setting. Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. It is associated with invasive vascular procedures e. When present in blood at pharmacologic concentrations, Activase remains active under in vitro conditions, which can result in degradation of fibrinogen in blood samples removed for analysis.

National Institute of Neurological Disorders and Stroke. Know stroke. Know the signs. Act in time. National Institute of Neurological Disorders and Stroke website. Last modified March 29, Accessed August 12, Clinical features of proven basilar artery occlusion. HINTS to diagnose stroke in the acute vestibular syndrome: three-step bedside oculomotor examination more sensitive than early MRI diffusion-weighted imaging.

Missed ischemic stroke diagnosis in the emergency department by emergency medicine and neurology services. Academic Emergency Medicine. Mechanical thrombectomy-ready comprehensive stroke center requirements and endovascular stroke systems of care: recommendations from the Endovascular Stroke Standards Committee of the Society of Vascular and Interventional Neurology SVIN.

Intervent Neurol. Solitaire Revascularization Device. Medtronic website. Updated February Accessed May 9, Accessed August 9, N Engl J Med. FDA Access Summary basis of approval. Accessed August 14, Comprehensive overview of nursing and interdisciplinary care of the acute ischemic stroke patient: a scientific statement from the American Heart Association. Guide to the Care of the Patient with Ischemic Stroke. Impact of stroke care unit on patient outcomes in a community hospital.

Centers for Medicare and Medicaid Services website. Published June 28, Accessed August 13,



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