reteplase

RE-te-plase

Therapeutic Classification: thrombolytics

Pharmacologic Classification: plasminogen activators

High Alert

Acute myocardial infarction (MI).

Unlabeled Use:

Occluded central venous access devices.
Deep venous thrombosis (DVT).
Acute peripheral arterial thrombosis.

Directly converts plasminogen to plasmin, which then degrades clot-bound fibrin.

Therapeutic effects:

Lysis of thrombi in coronary arteries, with improvement of ventricular function, and reduced risk of heart failure or death.
Restoration of cannula or catheter function.
Restoration of blood flow following lysis of peripheral venous or arterial thrombi.

Absorption: Complete after IV administration. Intracoronary administration or administration into occluded catheters or cannulae has a more localized effect.

Distribution: Unknown.

Metabolism/Excretion: Cleared primarily by the liver and kidneys.

Half-Life: 13–16 min.

(fibrinolysis)

ROUTE	ONSET	PEAK	DURATION
IV	30 min	30–90 min	48 hr

Contraindicated in:

Active internal bleeding;
History of cerebrovascular accident;
Recent (within 2 mo) intracranial or intraspinal injury or trauma;
Intracranial neoplasm, arteriovenous malformation, or aneurysm;
Severe uncontrolled hypertension;
Known bleeding tendencies;
Hypersensitivity.

Use Cautiously in:

Recent (within 10 days) major surgery, trauma, GI or GU bleeding;
Left heart thrombus;
Severe hepatic or renal disease;
Hemorrhagic ophthalmic conditions;
Septic phlebitis;
Previous puncture of a noncompressible vessel;
Subacute bacterial endocarditis or acute pericarditis;
Geriatric patients (>75 yr; increased risk of intracranial bleeding);
Pregnancy, lactation, or children (safety not established).

Exercise Extreme Caution in:

Patients receiving concurrent anticoagulant therapy (increased risk of intracranial bleeding).

CV: hypotension, RECURRENT ISCHEMIA/THROMBOEMBOLISM, reperfusion arrhythmias

Derm: ecchymoses, flushing, urticaria

EENT: epistaxis, gingival bleeding

GI: GI BLEEDING, nausea, RETROPERITONEAL BLEEDING, vomiting

GU: GU TRACT BLEEDING

Hemat: BLEEDING

Local: hemorrhage at injection site, phlebitis at injection site

MS: musculoskeletal pain

Neuro: INTRACRANIAL HEMORRHAGE

Resp: bronchospasm, hemoptysis

Misc: ANAPHYLAXISALLERGIC REACTIONS INCLUDING , fever

Drug-drug:

Aspirin, other NSAIDs, warfarin, heparin and heparin-like agents, eptifibatide, tirofiban, clopidogrel, or dipyridamole—concurrent use ↑ risk of bleeding, although these agents are frequently used together or in sequence.
Effects may be ↓ by antifibrinolytic agents, including aminocaproic acid or tranexamic acid.

Drug-Natural Products:

↑anticoagulant effect and bleeding risk with anise, arnica, chamomile, clove, dong quai, fenugreek, feverfew, garlic, ginger, ginkgo, Panax ginseng, licorice, and others.

IV (Adults ): 10 units, followed 30 min later by an additional 10 units.

Powder for injection: 10.8 units (18.8 mg)/vial

Begin therapy as soon as possible after the onset of symptoms.
- Monitor vital signs, including temperature, continuously for myocardial infarction and at least every 4 hr during therapy for other indications. Do not use lower extremities to monitor BP. Notify health care professional if systolic BP >180 mm Hg or diastolic BP >110 mm Hg. Thrombolytic therapy should not be given if hypertension is uncontrolled. Inform health care professional if hypotension occurs. Hypotension may result from the drug, hemorrhage, or cardiogenic shock.
- Assess patient carefully for bleeding every 15 min during the 1st hr of therapy, every 15–30 min during the next 8 hr, and at least every 4 hr for the duration of therapy. Frank bleeding may occur from sites of invasive procedures or from body orifices. Internal bleeding may also occur (decreased neurologic status; abdominal pain with coffee-grounds emesis or black, tarry stools; hematuria; joint pain). If uncontrolled bleeding occurs, stop medication and notify health care professional immediately.
- Assess patient for hypersensitivity reaction (rash, dyspnea, fever, changes in facial color, swelling around the eyes, wheezing). If these occur, inform health care professional promptly. Keep epinephrine, an antihistamine, and resuscitation equipment close by in the event of an anaphylactic reaction.
- Assess neurologic status throughout therapy. Altered sensorium or neurologic changes may be indicative of intracranial bleeding.
Myocardial Infarction: Monitor ECG continuously. Notify health care professional if significant arrhythmias occur. IV lidocaine or procainamide (Pronestyl) may be ordered prophylactically. Monitor cardiac enzymes. Radionuclide myocardial scanning and/or coronary angiography may be ordered 7–10 days after therapy to monitor effectiveness of therapy.
- Assess intensity, character, location, and radiation of chest pain. Note presence of associated symptoms (nausea, vomiting, diaphoresis). Administer analgesics as directed. Notify health care professional if chest pain is unrelieved or recurs.
- Monitor heart sounds and breath sounds frequently. Inform health care professional if signs of HF occur (rales/crackles, dyspnea, S₃ heart sound, jugular venous distention, relieved CVP).
Deep Vein Thrombosis/Acute Arterial Occlusion: Observe extremities and palpate pulses of affected extremities every hour. Notify health care professional immediately if circulatory impairment occurs. Computerized tomography, impedance plethysmography, quantitative Doppler effect determination, and/or angiography or venography may be used to determine restoration of blood flow and duration of therapy; however, repeated venograms are not recommended.
Cannula/Catheter Occlusion: Monitor ability to aspirate blood as indicator of patency. Ensure that patient exhales and holds breath when connecting and disconnecting IV syringe to prevent air embolism.

Lab Test Considerations:

Hematocrit, hemoglobin, platelet count, fibrin/fibrin degradation product (FDP/fdp) titer, fibrinogen concentration, prothrombin time, thrombin time, and activated partial thromboplastin time may be evaluated before and frequently during therapy. Bleeding time may be assessed before therapy if patient has received platelet aggregation inhibitors.
- Obtain type and crossmatch and have blood available at all times in case of hemorrhage.
- Stools should be tested for occult blood loss and urine for hematuria periodically during therapy.

Toxicity and Overdose:

High Alert: If local bleeding occurs, apply pressure to site. If severe or internal bleeding occurs, discontinue infusion. Clotting factors and/or blood volume may be restored through infusions of whole blood, packed RBCs, fresh frozen plasma, or cryoprecipitate. Do not administer dextran; it has antiplatelet activity. Aminocaproic acid (Amicar) may be used as an antidote.

High Alert: Overdosage and under-dosage of thrombolytic medications have resulted in patient harm or death. Have second practitioner independently check original order, dosage calculations, and infusion pump settings. Do not confuse the abbreviation t-PA for alteplase (Activase) with the abbreviations TNK t-PA for tenecteplase (TNKase) and r-PA for reteplase (Retevase). Clarify orders that contain any of these abbreviations.
Thrombolytic agents should be used only in settings in which hematologic function and clinical response can be adequately monitored.
- Starting two IV lines before therapy is recommended: one for the thrombolytic agent, the other for any additional infusions.
- Avoid invasive procedures, such as IM injections or arterial punctures, with this therapy. If such procedures must be performed, apply pressure to all arterial and venous puncture sites for at least 30 min. Avoid venipunctures at noncompressible sites (jugular vein, subclavian site).
- Acetaminophen may be ordered to control fever.

IV Administration:

Intermittent Infusion: Diluent: Vials are packaged with sterile water for injection (without preservatives) to be used as diluent. Do not use bacteriostatic water for injection. Reconstitute 10.4 unit vials with 10 mL. Avoid excess agitation during dilution; swirl or invert gently to mix. Solution may foam upon reconstitution. Bubbles will resolve upon standing a few min. Solution should be reconstituted immediately prior to use, but is stable for 4hr at room temperature.
Rate: Prior to and after administering reteplease, flush line with normal saline or D5W.
- Two bolus doses are used for Myocardial Infarction: each is administered over 2 minutes.
Y-Site Incompatibility:
- heparin
- No other medication should be infused or injected into line used for reteplase

Explain purpose of medication and the need for close monitoring to patient and family. Instruct patient to report hypersensitivity reactions (rash, dyspnea) and bleeding or bruising.
Explain need for bedrest and minimal handling during therapy to avoid injury. Avoid all unnecessary procedures such as shaving and vigorous tooth brushing.

Lysis of thrombi and restoration of blood flow.

Retavase

NDC Code

10122- Chiesi USA, Inc.
- 10122-141- Retavase
  - 10122-141-02- 1 KIT in 1 BOX (10122-141-02) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 SYRINGE (10122-142-01)

10122- Chiesi USA, Inc.
- 10122-143- Retavase
  - 10122-143-01- 1 KIT in 1 BOX (10122-143-01) * 10 mL in 1 VIAL, SINGLE-USE * 10 mL in 1 SYRINGE (10122-142-01)

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