ALTEPLASE RECOMBINANT

ALTEPLASE RECOMBINANT
(al'te-plase)
Actilyse, Activase, Cathflo Activase
Classifications: thrombolytic enzyme, tissue plasminogen activator;
Therapeutic: thrombolytic agent

Pregnancy Category: C

Availability

50 mg, 100 mg vials

Action

This recombinant DNA-derived form of human tissue-type plasminogen activator (t-PA) is a thrombolytic agent. Plasma is capable of degrading fibrin, fibronogen, and factors V, VIII, and XII.

Therapeutic Effect

The agent t-PA promotes thrombolysis by forming the active proteolytic enzyme plasmin.

Uses

Indicated in selective cases of acute MI, preferably within 6 h of attack for recanalization of the coronary artery; lysis of acute pulmonary emboli; acute ischemic stroke or thrombotic stroke (within 3 h of onset); treatment of acute coronary artery thrombosis in the setting of percutaneous coronary intervention (PCI); reestablishing patency of occluded IV catheter.

Unlabeled Uses

Lysis of arterial occlusions in peripheral and bypass vessels; DVT.

Contraindications

Active internal bleeding, history of cerebrovascular accident, aneurysm, recent (within 2 mo) intracranial or interspinal surgery or trauma, intracranial neoplasm, increased intracranial pressure; arteriovenous malformation, bleeding disorders, severe uncontrolled hypertension, likelihood of left heart thrombus, acute pericarditis, bacterial endocarditis, severe liver or renal dysfunction, septic thrombophlebitis, current use of oral anticoagulants, pregnancy (category C).

Cautious Use

Recent major surgery (within 10 d), cerebral vascular disease, recent GI or GU bleeding, recent trauma, renal impairment, hypertension, hemorrhagic ophthalmic conditions; age >75; lactation.

Route & Dosage

Acute MI
Adult: IV ≥65 kg, 60 mg over first hour, 20 mg/h over second hour, and 20 mg over third hour (for a total of 100 mg over 3 h; <65 kg, 1.25 mg/kg over 3 h (60% of dose over first hour, 20% of dose over second hour, and 20% of dose over third hour). Accelerated schedule (with heparin and aspirin): >67 kg, 15 mg bolus, then 50 mg over next 30 min, then 35 mg over next 60 min. Accelerated schedule (with heparin and aspirin): ≤67 kg, 15 mg bolus, then 0.75 mg/kg (not to exceed 50 mg) over next 30 min, then 0.50 mg/kg (not to exceed 35 mg) over next 60 min

Acute Ischemic Stroke/Thrombotic Stroke
Adult: IV 0.9 mg/kg over 60 min with 10% of dose as an initial bolus over 1 min (max: 90 mg)

Pulmonary Embolism
Adult: IV 100 mg infused over 2 h

Reopen Occluded IV Catheter
Adult/Child (>30 kg): IV Instill 2 mg/2 mL into dysfunctional catheter for 2 h. May repeat once if needed.
Child: IV ≥2 y, 10–29 kg, Instill 110% of internal lumen volume with 1 mg/mL concentration (max 2 mg). May repeat if function not restored within 2 h.  IV <2 y, <10 kg, 0.5 mg diluted in a volume to fill the lumen of the catheter.

Administration

Intravenous

PREPARE: IV Infusion: ??Reconstitute the 50-mg vial as follows: Do not use if vacuum in vial has been broken. Use a large-bore needle (e.g., 18 gauge) and do not prime needle with air. ??Dilute contents of vial with sterile water for injection supplied by manufacturer.??Direct stream of sterile water into the lyophilized cake. Slight foaming is usual. Allow to stand until bubbles dissipate. Resulting concentration is 1 mg/mL.??Reconstitute the 100-mg vial using supplied transfer device for reconstitution. Follow manufacturer's directions. 

ADMINISTER: IV Infusion: ??Start IV infusion as soon as possible after the thrombolytic event, preferably within 6 h.??Administer drug as reconstituted (1 mg/mL) or further diluted with an equal volume of NS or D5W to yield 0.5 mg/mL. Acute MI: ??Administer 60% of total dose in the first hour for acute MI, with 6–10% given as a bolus dose over 1–2 min and remainder of first dose infused over hour 1. Follow with second dose (20% of total) over hour 2, and third dose (20% of total) over hour 3. ??For patients weighing <65 kg calculate dose using 1.25 mg/kg over 3 h. See accelerated schedule under Route & Dosage. Pulmonary embolism: ??Administer entire dose over a 2 h period. Acute ischemic stroke: ??Give 5 mg as an initial bolus over 1 min, then give the remainder of the 0.75 mg/kg dose over 60 min.??Do not exceed a total dose of 100 mg. Higher doses have been associated with intracranial bleeding. ??Follow infusion of drug by flushing IV tubing with 30–50 mL of NS or D5W. ??Reconstituted drug is stable for 8 h in above solutions at room temperature (2°–30° C; 36°–86° F). Since there are no preservatives, discard any unused solution after that time. 

INCOMPATIBILITIES Solution/additive: Dobutamine, dopamine, heparin. Y-site: Bivalirudin, dobutamine, dopamine, heparin, nitroglycerin.

  • Store above reconstituted solutions at room temperature 2°–30° C (36°–86° F) for no longer than 8 h. Discard any unused solution after that time.

Adverse Effects (≥1%)

Hematologic: Internal and superficial bleeding (cerebral, retroperitoneal, GU, GI).

Pharmacokinetics

Peak: 5–10 min after infusion completed. Duration: Baseline values restored in 3 h. Metabolism: In liver. Elimination: In urine. Half-Life: 26.5 min.

Nursing Implications

Assessment & Drug Effects

  • Monitor for S&S of excess bleeding q15min for the first hour of therapy, q30min for second to eighth hour, then q8h. Monitor neurological checks throughout drug infusion q30min and qh for the first 8 h after infusion.
  • Protect patient from invasive procedures because spontaneous bleeding occurs twice as often with alteplase as with heparin. IM injections are contraindicated. Also prevent physical manipulation of patient during thrombolytic therapy to prevent bruising.
  • Lab tests: Coagulation tests including APTT, bleeding time, PT, TT, INR, must be done before administration of drug. Also check baseline Hct, Hgb, and platelet counts, in case of bleeding. Draw Hct following drug administration to detect possible blood loss.
  • Keep patient in bed while receiving this medication.
  • Check vital signs frequently. Be alert to changes in cardiac rhythm.
  • Stop therapy immediately if dysrhythmias occur.
  • Report signs of bleeding: gum bleeding, epistaxis, hematoma, spontaneous ecchymoses, oozing at catheter site, increased pain from internal bleeding. Stop the infusion, then resume when bleeding stops.
  • Use the radial artery to draw ABGs. Pressure to puncture sites, if necessary, should be maintained for up to 30 min.
  • Continue monitoring vital signs until laboratory reports confirm anticoagulant control; patient is at risk for postthrombolytic bleeding for 2–4 d after intracoronary alteplase treatment.

Patient & Family Education

  • Report immediately a sudden severe headache.
  • Report blood in urine and bloody or tarry stools.
  • Report any signs of bleeding or oozing from cuts or places of injection.
  • Remain quiet and on bedrest while receiving this medicine.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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