Alteplase

CLINICAL USE

Fibrinolytic drug:

Acute myocardial infarction

Pulmonary embolism

Acute ischaemic stroke

To unblock dialysis lines (unlicensedindication)

DOSE IN NORMAL RENAL FUNCTION

Myocardial infarction: acceleratedregimen (initiated within 6 hours) 15 mg
IV bolus, 50 mg over 30 minutes, then
35 mg over 1 hour (total dose 100 mg); or
(if initiated within 6–12 hours) 10 mg over
1–2 minutes followed by IV infusion of
50 mg over 1 hour, then 4 infusions each
of 10 mg over 30 minutes (total dose –
100 mg over 3 hours)

Pulmonary embolism: 10 mg by IVinjection over 1–2 minutes, followed by an
infusion of 90 mg over 2 hours. Total dose
should not exceed 1.5 mg/kg in patients
who weigh <65 kg

Acute ischaemic stroke: 0.9 mg/kg over

60 minutes, 10% of dose as initial bolus;
maximum 90 mg. Start within 3 hours of
symptoms

PHARMACOKINETICS

Molecular weight :
65 000 (non-
glycosylated protein)

%Protein binding :
No data

%Excreted unchanged in urine :
Minimal

Volume of distribution (L/kg) :
0.1

half-life – normal/ESRD (hrs) :
α: 4–5 minutes; β:
40 minutes

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Dose as in normal renal function

10 to 20 : Dose as in normal renal function

<10 :
Dose as in normal renal function

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD :
Not dialysed. Dose as in normal renal function

HD :
Not dialysed. Dose as in normal renal function

HDF/high flux :
Unknown dialysability. Dose as in
normal renal function

CAV/VVHD :
Not dialysed. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Risk of haemorrhage can be increased bythe use of coumarin derivatives, platelet
aggregation inhibitors, heparin, and other
agents influencing coagulation

ADMINISTRATION

Reconstition

50 mg vial: dissolve in 50 mL water forinjection
20 mg vial: dissolve in

20 mL water forinjection.
The reconstituted solutions can be further

diluted (minimum concentration 0.2 mg/
mL) with sterile sodium chloride 0.9%

Route

Rate of Administration

See under dose

Comments

Water or glucose solution must NOT beused for dilution

50 mg vial = 29 mega units/vial

20 mg vial = 11.6 mega units/vial

OTHER INFORMATION

Patients weighing less than 65 kg shouldreceive a total dose of 1.5 mg/kg according
to dose schedule

Allergic reactions are less likely withalteplase than streptokinase and repeated
administration is possible

1.7 g arginine in the 50 mg vial, 0.7 garginine in 20 mg vial – may lead to
hyperkalaemia in renal failure

Pay attention to potential bleeding sitesduring treatment

To unblock dialysis lines, use 2 mg in 2 mLdown each lumen and leave in situ for at
least 60 minutes or until the next dialysis
session

Alternative regimens for unblockingdialysis lines: an infusion of 20 mg over
20 hours, or 50 mg over 12 hours

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