Dosing and uses of Trasylol (aprotinin)
Adult dosage forms and strengths
injectable solution
- 10,000,000 International Units/mL
Regimen a
Administer test dose (10,000 KIU) IV at least 10 minutes before loading dose
Load: 2 million KIU IV over 20-30 minutes, THEn
Pump Prime (added during recirculation of priming fluid): 2 million KIU IV, THEn
500,000 KIU/hour IV continuous infusion during operation
Regimen B
Each dose half of regimen A
Administer test dose (10,000 KIU) IV at least 10 minutes before loading dose
Load: 1 million KIU IV over 20-30 minutes, THEn
Pump Prime (added during recirculation of priming fluid): 1 million KIU IV, THEn
250,000 KIU/hour IV continuous infusion during operation
Other Information
No safety/efficacy difference between regimens in low-risk patients
Other Indications & Uses
Blood loss prophylaxis in patients undergoing CABg
Pediatric dosage forms and strengths
Safety & efficacy not established
Trasylol (aprotinin) adverse (side) effects
>10%
Atrial fibrillation (21%)
Fever (15%)
Elevated ALT (14%)
Nausea (11%)
1-10%
Hypotension (8%)
Lung disorder (8%)
Pleural effusion (7%)
Myocardial infarction (6%)
Tachycardia (6%)
Infection (6%)
Ventricular extrasystoles (6%)
Ventricular tachycardia (5%)
Atelectasis (5%)
Heart failure (5%)
Pericarditis (5%)
peripheral edema (5%)
Supraventricular tachycardia (4%)
Arrhythmia (4%)
Constipation (4%)
Dyspnea (4%)
Pneumothorax (4%)
Hypertension (4%)
Atrial arrhythmia (3%)
Vomiting (3%)
Uurinary retention (3%)
Diarrhea (3%)
LFT abnormalities (3%)
Kidney function abnormal (3%)
Asthenia (2%)
Asthma (2%)
Anemia (2%)
Chest pain (2%)
Creatine phosphokinase increased (2%)
Hypoxia (2%)
Musculoskeletal event (2%)
Rash (2%)
Urinary tract infection (2%)
Frequency not defined
Cardiovascular symptoms most likely sequelae of open-heart surgery
Warnings
Black box warnings
Aprotinin administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial test dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial test dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure. A history of any prior aprotinin exposure must be sought prior to administration of this agent
The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Aprotinin should be administered only in operative settings where cardiopulmonary bypass can be rapidly initiated. The benefit of aprotinin to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin
Contraindications
Hypersensitivity
Cautions
Use test dose first to determine anaphylactic rxn possibility
Has been linked to serious kidney problems, heart attacks & stroke
Pregnancy and lactation
Pregnancy category: B
Lactation: not applicable
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Trasylol (aprotinin)
Half-Life: 2.5-10 hr
Absorption: rapid
Excretion: urine
Mechanism of action
Proteinase inhibitor, blocks fibrinolysis through inhibition of plasmin, kallikrein
Administration
IV Incompatibilities
Do not administer any other drug using the same line
IV Administration
Administer through a central line
Follow either regimen A or B
Both regimens include a 1 mL test dose, a loading dose, a dose to be added while recirculating the priming fluid of the cardiopulmonary bypass circuit ("pump prime" dose), & a constant infusion dose
To avoid physical incompatibility of Trasylol and heparin when adding to pump prime solution, each agent must be added during recirculation of pump prime to assure adequate dilution prior to admixture with other component
Storage
Store between 2-25°C
Protect from freezing
