Biva IV Injection
Bivalirudin
250mg/5ml
Healthcare Pharmaceuticals Ltd.
| Pack size | 250 mg |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 10000.00 AED |
Indications
Biva IV Injection is used for:
Percutaneous coronary intervention
Adult Dose
Intravenous
As an anticoagulant in percutaneous coronary intervention
Adult: The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion for the duration of the procedure.
Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
Consider extending duration of infusion post-procedure up to 4 hours in patients with ST-segment elevation MI (STEMI).
Child Dose
Renal Dose
Renal impairment
Bolus Dose
No reduction is required for any degree of renal impairment
IV infusion
Moderate (CrCl 30-59 mL/min): 1.75 mg/kg/hr
Severe (CrCl <30 mL/min): 1 mg/kg/hr
Hemodialysis: 0.25 mg/kg/hr
Administration
IV Preparation
To each 250 mg vial add 5 mL SWI
Gently swirl until all material is dissolved
Dilute each vial in 50 mL of D5W or NS to yield a final concentration of 5 mg/mL
If low-rate infusion is used after initial infusion, a lower concentration bag should be prepared
Inspect for particulate matter and discoloration prior to administration
Do not use preparations containing particulate matter
Reconstituted drug will be a clear to slightly opalescent, colorless to slightly yellow solution
IV Administration
Initial bolus injection followed by continuous infusion
Contra Indications
Significant active bleeding
Hypersensitivity to bivalirudin or its components
Precautions
Bleeding events: Bivalirudin increases the risk of bleeding. Its anticoagulant effect subsides approximately one hour after discontinuation.
Thrombotic risk with coronary artery brachytherapy: An increased risk of thrombus formation, including fatal outcomes, in gamma brachytherapy.
Monitoring Parameters
Monitor for signs and symptoms of bleeding;
Monitor more frequently for bleeding, patients with disease states associated with increased risk of bleeding
Pregnancy-Lactation
Pregnancy
There are no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Animal data
Reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times maximum recommended human dose (MRHD) of 15 mg/kg/day based on body surface area (BSA) during organogenesis, respectively, revealed no evidence of fetal harm
Lactation
Not known whether drug is present in human milk; no data are available on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Interactions
May increase risk of bleeding when used w/ thrombolytics, oral anticoagulants or drugs that affect platelet function.
Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use.
Contraindicated (3)
defibrotide
mifepristone
prothrombin complex concentrate, human
Adverse Effects
Side effects of Bivalirudin :
>10%
Back pain (42%)
General pain (15%)
Nausea (15%)
Hemorrhage, minor (13.6%)
Headache (12%)
Hypotension (12%)
1-10%
Injection site pain (8%)
Insomnia (7%)
Pelvic pain (6%)
Hypertension (6%)
Anxiety (6%)
Vomiting (6%)
Bradycardia (5%)
Dyspepsia (5%)
Abdominal pain (5%)
Fever (5%)
Nervousness (5%)
Urinary retention (4%)
Hemorrhage, major (2.3%)
>3g/dL fall in Hgb (1.9%)
TIMI minor bleeding (1.3%)
RBC transfusions (1.3%)
Mechanism of Action
Bivalirudin is a synthetic 20-amino acid analogue of the naturally occurring hirudin. It is a specific and reversible direct thrombin inhibitor thats works by binding to the catalytic and anionic exosite of circulating and clot-bound thrombin. It is used as an anticoagulant in percutaneous coronary intervention.
Note
Biva 250mg/5ml IV Injection manufactured by Healthcare Pharmaceuticals Ltd.. Its generic name is Bivalirudin. Biva is availble in Bangladesh.
Farmaco BD drug index information on Biva IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.