Idarucizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection/infusion containing idarucizumab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Rapid reversal of dabigatran's anticoagulant effect
When rapid reversal of dabigatran's anticoagulant effect is required.
Such as:
For emergency surgery/urgent procedures.
In life threatening or uncontrolled bleeding.
Dosage
Adults
The recommended dose of idarucizumab is 5g.
Administration of a second 5g dose of idarucizumab may be considered in the following situations:
Recurrence of clinically relevant bleeding together with prolonged clotting times.
If potential re-bleeding would be life threatening and prolonged clotting times are observed.
Patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
Additional Dosage Information
In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab.
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Administration
For intravenous administration.
Idarucizumab is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Contraindications
Children under 18 years
Hereditary fructose intolerance
Precautions and Warnings
Restricted sodium intake
Breastfeeding
Pregnancy
Thromboembolic disorder
Contains more than 1 mmol (23 mg) sodium per dose
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Record name and batch number of administered product
May affect results of some laboratory tests
Resume anticoagulant therapy as soon as medically appropriate
Discontinue if severe hypersensitivity reactions occur
Hospital use only
Dabigatran treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.
After administration of idarucizumab, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Idarucizumab binds specifically to dabigatran and reverse its anticoagulant effect. It will not reverse the effects of other anticoagulants.
The risk of using idarucizumab in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such emergency treatment.
If idarucizumab is administered in patients with hereditary fructose intolerance, intensified medical care during idarucizumab exposure and within 24 hours of exposure is required.
Pregnancy and Lactation
Pregnancy
Use idarucizumab with caution during pregnancy.
The manufacturer advises idarucizumab may be used during pregnancy, if the expected clinical benefit outweighs the potential risk. At the time of writing there is limited published information regarding the use of idarucizumab during pregnancy. Potential risks are unknown.
Lactation
Use idarucizumab with caution during breastfeeding.
The manufacturer makes no recommendation regarding breastfeeding. The presence of idarucizumab in human breast milk is unknown but due to its large molecular weight, transfer is not expected. Effects on exposed infants are unknown.
Side Effects
Hypersensitivity reactions including anaphylaxis
Proteinuria
Effects on Laboratory Tests
Idarucizumab causes transient proteinuria and does not indicate renal damage when urine testing. Transient proteinuria is a result of renal protein overflow after 5g bolus/short-term idarucizumab intravenous injection. Transient proteinuria peaks at 4 hours after administration and returns to normal within 12 to 24 hours. Transient proteinuria lasted more then 24 hours in single cases.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2019
Reference Sources
Summary of Product Characteristics: Praxbind 2.5g/50ml solution for injection/infusion. Boehringer Ingelheim Ltd. Revised August 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 July 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Idarucizumab Last revised: 03 December 2018
Last accessed: 08 July 2019
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