Praxbind Injection
Idarucizumab
50mg/ml
Boehringer Ingelheim International GmbH
| Pack size | 50ml Glass Vial x 2 |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | GULF DRUG EST. |
| Retail Price | 13934.50 AED |
Indications
Praxbind Injection is used for:
Dabigatran Reversal
Adult Dose
Dabigatran Reversal
Humanized monoclonal antibody fragment (Fab) indicated in patients treated with dabigatran when reversal of the anticoagulant effects are needed for emergency surgery or urgent procedures, or in the event of life-threatening or uncontrolled bleeding
5 g IV, provided as 2 separate vials each containing 2.5 g/50 mL
Child Dose
Renal Dose
Renal impairment: Renal impairment did not impact the reversal effect of idarucizumab; no dosage adjustment required
Administration
IV Preparation
Ensure aseptic handling when preparing
Inspect visually for particulates and discoloration before infusion
Once solution has been removed from the vial, administration should begin promptly; solution in vials may be stored at room temperature (25°C [77°F]), but must be used within 6 hr (also see storage)
Do not mix with other medications
IV Administration
Infuse 5-g dose IV as 2 consecutive 2.5-g infusions or give as a bolus injections by injecting both 2.5-g vials consecutively one after another via syringe
A preexisting IV line may be used for administration; flush with sterile 0.9% NaCl solution prior to infusion
No other infusion should be administered in parallel via the same IV access
Can be used in conjunction with standard supportive measures, which should be considered as medically appropriate
Contra Indications
Precautions
Patients treated with dabigatran have underlying disease states that predispose them to thromboembolic events; reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease; to reduce this risk, resume anticoagulant therapy as soon as medically appropriate
There is insufficient clinical experience to evaluate risk of hypersensitivity to idarucizumab; discontinue if a serious hypersensitivity reaction occurs
Caution with hereditary fructose intolerance; the recommended dose of idarucizumab contains 4 g sorbitol as an excipient; when prescribing to patients with hereditary fructose intolerance, consider the combined daily metabolic load of sorbitol/fructose from all sources; administration of sorbitol in these patients is known to cause serious adverse reactions, including fatal reactions including hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, and acute liver failure with breakdown of excretory and synthetic function
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies of idarucizumab in pregnant women to inform on associated risks
Animal reproductive and development studies have not been conducted; it is also not known whether idarucizumab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity
Has not been studied for use during labor and delivery
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Adverse Effects
Side effects of Idarucizumab :
1-10%
Hypokalemia (7%)
Delirium (7%)
Constipation (7%)
Pyrexia (6%)
Pneumonia (6%)
Headache (5%)
Frequency Not Defined
Thromboembolic events
Hypersensitivity
Mechanism of Action
Specific reversal agent for dabigatran
It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, and thereby neutralizes dabigatran and its metabolites anticoagulant effect
Note
Praxbind 50mg/ml Injection manufactured by Boehringer Ingelheim International GmbH. Its generic name is Idarucizumab. Praxbind is availble in United Arab Emirates.
Farmaco UAE drug index information on Praxbind Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.