Data from FDA - Curated by EPG Health - Last updated 11 January 2018
(6.1) In patients, the most frequently
(6.1) To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
Three clinical trials in
In these trials during the treatment period the overall frequency of
Among those subjects treated with idarucizumab,
In the interim analysis of the RE-VERSE AD™ (RE-VERSal Effects of idarucizumab on
Of the total,
Thromboembolic Events In the interim analysis of the RE-VERSE AD trial, 5 of
None of these patients were on antithrombotic therapy at the time of the event, and in each of these cases, the thrombotic event could be attributed to the underlying medical condition of the patient [see Warnings and Precautions (5.1)].
Hypersensitivity Pyrexia, bronchospasm, hyperventilation, rash, and pruritus have been reported in clinical trials with idarucizumab [see Warnings and Precautions (5.3)].
6.2 Immunogenicity As with all proteins there is a
Using an electro-chemiluminescence (ECL) based assay, plasma samples from 283 subjects (224 treated with idarucizumab) were tested for antibodies cross-reacting with idarucizumab.
Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 13 % (36/283) of the subjects.
The majority of pre-existing antibodies were shown to have
Treatment-emergent possibly persisting
The epitope specificity of antibodies to idarucizumab was characterized using probe molecules.
For pre-existing antibodies, 97 % (35/36) had specificity for the C-terminus, a region of idarucizumab to which dabigatran does not bind.
For treatment emergent possibly
Detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of antibody
For these reasons, comparison of the incidence of
2 DOSAGE AND ADMINISTRATION For intravenous use only.
For intravenous use only.
(2.1) There is
2.2 Preparation Ensure aseptic handling when preparing the infusion.
Parenteral drug products should be inspected visually for particulate matter and
2.3 Administration Do not mix with other medicinal products.
Use aseptic technique when administering PRAXBIND.
Intravenously administer the dose of 5 g (2 vials, each contains 2.5 g) as Two consecutive infusions (see Figure 2) or Bolus injection by injecting both vials consecutively one after another via syringe (see Figure 3).
A pre-existing intravenous line may be used for administration of PRAXBIND.
PRAXBIND treatment can be used in
figure-1 figure-2 figure-3 2.4 Restarting Antithrombotic Therapy Patients being treated with dabigatran therapy have underlying disease states that predispose them to thromboembolic events.
Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Idarucizumab is a specific reversal agent for dabigatran, with
Pradaxa treatment can be initiated 24 hours after administration of PRAXBIND [see Clinical Pharmacology (12.2)].
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are
Animal reproductive and development studies have not been conducted with idarucizumab.
It is also not known whether PRAXBIND can cause fetal
PRAXBIND should be given to a pregnant woman only if clearly needed.
The background risk of major birth
In the U.S. general population, the estimated background risk of major birth
Clinical Considerations Labor or Delivery PRAXBIND has not been studied for use during labor and delivery.
8.2 Lactation Risk Summary There are
It is not known whether idarucizumab is excreted in human milk.
Because many drugs are excreted in human milk,
The developmental and health
8.4 Pediatric Use
8.5 Geriatric Use A total of 111 (90 %) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 74 (60 %) were 75 years of age and older.
|Agency product number||97RWB5S1U6|
|Date Last Revised||28-10-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Boehringer Ingelheim Pharmaceuticals, Inc.|