Praxbind

Last updated on RxList: 4/23/2018
Praxbind Side Effects Center

Last reviewed on RxList 4/23/2018

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: for emergency surgery/urgent procedures, or in life-threatening or uncontrolled bleeding. Common side effects of Praxbind include:

The recommended dose of Praxbind is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab. Praxbind may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using Praxbind; it is unknown if it would harm a fetus. It is unknown if Praxbind passes into breast milk. Consult your doctor before breastfeeding.

Our Praxbind (idarucizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Praxbind Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

When the effects of dabigatran are reversed, you will not be protected against blood clots. Because of this, you may be susceptible to the effects of your underlying disease. Until you start taking dabigatran again, watch for signs and symptoms of blood clots, such as:

  • sudden numbness or weakness (especially on one side of the body);
  • problems with vision or speech;
  • chest pain, wheezing, coughing up blood; or
  • pain, swelling, warmth, or redness in one or both legs.

After you receive idarucizumab, tell your caregivers right away if you have any bleeding that will not stop.

Common side effects may include:

  • confusion, headache;
  • fever; or
  • constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Praxbind (Idarucizumab for Injection)

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Praxbind Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in more detail elsewhere in the labeling:

  • Thromboembolic Risk [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In three healthy volunteer clinical trials, 224 subjects were treated with idarucizumab. In these trials during the treatment period the overall frequency of adverse events was similar between idarucizumab-treated subjects (55/224, 25%) and placebo-treated subjects (26/105, 25%). Among those subjects treated with idarucizumab, adverse reactions reported in ≥5% of subjects was headache (12/224, 5%).

In the RE-VERSE AD™ (RE-VERSal Effects of idarucizumab on Active Dabigatran) trial, a total of 503 dabigatran-treated patients were administered idarucizumab either because they required an emergency surgery or urgent procedure, or because they presented with life-threatening or uncontrolled bleeding [see Clinical Studies]. The adverse reactions reported in ≥5% of patients were constipation (33/503, 7%) and nausea (23/503, 5%). Of the 503 dabigatran-treated patients in the entire study period, 101 patients died, 19 within the first day after idarucizumab dosing; each of these deaths could be attributed either as a complication of the index event or associated with co-morbidities.

Thromboembolic Events

In the RE-VERSE AD trial, 33 of 503 patients reported thrombotic events, 11 patients within 5 days after treatment with idarucizumab and 22 patients 6 days or more after treatment with idarucizumab. Most of these patients were not 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].

Hypersensitivity

Pyrexia, bronchospasm, hyperventilation, rash, and pruritus have been reported in clinical trials with idarucizumab [see WARNINGS AND PRECAUTIONS].

Immunogenicity

As with all proteins there is a potential for immunogenicity with idarucizumab. Detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to idarucizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Using an electro-chemiluminescence (ECL) based assay, plasma samples from 283 subjects (224 treated with idarucizumab) in phase I trials and 501 patients were tested for antibodies cross-reacting with idarucizumab. Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 12% (33/283) of the subjects and 4% (19/501) of patients. The majority of pre-existing antibodies were shown to have low titers. No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed. Treatment-emergent possibly persisting anti-idarucizumab antibodies with low titers were observed in 4% (10/224) of the subjects and 2% (8/501) of patients treated with idarucizumab. Nine patients were re-dosed with idarucizumab. All nine patients were re-dosed within 6 days after the first idarucizumab dose. None of these patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies.

The epitope specificity of antibodies to idarucizumab was characterized using probe molecules. For pre-existing antibodies in patients, 95% (18/19) had specificity for the C-terminus, a region of idarucizumab to which dabigatran does not bind. For treatment emergent antibodies in patients, 67% (6/9) had specificity for the C-terminus, 22% (2/9) had specificity for the variable region, and 11% (1/9) had mixed specificity.

Read the entire FDA prescribing information for Praxbind (Idarucizumab for Injection)

© Praxbind Patient Information is supplied by Cerner Multum, Inc. and Praxbind Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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