Does Praxbind (idarucizumab) cause side effects?
Praxbind (idarucizumab) is an antibody used to reverse the effect of Pradaxa (dabigatran) for emergency surgery/urgent procedures or if life-threatening or uncontrolled bleeding occurs while taking dabigatran.
Dabigatran is an anticoagulant (blood thinner) used to prevent blood clots in people with non-valvular atrial fibrillation and for treating deep venous thrombosis (DVT) and pulmonary embolism (PE).
Common side effects of Praxbind include
- low blood potassium,
- allergic reactions,
- increased levels of laboratory markers for blood clotting, and
- idarucizumab antibodies.
Serious side effects of Praxbind include removal of the protective effect of dabigatran in people who are at risk for blood clots, and risk for adverse reactions in patients with hereditary fructose intolerance because idarucizumab contains sorbitol.
There are no known drug interactions for Praxbind.
There are no adequate or well-controlled trials of Praxbind use in pregnant women. Praxbind should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is unknown if Praxbind is excreted into human milk. Consult your doctor before breastfeeding.
What are the important side effects of Praxbind (idarucizumab)?
Common side effects of idarucizumab include:
- Low blood potassium
Other reported side effects include:
- Allergic reactions
- Increased levels of laboratory markers for blood clotting
- Idarucizumab antibodies
Possible serious side effects of idarucimab include:
- Reversing the effect of dabigatran removes the protective effect of dabigatran in people who are at risk for blood clots. Therefore, anticoagulation should be started as soon as possible after treatment with idarucizumab.
- If patients continue to bleed or require a second emergency surgery/urgent procedure, an additional 5 g dose of idarucizumab may be considered.
- Idarucizumab contains sorbitol. Patients with hereditary fructose intolerance may be at risk for adverse reactions.
Praxbind (idarucizumab) side effects list for healthcare professionals
The following serious adverse reactions are described in more detail elsewhere in the labeling:
- Thromboembolic Risk
- Hypersensitivity Reactions
- Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient
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.
- 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.
- 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.
- Pyrexia, bronchospasm, hyperventilation, rash, and pruritus have been reported in clinical trials with idarucizumab.
- 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.
Praxbind (idarucizumab) is an antibody used to reverse the effect of Pradaxa (dabigatran) for emergency surgery/urgent procedures or if life-threatening or uncontrolled bleeding occurs while taking dabigatran. Dabigatran is an anticoagulant (blood thinner) used to prevent blood clots in people with non-valvular atrial fibrillation and for treating deep venous thrombosis (DVT) and pulmonary embolism (PE). Common side effects of Praxbind include headache, low blood potassium, delirium, constipation, fever, pneumonia, allergic reactions, increased levels of laboratory markers for blood clotting, and idarucizumab antibodies. There are no adequate or well-controlled trials of Praxbind use in pregnant women. It is unknown if Praxbind is excreted into human milk.
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Related Disease Conditions
Blood Clots (in the Leg)
Blood clots can form in the heart, legs, arteries, veins, bladder, urinary tract, and uterus. Risk factors include high blood pressure and cholesterol, diabetes, smoking, and family history. Symptoms and treatment depend on the location of the clot.
Pulmonary Embolism (Blood Clot in the Lung)
A pulmonary embolism (PE) occurs when a piece of a blood clot from deep vein thrombosis (DVT) breaks off and travels to an artery in the lung where it blocks the artery and damages the lung. The most common symptoms of a pulmonary embolism are shortness of breath, chest pain, and a rapid heart rate. Causes of pulmonary embolism include prolonged immobilization, certain medications, smoking, cancer, pregnancy, and surgery. Pulmonary embolism can cause death if not treated promptly.
Deep Vein Thrombosis (DVT, Blood Clot in the Legs)
Deep vein thrombosis (DVT) is a blood clot in the deep veins, and can be caused by broken bones, trauma to a limb, immobility, medications, smoking, cancer, genetic predisposition, and cancer. Symptoms and signs of a deep vein thrombosis in a leg are swelling, tenderness, redness, warmth, and pain. Treatments for DVT include medications and surgery.
How Serious Is a Blood Clot in the Lungs?
A blood clot is a solid or semisolid clump of blood. When the tissues of our body are injured, excessive blood loss is prevented by the clotting of blood. When a blood clot occurs inside the blood vessels it may lead to serious medical conditions. When a blood clot occurs inside the arteries to the lungs, the condition is called pulmonary embolism (PE).
DVT and Birth Control Pills (Oral Contraceptives)
Deep vein thrombosis (DVT) is a blood clot that has traveled deep into the veins of the arm, pelvis, or lower extremities. Oral contraceptives or birth control pills can slightly increase a woman's risk for developing blood clots, including DVT. DVT symptoms and signs in the leg include leg or calf pain, redness, swelling, warmth, or leg cramps, and skin discoloration. If a blood clot in the leg is not treated, it can travel to the lungs, which can cause a pulmonary embolism (blood clot in the lung) or post-thrombotic syndrome, both of which can be fatal if not treated immediately. Increased risk factors for DVT and birth control pills include over 40 years of age, family history, smoking, and obesity. Other medical problems that increase the risks of blood clots, for example, lung or heart disease, or inflammatory bowel disease or IBD (Crohn's disease and ulcerative colitis (UC). Other options for preventing pregnancy include IUDs, birth control shots, condoms, diaphragms, and progestin-only oral contraceptives.
How Do You Know If You Have a Blood Clot in Your Leg?
Blood clots are clumps of blood formed when the blood changes from a fluid to a semisolid form. When a blood clot is formed in one of the large veins in the legs or arms, the condition is called deep vein thrombosis (DVT). A blot clot in your leg can hamper the flow of oxygen and nutrients to the affected area. An untreated DVT may cause the clot to grow bigger and break in small pieces that can travel to other organs, such as the heart and lungs, causing serious consequences.
DVT (Deep Vein Thrombosis) During Pregnancy
Deep vein thrombosis or DVT is a condition in which a blood clot becomes embedded in one of the deep veins of the arms, thighs, pelvis, or lower legs. Warning signs and symptoms of DVT include pain, warmth, redness, swelling, leg cramps, and worsening leg pain in the affected extremity. Many conditions and other factors can cause DVTs, for example, during pregnancy including postpartum (6-8 weeks after delivery of the baby), obesity, heart attacks or heart failure, cancer, birth control pills (oral contraceptives), recent surgery, high altitudes, and advanced age. Treatment guidelines for DVT diagnosed during pregnancy is anticoagulation (anti-clotting) drugs, usually, low-molecular-weight heparins. DVT treatment may need to be continued postpartum. Warfarin (Coumadin, Jantoven) should not be used to treat DVT during pregnancy because it can harm the developing fetus.
What Does a Blood Clot Feel Like?
Blood clots are semi-solid masses of blood that may be immobile (thrombosis) and impede blood flow or dislodge to other parts of the body (embolism). Deep vein clots, if dislodged, can travel through veins through the lungs to the arteries in the lungs. This is referred to as a pulmonary embolism and can be deadly. Blood clots can also lead to a heart attack or stroke.
Treatment & Diagnosis
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- Pulmonary Embolism -Lung Blood Clot Risk Factors In Women
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- Serena Williams Battles Pulmonary Embolism and a Hematoma
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- What Causes Deep Vein Thrombosis in the Leg?
- How Do You Know You Have Deep Vein Thrombosis?
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.