Idarucizumab (Intravenous)

Overview

For patients who need surgery but who are also on blood thinners such as dabigatran, the potential for excessive bleeding can make surgery dangerous. For patient who are on the blood thinner dabigatran, a doctor will give Idarucizumab intravenously prior to surgery to help reverse the blood thinning effects of dabigatran and allow the patient to safely undergo a procedure.

There are a variety of side effects, such as an allergic reaction, breathing difficulty, constipation or other uncommon reactions. Patients may be given instructions post-surgery regarding food or drink intake, to help reduce the likelihood of side effects after surgery.

In some cases, a patient may be given Idarucizumab in an emergency surgery situation. If the patient is pregnant or breastfeeding, or if they have a hereditary fructose allergy or intolerance, it's important that the doctor be made aware of these conditions prior to being given Idarucizumab.

The physician may order blood tests after giving the patient Idarucizumab, in order to ensure that there are no issues with blood, or to determine when the patient may continue taking the dabigatran medication.

Conditions Treated

  • Reversal of blood thinner dabigatran

Type Of Medicine

  • Antidote
  • Monoclonal Antibody

Side Effects

For patients taking Idarucizumab, there are certain side effects that may be experienced by some patients. The most common of these are lower potassium in the bloodstream, dizziness or confusion, constipation, headache, pneumonia and fever. In some patients, Idarucizumab may result in trouble breathing.

Certain rare side effects may indicate an allergic reaction to Idarucizumab. These include a sudden difficulty breathing, itching, rash, hives, or swelling of the lips, mouth, eyelids or tongue.

There are other potential side effects that have been reported, however these are not common among most patients given Idarucizumab. These include the following:

  • Mood changes such as anxiety, depression
  • Nervousness or restlessness
  • Vision changes including blurred vision
  • Bone pain
  • Coma
  • Convulsions
  • Cool, pale skin
  • Drowsiness
  • Dark-colored urine
  • Deep or fast breathing with dizziness
  • Fast heartbeat
  • Changes in appetite, either increased or decreased hunger
  • Light-colored stools
  • Loss of appetite
  • Muscle tremors
  • Nausea or vomiting
  • Numbness of the feet, hands, and around the mouth
  • Sudden, severe weakness or numbness in the arm or leg
  • Pain in the chest, groin, or legs, especially the calves
  • Rapid, deep breathing
  • Seizures
  • Shakiness
  • Stomach pain, continuing
  • Stomach cramps
  • Slurred speech
  • Sudden loss of coordination
  • Unusual tiredness or weakness
  • Yellow eyes or skin

The above list is not intended to be complete. Patients may experience some side effects that are not listed here, and should check with their doctor in case of any discomfort or concern. Patients can also report side effects to the FDA, by calling 1-800-FDA-1088.

Dosage

Idarucizumab is administered in a hospital setting, by a health care professional and in the course of surgery. Generally, the adult dose of Idarucizumab is 5 grams (g), split into two injections which are administered consecutively. The patient's doctor will determine what specific dosage is correct depending on the individual patient's medical need and history.

Since patients are given this medication by a doctor or nurse in a hospital setting, there is not much of a likelihood that a patient will overdose on Idarucizumab. Similarly, there is also no likelihood for a patient to miss a dose. Instead, this medication will be prescribed by a doctor on an as-needed basis, and administered by the healthcare team performing emergency surgery.

The safety and effectiveness of Idarucizumab for use in children under age 18 has not been determined. Since this medication is prescribed in an emergency surgery situation, however, a doctor will determine whether this medication can be safely used by a patient younger than 18 years old.

Major Drug Interactions:

There are not any major drug interactions of note that might cause a reaction to patients being given Idarucizumab. This medication is usually given in an emergency surgery setting, so a doctor will make the determination based on the patient's history, and whether that need outweighs any potential interaction with other medications.

In order to determine what, if any, medications may interact with Idarucizumab, patients should provide a complete medical history to their doctor. Before being given Idarucizumab, patients should inform their doctor of all other medications being taken, both prescription and non-prescription (over the counter) as well as supplements and herbal remedies.

Warnings

Idarucizumab is given in a surgical setting, and in many cases is administered in an emergency surgery situation. During surgery, the doctor will monitor the patient's reaction to this medication while it is being administered. After surgery, it is possible that the doctor may order follow-up blood tests to ensure that there are no lasting side effects from taking Idarucizumab, or to determine progress after being given Idarucizumab.

Since Idarucizumab is a clotting medication, there is a possibility that Idarucizumab can cause blood clots in some patients. While the patient is being given Idarucizumab, they will not have protection from their underlying medical condition which is normally treated by taking dabigatran. Until a patient is put back on the dabigatran following their surgery, it is possible that blood clots could return, which could cause severe damage. Patients should be aware that having a blood clot is a medical emergency, and should watch for the occurrence of any sign of blood clots. Some of the symptoms of blood clots include: any pain in the groin area, or in the legs or chest, especially in the calf area on the leg; trouble with breathing or a sudden unusual shortness of breath; a headache that is severe or sudden; slurred speech or difficult speaking; a loss of coordination or dizziness which appears suddenly; any changes in the vision; and a weakness of the arms or legs which appears suddenly or is severe. A patient should inform their doctor immediately or seek emergency attention if they experience any of these symptoms.

In some patients, Idarucizumab can cause a serious allergic reaction, including anaphylaxis. Anaphylaxis is a more severe allergic reaction, and can result in death or disability. As a result, any kind of allergic reaction to Idarucizumab should be treated immediately. Patients should seek emergency medical attention if they have any of the following: redness, itching or rash anywhere on the body; any difficulty breathing, swallowing or speaking, or if they experience tightness in the throat; and any swelling in the face, hands, mouth or tongue.

Since Idarucizumab contains the fructose ingredient sorbitol, any patients who have a fructose intolerance or allergy may not be able to take Idarucizumab. While Idarucizumab may be given in an emergency setting, it is important that the doctor be informed if the patient has this kind of medical condition. The doctor should be informed if the patient experiences any of the following while being given Idarucizumab or after taking it: change in appetite such as increase in hunger; chills or cold sweats; vision problems such as blurry vision; rapid heartbeat; unsteadiness, shaking or trembling; stomach or abdominal pain; darkened urine or light or chalky colored stools; unusual feeling of weakness or tiredness; and yellowed skin or eyes.

Patients who are pregnant should not take Idarucizumab, as the effects on an unborn child are not known. If the patient is pregnant or may become pregnant, it is important to inform the doctor if possible prior to being given Idarucizumab.

Storage

Since patients are given Idarucizumab by a healthcare professional during surgery, there is no need for a patient to store this medication. In a hospital setting, this medication is generally kept refrigerated in a secure location.

Summary

Patients who need emergency surgery, but who are on blood thinners such as dabigatran, must have a medication to help stop excessive bleeding in order to undergo the procedure. In this case, a doctor may use Idarucizumab intravenously during the procedure to reverse the effects of dabigatran and thereby permit the patient to safely undergo surgery.

The type of side effects that may occur while using Idarucizumab include having an allergic reaction (and possibly anaphylaxis), experiencing trouble breathing, having constipation, experiencing confusion or dizziness; or having symptoms of blood clots such as having trouble speaking, having pain or numbness in the arms or legs, or experiencing a sudden weakness. The patient's physician will follow up after surgery to ensure that the effects of the Idarucizumab have not caused severe side effects.

If the patient is pregnant or breastfeeding, or if they have a hereditary fructose allergy or intolerance, it's important that the doctor be made aware of these conditions prior to the patient being given Idarucizumab.

The physician may order blood tests after giving the patient Idarucizumab, in order to ensure that there are no issues with blood clots, and to determine whether the patient can restart the taking of dabigatran.