Pronunciation:

eye-da-roo-SIZ-ue-mab

Brand Names:

• Praxbind

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidote

Pharmacologic—

Monoclonal Antibody Fragment

Uses of This Medicine:

Idarucizumab injection is used in patients who are taking dabigatran (a blood thinner) during emergency or life-threatening situations when bleeding cannot be controlled.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of idarucizumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of idarucizumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood clots, history of—Use with caution. May make these conditions worse.

• Hereditary fructose intolerance—This medicine contains sorbitol, which may increase risk for more serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests will be needed to check for unwanted effects.

This medicine may increase your risk of blood clots. Tell your doctor if you have the following symptoms: pain in the chest, groin, or legs, especially the calves, difficulty with breathing, severe, sudden headache, slurred speech, sudden, unexplained shortness of breath, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may cause serious side effects in patients with hereditary fructose intolerance. Tell your doctor right away if you have increased hunger, cold sweats, blurred vision, fast heartbeat, shakiness, trembling, stomach pain, dark urine or light colored stools, unusual tiredness or weakness, or yellow eyes or skin.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Anxiety

blurred vision

bone pain

chills

cold sweats

coma

confusion

convulsions

cool, pale skin

cough

dark-colored urine

deep or fast breathing with dizziness

depression

difficulty with breathing

difficulty with swallowing

dizziness

drowsiness

fast heartbeat

fever

general feeling of tiredness or weakness

headache

hives, itching, or skin rash

increased hunger

light-colored stools

loss of appetite

muscle tremors

nausea

nervousness

nightmares

numbness of the feet, hands, and around the mouth

pain in the chest, groin, or legs, especially the calves

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, deep breathing

restlessness

seizures

severe, sudden headache

shakiness

slurred speech

stomach cramps

stomach pain, continuing

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

tightness in the chest

unusual tiredness or weakness

vision changes

vomiting

yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.