Pronunciation:

koh-a-gyoo-LAY-shun FAK-tor TEN A re-KOM-bin-ant, in-AK-ti-vay-ted - zhzo

Brand Names:

• Andexxa

Dosage Forms:

• Powder for Solution

Warnings:

Thromboembolic Risks, Ischemic Risks, Cardiac Arrest, and Sudden DeathsTreatment with coagulation factor Xa (recombinant) IV injection has been associated with serious and life-threatening adverse events, including:Arterial and venous thrombolic eventsIschemic events, including myocardial infarction and ischemic strokeCardiac arrestSudden deathsMonitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed .

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Coagulation factor Xa (recombinant), inactivated-zhzo injection is used to treat life-threatening or uncontrolled bleeding in patients who are receiving other medicines (including apixaban and rivaroxaban).

This medicine is to be given only by or under the supervision of your doctor or other health care professional.

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 coagulation factor Xa (recombinant), inactivated-zhzo 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 coagulation factor Xa (recombinant), inactivated-zhzo injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine to make sure it is working properly. Blood tests will be needed to check for unwanted effects.

This medicine may increase your risk for blood clots, including stroke and heart attack, within 30 days of receiving the injection. Tell your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness.

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:

More common

Anxiety

blue lips, fingernails, or skin

chest pain or discomfort

confusion

cool, sweaty skin

cough

decreased urine output

difficulty in speaking

dilated neck veins

dizziness

double vision

extreme tiredness or weakness

fainting

fast heartbeat

headache

inability to move the arms, legs, or facial muscles

inability to speak

irregular heartbeat

irregular, fast or slow, or shallow breathing

lightheadedness

nausea

pain or discomfort in the arms, jaw, back, or neck pain

redness, or swelling in the arm or leg

slow speech

sweating

swelling of the face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

vomiting

weakness

weight gain

Less common

Fast, pounding, or irregular heartbeat or pulse

palpitations

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bladder pain

bloody or cloudy urine

change in taste

chills

cough

difficult, burning, or painful urination

feeling of warmth

fever

frequent urge to urinate

loss of taste

lower back or side pain

redness of the face, neck, arms, and occasionally, upper chest

sneezing

sore throat

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.