Coagulation factor xa recombinant, inactivated-zhzo (Intravenous)

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

This medicine should only be given by or under the supervision of your doctor or another health care professional.

It is very important that your doctor monitors you closely while you are receiving this medicine to ensure 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.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how coagulation factor Xa (recombinant), inactivated-zhzo injection affects children. Its safety and effectiveness have not been established in the pediatric population.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of coagulation factor Xa (recombinant), inactivated-zhzo injection. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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.

In the U.S.

• Andexxa

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Blood Modifier Agent

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.