Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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