drotrecogin alfa-injectable, Xigris (cont.)
SIDE EFFECTS: No minor side effects are expected to occur. If any minor non-bleeding side effects occur, notify the doctor. Tell the doctor immediately if any of these unlikely but serious side effects occur: easy bruising or bleeding, bloody diarrhea, black stool, coffee-ground vomit, pink-colored/red urine, stomach/abdominal pain, one-sided weakness, vision problems, slurred speech, confusion. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact the doctor.
PRECAUTIONS: This medication is not recommended for use if you have the following medical conditions: severe bleeding problems (e.g., internal bleeding, severe injury), conditions at risk for severe bleeding (e.g., recent stroke, recent head or spine surgery), brain disorders (e.g., aneurysm, tumors), currently have an epidural catheter. Tell your doctor your medical history, especially of: kidney disease, liver disease, HIV, organ transplants (especially of the bone marrow, lung, liver, pancreas, or small bowel), ulcers, low platelet counts, any allergies. This medication should be stopped 2 hours before having a surgical procedure and, if required, not restarted until 12 hours after the procedure. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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