"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
Xigris Patient Information including How Should I Take
In this Article
- What is drotrecogin alfa (Xigris)?
- What are the possible side effects of drotrecogin alfa (Xigris)?
- What is the most important information I should know about drotrecogin alfa (Xigris)?
- What should I discuss with my health care provider before receiving drotrecogin alfa (Xigris)?
- How is drotrecogin alfa given (Xigris)?
- What happens if I miss a dose (Xigris)?
- What happens if I overdose (Xigris)?
- What should I avoid while receiving drotrecogin alfa (Xigris)?
- What other drugs will affect drotrecogin alfa (Xigris)?
- Where can I get more information?
What should I discuss with my health care provider before receiving drotrecogin alfa (Xigris)?
You should not use this medication if you are allergic to drotrecogin alfa, or if you have:
- active internal bleeding;
- brain cancer, tumor, or bleeding in the brain;
- if you have had brain or spine surgery or a head injury in the past 2 months; or
- if you have had a stroke within the past 3 months.
Before you receive drotrecogin alfa, tell your doctor if you are allergic to any drugs, or if you have:
- severe liver disease;
- a bleeding or blood clotting disorder;
- if you have had stomach or intestinal bleeding within the past 6 weeks;
- if you have received treatment for blood clots within the past 3 days; or
- if you have taken aspirin or a blood thinner (such as warfarin, Coumadin), or anti-platelet medication (dipyridamole, Persantine, clopidogrel, Plavix) within the past 7 days.
If you have any of these conditions, you may need a dose adjustment or special tests to safely receive drotrecogin alfa.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether drotrecogin alfa passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
How is drotrecogin alfa given (Xigris)?
Drotrecogin alfa is given as an injection through a needle placed into a vein. You will most likely receive this injection in a hospital setting.
Drotrecogin alfa must be given slowly through an IV infusion, and can take up to 4 days to complete.
Additional Xigris Information
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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