prothrombin complex

What is the most important information I should know about prothrombin complex?

Tell your doctor if you have ever had a heart attack, stroke, TIA or "mini-stroke", chest pain, severe circulation problems, or a blood clot (especially within the past 3 months).

This medicine is for use in people who use blood thinners such as warfarin. After you are treated with prothrombin complex, do not start using your blood thinner again until your doctor tells you to.

What is prothrombin complex?

Prothrombin complex is used to quickly reverse the effects of a blood-thinning medicine (such as warfarin) during a major bleeding episode, or when there is a need for emergency surgery or invasive medical procedure.

Prothrombin complex may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving prothrombin complex?

• low levels of platelets in your blood after using heparin;
• excessive blood-clotting caused by a condition called disseminated intravascular coagulation; or
• a history of severe allergic reaction to prothrombin complex, Protein C or Protein S, Antithrombin III, heparin, human albumin, or Factors II, VII, IX, X.

If possible before you receive prothrombin complex, tell your caregivers if you have ever had:

• a stroke, including TIA (transient ischemic attack) or "mini-stroke";
• a heart attack;
• disseminated intravascular coagulation;
• severe circulation problems;
• chest pain (angina); or
• if you have had a blood-clot within the last 3 months.

Tell your doctor if you are pregnant or breastfeeding.

Prothrombin complex is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How is prothrombin complex given?

Prothrombin complex is given as an infusion into a vein. A healthcare provider will give you this injection.

After you are treated with prothrombin complex, do not start using your blood thinner again until your doctor tells you to.

What happens if I miss a dose?

Since prothrombin complex is used when needed, it is usually given as a single dose.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving prothrombin complex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of prothrombin complex?

• a light-headed feeling, like you might pass out;
• chest pain or pressure, pain when you breathe, shortness of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot deep in the body --swelling or pain in your arms, legs, or stomach.

Common side effects may include:

• low blood pressure;
• anemia;
• nausea, vomiting; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prothrombin complex?

Other drugs may affect prothrombin complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about prothrombin complex.