Prothrombin Complex Concentrate (Human), Infusion

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KEY POINTS

• This medicine is given by IV infusion to treat severe bleeding caused by warfarin. You may be at a higher risk of developing a blood clot after treatment with this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihemorrhagic

Generic and brand names: prothrombin complex concentrate (human), infusion; Kcentra

What is this medicine used for?

This medicine is given by IV infusion to treat severe bleeding caused by warfarin, a medicine to prevent blood clots.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Blood clots
• Heart disease, heart attack, or angina (chest pain)
• Heparin-induced thrombocytopenia (HIT)
• Peripheral vascular disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is usually given by IV infusion (slow drip into a large vein) by your healthcare provider while you are in the hospital.

What should I watch out for?

You may be at a higher risk of for developing a blood clot after treatment with this medicine. Talk with your healthcare provider about this.

This medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): unusual tiredness or weakness, chest pain; trouble breathing; arm or leg pain or swelling; or any unexplained swelling; unusual bruising or bleeding; severe lightheadedness or fainting.

Other: Headache, dizziness, nausea, vomiting, joint aches, injection site pain.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.