Prothrombin Complex Concentrate (Human) for injection

What is this medication?

PROTHROMBIN COMPLEX CONCENTRATE (proh THROM bin KUM pleks KON suhn treyt) is used in patients who are taking a vitamin K antagonist like warfarin to stop bleeding or when urgent surgery is needed.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Kcentra

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease or recent heart attack
• history of disseminated intravascular coagulation
• history of heparin-induced thrombocytopenia
• history of stroke or transient ischemic attack
• peripheral vascular disease
• an unusual or allergic reaction to prothrombin complex concentrate, heparin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medication?

This medicine may interact with the following medications:

• factor VIIa

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• confusion, trouble speaking or understanding
• cough or other signs of infection
• fever or chills
• severe headaches
• shortness of breath, chest pain, swelling in a leg
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea, vomiting
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.