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Prothrombin complex concentrate (human)

Generic Name: prothrombin complex concentrate (human) (pro-THROM-bin)
Brand Name: Kcentra

Patients are treated with vitamin K antagonists (eg, warfarin) because they have health problems that put them at increased risk for blood clots. Very bad and sometimes deadly blood clots have occurred after using prothrombin complex concentrate (human) to reverse the effects of vitamin K antagonists. Talk with your doctor about using prothrombin complex concentrate (human) to reverse the effects of the vitamin K antagonist, especially if you have ever had a blood clot. Tell your doctor if you have had a blood clot, heart attack, a certain blood problem (disseminated intravascular coagulation [DIC]), stroke or transient ischemic attack (TIA), chest pain, or severe blood vessel disease within the past 3 months. You need to be sure that the benefits of using prothrombin complex concentrate (human) outweigh the risks.

Prothrombin complex concentrate (human) is used for:

Reversing the effects of a vitamin K antagonist (eg, warfarin) in people with major bleeding or who need to have surgery or another procedure right away. It may also be used for other conditions as determined by your doctor.

Prothrombin complex concentrate (human) is a human clotting factor complex derived from human plasma. It works by increasing the amount of certain clotting factors in the blood, which helps the blood form clots and stop bleeding.

Do NOT use prothrombin complex concentrate (human) if:

  • you are allergic to any ingredient in prothrombin complex concentrate (human), heparin, or to other products that are made from human plasma
  • you have DIC
  • you have a history of low platelet counts after taking heparin

Contact your doctor or health care provider right away if any of these apply to you.

Before using prothrombin complex concentrate (human):

Some medical conditions may interact with prothrombin complex concentrate (human). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of blood clots, blood or bleeding problems (eg, DIC), heart attack, blood vessel problems, stroke or TIA (mini-stroke), or chest pain

Some MEDICINES MAY INTERACT with prothrombin complex concentrate (human). However, no specific interactions with prothrombin complex concentrate (human) are known at this time.

Ask your health care provider if prothrombin complex concentrate (human) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use prothrombin complex concentrate (human):

Use prothrombin complex concentrate (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Prothrombin complex concentrate (human) is given as an injection at your doctor's office, hospital, or clinic.
  • Only 1 dose of prothrombin complex concentrate (human) is required. If you miss a dose of prothrombin complex concentrate (human), contact your doctor right away.

Ask your health care provider any questions you may have about how to use prothrombin complex concentrate (human).

Important safety information:

  • Prothrombin complex concentrate (human) comes from human blood. Rarely, patients receiving products that come from human blood have developed certain viral infections (eg, hepatitis A) or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of these problems have been found in patients who have used prothrombin complex concentrate (human). Discuss any questions or concerns with your doctor.
  • Prothrombin complex concentrate (human) should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if prothrombin complex concentrate (human) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using prothrombin complex concentrate (human) while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use prothrombin complex concentrate (human), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of prothrombin complex concentrate (human):

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; joint pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty or fast breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain or pressure; confusion; coughing up blood; fainting; fast heartbeat; one-sided weakness; severe or persistent dizziness or headache; shortness of breath; slurred speech; stomach pain or swelling; trouble walking or moving around; unusual or persistent bruising or bleeding; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of prothrombin complex concentrate (human):

Prothrombin complex concentrate (human) is usually handled and stored by a health care provider. If you are using prothrombin complex concentrate (human) at home, store prothrombin complex concentrate (human) as directed by your pharmacist or health care provider. Keep prothrombin complex concentrate (human) out of the reach of children and away from pets.

General information:

  • If you have any questions about prothrombin complex concentrate (human), please talk with your doctor, pharmacist, or other health care provider.
  • Prothrombin complex concentrate (human) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take prothrombin complex concentrate (human) or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about prothrombin complex concentrate (human). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to prothrombin complex concentrate (human). This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using prothrombin complex concentrate (human).

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.