Prothrombin Complex Concentrate, Human

Prothrombin Complex Concentrate, Human is a prescription medication used for reversing acquired coagulation factor deficiency induced by Vitamin K antagonist therapy in adult patients with acute major bleeding.

• Prothrombin Complex Concentrate, Human is available under the following different brand names: Kcentra

Adult and pediatric dosage

Lyophilized concentrate for reconstitution

• 500 units/vial
• 1000 units/vial
• Composition/vial
• The exact potency of all coagulation factors and antithrombotic proteins are listed on each carton
  • Total protein: 120-280mg
  • Factor II: 380-800 units
  • Factor VII: 200-500 units
  • Factor IX: 400-620 units
  • Factor X: 500-1020 units
  • Protein C: 420-820 units
  • Protein S: 240-680 units
  • Heparin: 8-40 units
  • Antithrombin III: 4-30 units
  • Human albumin: 40-80mg
  • NaCl: 60-120mg
  • Sodium citrate: 40-80mg
  • Buffering agents (HCl, NaOH): Small amounts
• Vitamin K Antagonist Reversal
• Adult dosage
• Dosing guidelines
  • The dose in units below is based on factor IX content in the product
  • INR 2 to below 4: 25 units/kg; not to exceed 2500 units
  • INR 4-6: 35 units/kg; not to exceed 3500 units
  • INR above 6: 50 units/kg; not to exceed 5000 units
• Example dosing calculation
  • For 80 kg patient with INR 5.0: 35 units/kg x 80 kg = 2800 units
  • For vial with actual potency of 30 units/mL Factor IX, 93 mL would be administered (2800 units ÷ 30 units/mL = 93 mL)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Prothrombin Complex Concentrate, Human include:

• headache,
• nausea,
• vomiting,
• joint pain,
• low blood pressure (hypotension), and
• low levels of iron in the blood (anemia).

Serious side effects of Prothrombin Complex Concentrate, Human include:

• a light-headed feeling,
• chest pain or pressure, 
• pain while breathing, 
• 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 the arms, legs, or stomach.

Rare side effects of Prothrombin Complex Concentrate, Human, recombinant include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Prothrombin Complex Concentrate, Human has severe interactions with the following drugs:
  • alteplase
  • anti-inhibitor coagulant complex
  • apixaban
  • argatroban
  • bivalirudin
  • dabigatran
  • dalteparin
  • enoxaparin
  • Factor IX
  • Factor IX, recombinant
  • Factor VIIa, recombinant
  • heparin
  • protein C concentrate
  • reteplase
  • rivaroxaban
  • tenecteplase
  • tranexamic acid injection
• Prothrombin Complex Concentrate, Human has serious interactions with no other drugs.
• Prothrombin Complex Concentrate, Human has moderate interactions with the following drugs:
  • dichlorphenamide
  • emicizumab
  • Factor X, human
  • Prothrombin Complex Concentrate, Human has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Anaphylaxis or severe systemic reactions to any component
• Disseminated intravascular coagulation (DIC) Known heparin-induced thrombocytopenia (HIT)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Prothrombin Complex Concentrate, Human?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Prothrombin Complex Concentrate, Human?”

Cautions

• Fatal and nonfatal arterial and venous thromboembolic complications were reported (see Black Box Warnings)
• Reversing VKA therapy, due to thromboembolic complications, exposes patients to the thromboembolic risk of their underlying disease; once the risk of thromboembolic events outweighs the risk of acute bleeding, resumption of anticoagulation should be carefully considered following administration of Kcentra and Vitamin K
• Because of the risk of thromboembolism associated with reversal of VKA, closely monitor patients for signs and symptoms of thromboembolism during and after therapy administration
• Hypersensitivity reactions were reported, including flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm
• Made from human blood; risk of transmitting infectious agents (eg, viruses including hepatitis and HIV, Creutzfeldt-Jakob variant or disease)

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risk during pregnancy
• Lactation
  • Unknown whether distributed in human breast milk; breastfeeding not advised