Prothrombin complex human (Intravenous)

Prothrombin complex concentrate human injection is used to reverse the effects of anticoagulants or blood thinners (e.g., warfarin, Coumadin®, Jantoven®) in adult patients with acute major bleeding.

Prothrombin complex human contains coagulation factors II, VII, IX, and X, as well as proteins C and S. This medicine helps stop bleeding by assisting the blood in clotting.

This medicine is to be given only by or under the supervision of your doctor.

It is very important that your doctor monitors you closely while you are receiving this medicine to ensure it is working properly and to check for any side effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical attention. Inform your doctor or nurse right away if you experience a cough, difficulty swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, trouble breathing, chest tightness, or swelling in your face, hands, tongue, or throat after receiving the medicine.

This medicine may increase your risk of blood clotting problems. Tell your doctor immediately if you have a sudden or severe headache, issues with vision or speech, chest pain, trouble breathing or swallowing, swelling or tenderness in your leg, or numbness or weakness while you are receiving this medicine.

This medicine is made from donated human blood. Some human blood products have passed on certain viruses to people who received them, although the risk is low. Both human donors and donated blood are tested for viruses to keep the transmission risk low. Discuss with your doctor if you are worried about this risk.

In deciding to use a medicine, you must consider the risks of taking it against the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies to determine how age affects the use of prothrombin complex concentrate human injection in children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not shown any age-related issues that would limit the usefulness of prothrombin complex concentrate human injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together, even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Coagulation Factor VIIa

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergy to heparin, coagulation factors II, VII, IX, and X, proteins C and S, antithrombin III, or human albumin, history of or
• Disseminated intravascular coagulation (a blood clotting disorder) or
• Thrombocytopenia (low platelets), heparin-induced—This medicine should not be used in patients with these conditions.

• Congestive heart failure—Use with caution. This may worsen the condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do occur, they might require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Blurred vision
• chest pain
• confusion
• convulsions
• decrease in the amount of urine
• dizziness
• dizziness, faintness, or lightheadedness when getting up quickly from a lying or sitting position
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• sudden, severe headache
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea or vomiting
• nervousness
• noisy, rattling breathing
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• slow or fast heartbeat
• sweating
• swelling of the fingers, hands, feet, or lower legs
• tightness in the chest
• troubled breathing
• troubled breathing at rest
• unusual tiredness or weakness
• weakness
• weight gain

Incidence not known

• Anxiety
• blood in the stools or urine
• blue lips and fingernails
• bruising
• chest discomfort
• coughing or vomiting blood
• coughing that sometimes produces a pink frothy sputum
• difficult or labored breathing
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with speaking
• double vision
• fainting
• feeling of warmth
• headache
• hives or welts
• inability to move the arms, legs, or facial muscles
• increased sweating
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• pale skin
• persistent bleeding or oozing from puncture sites, mouth, or nose
• rash
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• slow speech
• sudden shortness of breath or troubled breathing
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints

Less common

• Diarrhea
• difficulty having a bowel movement (stool)
• tearing of skin
• trouble sleeping

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Kcentra

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.