Pronunciation:

pro-THROM-bin KOM-plex HUE-man

Brand Names:

• Kcentra

Dosage Forms:

• Powder for Solution

Warnings:

Patients receiving treatment with vitamin K antagonists (VKAs) may be at increased risk of thromboembolic events (TE) due to underlying disease states. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported. The potential benefits of reversing VKAs should be weighed against the potential risk of TE. Monitor patients receiving prothrombin complex concentrate (human) for signs and symptoms of TE. Resumption of anticoagulation should be carefully considered as soon as the risk of TE outweighs the risk of acute bleeding. Prothrombin complex concentrate (human) may not be suitable in patients with TE within the last 3 months prior to use .

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

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

Prothrombin complex human contains coagulation factors II, VII, IX, and X, and proteins C and S. This medicine is used to stop bleeding by helping the blood to clot.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of prothrombin complex concentrate human injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prothrombin complex concentrate human injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Coagulation Factor VIIa

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you 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 (blood clotting disorder) or
• Thrombocytopenia (low number of platelets), heparin-induced—Should not be used in patients with these conditions.

• Congestive heart failure—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

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

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have a sudden or severe headache, problems 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 transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you are concerned about this risk.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 suddenly from a lying or sitting position

dry mouth

fast, pounding, or irregular heartbeat or pulse

headache, sudden, severe

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 about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.