Pronunciation:

pro-THROM-bin KOM-plex HUE-man - lans

Brand Names:

• Balfaxar

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Arterial and Venous Thromboembolic ComplicationsPatients being treated with Vitamin K antagonist (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with prothrombin complex concentrate, human-lans in clinical trials and post marketing surveillance. Monitor patients receiving prothrombin complex concentrate, human-lans for signs and symptoms of thromboembolic events.Prothrombin complex concentrate, human-lans may not be suitable in patients with thromboembolic events in the prior 3 months

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Prothrombin complex, human-lans injection is used to reverse the effects of anticoagulants or blood thinners (eg, warfarin, Coumadin®, Jantoven®) in patients who need surgery.

Prothrombin complex, human-lans 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 Balfaxar® 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 Balfaxar® 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 or
• Immunoglobulin A (IgA) deficiency with antibodies against IgA or
• Thrombocytopenia (low number of platelets), heparin-induced, history of—Should not be used in patients with these conditions.

• Blood clotting problems or
• Heart disease, history of or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor 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.

Check with your doctor right away if you have blood in the stools, blood in the urine, bruising, confusion, coughing or vomiting blood, persistent bleeding or oozing from puncture sites, mouth, or nose, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area, or trouble breathing. These may be symptoms of blood clotting problems.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jacob disease) 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 have concerns 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:

More common

Pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Increase in blood pressure

increase in body temperature

Incidence not known

Blood in the urine

blood in the stools

blue lips, fingernails, or skin

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

bruising

chest pain, discomfort, or tightness

chills

confusion

cough

coughing or vomiting blood

diarrhea

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fever

headache

hives, itching, skin rash

inability to speak

joint or muscle pain

lightheadedness, dizziness, or fainting

nausea

nervousness

no blood pressure or pulse

numbness or tingling of the face, hands, or feet

pain in the chest, groin, or legs, especially the calves

persistent bleeding or oozing from puncture sites, mouth, or nose

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness or soreness of the eyes

shakiness in the legs, arms, hands, or feet

seizures

severe or sudden headache

slow or irregular heartbeat

slurred speech

sores in the mouth

stomach pain

stopping of the heart

sudden loss of coordination

sweating

swelling of the feet or lower legs

temporary blindness

trembling or shaking of the hands or feet

unconsciousness

vision changes

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

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

Lack or loss of strength

Less common

Redness or pain at the catheter 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.