Prothrombin complex human-lans (Intravenous)

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

Prothrombin complex human-lans contains coagulation factors II, VII, IX, and X, along with 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 for your doctor to monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and if you should continue taking it. You may need blood tests to check for side effects.

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

Contact your doctor immediately if you notice blood in your stools, blood in your 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 in the affected area, or trouble breathing. These may indicate blood clotting problems.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (e.g., Creutzfeldt-Jacob disease) to people who have received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize the transmission risk. Talk to your doctor if you have concerns about this risk.

In deciding whether to use a medicine, you need to consider the risks against the benefits. This is a decision you will make with your doctor. For this medicine, keep the following in mind:

Allergies

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

Pediatric

There have not been appropriate studies on how Balfaxar® affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of Balfaxar®.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, but in other cases, two different medicines may be used together even if there is a chance of interaction. In such situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

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

• Blood clotting problems or
• Heart disease, history of or
• Liver disease—Use with caution. This may worsen these conditions.

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

Check with your doctor or nurse right away 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. Your health care professional may also 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.

In the U.S.

• Balfaxar

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

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.