Note: This document contains side effect information about prothrombin complex. Some dosage forms listed on this page may not apply to the brand name Balfaxar.
Applies to prothrombin complex: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
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.
Serious side effects of Balfaxar
Along with its needed effects, prothrombin complex (the active ingredient contained in Balfaxar) 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 while taking prothrombin complex:
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
Other side effects of Balfaxar
Some side effects of prothrombin complex 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
For Healthcare Professionals
Applies to prothrombin complex: intravenous powder for injection.
General
The most common adverse reactions were headache, nausea/vomiting, arthralgia, and hypotension.
The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.[Ref]
Cardiovascular
Common (1% to 10%): Hypotension (4.9%), tachycardia (2.9%), increased blood pressure/hypertension (2.9%)
Uncommon (0.1% to 1%): Venous thrombosis, calf (1.0%), deep vein thrombosis (1.0%), fistula clot (1.0%)
Postmarketing reports: Arterial thromboembolic events (including acute myocardial infarction and arterial thrombosis), venous thromboembolic events (including pulmonary embolism and venous thrombosis), and disseminated intravascular coagulation[Ref]
Gastrointestinal
Common (1% to 10%): Nausea/vomiting (3.9%), constipation (1.9%)[Ref]
Hypersensitivity
Postmarketing reports: Flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm[Ref]
Metabolic
Common (1% to 10%): International normalized ratio increased (2.9%), hypokalemia (1.9%)
Uncommon (0.1% to 1%): Fluid overload (1.0%)[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia (3.9%)
Uncommon (0.1% to 1%): Chest pain (1.0%)[Ref]
Nervous system
Common (1% to 10%): Headache (7.8%), hemorrhage intracranial (2.9%), ischemic cerebrovascular accident (1.9%)[Ref]
Other
Common (1% to 10%): Skin laceration/contusion/subcutaneous hematoma (2.9%)
Uncommon (0.1% to 1%): Sudden death, unknown cause (1.0%)[Ref]
Psychiatric
Common (1% to 10%): Mental status changes (1.9%)
Uncommon (0.1% to 1%): Insomnia (1.0%)[Ref]
Respiratory
Common (1% to 10%): Respiratory distress/dyspnea/hypoxia (1.9%)
Uncommon (0.1% to 1%): Abnormal breath sounds/rales (1.0%)[Ref]
