Coagadex

Factor X Human injection is a clotting factor used to treat and control bleeding episodes and prevent bleeding during surgery in patients with mild hereditary Factor X deficiency. 

This drug is to be given only by or under the supervision of your healthcare professional.

Before taking this drug, the risks and benefits for your body should be discussed with your healthcare provider. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. 

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.  Studies on the correlation of age to the effects of CoagadexВ® in the pediatric population have not been performed while safety and efficacy have not been established in children younger than 12 years of age. 

No geriatric-specific problems have been reported in geriatric studies. Studies regarding infant risk when taking this drug during breastfeeding have not been performed. Discuss with your healthcare professional the possible risks and benefits before taking this drug while breastfeeding. 

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects. 

Inform your healthcare professional if you are taking any other prescription or non-prescription drugs. Intake of specific food or using alcohol or tobacco with magnesium is associated with an increased risk of certain side effects. 

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems.

A trained health professional will be the only one to give you this drug. This drug is administered intravenously through a needle placed in one of your veins. Seek advice from your healthcare professional for any concerns.

Your healthcare provider should closely monitor the effectiveness of this drug as well as check for unwanted effects. Unwanted effects may be screened using blood tests. 

Contact emergency medical services immediately if you experience symptoms of anaphylaxis such as rash, itching skin, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain. 

This drug is made from donated human blood which may carry a low risk of transmitting viruses to people who have received them. Human donors and donated blood are both tested for viruses to keep the transmission risk low. 

Seek advice from your healthcare professional if you experience bleeding problems.

Side effects may vary for each individual and prompt medical attention should be given if they occur. 

Inform you healthcare provider immediately if you experience any unusual symptoms such as: 

• blurred vision
• burning, stinging, redness, pain, or swelling at the infusion site
• chills
• confusion
• cough
• difficulty with swallowing
• dizziness
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse feeling of warmth fever hives
• itching, or skin rash large
• hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• sweating
• tightness in the chest
• trouble breathing
• unusual drowsiness
• dullness
• tiredness or weakness or feeling of sluggishness
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, these side effects may eventually disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

 If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. 

If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.