Factor x human (Intravenous)

Factor X (Human) injection is used to treat, control, and reduce bleeding episodes and to prevent bleeding during surgery in patients with mild and moderate hereditary Factor X deficiency.

Factor X deficiency is an inherited bleeding disorder that stops blood from clotting normally. Factor X (Human) injection replaces the missing Factor X and helps your blood to clot.

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

It is very important that your doctor checks you or your child closely while receiving this medicine to ensure it is working properly. Blood tests will be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child has a rash, itching skin, difficulty swallowing, dizziness, fast heartbeat, lightheadedness or fainting, restlessness, trouble breathing, swelling in your face, hands, tongue, or throat, or chest pain after you receive the 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 have concerns about this risk.

Call your doctor right away if you or your child start to have bleeding problems, especially if this medicine has worked well for you before.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it compared to the benefits it will provide. Here are important points to consider for this medicine:

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

Appropriate studies so far have not shown any specific problems for children that would limit the usefulness of Coagadex® in young patients. Its safety and effectiveness have been confirmed.

Geriatric

While appropriate studies on how age affects Coagadex® have not been done in older adults, there have been no documented problems specific to this age group. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may need caution and possible dose adjustments for those taking this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. 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 food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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

Contact your doctor or nurse right away if you experience any of the following side effects:

Incidence not known

• Blurred vision
• Burning, stinging, redness, pain, or swelling at the infusion site
• Chills
• Confusion
• Cough
• Difficulty swallowing
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting down
• 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 genitals
• Nausea
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Redness of the face, neck, arms, and sometimes, upper chest
• Restlessness
• Sweating
• Tightness in the chest
• Trouble breathing
• Unusual drowsiness, dullness, tiredness, or weakness or feeling sluggish
• Unusual tiredness or weakness
• Vomiting

Some side effects might occur that usually do not require medical attention. These side effects may fade as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or lessen some of these side effects. Consult your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

• Back pain

Other side effects not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Coagadex

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

A doctor or other trained health professional will give you or your child this medicine at a medical facility. You may also be trained to administer this medicine yourself. This medicine is given through a needle placed into one of your veins.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.