Factor IX

Contraindications

Hypersensitivity to mouse proteins

Cautions

Theoretical risk of pathogen transmission with human-derived products

For minor spontaneous hemorrhage, goal should be 10-15% increase

For major trauma or surgery, goal should be 25% increase for 1 wk before & after

Factor IX (Human) may stick to glass, use plastic syringes only

Development of factor IX antibodies reported

Observe closely for signs or symptoms of thromboembolic disorders

Use caution in hepatic impairment

Serious side effects have been reported with Factor IX. “Drug Precautions” section.

Common side effects of Factor IX include distorted taste and pain in the extremities.

Common side effects of long-acting Factor IX include headache and tingling and/or numbness in the mouth.

This is not a complete list of Factor IX side effects. Ask your doctor or pharmacist for more information.

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

No Factor IX drug interactions have been reported, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Factor IX including:

• Hypersensitivity reactions, including anaphylaxis. Tell your healthcare provider right away if you have some or all of the following symptoms…
  • swelling of the face or lips
  • chest tightness
  • a drop in blood pressure
  • lethargy (sluggishness)
  • nausea
  • vomiting
  • tingling in hands or feet
  • restlessness
  • wheezing
  • difficulty breathing
• Development of proteins that inhibit (stop) the activity of Factor IX. Your healthcare provider will want to monitor for this development.
• Nephrotic syndrome (kidney damage). Tell your healthcare provider right away if you have some or all of the following symptoms…
  • urine with a foamy appearance
  • poor or decreased appetite
  • swelling around the eyes, feet, and ankles, and in the abdomen (stomach area)
  • weight gain from an increase in fluid in the body
• Thromboembolic complications. This is a process of blood clot formation. This can be especially dangerous if a blood clot gets stuck in the leg (deep vein thrombosis), the lungs (pulmonary embolism), or if you have a stroke (clotting of a vessel leading to the brain).

 Do not take Factor IX if you:

• have a known hypersensitivity (allergic reaction) to Factor IX or its ingredients
• are allergic to hamsters
• develop disseminated intravascular coagulation (DIC). (DIC is when clotting and bleeding of the blood becomes unbalanced.)
• develop signs of fibrinolysis. (Fibrinolysis is when your blood loses its ability to clot.)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Factor IX, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Factor IX, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had any medical problems
• have any allergies, including allergies to hamsters
• are breastfeeding. It is not known if Factor IX passes into your milk and if it can harm your baby.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

If you take too much Factor IX call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at refrigerated temperature 2° to 8°C (35 to 46°F). Do not freeze.
• Do not use after the expiration date printed on the carton or vial.
• Do not share Factor IX with other people, even if they have the same symptoms as you do.
• Keep out of reach of children.