Profilnine SD

Coagulation factor IX recombinant, or Factor IX, is a prescription medicine used to prevent and control bleeding in people with hemophilia B, an inherited bleeding disorder. Factor IX belongs to a group of drugs called antihemophilic agents which work by replacing clotting factors required to stop bleeding that are missing in people with hemophilia B. 

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

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.

Factor IX is a prescription medication used for:

• control and prevention of bleeding episodes in adults with hemophilia B
• perioperative (before and after surgery) use in adults with hemophilia B
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes (long-acting factor IX)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Alpha Therapeutic Corp.

• Grifols Biologicals Inc.

• Grifols, Inc.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Factor IX falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. Factor IX should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether Factor IX crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Factor IX.

Take Factor IX exactly as prescribed.

Factor IX is given directly into the bloodstream. Factor IX should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse their Factor IX by themselves or with the help of a family member.

You may have to have blood tests done after getting Factor IX to be sure that your blood level of factor IX is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking Factor IX.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Factor IX at the same time.

Take Factor IX exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your healthcare provider will tell you how much Factor IX to use based on your weight, the severity of the factor IX deficiency, the location and extent of bleeding, your clinical condition, age and recovery of factor IX.

Routine prophylaxis with long-acting factor IX: 50 IU/kg once weekly or 100 IU/kg once every 10 days.

• Dose will be adjusted based on individual response.

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.