Factor IX Complex

Factor IX Complex is a prescription medication used for the prevention and control of hemorrhagic episodes in adult patients with Hemophilia B. 

• Factor IX Complex is available under the following different brand names: Bebulin, Profilnine SD, Bebulin VH

Common side effects of Factor IX Complex include:

• Pain at the injection site,
• Chills,
• Tingling,
• Flushing,
• Headache,
• Nausea, and
• Vomiting

Serious side effects of Factor IX Complex include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Swelling at the injection site,
• Fast heartbeat,
• Shortness of breath,
• Change in the amount of urine,
• Swelling of the ankles or feet,
• Pain, redness, swelling of arms or legs,
• New or increased bleeding or bruising,
• Chest pain,
• Bluish fingers,
• Fever,
• Persistent sore throat,
• Unusual tiredness,
• Persistent nausea or vomiting,
• Yellowing of the eyes or skin (jaundice),
• Dark urine, and
• Severe dizziness

Rare side effects of Factor IX Complex include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Lyophilized powder for reconstitution

• Derived from human plasma.
• Standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU)

Bebulin, Bebulin VH

• Purified, sterile, stable, freeze-dried concentrate of the coagulation Factors IX (Christmas Factor) as well as II (Prothrombin) and X (Stuart Prower Factor) and low amounts of Factor VII
• Contains small amounts of heparin (0.15 IU heparin or less per IU Factor IX)

Profilnine SD

• Solvent Detergent Treated, is a sterile, lyophilized concentrate of Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma.
• Factor II (below 150 Units per 100 Factor IX Units), Factor X (below 100 Units per 100 Factor IX Units), and Factor VII (below 35 Units per 100 Factor IX Units)
• Does not contain heparin.

Hemophilia B

Adult dosage

• Bebulin, Bebulin VH: Number of Factor IX IU required = body weight (kg) x desired increase in plasma Factor IX (%) x 1.2 IU/kg
• Profilnine SD: Number of Factor IX IU required = body weight (kg) x desired increase in plasma Factor IX (%) x 1 IU/kg

Management of bleeding

• Typical initial doses suggested below; usually, two-thirds of the initial dose given for maintenance Minor: Single dose of 25-35 IU/kg intravenous for 1 dose; may repeat dose after 24 hours.
• Moderate: 40-55 IU/kg/day intravenous for 2 days or until adequate wound healing
• Major: 60-70 IU/kg/day intravenous for 2-3 days or until adequate wound healing

Management of surgical procedures

• Minor: 50-60 IU/kg intravenous on the day of surgery, decrease to 25-55 IU/kg/day during the initial postop period (ie, 1st to 2nd week)
• Major: 70-95 IU/kg intravenous on the day of surgery, decrease to 35-70 IU/kg/day during the initial postop period (ie, 1st to 2nd week), than 25-35 IU/kg/day late post-op period (ie, 3rd week onwards)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Factor IX Complex has severe interactions with no other drugs.
• Factor IX Complex has serious interactions with the following drugs.
  • tranexamic acid oral
• Factor IX Complex has moderate interactions with no other drugs.
• Factor IX Complex has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Bebulin, Bebulin VH: Known allergy to heparin or history of heparin-induced thrombocytopenia.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Factor IX Complex?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Factor IX Complex?”

Cautions

• Made from pooled human plasma, it may carry a risk of transmitting infectious agents (. g, viruses), and theoretically, the Creutzfeldt-Jakob disease (CJD) agent
• Thromboembolic events (DVT, PE, thrombotic stroke) and DIC were reported.
• Factor IX Complex products may partially counteract the effect of warfarin treatment; do NOT include adequate FVII levels to be used to reverse warfarin-induced bleeding.
• Formation of circulating antibodies inhibiting Factor IX reported.

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.
• Lactation
  • Unknown if distributed in human breast milk.