Factor IX

Factor IX is a prescription medication indicated for the control or prevention of bleeding in factor IX deficiency, also known as Hemophilia B or Christmas disease.

• Factor IX is available under the following different brand names: AlphaNine SD, Mononine

Common side effects of Factor IX include:

• headache
• flushing (warmth or tingly feeling under your skin)
• nausea
• vomiting
• dizziness
• injection site reactions (pain, redness, or swelling)

Serious side effects of Factor IX include:

• swelling at the injection site 
• fast heartbeat
• shortness of breath
• signs of kidney problems (such as a change in the amount of urine)
• swelling of the ankles/feet and pain/redness/swelling of arms or legs
• new or increased bleeding/bruising

Rare side effects of Factor IX 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, coordination loss, 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 and pediatric dosage

Solution reconstituted

• 250 IU (Mononine)
• 500 IU (AlphaNine SD, Mononine)
• 1000 IU (AlphaNine SD, Mononine)
• 1500 IU (Alphanine)

Hemophilia B

Adult and Pediatric dosage

• Individualize dosing based on the severity of factor IX deficiency, extent, and location of bleeding and clinical status of the patient
• AlphaNine SD, Mononine: 1 unit/kg × body weight (kg) × desired increase (% of normal) = Number of factor IX units required

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, healthcare provider, or pharmacist first.

• Factor IX has severe interactions with the following drug:
  • prothrombin complex concentrate, human
• Factor IX has serious interactions with the following drugs:
  • tranexamic acid injection
  • tranexamic acid oral
• Factor IX has moderate interactions with no other drugs
• Factor IX 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 the products you use. 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 to mouse proteins

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Factor IX?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Factor IX?"

Cautions

• Theoretical risk for pathogen transmission with human-derived products
• For minor spontaneous hemorrhage, the goal should be a 10%-15% increase
• For major trauma or surgery, the goal should be a 25% increase for 1 week before and 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

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation 
  • Not known if excreted in breast milk; use caution