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Benefix

factor IX recombinant
Used for Hemophilia
Used for Hemophilia

Factor IX recombinant products, such as BeneFix, are clotting factor replacements made in a lab using recombinant technology. They're used to prevent and control bleeding in people with hemophilia B (also known as Christmas disease or factor IX deficiency). Factor IX recombinant products are given through the vein (intravenously, or IV) as an infusion, typically once or twice a week. Some common side effects they cause include rash, headache, and injection site pain. There are multiple brands available and they can be expensive.

Last reviewed on August 25, 2022
basics-icon

What is Factor IX recombinant?

What is Factor IX recombinant used for?

  • To prevent or treat bleeding in adults and children with hemophilia B

How Factor IX recombinant works

Factor IX recombinant is a clotting factor replacement used for people who are missing the clotting factor called factor IX. Factor IX is one of many proteins known as clotting factors that works in your body to form blood clots. Factor IX recombinant replaces the missing factor IX to help prevent and treat bleeding in people with hemophilia B.

Are you looking for information on AlphaNine SD (factor IX) human plasma product instead?

Drug Facts

Drug ClassCoagulation factor replacement
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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$28984.07(save 7.68%)
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What are the side effects of Factor IX recombinant?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

The side effects below were reported by people who used BeneFix during clinical trials. If you're using a product besides BeneFix, the side effects you experience and your risk of side effects might be different.
  • Headache (11%)
  • Dizziness (8%)
  • Injection site reaction (up to 8%)
  • Nausea (6%)
  • Pain at injection site (6%)
  • Rash (up to 6%)
  • Changes in taste (5%)

Other Side Effects

  • Blurry vision
  • Vomiting
  • Fever
  • Skin infection or inflammation at IV site
  • Shaking
  • Sleepiness
  • Cough
  • Chest tightness
  • Hives
  • Flushing

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious allergic reaction (anaphylaxis): difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
  • Blood clots: lungs (cough, difficulty breathing, chest pain), legs (redness, pain, tenderness, swelling of the skin), heart attack (chest pain, pain in the arms or shoulders, pain in the neck or jaw), stroke (difficulty speaking, numbness on one side of the body, confusion)

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Cough

fever

Less common

Back or side pain

blurred vision

chest tightness

chills

confusion

difficult or labored breathing

fast heartbeat

hives

itching, pain, redness, swelling, tenderness, blue discoloration, or warmth of the skin at the injection site

nausea

swelling of the foot or leg

vomiting

Incidence not known

Anxiety

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

cloudy or bloody urine

difficulty with swallowing

dizziness

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

headache

itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

pain, redness, or swelling in the arm or leg

pains in the chest, groin, or legs, especially calves of the legs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

severe headaches of sudden onset

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

sweating

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

trouble breathing

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vision problems

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Change in or loss of taste

drowsiness

feeling of warmth

pain in the arms or legs

redness of the face, neck, arms, and occasionally, the upper chest

shaking

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

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

pros-and-cons

Pros and cons of Factor IX recombinant

thumbs-up

Pros

Works well to prevent or treat bleeds for hemophilia B

Some factor IX recombinant products can be used in children as young as 1 years old (Alprolix and Rebinyn)

Might be possible to set up home infusions

Typically given once or twice weekly; for some people, Alprolix can be given once every 2 weeks

thumbs-down

Cons

Given IV

Raises your risk of clots

Can cause serious allergic reactions, such as trouble breathing, rash, and swelling of the face and throat

Might not work well after a while because can develop inhibitors to the medication

pharmacist-tips

Pharmacist tips for Factor IX recombinant

pharmacist
  • If your provider thinks it's safe for you to use factor IX recombinant products at home, make sure that you get the training that you need before you start. Usually, your provider or your home infusion center staff can train and make sure you're comfortable doing your own infusions. If you have any questions, please talk with your provider.

    • If you're giving yourself the infusion, only mix your factor IX recombinant product when you're ready to give yourself the infusion. Once mixed, it typically needs to be used within 3 hours. Please look at your product's package insert to find out the exact time frame you have to inject your medication.

      • You might experience side effects, such as headache, nausea, and dizziness, from factor IX recombinant days after your infusion. Talk with your provider if your side effects bother you or don't go away or lessen in 3 days.

        • Go to the emergency room right away if you experience symptoms of blood clots, including cough, difficulty breathing, chest pain, headache, trouble speaking, or weakness on one side of your body. Though rare, factor IX recombinant products can raise your risk of blood clots.

          faqs

          Frequently asked questions about Factor IX recombinant

          What is hemophilia B?
          Hemophilia B is a rare blood condition that makes it difficult for your blood to clot. This condition is typically genetic, meaning it's passed down from parent to child. But in some cases, people with this condition have no prior family history. If you have hemophilia B, your body is missing factor IX, which is one of the clotting factors your body needs to make clots. Without this clotting factor, you're at a higher risk for bleeds and can experience symptoms ranging from minor bruising and bleeding to more serious bleeding in the muscles and joints, depending on how severe your condition is.
          How long do I need to be treated with factor IX recombinant?
          The length of time you'll need to be treated with factor IX recombinant depends on why you're taking this medication. 1) You can use factor IX recombinant on an "as-needed" basis, meaning you'll receive treatment only when you're bleeding or to prevent bleeds during surgery. You'll be on this medication until you're healed and your bleed is stable, which typically ranges from 1 to 14 days, depending on how serious your condition is and how well your body responds to this medication. 2) You can also receive [EDITOR|DRUG_DISPLAY_NAME]] regularly, typically once or twice weekly, to prevent future bleeds (prophylaxis treatment). Your provider will keep you on factor IX recombinant for prophylaxis as long as it's helping your condition and you're not having side effects. Talk with your provider if you've any questions about how long you need factor IX recombinant treatment.
          Can I give myself factor IX recombinant infusions at home?
          Ask your provider if it's okay for you to give yourself factor IX recombinant infusions at home. If you're using it regularly to prevent bleeds (prophylaxis), then it's possible for you to receive factor IX recombinant at home. If you're able to set up home infusions, make sure your provider or the infusion center trains you on how to give yourself the infusion.
          What's the difference between factor IX recombinant products and factor IX human plasma products?
          Both factor IX recombinant products (e.g., BeneFIX) and human plasma products (e.g., AlphaNine SD) are clotting factor replacements used to treat hemophilia B. The main difference between them is how they're made. Factor IX human plasma products are made from donated human plasma, while factor IX recombinant products are made in a lab using recombinant technology. Factor products made from human plasma have a very small chance carrying viruses or other infectious material from human blood (though the manufacturer takes many steps to make sure it's safe). Recombinant products are generally considered safer because they don't carry the same risk of potential infections from receiving human-derived products. Currently, providers typically prefer recombinant factor IX products over ones made from human plasma.
          Can I take factor IX recombinant if I'm pregnant or breastfeeding?
          Factor IX recombinant hasn't been well studied in human pregnancy, so it's not known whether this medication is safe in pregnant females. There also haven't been any animal studies done on factor IX recombinant. Similarly, there's no information on the safety of breastfeeding while taking factor IX recombinant. If you're breastfeeding, pregnant, or thinking of becoming pregnant, talk with your provider about the risks and benefits of using factor IX recombinant before starting this medication.
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          What are the risks and warnings for Factor IX recombinant?

          Factor IX recombinant can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

          risk-warning

          Serious allergic reactions

          • Risk factors: Allergy to hamster or mouse protein (BeneFIX, Ixinity, Rebinyn)

            Factor IX recombinant can cause serious allergic reactions, including life-threatening reactions like anaphylaxis (closing of the throat). These reactions can happen anytime during or after an infusion. Because of this risk, your provider might give you the first 10 to 20 factor IX recombinant infusions in a medical office or at an infusion center so that you can receive care if you get an allergic reaction. Sometimes, you can even get an reaction 3 days after your infusion. If you notice dizziness, a choking sensation, sweating, dizziness, nausea, swelling around your eyes, swelling of the lips or tongue, or difficulty breathing after using factor IX recombinant, stop using it and get medical help right away.

            risk-warning

            Risk of blood clots

            • Risk factors: Receiving factor IX recombinant as a continuous infusion | Liver problems | Recent surgery | Newborns | Having medical conditions that raise your risk for clots

              Rarely, factor IX recombinant can cause blood clots in various parts of your body. People who developed blood clots while on this medication typically received factor IX recombinant as a continuous infusion through a central venous catheter. Symptoms of a blood clot might be different depending on the location of the clot, but they can include chest pain, difficulty breathing, swelling or warmth in the legs, and weakness of the face, legs, or arms. Call 911 if you have any of the symptoms above because this is a medical emergency.

              risk-warning

              Development of factor IX inhibitors

              It's possible you could develop certain antibodies, also known as inhibitors, against factor IX. These inhibitors block factor IX recombinant, making it less effective. Let your provider know if bleeding becomes difficult to control even after receiving factor IX recombinant. Your provider might need to check whether or not you have antibodies and make changes to your treatment.

              dosage

              Factor IX recombinant dosage forms

              Typical dosing for Factor IX recombinant

              Factor IX recombinant is given as an injection into the veins (intravenous or IV).

              Routine prevention of bleeds:
              Your provider will calculate your dose based on things like age, body weight, and response to the medication. The dose is typically given through your veins (IV), and how often you receive it will depend on the brand.

              • BeneFix: The typical dose is 100 international units (IU)/kg of body weight given IV once weekly.

              • Alprolix: The typical starting dose is 50 IU/kg to 60 IU/kg given IV once weekly, or 100 IU/kg once every 10 days.

              • Ixinity: The typical dose is 40 IU/kg to 70 IU/kg IV twice weekly.

              • Rebinyn: The typical dose is 40 IU/kg IV once weekly.

              On-demand treatment of bleeding, including during surgery: Your provider will calculate your dose based on things like body weight, how serious your bleed is, where the bleed is, the desired level of factor IX in your body, and the brand of factor IX recombinant you're receiving.

              interactions

              Interactions between Factor IX recombinant and other drugs

              Factor IX recombinant may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Factor IX recombinant. Please note that only the generic name of each medication is listed below.

              Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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              Factor IX recombinant contraindications

              Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Factor IX recombinant will not be safe for you to take.
              • Allergy to hamster protein (BeneFIX, Ixinity, Rebinyn)

              • Allergy to sucrose, mannitol, sodium chloride, L-histidine or polysorbate 20 (Alprolix)

              alternatives

              What are alternatives to Factor IX recombinant?

              There are a number of medications that your doctor can prescribe in place of Factor IX recombinant. Compare a few possible alternatives below.
              Factor IX recombinant
              Used for:
              • To prevent or treat bleeding in adults and children with hemophilia B

              $26758.25 Lowest GoodRx priceView Prices
              Used for:
              • To prevent or treat bleeding in adults with hemophilia B

              $69926.67 Lowest GoodRx priceView Prices
              Used for:
              • To prevent or treat bleeding in people with hemophilia B

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