Benefix
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.
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.
Drug facts
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%)
Less Common Side Effects
- Blurry vision
- Vomiting
- Fever
- Skin infection or inflammation at IV site
- Shaking
- Sleepiness
- Cough
- Chest tightness
- Hives
- Flushing
Factor IX recombinant 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)
The following Factor IX recombinant 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:
Less common
Back or side pain
blurred vision
chest tightness
chills
confusion
difficult or labored breathing
fast heartbeat
itching, pain, redness, swelling, tenderness, blue discoloration, or warmth of the skin at the injection site
swelling of the foot or leg
vomiting
Incidence not known
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
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.
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Pros and cons of Factor IX recombinant
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
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 for Factor IX recombinant
- 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.
Common questions about Factor IX recombinant
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.
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.
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.
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.
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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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.
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 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.
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.
Factor IX recombinant dosage
Kit| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| single dose of 250iu | 1 kit | $434.25 | $434.25 |
| single dose of 500iu | 1 kit | $862.25 | $862.25 |
| single dose of 1000iu | 4 kits | $6,854.25 | $1,713.56 |
| single dose of 2000iu | 10 kits | $34,246.25 | $3,424.63 |
| single dose of 3000iu | 6 kits | $30,822.25 | $5,137.04 |
Typical dosage 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 between Factor IX recombinant and other drugs
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.
How much does Factor IX recombinant cost?
$434.25
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)
