Idelvion
Idelvion (factor IX recombinant) is a clotting factor replacement for factor IX for people with hemophilia B (also known as Christmas disease or factor IX deficiency). It's made using recombinant technology. Idelvion (factor IX recombinant) is given as an infusion through the veins once every 1-2 weeks to prevent bleeding, or on-demand every few days to treat an active bleed. Most people don't notice much side effects from this medication, but some people have reported headache and dizziness.
What is Idelvion (factor IX recombinant)?
What is Idelvion (factor IX recombinant) used for?
- Prevention and treatment of hemophilia B in adults and children
How Idelvion (factor IX recombinant) works
Idelvion (factor IX recombinant) is a clotting factor replacement. It's used for people who are missing factor IX, which is a clotting factor. Clotting facotrs are proteins that work together in your body to form blood clots. Idelvion (factor IX recombinant) replaces the missing factor IX to help prevent and treat bleeding in people with hemophilia B.
Drug facts
Side effects of Idelvion (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
- Headache (2%)
- Dizziness (2%)
Less Common Side Effects
- Allergic reaction
- Rash
- Eczema
Idelvion (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: in the lungs (cough, difficulty breathing, chest pain); in the leg (redness, pain, tenderness, swelling of the skin); near the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw); in the brain (difficulty speaking, numbness on one side of the body, confusion)
The following Idelvion (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 immediately if any of the following side effects occur:
Check with your doctor immediately if any of the following side effects occur:
More common
Bluish coloring (especially of the hands and feet)
convulsions
dizziness or lightheadedness when getting up from a lying or sitting position
increased heart rate
large blue or purplish patches in the skin (at places of injection)
nausea or vomiting
pains in chest, groin, or legs (especially calves)
persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine
severe pain or pressure in the chest and/or the neck, back, or left arm
severe, sudden headache
shortness of breath or fast breathing
sudden loss of coordination
sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg
Check with your doctor immediately if any of the following side effects occur:
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 of Idelvion (factor IX recombinant)
Pros
- Works well to prevent or treat bleeds for hemophilia B
- Given once every 1-2 weeks (to prevent bleeds)
- Might be able to receive home infusions after proper training
Cons
- Needs to be given as an IV infusion
- Doesn't cure hemophilia B
- Might not work well after a while because can develop inhibitors to the medication
Pharmacist tips for Idelvion (factor IX recombinant)
- Mark your appointments on your calendar to see your provider and receive Idelvion (factor IX recombinant). It's important to see your provider on time so you doesn't miss any doses and your treatment is monitored properly.
- Tell your provider if you're pregnant, thinking of becoming pregnant, or breastfeeding. It's not completely known how safe Idelvion (factor IX recombinant) is for babies.
- Though not common Idelvion (factor IX recombinant) can cause dizziness or headaches. Talk with your provider if your side effects bother you. They can recommend ways for you to ease these side effects, such as through resting or drinking more water, or let you know if you need more medical attention.
- 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, taking Idelvion (factor IX recombinant) can raise your risk of blood clots.
Tips for using Idelvion (factor IX recombinant) at home:
- Idelvion (factor IX recombinant) is given as an injection into the veins. Never inject Idelvion (factor IX recombinant) into a muscle or under the skin.
- Make sure that you get the training that you need before you start giving yourself Idelvion (factor IX recombinant) at home. Read the instructions for use on how to prepare and administer the medication correctly. Contact your provider or pharmacist if you have any questions.
- Keep Idelvion (factor IX recombinant) in the original carton to protect it from light and store it at room temperature.
- Only mix Idelvion (factor IX recombinant) when you're ready to give yourself the infusion. Once mixed, it typically needs to be used within 4 hours.
- After your injection, throw Idelvion (factor IX recombinant) vials, syringes, and needles in a sharps container or a heavy-duty plastic container (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needle-stick injuries. Visit the FDA's website for guidance on how to throw away your sharps container safely in your specific state.
Common questions about Idelvion (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. However, in some cases, people with this condition have no prior family history. If you have hemophilia B, your body is missing functional 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.
Idelvion (factor IX recombinant) is given as an infusion into the veins (IV). The length of the infusion depends on how well you're tolerating Idelvion (factor IX recombinant) and the dose. The dose depends on several factors, such as your body weight, your factor IX levels, and the indication for which Idelvion (factor IX recombinant) is prescribed. Your provider will calculate the infusion rate for you. The maximum infusion rate is 10 mL/min.
Ask your provider if it's okay for you to give yourself Idelvion (factor IX recombinant) infusions at home. Your provider will likely give you the first few injections in an office, clinic, or infusion center to make sure you're tolerating the medication. If you're using it regularly to prevent bleeds (prophylaxis), then it's possible for you to receive Idelvion (factor IX recombinant) at home if your provider agrees and after you receive proper training on how to administer the medication.
Both Idelvion (factor IX recombinant) and Benefix are clotting factor replacements used to treat hemophilia B. The main difference is Idelvion (factor IX recombinant) has a longer half-life than BeneFix, which means it might last longer to help prevent bleeding. For example, to prevent bleeding, BeneFix is given once weekly, whereas Idelvion (factor IX recombinant) can be given once every 2 weeks.
Both Idelvion (factor IX recombinant) 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 Idelvion (factor IX recombinant) is made in a lab without human plasma. Factor products made from human plasma have a very small chance of carrying viruses or other infectious material from human blood (though the manufacturer takes many steps to make sure it's safe). Recombinant products 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.
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Risks and warnings for Idelvion (factor IX recombinant)
Idelvion (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
Idelvion (factor IX recombinant) can cause serious allergic reactions, including life-threatening reactions like anaphylaxis (closing of the throat). These reactions can happen any time during or after an infusion. Because of this risk, your provider might give you the first few Idelvion (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. 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 Idelvion (factor IX recombinant), stop using it and get medical help right away.
Development of factor IX inhibitors
It's possible you could develop certain antibodies, also known as inhibitors, against factor IX. These inhibitors block Idelvion (factor IX recombinant), making it less effective. Let your provider know if bleeding becomes difficult to control even after receiving Idelvion (factor IX recombinant). Your provider might need to check whether or not you have antibodies and make changes to your treatment.
Risk of blood clots
- Risk factors: Receiving Idelvion (factor IX recombinant) as a continuous infusion | Liver problems | Recent surgery | Newborns | Having medical conditions that raise your risk for clots
In some rare cases, Idelvion (factor IX recombinant) can cause blood clots in various parts of your body. 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.
Idelvion (factor IX recombinant) dosage
Typical dosage for Idelvion (factor IX recombinant)
Idelvion (factor IX recombinant) is given as an injection into the veins (intravenous or IV). Your provider will determine the dose based on your body weight.
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Routine prevention of bleeds:
- Adults and children ages 12 years and older: The typical dose is 25-40 international units (IU)/kg IV once per week. If your bleeding is well-controlled with the weekly dosing, your provider might switch you to 50-75 IU/kg once every 2 weeks.
- Children ages less than 12 years: The typical dose is 40-55 IU/kg IV once per week.
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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, and the desired level of factor IX in your body.
- Minor bleed or surgery with minor bleed risk: The dose is given every 2-3 days, but usually one dose is enough to control bleeding.
- Major bleed or surgery with major bleed risk: The dose is given every 2-3 days for 1 to 2 weeks, or until bleeding stops.
Interactions between Idelvion (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.
Idelvion (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 Idelvion (factor IX recombinant) will not be safe for you to take.
- Allergy to hamster protein
