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Idelvion

factor IX
Used for Hemophilia
Used for Hemophilia

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.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Allison Gourley, PharmD
Last reviewed on November 15, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageContraindicationsAlternativesReferencesPricesMedicare
basics-icon

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.

Are you looking for information on BeneFix, Alprolix, Ixinity, Rebinyn (factor IX recombinant) or AlphaNine SD (coagulation factor IX human plasma) instead?

Drug Facts

Common BrandsIdelvion
Drug ClassCoagulation factor replacement
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the 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%)

Other Side Effects

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)

Source: DailyMed

pros-and-cons

Pros and cons of Idelvion (factor IX recombinant)

thumbs-up

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

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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

Pharmacist tips for Idelvion (factor IX recombinant)

pharmacist

  • 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.

                    faqs

                    Frequently asked questions about Idelvion (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. 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.
                    How is Idelvion (factor IX recombinant) administered?
                    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.
                    Can I give myself Idelvion (factor IX recombinant) infusions at home?
                    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.
                    What's the difference between Idelvion (factor IX recombinant) and Benefix?
                    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.
                    What's the difference between Idelvion (factor IX recombinant) and factor IX human plasma products?
                    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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                    What are the 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.

                    risk-warning

                    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.

                      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 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-warning

                      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.

                        dosage

                        Idelvion (factor IX recombinant) dosage forms

                        Typical dosing 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.

                        • 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.

                        • 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.

                        contraindications-icon

                        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

                        alternatives

                        What are alternatives to Idelvion (factor IX recombinant)?

                        There are a number of medications that your doctor can prescribe in place of Idelvion (factor IX recombinant). Compare a few possible alternatives below.
                        Idelvion (factor IX recombinant)
                        Used for:

                        • Prevention and treatment of hemophilia B in adults and children

                        View Prices
                        Factor IX recombinant
                        Used for:

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

                        $27428.20 Lowest GoodRx priceView Prices
                        AlphaNine SD (factor IX)
                        Used for:

                        • To prevent or treat bleeding in adults with hemophilia B

                        $69587.29 Lowest GoodRx priceView Prices

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                        References

                        Best studies we found

                        American Society of Hematology. (n.d.). Blood clots.

                        bleedingdisorders.com. (n.d.). A quick look at bleeding disorders & coagulation. Takeda Pharmaceuticals U.S.A., Inc. 

                        Centers for Disease Control and Prevention. (2023). Treatment of hemophilia.

                        View All References (9)

                        Centers for Disease Control and Prevention. (2023). What is hemophilia?

                        Centers for Disease Control and Prevention. (2024). Inhibitors and hemophilia.

                        CSL Behring Lengnau AG. (2023). Idelvion- coagulation factor ix recombinant human [package insert]. DailyMed.

                        Grifols Inc. (n.d.). Pathogen safety.

                        National Bleeding Disorders Foundation. (n.d.). Hemophilia B.

                        National Organization for Rare Disorders. (2023). Hemophilia B.

                        Orlova, N. A., et al. (2012). Coagulation Factor IX for hemophilia B therapy. Acta Naturae.

                        U.S. Food and Drug Administration. (2021). Safely using sharps (needles and syringes) at home, at work and on travel.

                        Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. (2022). Benefix- coagulation factor ix (recombinant) [package insert]. DailyMed.

                        GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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