See commonly asked questions and helpful answers about IDELVION

IDELVION is an injectable medicine used to replace clotting Factor IX that is missing in people with hemophilia B. Hemophilia B, also called congenital Factor IX deficiency or Christmas disease, is an inherited bleeding disorder that prevents blood from clotting normally. IDELVION is used in children and adults to control and prevent bleeding episodes. Your healthcare provider may give you IDELVION when you have surgery. IDELVION can reduce the number of bleeding episodes when used regularly (prophylaxis).

You should not use IDELVION if you have had life-threatening hypersensitivity reactions to IDELVION, or are allergic to hamster proteins, or any ingredient of IDELVION. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using IDELVION.

Discuss the following with your healthcare provider:

• Your general health, including any medical condition you have or have had, including pregnancy, and any medical problems you may be having.
• Any medicines you are taking, both prescription and non-prescription, and including any vitamins, supplements, or herbal remedies.
• Allergies you might have, including allergies to hamster proteins.
• Known inhibitors to Factor IX that you’ve experienced or been told you have (because IDELVION might not work for you).

IDELVION is administered intravenously, directly into the bloodstream. IDELVION can be self-administered or administered by a caregiver with training and approval from your healthcare provider or hemophilia treatment center. (For directions on reconstituting and administering IDELVION, see the Instructions for Use in the FDA-Approved Patient Labeling section of the full prescribing information). Your healthcare provider will tell you how much IDELVION to use based on your weight, the severity of your hemophilia B, your age, and other factors. Call your healthcare provider right away if your bleeding does not stop after taking IDELVION. Blood tests may be needed after you start IDELVION to ensure that your blood level of Factor IX is high enough to properly clot your blood.

Allergic and hypersensitivity reactions have been reported with IDELVION. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or decrease in blood pressure. Your body can make antibodies, called inhibitors, against Factor IX, which could stop IDELVION from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. IDELVION might increase the risk of abnormal blood clots forming in your body, especially if you have risk factors for such clots. Call your healthcare provider if you experience chest pain, difficulty breathing, or leg tenderness or swelling while being treated with IDELVION. The most common side effects of IDELVION are headache and dizziness. These are not the only side effects possible. Tell your healthcare provider about any side effect that you experience.

Store vial in original carton to protect from light. Store at 2-25◦C (36-77◦F). Do not freeze. Do not use IDELVION after the expiration date printed on the label. The reconstituted product (after mixing dry product with diluent) must be used within 4 hours and cannot be stored or refrigerated. Discard any IDELVION left in the vial at the end of your infusion.

You and/or a caregiver should be trained on how to do infusions by your healthcare provider, or hemophilia treatment center. Many people with hemophilia B learn to infuse IDELVION by themselves, or with the help of a family member.

Yes, IDELVION is indicated for children and adults with Hemophilia B (congenital Factor IX deficiency) for Perioperative (surgical) management of bleeding. Your healthcare provider may choose to give you IDELVION when you have surgery.

IDELVION Connect offers help understanding the coverage process and working with insurance companies, while also providing resources and support as needed. If you have questions throughout the IDELVION treatment journey, contact IDELVION Connect at 1-800-676-4266 Monday through Friday, 8 am-8 pm ET or sign up on our website and a case manager will reach out to you.

Yes, IDELVION can travel with you anywhere you go. It may be stored at room temperature or in a refrigerator (36-77◦F). Do not freeze. Keep your vials in the original carton and out of light. Lastly, use IDELVION before the expiration date listed on the carton and vials.