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Important Safety Information

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is administered by intravenous injection into the bloodstream, and can be self-administered or administered by a caregiver. Do not inject IDELVION without training and approval from your healthcare provider or hemophilia treatment center.

Tell your healthcare provider of any medical condition you might have, including allergies and pregnancy, as well as all medications you are taking. Do not use IDELVION if you know you are allergic to any of its ingredients, including hamster proteins. Tell your doctor if you previously had an allergic reaction to any FIX product.

Stop treatment and immediately contact your healthcare provider if you see signs of an allergic reaction, including a rash or hives, itching, tightness of chest or throat, difficulty breathing, lightheadedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor IX, which could stop IDELVION from working properly. You might need to be tested for inhibitors from time to time. IDELVION might also increase the risk of abnormal blood clots in your body, especially if you have risk factors. Call your healthcare provider if you have chest pain, difficulty breathing, or leg tenderness or swelling.

In clinical trials for IDELVION, headache was the only side effect occurring in more than 1% of patients (1.8%), but is not the only side effect possible. Tell your healthcare provider about any side effect that bothers you or does not go away, or if bleeding is not controlled with IDELVION.

Indications

IDELVION is used to control and prevent bleeding episodes in people with hemophilia B. Your doctor might also give you IDELVION before surgical procedures. Used regularly as prophylaxis, IDELVION can reduce number of bleeding episodes.

Please see full prescribing information for IDELVION, including patient product information.

You are also encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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