Generic Name and Formulations:
Coagulation Factor IX (recombinant), albumin fusion protein 250 IU, 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
CSL Behring, LLC
Indications for IDELVION:
In patients with Hemophilia B: to control and prevent bleeding episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Limitations Of use:
Not for immune tolerance induction.
Adults and Children:
Dose (IU) = body weight (kg) x desired FIX increase (% of normal or IU/dL) x reciprocal of recovery (IU/dL per IU/kg). Dose adjustment may be necessary in children <12yrs. Individualize. Max infusion rate: 10mL/min. Bleeding: Minor/Moderate: 30–60% required; repeat every 48–72hrs for ≥1 day until bleeding stops and healing is achieved. Major: 60–100% required; repeat every 48–72hrs for 7–14 days until bleeding stops and healing is achieved; give maintenance dose weekly. Perioperative: Minor: 50–80% required; repeat every 48–72hrs for ≥1 day or until healing is achieved. Major: initially 60–100% required; every 48–72hrs for 7–14 days or until bleeding stops and healing is achieved; may repeat every 48–72hrs for the first week or until healing is achieved; give maintenance dose 1–2 times weekly. Routine prophylaxis: ≥12yrs: 25–40 IU/kg every 7 days or if well-controlled, may give 50–75 IU/kg every 14 days; <12yrs: 40–55 IU/kg every 7 days.
Hamster protein sensitivity.
Discontinue and treat if hypersensitivity symptoms occur. Monitor for development of Factor IX inhibitors. Liver disease, fibrinolysis, perioperative status, risk factors for thromboembolic events or disseminated intravascular coagulation; monitor for thromboembolism and consumptive coagulopathy. Pregnancy. Nursing mothers.
Headache, dizziness, hypersensitivity, rash, eczema.
Kit—1 (single-use vial + diluent, supplies)
Endocrinology Advisor Articles
- Efficacy and Safety of Alirocumab in Diabetes Mellitus
- Safety of DPP-IV Inhibitor, Cardiovascular Events After ACS in Type 2 Diabetes
- Adjunctive Metformin for Insulin Resistance in T1D: A Clinical Perspective
- Effect of Fructose, Allulose on Postprandial Glucose Regulation in Type 2 Diabetes
- Sex Hormone Levels May Affect Postmenopausal Heart Disease Risk
- Diabetes Treatments
- Metformin May Decrease Colorectal Cancer Risk Among Males With Diabetes
- SGLT2 Inhibitor, GLP-1 Receptor Agonist Combination Treatment for Type 2 Diabetes: Expert Insights
- Semaglutide May Induce Weight Loss in Type 2 Diabetes Despite BMI
- FDA Clears Omnipod DASH System for Diabetes Management
- Menopausal Hormone Therapy Slows Cognitive Decline in Postmenopausal Women
- Does Maintenance of Certification Status Affect Patient Care?
- Emotional Hyper-Reactivity and Cardiometabolic Risk in Remitted Bipolar Disorder
- Reduced Mortality for Women Undergoing Assisted Reproduction Likely Due to "Healthy Patient Effect"
- Romosozumab Followed by Denosumab Effective for BMD Increase in Postmenopausal Women