IDELVION® 3500 IU Vials Now Available to Provide Convenience to Patients

- The only treatment for hemophilia B FDA approved for up to 14-day dosing is now available in larger, 3500 IU vial size

- IDELVION is now offered in 5 convenient vial sizes to fit any dosing regimen: 250, 500, 1000, 2000 and 3500 IU

- New vial option delivers on CSL Behring's promise to enhance current treatments and provide more alternatives to patients

News provided by

CSL Behring

Aug 23, 2018, 09:00 ET

KING OF PRUSSIA, Pa., Aug. 23, 2018 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that IDELVION^® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B is now available in a 3500 IU (international unit) vial size. For some patients, the 3500 IU vial size will reduce the reconstitution time needed to prepare multiple vials for a similar dose. IDELVION is the first and only FDA-approved factor IX therapy that delivers zero median AsBR (annualized spontaneous bleeding rate) and is approved for up to 14-day dosing in appropriate patients. When used prophylactically at 7-day dosing, IDELVION has been shown to elevate factor IX levels to 21% at steady state.

"This enhancement to our IDELVION family of products represents our focus on patients and our commitment to help hemophilia patients lead full lives," said Bob Lojewski, Senior Vice President and General Manager, North America Commercial Operations, CSL Behring.

About Hemophilia B

Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX; nearly all affected patients are male. People with hemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. According to the U.S. Centers for Disease Control and Prevention, the condition occurs in approximately one in 25,000 male births.

About IDELVION^®

CSL Behring engineered IDELVION to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life. IDELVION is approved in more than 25 countries.

For more information about IDELVION, including full prescribing information, please visit http://labeling.cslbehring.com/PI/US/Idelvion/EN/Idelvion-Prescribing-Information.pdf. For more information about CSL Behring's recombinant products in development to treat hemophilia, visit https://www.cslbehring.com/en-us/patients/find-your-disease/hereditary-bleeding-disorders.

Important Safety Information

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), 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.

IDELVION 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.

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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs nearly 20,000 people, and delivers its life-saving therapies to people in more than 60 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.

SOURCE CSL Behring