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Safety from the clinical trial

Zero inhibitors in the clinical study*

  • Following administration of ALPROLIX, your body could make antibodies against your Factor IX called "inhibitors", which may stop ALPROLIX from working properly. Your healthcare provider should continue to monitor you for blood tests to check for inhibitors.

  • If you have developed an inhibitor with use of another Factor IX therapy, you may be at an increased risk of anaphylaxis with use of ALPROLIX.

  • Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX, including in previously untreated patients.

*Zero inhibitors in the clinical study of 123 previously treated people

Adverse reactions in the clinical study

In a clinical study of 119 previously treated people on routine prophylaxis or on-demand therapy, adverse reactions occurred in 10 participants (8.4%).
8.4%
Headache and abnormal sensation in the mouth occurred in 2 people (1.7%).
1.7%
Dizziness, bad taste in the mouth, breath odor, fatigue, infusion site pain, palpitations, hindrance of normal urine flow, and/or low blood pressure occurred in 1 person (0.8%).
0.8%
1 person with hematuria (blood in urine) developed a clot in the urinary collecting system. The clot resolved with hydration (fluids) and the person continued prophylactic treatment with ALPROLIX. A causal relationship of clot formation to ALPROLIX was not established
Doctor Discussion Guide PROPHY DOCTOR DISCUSSION GUIDE ON DEMAND DOCTOR DISCUSSION GUIDE

B-LONG, a multi-center, prospective, open-label clinical trial (N=123) evaluated the safety and efficacy of ALPROLIX in 123 previously treated male patients with severe hemophilia B, ages 12-71 (Factor IX activity 2% or less). Followed for up to 77 weeks, multiple characteristics of ALPROLIX were assessed, including safety, efficacy, and pharmacokinetics:1-4

  • In the once-weekly group, 63 people were given an initial dose of 50 IU/kg, which was adjusted to maintain desired Factor IX levels.
  • In the individualized prophylaxis group, 29 people were initially given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired Factor IX levels.
  • In the on-demand group, 27 people infused as needed with doses ranging between 20 to 100 IU/kg depending on the severity of the bleed.
  • In the surgical group, 12 people received ALPROLIX for bleed management in 14 major surgeries. 15 minor surgeries were also evaluated. Doses were adjusted according to the type of surgery. 4 people in this group did not participate in the other groups.
Indications
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.
Important Safety Information

Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding, or have been told you have inhibitors (antibodies) to Factor IX.

Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALPROLIX, which may stop ALPROLIX from working properly.

ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider or seek emergency care if you have symptoms of a possible abnormal blood clot, which may include: chest pain, difficulty breathing, unexpected swelling of an arm or leg with or without pain or tenderness.

Common side effects of ALPROLIX include headache and abnormal sensation of the mouth. These are not all the possible side effects of ALPROLIX. Talk to your healthcare provider right away about any side effect that bothers you or does not go away, and if bleeding is not controlled using ALPROLIX.

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

Please see full Prescribing Information.