Make the next move in your hemophilia B treatment journey and start a conversation with your healthcare team about a Factor IX replacement like ALPROLIX. Considering a switch to an extended half-life Factor IX like ALPROLIX? We have a downloadable discussion guide to help you confidently ask the right questions and get the answers you need to make the choice that's right for you.
If you're already on ALPROLIX, we have info to help you, too.
We've put together a helpful guide that can help you make the most out of your next doctor's appointment. Have a productive conversation about the direction you want to take your treatment:
Make sure you're prepared with any questions you need answered.
Know why you're thinking of switching to ALPROLIX, and write that on your guide as well.
Remember, be your own advocate.
There are terms your doctor might use when discussing treatment, terms you should be acquainted with before you get there.
Extended Half-life
There are hemophilia therapies available designed to extend the half-life of the medicine in your body. ALPROLIX was designed this way to allow for fewer infusions with extended protection from bleeds.
Fc FUSION
While some proteins can be broken down very quickly, research shows Fc Fusion allows ALPROLIX to use your body’s natural pathway to recycle and recirculate in the bloodstream longer.
Annual Spontaneous Bleed Rates
Internal and external bleeding episodes that occur without an obvious cause are called spontaneous bleeds. The number of these bleeds that a person with hemophilia gets in a year is referred to as their Annual Spontaneous Bleed Rate or AsBR. People infusing prophylactically with ALPROLIX have been shown to experience a median of 1 AsBR per year.
inhibitors
Following administration of ALPROLIX, your body could make antibodies against your Factor IX called "inhibitors," which may stop ALPROLIX from working properly. An inhibitor is an immune system response to infused clotting factor concentrates, which renders replacement therapy ineffective.
The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. In children <12 years of age, start at 60 IU/kg once weekly. Dosing regimen can be adjusted based on your individual response. More frequent or higher doses may be needed in children <12 years of age, especially in children <6 years of age.
If a switch to ALPROLIX is right for you, you and your doctor can work together to determine your recommended starting dosing schedule.
Children under 12 years of age may have higher Factor IX body weight-adjusted clearance, shorter half-life, and lower recovery. A higher dose per kilogram of body weight or more frequent dosing may be needed.
Dosing Extension
54% of previously treated adults and adolescents 12 and older who received individualized prophylaxis extended to ≥14-day dosing. The overall median dosing interval on study was 12.5 days. The median interval during the last 6 months in 26 subjects who were on study for at least 9 months was 13.8 days. The ability to extend was based on individual patient response.
INDICATION: ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency. Your healthcare provider may give you ALPROLIX when you have surgery.
important safety information and indication
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.
Common side effects of ALPROLIX include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.
Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.
Redness to the skin at the injection site may also occur.
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.
Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.
These are not all of 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, or if bleeding is not controlled using ALPROLIX.
INDICATION
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency. Your healthcare provider may give you ALPROLIX when you have surgery.
important safety information and indication
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.
Common side effects of ALPROLIX include headache, abnormal sensation in the mouth, and pain in your side with blood in your urine, which may be a sign of clot formation in the urinary collecting system.
Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.
Redness to the skin at the injection site may also occur.
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.
Your body can also make antibodies called "inhibitors" against ALPROLIX, which may stop ALPROLIX from working properly.
These are not all of 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, or if bleeding is not controlled using ALPROLIX.
INDICATION
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency. Your healthcare provider may give you ALPROLIX when you have surgery.
Please see full Prescribing Information
MANUFACTURED BY
Bioverativ Therapeutics Inc.
Waltham, MA 02451 USA
U.S. License #2078
CLICK HERE TO LEARN MORE ABOUT SANOFI'S COMMITMENT TO FIGHTING COUNTERFEIT DRUGS.
That's okay. We just had to let you know you're about to leave ALPROLIX.com. Thanks for stopping by.
See you again soon.