Make the next move in your treatment journey and start a conversation with your healthcare team about ALPROLIX. Considering a switch to 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.
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.
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.*
When your doctor agrees that a switch to ALPROLIX is right for you, your recommended starting dosing schedule will more than likely be 7 or 10 days. ALPROLIX is the only Factor IX treatment with two starting doses: 50 IU/kg every 7 days or 100 IU/kg every 10 days. But ask your doctor about extending. You may be able to work with him or her to extend your dosing schedule to 14 days or longer†.
*54% of people in the individualized prophy arm extended to ≥14-day dosing. The overall median dosing interval on study was 12.5 days. The median interval during the last six months in 26 subjects who were on study for at least nine months was 13.8 days.
†The recommended starting prophylaxis regimens are either 50 IU/kg once weekly, or 100 IU/kg once every 10 days. Dosing regimen can be adjusted based on individual response.
Children under 12 years of age may have higher Factor IX body weight-adjusted clearance, shorter half-life, and lower recovery. Higher dose per kilogram body weight or more frequent dosing may be needed.
It’s not uncommon to experience a period of adjustment when transitioning to a different hemophilia therapy. You may have had a breakthrough bleed. Or you may wonder if it’s possible to extend your dosing schedule. Whatever your reason, it’s important to work any issues out with your doctor. That’s why we’ve provided a few of the more common situations that could come up as thought starters to get the conversation going.
• If you’ve experienced a bleed since you started on ALPROLIX, talk to your doctor. There are many reasons bleeds can happen. One of these reasons may be a sign that you may need an adjustment to your dosing schedule to maintain proper protection. In the clinical trial patients experienced a median of 1 or fewer spontaneous bleed per year
• Keep a log of any breakthrough bleeds you experience and show it to your doctor at your next appointment.
• The recommended 7-day starting dose is 50 IU/kg while the recommended 10-day or longer extended dose is 100 IU/kg depending on how your body responds. In children under 12 years of age the recommended starting regimen is 60 IU/kg once weekly.
• ALPROLIX has been shown effective in treating breakthrough bleeds.
• Always talk to your doctor about changes in your life or what you’re planning to change.
• Your ALPROLIX dosing regimen should fit your individual needs so your doctor may adjust your dosing schedule to make sure you’re protected from bleeds*.
• Your factor regimen is based on your body’s weight and metabolism. So your doctor may need to adjust your ALPROLIX dosage or schedule depending on lifestyle changes.
• Extending your dosing schedule may be possible: More than half of the people who started on every 10-day dosing regimen at 100 IU/kg extended to 14 days or longer between infusions in the clinical trial†. You will need to work with your doctor to extend. Before meeting with your doctor write down your current ALPROLIX schedule, track your infusions and take note of any bleeds so you can bring those to your visit.
• At your visit, talk about how you and your doctor feel it's going on ALPROLIX. Discuss what an ideal extended dosing schedule would be for you, extending will typically include a dose adjustment to 100 IU/kg.
• It is not uncommon to feel different when changing your dosing regimen. It's important that you don't make any dosing changes on your own during this transition period. Always work with your doctor. Be sure to tell your doctor about it.
• It may take time to adjust to a different dosing regimen. It's important to follow your doctor's instructions during this period.
• Regular check-ins will help your doctor assure an effective transition to ALPROLIX.
*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.
†54% of people in the individualized prophy arm extended to ≥14-day dosing. The overall median dosing interval on study was 12.5 days. The median interval during the last six months in 26 subjects who were on study for at least nine months was 13.8 days.
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indications and important facts about alprolix
What is the most important information i should know about ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein]? You should not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using ALPROLIX.
Allergic reactions may occur. 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.
ALPROLIX may increase the risk of forming 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. Your healthcare provider may need to test your blood for inhibitors from time to time.
THE MOST 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. These are not all the possible side effects of ALPROLIX. Talk to your healthcare provider for more information and about any side effect that bothers you or does not go away.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE STARTING ALPROLIX?
Tell your healthcare provider about all your health conditions, including if you:
AFTER STARTING ALPROLIX:
If your bleeding is not controlled and you experience a lack of clinical response to Factor IX therapy, call your healthcare provider right away.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use ALPROLIX for a condition for which it was not prescribed. Do not share ALPROLIX with other people, even if they have the same symptoms that you have.
ALPROLIX 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.
HOW SHOULD I RECEIVE ALPROLIX?
ALPROLIX should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia B learn to infuse ALPROLIX by themselves or with the help of a family member. See the booklet called "Instructions for Use" packaged in your ALPROLIX for directions on infusing ALPROLIX. If you are unsure of the procedure, please ask your healthcare provider.
IMPORTANT FACTS ABOUT ALPROLIX
Please read this information carefully before using ALPROLIX and each time you get a refill, as there may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
The risk information provided here is not comprehensive. To learn more, talk about ALPROLIX with your healthcare provider or pharmacist.
The FDA-approved product labeling can be found at www.alprolix.com or 1-855-MyALPROLIX (692-5776).
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.
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