What could proven protection mean for you?
“Hemophilia doesn’t seem to be in the forefront of our daily lives anymore. It’s definitely given us a sense of him being protected.”
— Rose, Ben’s mother and care partner
Ben has hemophilia B without inhibitors
Currently taking 20 mg of Qfitlia® once every other month
The clinical trial program included 2 parent studies and 1 extension study.* The extension study featured a diverse group of 227 people around the world:
- Males over the age of 12 — 39 aged 12–17 years; 188 aged 18–72 years
- People with hemophilia A or B — 174 with hemophilia A; 53 with hemophilia B
- People with or without inhibitors — 149 without inhibitors; 78 with inhibitors
* The 2 parent studies included 177 male patients aged 12 years and older with severe hemophilia A or B, with or without inhibitors, who were previously treated on demand. People received Qfitlia prophylaxis or on-demand treatment with factor or bypassing agent during the studies. Following these parent studies, some people continued into an extension study, in which dosing was based on antithrombin levels.
Excluded from the study were patients with known coexisting clotting disorders other than hemophilia A or B, an increased risk of blood clots based on their history of blood clots, significant heart disease or atrial fibrillation, antithrombin activity <60% at screening, low platelet count, moderate to severe kidney impairment, or clinically significant liver disease.
Significant bleed reduction versus on-demand treatment
A reduction in annualized bleeding rate (ABR) was seen across people with and without inhibitors. ABR refers to the total number of bleeding events, both with and without a known cause or injury, over a 1-year period.
ABR: 5.1 (Qfitlia) vs 19.1 (bypassing agent on-demand)†
P=.0006
1.9 median total bleeds (ABR) per year†
People without inhibitors experienced ~14 fewer bleeds per year with Qfitlia prophylaxis compared to bypassing agent on-demand
ABR: 9.0 (Qfitlia) vs 31.4 (factor on-demand)†
P<.0001
3.8 median total bleeds (ABR) per year†
People without inhibitors experienced ~22 fewer bleeds per year with Qfitlia prophylaxis compared to factor replacement on-demand
† Based on treated bleeds.
Qfitlia bleed rates across participants
As part of the extension study, an exploratory analysis was also conducted. These data represent what was observed in the trial but cannot be used to make conclusions about how well Qfitlia works.
About 1 in 3 people (62/197) experienced 0 bleeds during the extension study
AsBR, or annualized spontaneous bleeding rate, is a measure of the number of bleeds that occur without a known cause in individuals with hemophilia A or B over a 1-year period.
It is not known if Qfitlia is safe and effective in children younger than 12 years of age.
Qfitlia can cause SERIOUS SIDE EFFECTS, including:
Abnormal blood clotting (thrombotic events): Serious blood clots have occurred in people treated with Qfitlia. Qfitlia can cause blood clots to form in the blood vessels in your arms, legs, lungs, heart, brain, eyes, or head. Your risk of blood clots is greater if your antithrombin (AT) blood level is persistently less than 15% or if you have certain other conditions. Your healthcare provider (HCP) will check your AT blood levels before and during treatment with Qfitlia
Gallbladder disease: Qfitlia can cause gallstones and inflammation of your gallbladder, which might require surgery to remove your gallbladder. Tell your HCP right away if you develop stomach pain, indigestion, nausea, or vomiting. Your HCP may temporarily or permanently stop Qfitlia if you develop any of these symptoms
What is the most important information I should know about Qfitlia?
Qfitlia helps your blood form clots. Do not stop using Qfitlia without talking to your HCP. If you miss doses or stop using Qfitlia, you may no longer be protected against bleeding.
Use of a clotting factor concentrate (CFC) or bypassing agent (BPA) to help protect against bleeding must be stopped within 7 days after your first dose of Qfitlia.
Your HCP may prescribe on-demand CFC or BPA if you bleed during treatment with Qfitlia. Carefully follow your HCP’s instructions regarding when to use on-demand treatment with CFC or BPA, including the prescribed dose and timing of the CFC or BPA.
Get medical help right away if you get any of these signs or symptoms of blood clots during or after treatment with Qfitlia:
- Swelling, pain, or redness in arms or legs
- Coughing up blood
- Shortness of breath
- Severe chest pain or tightness of the chest
- Fast heart rate
- Feeling faint or passing out
- Severe or persistent headache
- Difficulty speaking or understanding language
- Feeling confused
- Numbness or weakness in your face, arms, or legs
- Sudden loss or changes in your vision, eye pain, or swelling
What are the possible side effects of Qfitlia?
Qfitlia can cause other serious side effects, including an increase in your blood liver enzymes. Your HCP will do blood tests to check your liver function before and during treatment with Qfitlia
The most common side effects of Qfitlia include viral infection, common cold symptoms, and bacterial infection
These are not all the possible side effects of Qfitlia.
What should I tell my HCP before using Qfitlia?
Tell your HCP about all of your medical conditions, including if you have liver problems, a history of gallbladder disease, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed
Females who are able to become pregnant: Hormonal birth control may increase your risk of blood clots if used during treatment with Qfitlia. Talk to your HCP about effective forms of non-hormonal birth control you can use before starting and during treatment with Qfitlia
Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
