Before starting Qfitlia, your doctor will create a bleed management plan with you, including lower/less frequent factor replacement or bypassing agent doses while on Qfitlia to reduce thrombosis risk.
Qfitlia works differently, so using it with factor replacement or bypassing agents increases potential for excessive blood clotting, or thrombosis.
The bleed management plan must be followed when undergoing surgery while on Qfitlia. People have undergone both major (N=60) and minor (N=71) surgeries without discontinuing Qfitlia prophylaxis in clinical studies.
Sanofi Hemophilia Community Relations and Education (CoRe) Managers offer education to people living with hemophilia and their families. CoRe Managers provide information about living with hemophilia and treatment options.
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:
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
