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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