Starting Qfitlia^™(fitusiran)

3 steps to starting Qfitlia

For more information, download a copy of the Starter Guide

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Start Qfitlia with a 50 mg prefilled pen

Before starting Qfitlia, your doctor will run a blood test to measure antithrombin activity and liver function and to confirm your eligibility
Factor or bypassing agent prophylaxis must be discontinued 7 days after your first dose of Qfitlia
Your doctor will work with you to create a bleed management plan in case of a breakthrough bleed

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Find your right dose of Qfitlia

During at least your first 6 months of treatment, your doctor will run blood tests to measure your antithrombin level at Months 1, 3, 5, and 6 to decide if a dose adjustment is needed. This testing cycle will restart if a dose adjustment is made
Your doctor will also run a monthly blood test to monitor your liver function for at least 6 months. Liver monitoring will continue for at least 6 months if the dose is increased
In the extension study, 35% of people on Qfitlia did not require a dose adjustment

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Continue Qfitlia at the same dose to maintain protection

Your doctor will run a blood test to measure antithrombin activity once a year. Liver testing will continue periodically

Learn more about creating a bleed management plan with your doctor

Be prepared in case a breakthrough bleed occurs.

Be Prepared

Share your experience with Qfitlia

Join the community and share your first-hand experience of life on Qfitlia with others who are looking to begin their own treatment journey.

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Find a Sanofi Educator and connect today

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.

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Important Safety Information and Indication

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

Qfitlia™ (fitusiran) is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years and older with hemophilia A or B with or without Factor VIII or IX inhibitors.

It is not known if Qfitlia is safe and effective in children younger than 12 years of age.

IMPORTANT SAFETY INFORMATION

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

Please see full Prescribing Information, including SERIOUS SIDE EFFECTS, and Medication Guide.Learn more about Sanofi’s commitment to fighting counterfeit drugs.

Starting Qfitlia™ (fitusiran)