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Bleed protection with Qfitlia^™(fitusiran)

Discover what's possible with as few as 6 injections a year*

* In the clinical study, ~67% of people with hemophilia took Qfitlia every other month, and ~19% took it monthly.

Qfitlia was studied for over 7 years in a clinical development program

The clinical trials assessed the safety and efficacy of Qfitlia.

About the Qfitlia trials

The 2 parent studies included 177 males aged 12 years and older with severe hemophilia A or B, with or without inhibitors, who were previously treating on-demand. People received Qfitlia prophylaxis or on-demand treatment with factor or bypassing agent during the studies
An additional supportive study included 80 males aged 12 years and older with severe hemophilia A or B, with or without inhibitors, who were previously treated with prophylaxis (factor or bypassing agent). During the study, people continued their prophylaxis treatment before switching to Qfitlia prophylaxis
Following these parent studies, some people continued into an extension study, in which dosing was based on antithrombin levels. Out of 227 people included in this study, 213 were treated with the antithrombin-based dosing regimen
- 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, AT activity <60% at screening, low platelet count, moderate to severe kidney impairment, or clinically significant liver disease

Here's a participant breakdown from the extension study:

174 people

59 with inhibitors
115 without inhibitors

53 people

19 with inhibitors
34 without inhibitors

Qfitlia demonstrated significant bleed reduction with as few as 6 injections a year versus on-demand therapies

Qfitlia versus factor replacement on-demand^†‡

People without inhibitors experienced ~22 fewer bleeds per year with Qfitlia prophylaxis compared to factor replacement on-demand
Mean annualized bleed rate (ABR): 9.0 (Qfitlia) and 31.4 (factor replacement on-demand) (P<.0001)

73% reduction in ABR down arrow inside a yellow circle background

Qfitlia versus bypassing agent on-demand^†‡

People with inhibitors experienced ~14 fewer bleeds per year with Qfitlia prophylaxis compared to bypassing agent on-demand
Mean ABR: 5.1 (Qfitlia) and 19.1 (bypassing agent on-demand) (P=.0006)

^†Data based on treated bleeds.
^‡The efficacy of Qfitlia prophylaxis in the extension study was compared to the efficacy of bypassing agent or factor replacement on-demand from earlier studies that were part of the clinical development program.

Qfitlia ABR following previous prophylaxis treatment

Note that this data is from a supportive study that was not statistically tested and cannot directly be used to determine how well Qﬁtlia works.

Hemophilia A or B without inhibitors:

For Qfitlia versus factor prophylaxis, estimated mean ABR was 6.93 (Qfitlia) versus 5.96 (factor prophylaxis)^§
The estimated mean ABR observed with Qfitlia was comparable to prior factor prophylaxis

Hemophilia A or B with inhibitors:

For Qfitlia versus bypassing agent prophylaxis, estimated mean ABR was 3.41 (Qfitlia) versus 11.29 (bypassing agent prophylaxis)^§
The estimated mean ABR observed with Qfitlia was reduced vs prior BPA prophylaxis for patients with inhibitors

^§The efficacy of Qfitlia prophylaxis in the extension study was compared to the efficacy of bypassing agent or factor replacement prophylaxis from earlier studies that were part of the clinical development program.

Across people with hemophilia A or B from the extension study

Median total bleeds per year with Qfitlia^II:

3.8 in people without inhibitors^¶
1.9 in people with inhibitors^¶

^||_{Based on treated bleeds.}

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Median spontaneous bleeds per year with Qfitlia^||:

1.9 in people without inhibitors^¶
1.9 in people with inhibitors^¶

Note that this data was not statistically tested and cannot directly be used to determine how well Qﬁtlia works.

^|| _{Based on treated bleeds.}

^¶Total bleeds include both spontaneous and traumatic bleeds. Spontaneous bleeds occur without an obvious cause or injury, while traumatic bleeds are caused by an external trauma or injury.

People on Qfitlia who experienced 1 or fewer bleeds from the extension study

Note that this data was not statistically tested and cannot directly be used to determine how well Qfitlia works.

In the extension study, out of 197 people:

Outline of 3 people with 1 person filled in

About 1 in 3 people (62/197) had zero bleeds.

Outline of 2 people with 1 person filled in

About 1 in 2 people (93/197) had zero or one bleed.

Side effects and safety of Qfitlia

As with any treatment, some common side effects may occur with Qfitlia. Qfitlia is also associated with serious side effects.

Learn More

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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.

Bleed protection with Qfitlia™ (fitusiran)