Patient information: uses, side effects, how to take - Qfitlia

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 healthcare provider. 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 healthcare provider may prescribe on demand CFC (factor VIII or factor IX products) or BPA if you bleed during treatment with QFITLIA. Carefully follow your healthcare provider's instructions regarding when to use on-demand treatment with CFC or BPA, including the prescribed dose and timing of the CFC or BPA.

QFITLIA can cause serious side effects, including:

Abnormal blood clotting (thrombotic events). Serious blood clots have happened in people treated with QFITLIA. QFITLIA can cause blood clots to form in 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. 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
feel confused
numbness or weakness in your face, arms or legs
sudden loss or changes in your vision, eye pain or swelling

Gallbladder disease. QFITLIA can cause gallstones (cholelithiasis) and inflammation of your gallbladder (cholecystitis), which might require surgery to remove your gallbladder. Tell your healthcare provider right away if you develop stomach (abdomen) pain, indigestion, nausea or vomiting. Your healthcare provider may temporarily or permanently stop your treatment with QFITLIA if you develop any of these symptoms.
Liver problems. QFITLIA can cause an increase in your blood liver enzymes. Your healthcare provider will do blood tests to check your liver function before and during treatment with QFITLIA.
See "What are the possible side effects of QFITLIA?" for more information about side effects.

What is QFITLIA?

QFITLIA 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.

Before receiving QFITLIA, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems
have a history of gallbladder disease
are pregnant or plan to become pregnant. It is not known if QFITLIA may harm your unborn baby.
Females who are able to become pregnant: Hormonal birth control (contraception) may increase your risk of blood clots if used during treatment with QFITLIA. If you use hormonal birth control (contraception), talk to your healthcare provider about effective forms of non-hormonal birth control (contraception) options you can use before starting and during treatment with QFITLIA.
are breastfeeding or plan to breastfeed. It is not known if QFITLIA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use QFITLIA?

See the detailed "Instructions for Use" that comes with your QFITLIA for information on how to prepare and inject a dose of QFITLIA, and how to properly throw away (dispose of) the used prefilled pen, vial, needle and syringe.

Use QFITLIA exactly as prescribed by your healthcare provider.
Your healthcare provider may change your dose or how often you inject QFITLIA based on your AT blood level to help reduce your chance of abnormal blood clots. Your healthcare provider will check your AT blood level:
- before starting QFITLIA and at month 1, 3, 5 and 6 during QFITLIA treatment.
- after any change in your dose of QFITLIA.
- at yearly routine visits after your healthcare provider determines your target dose.
It is recommended that QFITLIA be given by or under the supervision of an adult in children 12 to 17 years of age.
QFITLIA is given as an injection under your skin (subcutaneous) by you or a caregiver.
Your healthcare provider should show you or your caregiver how to prepare, measure, and inject your dose of QFITLIA before you inject yourself for the first time.
Do not attempt to inject yourself or another person unless you have been taught how to do so by a healthcare provider.
After your first dose of QFITLIA, your healthcare provider will let you know when to take your next dose and how much QFITLIA to inject.
If you miss a dose of QFITLIA on your scheduled day, you should give the dose as soon as possible. After that, resume your dosing schedule either 1 time every month or 1 time every two months from the last dose, as instructed by your healthcare provider.

What are the possible side effects of QFITLIA?

See "What is the most important information I should know about QFITLIA?"

The most common side effects of QFITLIA include:

viral infection
common cold symptoms
bacterial infection

These are not all of the possible side effects of QFITLIA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store QFITLIA?

50 mg Prefilled Pen
- Store QFITLIA prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
- QFITLIA prefilled pen may be stored at room temperature between 59°F to 86°F (15°C to 30°C) for a single period of up to 3 months within the expiration date printed on the label.
- Throw away (dispose of) the QFITLIA prefilled pen after 3 months at room temperature or at the expiration date, whichever comes first.
- Do not return QFITLIA prefilled pen to the refrigerator after storing at room temperature.
20 mg Vial
- Store QFITLIA vial in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton to protect from light.
- Do not return QFITLIA vial to the refrigerator after storing at room temperature.
Do not shake the QFITLIA vial or prefilled pen at any time.
Do not heat the QFITLIA vial or prefilled pen.
Do not freeze the QFITLIA vial or prefilled pen.
Do not put the QFITLIA vial or prefilled pen into direct sunlight.
Throw away (dispose of) any unused QFITLIA.

Keep QFITLIA and all medicines out of the reach of children.

General information about the safe and effective use of QFITLIA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QFITLIA for a condition for which it was not prescribed. Do not give QFITLIA to other people even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about QFITLIA that is written for health professionals.

What are the ingredients in QFITLIA?

Active ingredient: fitusiran

Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, and Water for Injection, USP. Phosphoric acid (concentrated) and sodium hydroxide may be added to adjust pH to 7.

Manufactured by: Genzyme Corporation, Cambridge, MA 02141. A SANOFI COMPANY.

For patent information: https://www.sanofi.us/en/products-and-resources/patents

For more information, go to www.QFITLIA.com or call 1-800-745-4447.

INSTRUCTIONS FOR USE

QFITLIA ^®(kew fit lee ah)

(fitusiran)

injection, for subcutaneous use

Single-Dose Prefilled Pen (50 mg/0.5 mL)

This Instructions for Use contains information on how to inject QFITLIA.

Read this Instructions for Use before using the QFITLIA Prefilled Pen. Do not inject yourself or someone else until you have been shown how to inject QFITLIA Prefilled Pen. Your healthcare provider can show you or your caregiver how to prepare and inject a dose of QFITLIA before you try to do it yourself for the first time. Keep this Instructions for Use. Call your healthcare provider if you have any questions.

QFITLIA Prefilled Pen is only for use in adults and children 12 years of age and older. It is recommended that QFITLIA Prefilled Pen be given by adults or under adult supervision to children 12 to 17 years of age.

This QFITLIA Prefilled Pen is a single-dose device. It contains 50 mg of QFITLIA for injection under the skin (subcutaneous injection).

The parts of the QFITLIA Prefilled Pen are shown below:

Important information to know before injecting QFITLIA

Read all of the instructions carefully before using the QFITLIA Prefilled Pen.
Ask your healthcare provider how often you will need to inject the medicine.
Throw away (dispose of) the used QFITLIA Prefilled Pen right away after use.
Do not re-use a QFITLIA Prefilled Pen.
QFITLIA Prefilled Pen is for subcutaneous use only. Do not inject QFITLIA Prefilled Pen into a vein.

Storing QFITLIA Prefilled Pen

Store QFITLIA Prefilled Pen in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
QFITLIA Prefilled Pen may be stored at room temperature between 59°F to 86°F (15°C to 30°C) for a single period of up to 3 months within the expiration date printed on the label.
Do not return QFITLIA Prefilled Pen to the refrigerator after storing at room temperature.
Do not shake the QFITLIA Prefilled Pen at any time.
Do not heat the QFITLIA Prefilled Pen.
Do not freeze the QFITLIA Prefilled Pen.
Do not put the QFITLIA Prefilled Pen into direct sunlight.
Keep QFITLIA Prefilled Pen and all medicines out of the reach of children.

A. Get ready to inject

A1) Gather supplies

Find a clean, flat work surface. Make sure you have the following supplies:

A2) Check the QFITLIA Prefilled Pen

Note: The plunger stopper in the middle of the Window is normal.
Do not use the QFITLIA Prefilled Pen if it has been dropped or damaged.
Do not use the QFITLIA Prefilled Pen if the Blue Cap is missing or not securely attached.
Do not use the QFITLIA Prefilled Pen if the Window is yellow before use. A yellow Window means the QFITLIA Prefilled Pen has been used.

A3) Look at the label

Check the label to be sure that you have the correct prescribed medicine and dose.

Check the expiration date.
Do not use the QFITLIA Prefilled Pen if the expiration date has passed.

A4) Check the medicine

Look at the medicine through the Window, it should be clear and colorless to pale yellow.
Note: You may see air bubbles, this is normal.
Do not use the QFITLIA Prefilled Pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.

A5) If QFITLIA Prefilled Pen was stored in the refrigerator, warm up for 30 minutes.

Lay the QFITLIA Prefilled Pen on a clean, flat surface and let it warm up at room temperature between 59°F to 86°F (15°C to 30°C) for at least 30 minutes.
Do not heat the QFITLIA Prefilled Pen or put into direct sunlight.

B. Choose and prepare your injection site

B1) Wash your hands well with soap and water

B2) Choose an injection site

Thigh
Stomach except for the 2 inches (5 cm) around your belly button (navel).
A caregiver can also inject in the outer area of your upper arm.
Do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins.
For subcutaneous use only. Do not inject into a vein.
Do not inject through clothes.

B3) Prepare the injection site

Clean the injection site with an alcohol wipe.
Let the skin dry before injecting.
Do not touch the injection site again or blow on it before the injection.

C. Give the injection

C1) Remove Blue Cap

Remove the Blue Cap by pulling it straight off as shown. Do not twist the Blue Cap off.
Do not remove the Blue Cap until you are ready to inject.
Do not touch the Orange Needle Cover with your fingers. The Needle is inside.
Do not put the Blue Cap back on the QFITLIA Prefilled Pen after you have removed it.
Note: You may see a droplet on the needle tip. This is normal.

C2) Place QFITLIA Prefilled Pen on injection site

Hold the QFITLIA Prefilled Pen as shown so you can see the Window.
Place the Orange Needle Cover on the skin at a 90-degree angle.

C3) Press down firmly → Watch Window turn fully yellow

Press down and hold the QFITLIA Prefilled Pen firmly against the skin until you cannot see the Orange Needle Cover.

There will be a "click" when the injection starts, and
The Window will start to turn yellow.

Keep pressing the QFITLIA Prefilled Pen against the skin and watch the Window.

The Window will turn completely yellow, and
You may hear a 2nd "click." The injection is complete.

C4) Remove

After you have completed your injection pull straight up to remove QFITLIA Prefilled Pen from the skin. The Orange Needle Cover will cover the needle.
If you see any blood at the site, lightly dab a cotton ball or gauze pad.
Do not rub the skin after the injection.
If the Window does not turn completely yellow, or if it looks like you may not have received a full dose, call your healthcare provider right away.
Do not give a second dose without speaking to your healthcare provider.

D. Throw away (dispose of) used QFITLIA Prefilled Pen

Do not put the Blue Cap back on.

Keep your sharps disposal container out of the reach of children.

How to dispose of (throw away) QFITLIA Prefilled Pen

Put your used QFITLIA Prefilled Pen and Blue Cap in an FDA-cleared sharps disposal container right away after use.
Do not dispose of (throw away) QFITLIA Prefilled Pen and Blue Cap in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used QFITLIA Prefilled Pens.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.

Manufactured by:

Genzyme Corporation

Cambridge, MA 02141

A SANOFI COMPANY

QFITLIA is a registered trademark of GENZYME CORPORATION

For patent information: https://www.sanofi.us/en/products-and-resources/patents

For more information go to www.QFITLIA.com or call 1-800-745-4447.

This Instructions for Use has been approved by the US Food and Drug Administration.

Issued: September 2025