Brand Name
Qfitlia
Generic Name
Fitusiran
View Brand Information FDA approval date: September 13, 2018
Classification: Antithrombin-directed RNA Interaction
Form: Injection
What is Qfitlia (Fitusiran)?
QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
An Open-label, Single-arm Treatment Study to Investigate the Safety and Tolerability of Switching From Emicizumab to Fitusiran Prophylaxis in Male Participants Aged ≥12 Years of Age With Severe Hemophilia A, With or Without Inhibitors
Summary: This is an exploratory, single group, Phase 4, study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis. This study aims to evaluate the safety and tolerability of switching to fitusiran after a transition period from the last dose of emicizumab. The study will be conducted in male participants with severe hemophilia A, with or without inhibitors, aged ≥12 y...
Related Latest Advances
Brand Information
Qfitlia (fitusiran)
1INDICATIONS AND USAGE
QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
2DOSAGE FORMS AND STRENGTHS
QFITLIA is a clear, colorless to pale yellow solution in a single-dose:
- Injection: 50 mg/0.5 mL prefilled pen
- Injection: 20 mg/0.2 mL vial
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Thrombotic Events
- Acute and Recurrent Gallbladder Disease
- Hepatotoxicity
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to QFITLIA as fixed doses and AT-DR (N=335).
The safety of the QFITLIA AT-DR was assessed in 286 adult and pediatric male patients with hemophilia A or B with or without inhibitors
Among patients who received the AT-DR, 93% were exposed for 6 months or longer and 83% were exposed for 12 months or longer. The median duration of exposure across the studies was 674 days (with a maximum of 896 days).
Serious adverse reactions occurred in 4/286 (1.4%) patients who received the AT-DR, two of whom had serious adverse reactions of cholecystitis.
Permanent discontinuation of QFITLIA due to an adverse reaction occurred in 4/286 (1.4%) patients receiving the AT-DR and included liver injury, post-operative deep vein thrombosis, cerebral infarction and pruritus.
Dosage interruptions of QFITLIA due to an adverse reaction occurred in 2/286 (0.7%) patients receiving the AT-DR and included increased serum transaminases.
The most common adverse reactions (≥10%) reported in patients treated with the AT-DR were viral infection, nasopharyngitis, and bacterial infection.
5DESCRIPTION
QFITLIA injection contains fitusiran, an antithrombin-directed double-stranded small interfering ribonucleic acid (siRNA), which is covalently linked to a ligand containing a triantennary N-acetylgalactosamine (GalNAc) moiety. The molecular formula of fitusiran sodium is C
QFITLIA is supplied as a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous administration.
Each 50 mg single-dose prefilled pen delivers 50 mg fitusiran (equivalent to 53.0 mg fitusiran sodium) in 0.5 mL, and also contains dibasic sodium phosphate (0.585 mg), monobasic sodium phosphate (0.044 mg), sodium chloride (2.455 mg), and Water for Injection, USP. Phosphoric acid (concentrated) and sodium hydroxide may be added to adjust to pH 7.0.
Each 20 mg single-dose vial delivers 20 mg fitusiran (equivalent to 21.2 mg fitusiran sodium) in 0.2 mL, and also contains dibasic sodium phosphate (0.234 mg), monobasic sodium phosphate (0.018 mg), sodium chloride (0.982 mg), and Water for Injection, USP. Phosphoric acid (concentrated) and sodium hydroxide may be added to adjust to pH 7.0.
6CLINICAL STUDIES
The efficacy and safety of QFITLIA in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without inhibitors were established in two clinical studies:
- Hemophilia A or B with Inhibitory Antibodies: ATLAS-INH (NCT03417102)
- Hemophilia A or B without Inhibitory Antibodies: ATLAS-A/B (NCT03417245)
Patients in the above parent studies rolled over into the long-term extension study ATLAS-OLE (NCT03754790).
The clinical studies ATLAS-INH and ATLAS-A/B tested an 80 mg monthly fixed dose of QFITLIA. Because of thrombotic events with this dose, the QFITLIA AT-DR targeting AT activity of 15–35% was implemented in ATLAS-OLE. The AT-DR was initiated when studies ATLAS-INH and ATLAS-A/B were nearly completed, therefore, the efficacy of QFITLIA AT-DR treatment was assessed by comparing the QFITLIA AT-DR treatment data from the long-term extension study ATLAS-OLE to the control data from studies ATLAS-INH and ATLAS-A/B. The efficacy analyses were conducted according to the intent to treat (ITT) principle preserving the randomization in the parent studies.
7PATIENT COUNSELING INFORMATION
- Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
8INSTRUCTIONS FOR USE
QFITLIA® (kew fit lee ah)
(fitusiran)
injection, for subcutaneous use
Single-Dose Prefilled Pen (50 mg/0.5 mL)
(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.
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.
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
- 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
- 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 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 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
- There will be a
- 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,
- You may hear a
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:
- 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:
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.
9INSTRUCTIONS FOR USE
QFITLIA(kew fit lee ah)
(fitusiran)
injection, for subcutaneous use
Single-Dose Vial (20 mg/0.2 mL)
(fitusiran)
injection, for subcutaneous use
Single-Dose Vial (20 mg/0.2 mL)
This Instructions for Use contains information on how to inject QFITLIA from a vial.
Read this Instructions for Use before using QFITLIA.
QFITLIA is only for use in adults and children 12 years of age and older. In children 12 to 17 years of age it is recommended that QFITLIA be given by or under the supervision of an adult.
This QFITLIA vial is for single-use only. It contains 20 mg of QFITLIA for injection under the skin (subcutaneous injection).
Important information to know before injecting QFITLIA
- Read all of the instructions carefully before using QFITLIA.
- Ask your healthcare provider how often you will need to inject the medicine.
- Check your prescription label to make sure you draw up the correct medicine dose prescribed by your healthcare provider.
- Throw away (dispose of) the used vial, syringe and needle right away after use.
- Only use the vial one time. After you inject your dose, throw away (dispose of) any unused QFITLIA left in the vial. Do not save any unused QFITLIA in the vial for later use.
- QFITLIA is for subcutaneous use only.
Storing QFITLIA vial
- Store QFITLIA vial either 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 at any time.
- Do not heat the QFITLIA vial.
- Do not freeze the QFITLIA vial.
- Do not put the QFITLIA vial into direct sunlight.
- Keep QFITLIA vial and all medicines out of the reach of children.
A. Get ready to inject
A1) Gather the supplies.
Find a clean, flat work surface. Make sure you have the following supplies:
A2) Check the vial.
- Do not use the QFITLIA vial if it has been dropped or damaged.
- Check the label on the vial to be sure that you have the correct prescribed medicine and dose.
- Check expiration date (EXP:).
- Do not use QFITLIA if the expiration date on the vial has passed.
A3) Check the medicine.
- Look at the medicine in the vial to make sure it is clear and colorless to pale yellow.
- Do not use QFITLIA if the liquid in the vial is discolored or cloudy, or if it contains visible flakes or particles.
A4) If the QFITLIA vial was stored in the refrigerator, warm up for 30 minutes.
- Set the QFITLIA vial 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
- Do not heat the QFITLIA vial or put in direct sunlight.
A5) Wash your hands well with soap and water.
A6) Remove the protective cap from the QFITLIA vial. remove the stopper.
A7) Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry.
B. Choose and prepare the injection site
B1) Choose the 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
- Do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins.
- Do not inject into a vein. For subcutaneous use only.
- Do not inject through clothes.
B2) 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. Prepare the injection
Contact your healthcare provider if you have any questions about preparing your dose.
Contact your healthcare provider if you have any questions about preparing your dose.
C1) Attach the needle to the syringe and remove the needle cap.
- Attach the needle to the syringe.
- Hold the syringe body and pull the needle cap straight off the syringe.
- Do not touch the needle.
- Do not recap the needle.
C2) Withdraw the solution.
Withdraw slightly more than your prescribed dose into the syringe.
- Push the needle through the center of the rubber vial stopper.
- Leave the needle in the vial and turn both the syringe and vial upside down (vial on top).
- Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the QFITLIA solution.
- With your other hand, pull back on the plunger rod to withdraw slightly more than your prescribed dose into the syringe.
C3) Check for air bubbles.
- Keep the needle in the vial and make sure both syringe and vial are upside down (vial on top).
- If air bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top.
- Push the plunger rod up to push the bubbles out of the syringe.
C4) Adjust plunger to your prescribed dose.
- Push the plunger rod to push solution back into the vial until you have the prescribed dose in the syringe.
- If the medicine in the syringe is less than your prescribed dose, repeat steps C2, C3 and C4 until you have your correct dose.
- Remove the needle from the vial.
D. Inject QFITLIA
D1) Pinch a fold of skin and insert the needle.
Gently pinch a fold of skin at the cleaned injection site. Insert the needle into the skin fold at a 45° to 90° angle.
D2) Inject QFITLIA.
Relax the skin pinch. Slowly push the plunger rod all the way to the bottom of the syringe body and inject all of the QFITLIA solution.
D3) Gently pull out the needle and syringe from the injection site.
- Do not recap the used needle to avoid a needle-stick injury.
- Do not rub the skin after the injection.
- If you see any blood at the site, lightly dab it with a cotton ball or gauze pad. If your injection site becomes red or sore, call your healthcare provider right away.
E. Throw away (dispose of) used vial, needle and syringe
E1) Throw away (dispose of) your used vial, needle and syringe in an FDA-cleared sharps disposal container right away after use.
Do not re-use the vial, needle, or syringe.
Keep your sharps disposal container out of the reach of children.
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 tightfitting, 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 needles and syringes.
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:
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.
10PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton
NDC 58468-0348-1
Qfitlia™
For Subcutaneous Use Only
Dispense the enclosed Medication Guide to each patient.
One 0.5 mL Single-Dose Prefilled Pen
sanofi
11PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton
NDC 58468-0347-1
Qfitlia™
For Subcutaneous Use Only
Dispense the enclosed Medication
One 0.2 mL Single-Dose Vial.
sanofi
