How to take Qfitlia^™ (fitusiran)

Welcome

Welcome to this step-by-step video on how to inject using the Qfitlia Prefilled Pen. Before starting this tutorial, please read the following important information.

Make sure your healthcare provider showed you how to prepare and inject Qfitlia before you use it for the first time. They will tell you how often to inject Qfitlia. Qfitlia is only for use in adults and children 12 years of age and older. For those aged 12 to 17, an adult should either give or supervise the injection. Be sure to read the Instructions for Use carefully before starting. If you have any questions, reach out to your healthcare provider.

Get to know the Qfitlia Prefilled Pen

To start, it’s helpful to familiarize yourself with the Qfitlia Prefilled Pen. The prefilled pen has a Qfitlia label, a Blue Cap protecting the hidden Orange Needle Cover, and the Medicine which can be viewed through a Window. Do not remove the Blue Cap until you are ready to inject. There are 4 steps to inject using the Qfitlia Prefilled Pen.

A. Get ready to inject

Let’s get ready to inject using the prefilled pen. First, gather the supplies you need. Lay these out on a clean, flat surface. If the Qfitlia Prefilled Pen was stored in the refrigerator, allow enough time for it to reach room temperature before use.

Next, inspect your prefilled pen before injecting. The next few steps will guide you on how to properly inspect the pen.

First, check the prefilled pen itself. The Plunger Stopper in the middle of the Window is normal. Do not use the prefilled pen if it has been dropped or damaged. Make sure the Blue Cap is securely attached. Do not use the prefilled pen if the Window is yellow. A yellow Window means the prefilled pen is used.

Next, check the label to make sure you have the right medicine…and dose prescribed by your doctor. Next, read the expiration date. Do not use the prefilled pen if the date has passed. Finally, check the medicine through the Window. The liquid inside should be clear and colorless-to-pale yellow. Do not use the prefilled pen if the liquid is discolored, cloudy, or contains visible flakes or particles. You may see air bubbles, this is normal. If your prefilled pen doesn’t look right, contact your healthcare provider.

B. Choose and prepare your injection site

Next, you need to prepare the injection site. Start by washing your hands with soap and water. Now, choose an appropriate injection site. You can inject into your thigh or stomach, except for the 2 inches around your belly button.

A loved one or caregiver can also inject in the outer area of your upper arm. This injection site is only appropriate if someone else is doing the injection. Do not self-inject in this area. Remember, Qfitlia is for subcutaneous use only. Inject it directly under the skin and never into a vein. Clean the chosen area with an alcohol wipe and let it air dry. Do not touch the injection site again or blow on it before the injection.

C. Give the injection

Once the injection site is ready, remove the Blue Cap from the prefilled pen by pulling it straight off without twisting. You may see a droplet on the needle tip. This is normal.

Hold the prefilled pen firmly with the Window visible. You’ll want to watch the Window as you give the injection. Place the Orange Needle Cover on the skin at a 90-degree angle. Firmly press the prefilled pen against the skin until you can’t see the Orange Needle Cover anymore. You will feel the needle going into your skin and will hear a click. Make sure you watch the Window as you press against your skin. When it starts to turn yellow, it means the injection started.

Keep pressing against the skin and continue watching the Window until it’s completely yellow. You may also hear a second click. When the Window is fully yellow, the injection is complete. It’s important not to remove the prefilled pen until the injection is complete. To remove the prefilled pen, pull it straight off the skin. The Orange Needle Cover will cover the needle.

Great job, your injection is complete!

If you see a few drops of blood, just press a cotton ball or gauze against the skin. Do not rub your skin after the injection. If the Window doesn’t turn completely yellow, or if it seems like you might not have received the full dose, safely throw away the pen and call your healthcare provider right away. Do not give yourself a second dose without speaking to your healthcare provider.

D. Throw away the used Qfitlia Prefilled Pen

Once the injection is complete, throw away the used prefilled pen without putting the Blue Cap back on. Use an FDA-cleared sharps disposal container if possible. Otherwise, you can use a suitable household container. Never re-use a Qfitlia Prefilled Pen.

Thanks for watching. Remember to refer to the Qfitlia Instructions for Use and speak to your healthcare provider if you have any questions.

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 heartrate
• 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 accompanying full Prescribing Information, including SERIOUS SIDE EFFECTS, and Medication Guide.