Fitusiran Injection (Prefilled Pen)

What is this medication?

FITUSIRAN (FIT ue SIR an) prevents or reduces how often bleeding episodes occur in people with hemophilia A. It works by helping your body make a protein that helps your blood clot. This lowers the risk of bleeding.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Qfitlia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Conditions that cause blood clots
• Gallbladder disease
• Having surgery
• Liver disease
• An unusual or allergic reaction to fitusiran, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It can be given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are not able to keep your appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. Then, resume your dosing schedule based on the day you took this dose. Do not take double or extra doses. Talk to your care team if you have questions.

What may interact with this medication?

• Estrogen hormones
• Factor eight inhibitor bypassing activity (FEIBA)
• Some blood clotting factors, such as factor VIIa, factor VIII, factor IX

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication can increase the risk of blood clots. The risk is increased if your antithrombin (AT) level is often less than 15%. Antithrombin is a protein that helps your blood clot. In general, the risk of blood clots is increased in people with certain health conditions, such as heart disease or cancer. Blood clots are also more likely to form after surgery, in people who sit or lay down for a long time, and in those who are overweight, use tobacco, or take estrogen hormones. Talk to your care team right away if you have signs or symptoms of a blood clot.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cough
• Headache
• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Keep this medication in the original carton until you are ready to take it. Protect from light and extreme heat and cold.

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Get rid of any unused medication after the expiration date.

Room temperature: This medication may be stored at room temperature between 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F) for up to 3 months. Do not return it to the refrigerator. Get rid of any unused medication after 3 months or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.