Fitusiran

Fitusiran is used in adults and children who are at least 12 years old with hemophilia A or B to help prevent bleeding episodes or reduce how often they happen.

Your doctor will confirm that you can be treated with fitusiran.

Fitusiran may also be used for reasons not mentioned in this medication guide.

Using fitusiran can raise your risk of blood clots, particularly if you have specific medical conditions or if you are taking other medicines that treat blood clots.

Fitusiran can also increase your risk of gallbladder disease. Contact your doctor immediately if you experience unexplained stomach pain, nausea, vomiting, or heartburn.

Tell your doctor if you have or have ever had:

• blood clots or any other blood clotting disorder;
• gallbladder disease; or
• liver disease.

It is not known if fitusiran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Using fitusiran with certain hormonal birth controls can increase your risk of blood clots. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Ask your doctor if you have any questions.

Ask a doctor if it is safe to breastfeed while using this medicine.

Do not allow a child to use fitusiran without help from an adult.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Seek medical help right away if you show signs of a blood clot such as sudden numbness or weakness (especially on one side of the body), severe headache, confusion, vision changes, slurred speech, chest pain, shortness of breath, fast heart rate, dizziness, coughing up blood, or pain, swelling, or warmth in your arms or legs.

Fitusiran may cause serious side effects. Call your doctor at once if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• gallbladder problems--stomach pain after eating, nausea, vomiting, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Common side effects of fitusiran may include:

• bacterial or viral infections; or
• cold symptoms such as a stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Tell your doctor if you are using other treatments to help protect against bleeding. Your healthcare provider will provide instructions for stopping your current treatment when switching to fitusiran.

Fitusiran is injected under the skin. Your healthcare provider will show you or your caregiver where to inject fitusiran. Your doctor will determine your treatment schedule.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of your navel, or areas where the skin is tender, damaged, scaly, has bruises, scars, or visible veins. Do not inject into the same place two times in a row.

Throw away after one use, even if there is still medicine left inside.

Your blood may need to be tested often before and during treatment. Your doctor will need to check your progress on a regular basis.

You may be given other medicines to treat unexpected bleeding during treatment with fitusiran. Follow your doctor's instructions very carefully.

Your condition may get worse if you stop using fitusiran suddenly. Ask your doctor before stopping the medicine.

Call your doctor if your symptoms do not improve, or if they get worse.

Store fitusiran in the original container in the refrigerator. Protect from light and do not freeze or shake the medicine.

Take the medicine out of the refrigerator and let it reach room temperature before using. Do not warm the medicine with hot water, sunlight, or a microwave.

You may store fitusiran at room temperature. Certain formulations may only be stable for a limited number of months after being removed from the refrigerator. Throw away any medicine not used within that time. Talk to your pharmacist if you have any questions.

Use the medicine as soon as you remember, and then return to your regular schedule. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may affect fitusiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.