Fitusiran (By injection)

Fitusiran (fit-ue-SIR-an)

Prevents and decreases the frequency of bleeding in patients with hemophilia A or hemophilia B.

Brand Name(s):

Qfitlia, Qfitlia Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually injected into the thigh, stomach, or upper arm.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, damaged, bruised, or into areas with scars or with visible veins. Do not inject through clothes.
• This medicine is available in 2 forms: a prefilled pen and a vial.
• Allow 30 minutes for the prefilled pen or vial to warm up to room temperature. Do not warm using heat sources (including direct sunlight).
• Check the liquid in the prefilled pen or vial. It should be clear and colorless to pale yellow. Do not use it if it is discolored, cloudy, or has flakes or particles in it. Do not shake.
• Prefilled pen:
  • Wash your hands with soap and water before and after using this medicine.
  • Do not use the prefilled pen if it has been dropped, damaged, or if the blue cap is missing or not attached. Do not use it if the window is yellow (has been used).
  • Remove the blue cap by pulling it straight off. Do not twist it off. Do not touch the orange needle cover. Do not put the cap back on.
  • Hold the prefilled pen at a 90 degree angle. Press down and hold the pen firmly against the skin until you cannot see the orange needle cover. You will hear a "click" sound. The window will start to turn yellow. Keep pressing the pen against the skin. You will hear a second click. You should see the yellow color in the window. If the window has not turned yellow, this means you may not have received the full dose.
  • Pull the pen straight up. The orange needle cover will cover the needle.
• Vial:
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the protective cap from the vial. Attach the needle to the syringe. Do not touch the needle. Do not recap.
  • Push the needle through the center of the rubber vial stopper. Leave the needle in and turn the vial upside down. Hold the syringe and vial with one hand. Make sure the tip of the needle is in the solution. With your other hand, pull back on the plunger rod to withdraw the prescribed dose.
  • 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. Remove the needle from the vial.
  • Gently pinch a fold of your skin. Insert the needle into the skin at a 45 to 90 degree angle. Slowly push the plunger rod all the way to the bottom of the syringe.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Resume your dosing schedule either 1 time every month or 1 time every 2 months from the last dose, as directed.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. You may store the prefilled pen at room temperature for up to 3 months. Do not put it back in the refrigerator. Throw the prefilled pen away after 3 months. You may store the vial at room temperature. Do not put it back in the refrigerator.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how fitusiran works. Tell your doctor if you are using any type of hormonal birth control, including estrogen.
• If you are using other medicines to treat or prevent bleeding (including clotting factor concentrate, bypassing agent), you will need to stop using them within 7 days after your first dose of this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or a history of gallbladder problems.
• If you can get pregnant, your doctor will ask you to use non-hormonal birth control before starting and during treatment with this medicine.
• This medicine may cause the following problems:
  • Increased risk of blood clots
  • Gallbladder problems, including cholelithiasis, cholecystitis
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will need to check your blood before starting this medicine and at month 1, 3, 5, and 6 during treatment with this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood
• Dark urine or pale stools, loss of appetite
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden or severe headache, problems with vision, speech, or walking
• Sudden and severe stomach pain, nausea, vomiting, passing gas, stomach upset or bloating, yellow eyes or skin

If you notice these less serious side effects, talk with your doctor:

• Muscle or joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Last Updated: 6/4/2025