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Overview: Qfitlia is used for hemophilia A and hemophilia B, which are inherited bleeding disorders. Qfitlia reduces the risk of bleeding by increasing the amount of a substance in the body, called thrombin, that helps blood to clot. The most common side effect is an infection, especially infections in the nose and throat. Keep all appointments to have your blood checked. Tell your health care provider right away if you get severe stomach pain or vomiting. Get emergency help if you have eye pain, vision changes, chest pain, swelling, weakness on one side of your body, trouble breathing or trouble speaking.

Uses

What is Qfitlia used for?

Qfitlia (fitusiran) is commonly used for the following inherited bleeding disorders.

Learn more about Qfitlia for hemophilia.

Qfitlia may also be used for other conditions as determined by your health care provider.

How does Qfitlia work (mechanism of action)?

Many people with hemophilia do not have enough thrombin, a substance that helps the blood to clot. Another substance in the body, called antithrombin, keeps the body from making more thrombin. Qfitlia blocks antithrombin, which increases the amount of thrombin and reduces the risk of bleeding.

How is Qfitlia supplied (dosage forms)?

Brands and other names

  • Qfitlia

Dosage forms and strengths

  • 50 mg/0.5 mL single-dose prefilled pen

Qfitlia is also available in an injectable form that is given by a healthcare provider.

How should I store Qfitlia?

Prefilled Pen. Qfitlia prefilled pens should be kept in the original carton to protect them from light. Store them in the refrigerator, between 36 F and 46 F (2 C and 8 C). Do not freeze. The medicine can be stored between 59 F and 86 F (15 C and 30 C), for a single period of up to three months. Do not return the prefilled pens to the refrigerator, and throw away any unused medicine after three months.

Vial. Qfitlia vials should be kept in the original carton to protect them from light. They may be stored in the refrigerator or at room temperature, between 36 F and 86 F (2 C and 30 C). Do not freeze. If the medicine has been stored outside of the refrigerator, do not put it back into the refrigerator.

Side Effects

What are the most common side effects of Qfitlia?

The most common side effects of Qfitlia are infections, including infections in the nose or throat, sore throat, or common cold symptoms. Tell your health care provider if you have any infections that bother you.

There may be other side effects of Qfitlia that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Qfitlia?

While less common, the most serious side effects of Qfitlia are described below, along with what to do if they happen.

Severe Allergic Reactions. Qfitlia may cause allergic reactions, which can be serious. Stop using Qfitlia and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Qfitlia may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). This risk may be higher in people who use hormonal birth control. Stop using Qfitlia and get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Coughing up blood
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Confusion or passing out 
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes or eye pain
  • Double vision

Gallbladder Problems. Using Qfitlia can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area 
  • Nausea, vomiting, or upset stomach
  • Stool (poop) that is clay-colored

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Qfitlia. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Qfitlia?

Allergies to Ingredients. People who are allergic to any of the following should not use Qfitlia.

  • Fitusiran
  • Qfitlia
  • Any of the ingredients in the specific product dispensed 

Your pharmacist can tell you all of the ingredients in Qfitlia.

What should I know about Qfitlia before using it?

Do not use Qfitlia unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Qfitlia with other people, even if they have the same condition as you. It may harm them.

Keep Qfitlia out of the reach of children. Since this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

This medicine is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Qfitlia. Do not heat or shake the medicine. If you have any questions, talk to your health care provider.

Qfitlia is a medicine you use regularly to prevent bleeding. It should not be used to treat an active bleed. Talk with your healthcare provider about how and when to treat bleeding.

When you start Qtiflia, you may need to make changes to the way you use other medicines for your blood disorder. Talk to your healthcare provider about all of the medicines that you currently use to manage your blood disorder.

Keep all appointments for blood work while you are using this medicine.

What should I tell my health care provider before using Qfitlia?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Qfitlia is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Gallbladder problems

Pregnancy. It is not known if or how Qfitlia could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Qfitlia while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Qfitlia passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Qfitlia while you are breastfeeding.

How can I get more information about Qfitlia?

For more information about Qfitlia, you can visit the drugmaker’s website at www.qfitlia.com or call them at 800-745-4447.

Interactions

Does Qfitlia interact with foods or drinks?

There are no known interactions between Qfitlia and foods or drinks.

It is unknown if drinking alcohol will affect Qfitlia, but drinking large amounts of alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Qfitlia interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

 In particular, make sure that you discuss if you are using any of the following before using Qfitlia.

  • Estrogen, which is found in certain birth control pills, patches, creams, rings, or vaginal suppositories 
  • Any other medicine that is used to manage your bleeding disorder

This may not be a complete list of medicines that can interact with Qfitlia. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Qfitlia?

If you or someone else has used too much Qfitlia, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Qfitlia?

If you miss a dose, use it as soon as you remember. If you missed your dose by more than one day, you will need to change the schedule of your future doses. For example, if you use Qfitlia once a month, you should use your next dose one month after your missed dose. Talk with your health care provider if you have questions about your dose schedule.