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Idelvion is an intravenous (IV) medicine used to treat or prevent certain types of bleeding in people with hemophilia B. It works by replacing factor IX, which temporarily helps your blood to clot properly. Headache and dizziness are common side effects. Get emergency help if you have trouble breathing, chest pain, vision changes, or sudden weakness on one side of your body.

Uses

What is Idelvion used for?

Idelvion (factor IX, recombinant/albumin fusion protein) is commonly used in people with hemophilia B, which is an inherited condition that causes you to have trouble forming blood clots to stop bleeding. It can be used for the following.

  • To prevent or treat bleeding episodes
  • To prevent or treat bleeding during or after surgery

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

How does Idelvion work (mechanism of action)?

Hemophilia B is caused when your body does not make enough of a protein called factor IX, which normally helps your body form blood clots to stop bleeding. Idelvion works by replacing factor IX, which temporarily helps your blood to clot properly.

How is Idelvion supplied (dosage forms)?

Brands and other names

  • Idelvion

Dosage forms and strengths

  • 250 IU single-dose vials
  • 500 IU single-dose vials
  • 1000 IU single-dose vials
  • 2000 IU single-dose vials
  • 3500 IU single-dose vials

How should I store Idelvion?

If you or a caregiver will store Idelvion at home, store the vial in the box until you are ready to use the medicine. Store Idelvion in the refrigerator, between 36 F and 46 F (2 C and 8 C), or at room temperature, up to 77 F (25 C). Do not freeze. Throw away after the expiration date on the carton or vial. 

Once the medicine is prepared for use, use it within four hours or throw it away. 

Side Effects

What are the most common side effects of Idelvion?

The most common side effects of Idelvion are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Dizziness
  • Allergic reactions (see below)
  • Rash

There may be other side effects of Idelvion 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 Idelvion?

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

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

  • Breathing problems or wheezing
  • Racing heart
  • Chest tightness
  • Low blood pressure
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Antibodies. Your body may make antibodies (proteins made by your immune system to attack a foreign substance) against Idelvion while you are using it. These antibodies can keep Idelvion from working the way it should. Your health care provider may do blood tests to monitor your factor IX levels and look for these antibodies. Keep all of your appointments, including those for lab tests, while you are using it. Tell your health care provider if you are bleeding more often or Idelvion does not seem to be working as well as it used to. 

Blood Clots. Idelvion may cause blood clots 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 venous thrombosis (DVT). You may be at higher risk for blood clots if you have certain health conditions. Stop using Idelvion 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
  • 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
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Warnings & Precautions

Who should not use Idelvion?

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

  • Factor IX, recombinant/albumin fusion protein
  • Hamster proteins
  • Idelvion
  • Any of the ingredients in the specific product dispensed

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

What should I know about Idelvion before using it?

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

This medicine is given into one of your veins. If you use Idelvion at home, read and follow the “Instructions for Use” that come with the medicine. Make sure that you or a caregiver understands how to properly prepare and use Idelvion. 

Most people use Idelvion to prevent bleeding episodes. You may also use it to treat bleeding. The dose you use to prevent bleeding and to treat bleeding may be different. When you treat bleeding your dose may depend on where the bleeding is coming from. If you have any questions about this, talk to your health care provider. 

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

Keep Idelvion 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.

Your health care provider will likely monitor your blood test results while you are using Idelvion. Keep all appointments to have your blood checked.

Idelvion contains small amounts of hamster proteins. It may cause you to have an allergic reaction to hamster proteins. Talk to your health care provider if you have concerns.

If you are using Idelvion at home to treat a bleeding episode, call your health care provider or get medical care right away if your bleeding does not stop. 

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

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 Idelvion 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
  • Planned surgery
  • History of blood clots, including a deep vein thrombosis (DVT), heart attack, or stroke
  • Have antibodies or inhibitors to factor IX

Other Medicines and Supplements. Idelvion may interact with other medicines and supplements. Before using Idelvion, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Idelvion could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Idelvion 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 Idelvion while breastfeeding.

How can I get more information about Idelvion?

For more information about Idelvion, you can visit the drugmaker’s website at www.idelvion.com or call them at 800-676-4266.

Interactions

Does Idelvion interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Idelvion. Alcohol can increase your risk of bleeding. The risk of dizziness may increase if you drink alcohol while using Idelvion. It is best to limit the amount of alcohol that you drink.

Does Idelvion interact with other medicines (drug interactions)?

Idelvion may interact with certain medicines. 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.

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 Idelvion?

If you or someone else has used too much Idelvion, 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 Idelvion?

Missing doses of Idelvion can cause it to not work as well. So, it is important not to miss or skip doses.

If a health care provider gives you Idelvion, your health care provider will make sure you are receiving it as scheduled. If you miss an appointment to get your Idelvion dose, call to make another appointment as soon as possible. 

If you get your Idelvion doses at home and miss a dose, call your health care provider for instructions.