Idelvion (coagulation factor IX [recombinant], albumin fusion protein)

Idelvion generic

Idelvion is available only as a brand-name biologic medication. It’s not currently available in a biosimilar form. A biosimilar medication is a drug that’s similar to a brand-name biologic drug. Biosimilars are like generics, but they aren’t exact copies because biologics are made from living cells. Generic drugs, which are made from chemicals, contain exact copies of the active ingredients in non-biologic drugs.

Idelvion dosage

The Idelvion dosage your doctor prescribes will depend on several factors. These include:

• the severity of your condition
• the severity of your bleeding episode (minor, moderate, or major) and the location of your bleeding
• your risk level for having a bleeding episode (for instance, your risk of bleeding may be higher with a major surgery and lower with a minor procedure)
• your age
• your body weight in kilograms (kg)

For reference, one kg is about 2.2 pounds (lb).

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Idelvion is given as an intravenous (IV) injection (a slow injection given directly into a vein). It’s usually administered by a doctor or other healthcare professional in a hospital or clinic. In some cases, you or a caregiver can give Idelvion doses at home after receiving proper training.

Idelvion comes as a powder in a single-use vial. Each vial of Idelvion comes in a kit with sterile water and other supplies that are used to prepare the injection. It is available in the following strengths:

• 250 international units (IU)
• 500 IU
• 1000 IU
• 2000 IU
• 3500 IU

Dosage for on-demand treatment of bleeding episodes

Idelvion is used to treat bleeding episodes in people with hemophilia B. For this use, the dosage depends on the severity of the bleeding. The recommended dosage is one dose every 48 to 72 hours until bleeding stops.

A single dose of Idelvion is usually enough for minor or moderate bleeding episodes. Examples of these include mouth bleeding or bleeding into a joint. But for major or life threatening bleeding, Idelvion treatment may continue for 7 to 14 days until your bleeding stops.

Your doctor will calculate your exact dose based on your body weight and how much is needed to raise your factor IX (roman numeral nine) levels to stop the bleeding.

Your doctor may adjust your dosage based on how you respond to treatment.

Dosage for managing bleeding from surgery

Idelvion is used to manage bleeding from surgery in people with hemophilia B. For this use, the dosage depends on the type of surgery. The recommended dosage is one dose every 48 to 72 hours until any bleeding stops.

A single dose of Idelvion is usually enough for minor surgeries, such as having a tooth pulled. But for major surgeries, Idelvion treatment may continue for 7 to 14 days or until any bleeding stops. You’ll likely receive one dose every 48 to 72 hours for the first week, followed by one dose given once or twice per week.

In Idelvion’s studies, most people received a single dose before their surgery and did not need additional doses.

Your doctor will calculate your exact dose based on your body weight and how much is needed to raise your factor IX levels to manage your risk of bleeding from surgery.

Your doctor may adjust your dosage based on how you respond to treatment.

Dosage to help prevent bleeding episodes

Idelvion is used to help prevent bleeding episodes in people with hemophilia B. For this use, the recommended dosage for adults and children ages 12 years and older is 25 IU to 40 IU of Idelvion per kg of body weight, given once every 7 days.

If Idelvion is working well to reduce how often you have bleeding episodes, your doctor may recommend a less frequent dosage option. This is 55 IU to 75 IU of Idelvion per kg of body weight, given once every 14 days.

If you inject the drug at home, your doctor will tell you how much to inject and how often.

Children’s dosage

Idelvion is used to treat, manage, and help prevent bleeding episodes in children of all ages with hemophilia B. Children ages 12 years and older typically follow the same Idelvion dosages as adults.

Your child’s doctor will calculate the exact dosage. This amount will be based on your child’s body weight and how much is needed to raise the factor IX levels to stop bleeding or manage bleeding risk from surgery.

To help prevent bleeding episodes in children younger than ages 12 years, the recommended dosage of Idelvion is 40 IU to 55 IU of Idelvion per kg of body weight, given once every 7 days. Your child’s doctor may adjust the dose or frequency based on how your child responds to the drug.

If you inject the drug at home, your doctor will tell you how much to inject and how often.

How to inject

Idelvion is given as an intravenous (IV) injection (a slow injection given directly into a vein). It’s usually administered by a doctor or other healthcare professional in a hospital or clinic.

In some cases, you or a caregiver may be able to administer Idelvion doses at home after receiving proper training. Idelvion comes in a kit with sterile water and other supplies that are used to prepare the injection. If you inject Idelvion at home, you will also need syringes and needles. (They are not included in the kit.) If you inject the drug at home, your doctor will tell you how much to inject and how often.

You can learn more about Idelvion administration by talking with your doctor or visiting the manufacturer’s website.

About taking Idelvion

Below you’ll find information about key dosage issues.

• If you miss a dose: If you use Idelvion to help prevent bleeding episodes and miss a dose, contact a healthcare professional. They can advise you on when to take your next dose.
• Length of use: Idelvion may be used as a short-term or a long-term treatment. For treating bleeding episodes and managing bleeding after surgery, it’s usually a short-term treatment. For helping to prevent bleeding episodes, it’s meant to be a long-term treatment. Talk with your doctor to determine how long you’ll need to use Idelvio.
• Length of time to work: Idelvion starts working right away. It may take one day or up to 7 to 14 days to become fully effective. The amount of time varies because it depends on whether Idelvion is being used to treat an active bleeding episode, manage bleeding from surgery, or help prevent bleeding episodes. Your doctor will monitor your bleeding. They will also do a blood test to check that the medication is working to reach and maintain the goal levels of clotting factor IX in your blood.

Overdose

Do not use more Idelvion than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Idelvion

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Idelvion side effects

Idelvion can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Idelvion. These lists do not include all possible side effects.

For more information about the possible side effects of Idelvion, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Idelvion, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Idelvion. To learn about other mild side effects, talk with your doctor or pharmacist, or view Idelvion’s prescribing information.

Mild side effects of Idelvion can include:

• headache
• dizziness
• rash
• eczema

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects may occur with Idelvion. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Hypersensitivity reaction, a severe allergic reaction, has rarely occurred in studies of Idelvion. However, no other serious side effects have been reported.

The following serious side effects and symptoms have been reported with the use of medications that are similar to Idelvion, which means there’s a chance these could occur with Idelvion:

• blood clots, which may include symptoms such as:
  • pain, warmth, or swelling in your leg or arm
  • difficulty breathing
• a kidney problem called nephrotic syndrome, which may include symptoms such as:
  • swelling in the legs and feet due to edema (fluid retention)
  • sudden weight gain from fluid retention
  • foamy urine

Side effects in children

In studies, the safety and side effects of Idelvion in children were similar to its safety and side effects in adults.

ALLERGIC REACTION

Idelvion can cause an allergic reaction. This was a common side effect in the drug’s studies.

In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Idelvion, your doctor may recommend taking a different medication instead.

Idelvion uses

The Food and Drug Administration (FDA) approves prescription drugs such as Idelvion to treat certain conditions. Idelvion may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Idelvion for hemophilia B

Idelvion is FDA approved for the following uses in adults and children with congenital (born with the condition) hemophilia B to:

• treat active bleeding episodes when they occur, which is also called “on-demand” treatment
• manage bleeding from surgery
• help prevent bleeding (also called routine prophylaxis), so that bleeding episodes occur less often

Hemophilia B is a rare genetic condition in which your body doesn’t have enough of a certain protein needed for blood clotting. This protein is called coagulation factor IX, also known as clotting factor IX. People with hemophilia B bleed longer than others because their blood can’t clot as well. When bleeding starts and takes a while to stop (or won’t stop), it’s called a bleeding episode.

Hemophilia B can range from mild to severe depending on the activity level of factor IX. In mild cases, bleeding episodes may only occur after an injury or surgery. However, in more severe cases, bleeding can happen often and even spontaneously (at any time, for no clear reason).

Idelvion is not approved for immune tolerance induction in people with hemophilia B. This means the drug is not meant to help the immune system stop rejecting certain treatments.

Idelvion and children

Idelvion is FDA approved to treat, manage, and help prevent bleeding episodes in children of all ages with hemophilia B.

Idelvion interactions

Idelvion is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the drug’s prescribing information.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Idelvion.

Before starting Idelvion treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Idelvion cost and coupons

As with all medications, the cost of Idelvion can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Idelvion or if you need help understanding your insurance coverage, help is available.

A program called Idelvion Connect is available for Idelvion. For more information and to find out if you’re eligible for support, call 800-676-4266 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic or biosimilar version: Idelvion is not available in a biosimilar form. A biosimilar is a drug that’s similar to a biologic, but it can’t be exactly copied because biologics are made from living cells. Biosimilars are safe, effective, and often cheaper, like generics, which are exact copies of traditional, chemical-based drugs.

To learn more about saving money on prescriptions, check out this article.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Idelvion, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Idelvion in that they all contain a recombinant (synthetic) form of coagulation (clotting) factor IX:

• Alprolix
• BeneFIX
• Ixinity
• Rebinyn
• Rixubis

Things to consider when taking Idelvion

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Idelvion and pregnancy

It’s not known whether Idelvion should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

Idelvion and breastfeeding

It’s not known whether Idelvion should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication.

Common questions about Idelvion

Here are answers to some frequently asked questions about Idelvion.

How does Idelvion work?

People with hemophilia B have a deficiency of a certain protein needed for blood clotting. This protein is called coagulation factor IX (roman numeral nine), also known as clotting factor IX. People with hemophilia B bleed longer than others because their blood can’t clot as well. When bleeding starts and takes a while to stop (or won’t stop), it’s called a bleeding episode.

Idelvion contains a recombinant (synthetic or lab-made) version of clotting factor IX, which helps your blood clot properly. It works by replacing the missing or low levels of factor IX in people with hemophilia B. This treats and helps to prevent bleeding episodes, including those related to surgery.

Talk with your doctor if you have questions about what to expect with Idelvion treatment.

How does Idelvion compare with Alprolix?

Both Idelvion and Alprolix are used to treat and help prevent bleeding episodes in people with hemophilia B. They both work the same way by replacing clotting factor IX.

However, Idelvion lasts longer in the body, which means it may require less frequent dosing. For example, to help prevent bleeding episodes in adults, Alprolix is typically given once every 7 or 10 days. In comparison, Idelvion may be given once every 7 or 14 days for this purpose.

Talk with your doctor to learn more about the similarities and differences between Idelvion and Alprolix. They can help decide which option best suits your needs.