Idelvion

IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), is an antihemophilic factor indicated in patients with hemophilia B (congenital FIX deficiency) or Christmas disease for:

• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• Control and prevention of bleeding episodes
• Control and prevention of bleeding in the perioperative setting

Studies described in this monograph have been performed only in previously treated patients (PTPs).

See subsection Special Population, under Section WARNINGS AND PRECAUTIONS.

See subsection Special Population, under Section WARNINGS AND PRECAUTIONS.

No symptoms of overdose with IDELVION have been reported.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Adverse Drug Reaction Overview

The most common adverse reaction (incidence ≥ 1%) reported in clinical trials was headache.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

In 4 multicenter, prospective, open-label clinical trials with IDELVION, 107 previously treated patients (PTPs, exposed to a FIX-containing product for ≥ 100 exposure days) were evaluated. A total of 6,384 injections were administered over a median of 469 days (range: 25 to 986 days), with a median 3000 IU per injection (range: (138.9-10,570.0 IU). The median total amount of rIX-FP administered was 127,110.0 IU (range: 1900.0-999,051.4).

Two subjects withdrew from the study due to an adverse reaction (headache, infusion related reaction). No neutralizing antibodies (inhibitors) to FIX or antibodies to CHO host cell protein have been detected with the use of IDELVION. No events of anaphylaxis or thrombosis were reported.

Related Adverse Events were reported in 8 of 107 (7.5%) subjects. Out of these 8 cases, 5 cases were considered to be Adverse Reactions (ARs) and are listed in Table 1.

Table 1: Summary of Adverse Reactions

One previously untreated patient from the ongoing clinical trial reported low-titer inhibitor against factor IX. There are insufficient data to provide information on inhibitor incidence in PUPs.

Read the entire FDA prescribing information for Idelvion (Coagulation Factor IX (Recombinant) Albumin Fusion Protein Lyophilized Powder Intravenous Injection )

Coagulation factor IX is a man-made protein similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VIII deficiency.

Coagulation factor IX may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if:

• you have had an allergic reaction to clotting factor medicine;

• you have signs of excessive blood clotting; or

• you are allergic to hamster proteins.

To make sure coagulation factor IX is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• coronary artery disease (hardening of the arteries); or

• history of heart attack or stroke.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using coagulation factor IX.

It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Coagulation factor IX is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Other drugs may interact with coagulation factor IX, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) has the following uses:

Coagulation factor IX (recombinant), albumin fusion protein (rIX-FP), a recombinant human blood coagulation factor, is indicated in children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. 1

Coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) has the following limitations of use:

Coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) is not indicated for immune tolerance induction in patients with hemophilia B.1

Patient Counseling Information

Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).1

Advise patients to report any adverse reactions or problems following coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) administration to their healthcare provider.1

Inform patients of the early signs and symptoms of hypersensitivity or allergic reactions (including hives, generalized urticaria, chest tightness, wheezing, and hypotension). Instruct patients to discontinue use of coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) and contact their healthcare provider and/or seek immediate emergency care if these symptoms occur.1

Advise patients to contact their healthcare provider or hemophilia treatment center for further treatment and/or assessment if they experience a lack of clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor.1

Use Idelvion as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• This medicine may be given at home.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• Use within 4 hours of making.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.