IDELVION:
THE ONLY FDA-APPROVED FIX PRODUCT
WITH FLEXIBLE 7- AND 14-DAY DOSING
The flexibility of 2 dosing schedules that meet your patients’ individual needs
With 7-day and 14-day IDELVION dosing options, you can adjust the dosing schedule based on the changing lifestyles and activities of adolescent and adult patients.
Choose the regimen that’s right for your patients and adjust based on their clinical condition and response.
*Once well-controlled (1 month without spontaneous bleeding or requiring dose adjustments on a weekly dose of ≤40 IU/kg), people 12 years and older can be transitioned to 14-day dosing.
The above information is intended for prophylactic dosing. For detailed information about surgical dosing, consult the prescribing information.
| Type of Bleeding Episode | Circulating Factor IX Activity Required (% or IU/dL) | Frequency of Dosing (hours) | Duration of Therapy (days)† |
|---|---|---|---|
| MINOR OR MODERATE Uncomplicated hemarthrosis, muscle bleeding (except iliopsoas) or oral bleeding | 30–60 | 48–72 | At least 1 day, until bleeding stops and healing is achieved. Single dose should be sufficient for majority of bleeds. |
| MAJOR Life- or limb-threatening hemorrhage, deep muscle bleeding, including iliopsoas, intracranial, retropharyngeal | 60–100 | 48–72 | 7–14 days, until bleeding stops and healing is achieved. Maintenance dose weekly. |
| Type of Bleeding Episode | |
| MINOR OR MODERATE Uncomplicated hemarthrosis, muscle bleeding (except iliopsoas) or oral bleeding | MAJOR Life or limb threatening hemorrhage, deep muscle bleeding, including iliopsoas, intracranial, retropharyngeal |
| Circulating Factor IX Activity Required (% or IU/dL) | |
| 30–60 | 60–100 |
| Frequency of Dosing (hours) | |
| 48–72 | 48–72 |
| Duration of Therapy (days)† | |
| At least 1 day, until bleeding stops and healing is achieved. Single dose should be sufficient for majority of bleeds. | 7–14 days, until bleeding stops and healing is achieved. Maintenance dose weekly. |
| Type of Surgery | Circulating Factor IX Activity Required (% or IU/dL) | Frequency of Dosing (hours) | Duration of Therapy (days)† |
|---|---|---|---|
| MINOR (including uncomplicated tooth extraction) | 50–80 | 48–72 | At least 1 day, or until healing is achieved. Single dose should be sufficient for a majority of minor surgeries. |
| MAJOR (including intracranial, pharyngeal, retropharyngeal, retroperitoneal) | 60–100 (initial level) |
48–72 | 7–14 days, or until bleeding stops and healing is achieved. Repeat dose every 48–72 hours for the first week or until healing is achieved. Maintenance dose 1–2 times per week. |
| Type of Surgery | |
| MINOR (including uncomplicated tooth extraction) | MAJOR (including intracranial, pharyngeal, retropharyngeal, retroperitoneal) |
| Circulating Factor IX Activity Required (% or IU/dL) | |
| 50–80 | 60–100 (initial level) |
| Frequency of Dosing (hours) | |
| 48–72 | 48–72 |
| Duration of Therapy (days)† | |
| At least 1 day, or until healing is achieved. Single dose should be sufficient for a majority of minor surgeries. | 7–14 days, or until bleeding stops and healing is achieved. Repeat dose every 48–72 hours for the first week or until healing is achieved. Maintenance dose 1–2 times per week. |
†Adapted from the WFH Guidelines for the Management of Hemophilia.
More vial sizes may mean less to reconstitute and infuse
5 vial sizes for optimal flexibility and efficiency
- A range of sizes to facilitate the regimen you choose
- Reconstituting is fast and simple using the Mix2Vial® needle-free reconstitution and transfer system
No refrigeration required
- May be stored at room temperature or in refrigerator (36°F–77°F). Do not freeze
- Do not store past expiration date printed on carton and vial
KIT NDC: 69911-864-02 2.5-mL diluent
KIT NDC: 69911-865-02 2.5-mL diluent
KIT NDC: 69911-866-02 2.5-mL diluent
KIT NDC: 69911-867-02 5-mL diluent
KIT NDC: 69911-869-02 5-mL diluent
Images are representations, not actual depictions of actual vials.
Mix2Vial® is a registered trademark of West Pharma Services IL, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.
When switching to IDELVION, Ray made the transition from on-demand to an extended prophylaxis regimen
“Extending dosing let me work with my doctor to develop a dosing schedule that works for me.”
Watch Ray’s full story
High and sustained Factor IX levels in clinical trials in adolescents and adults
SEE IDELVION FACTOR IX LEVELS
Patients who started and stayed on prophylaxis prove IDELVION has powerful efficacy with both 7- and 14-day dosing‡
‡Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median AsBR during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 based on matched-pairs design.
References: 1. Gill JC, Roberts J, Li Y, Castaman G. Sustained high trough factor IX activity levels with continued use of rIX-FP in adult and paediatric patients with haemophilia B. Haemophilia. 2019. doi:10.1111/hae.13735. 2. Santagostino E, Martinowitz U, Lissitchkov T, et al. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016;127(14):1761-1769. doi:10.1182/blood-2015-09-669234.