Important Safety Information
IDELVION 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
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.
IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to
the product or its components, including hamster proteins.
IDELVION is for intravenous use only. IDELVION can be self-administered or administered
by a caregiver with training and approval from a healthcare provider or hemophilia
treatment center. Higher dose per kilogram body weight or more frequent dosing may be
needed for pediatric patients.
Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients who
self-administer to immediately report symptoms of hypersensitivity, including angioedema,
chest tightness, hypotension, generalized urticaria, wheezing, and dyspnea. If symptoms
occur, discontinue IDELVION and administer appropriate treatment.
Development of neutralizing antibodies (inhibitors) to IDELVION may occur. If expected
Factor IX activity plasma levels are not attained or bleeding is not controlled with
appropriate dose, perform an assay to measure Factor IX inhibitor concentration. Factor IX
activity assay results may vary with the type of activated partial thromboplastin time
reagent used.
Thromboembolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis)
can occur when using Factor IX-containing products. In addition, nephrotic syndrome has
been reported following immune tolerance induction in hemophilia B patients with
Factor IX inhibitors and allergic reactions to Factor IX.
The most common adverse reaction (incidence ≥1%) reported in clinical trials
was headache.
Please see brief summary of full prescribing information on following page.
®
CoagulationFactor IX (Recombinant),Albumin FusionProtein