Medical Editor: John P. Cunha, DO, FACOEP
Ixinity [coagulation factor IX (recombinant)] is a coagulation factor IX (recombinant) indicated in adults and children 12 years of age or older with hemophilia B for control and prevention of bleeding episodes, and for perioperative management. Ixinity is not indicated for induction of immune tolerance in patients with hemophilia B. Common side effects of Ixinity include:
- allergic reactions which may be severe (skin swelling, chest tightness, low blood pressure, lethargy, nausea, vomiting, tingling or pricking sensation, restlessness, wheezing, and shortness of breath),
- injection site discomfort,
- weakness or lack of energy,
- changes in taste,
- depression, or
- itchy rash.
Dosage and duration of treatment for factor IX products such as Ixinity depend on the severity of the factor IX deficiency, the location and extent of bleeding, the patient's clinical condition, age, and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life. Ixinity may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ixinity should only be administered if prescribed. It is unknown if Ixinity passes into breast milk. Consult your doctor before breastfeeding.
Our Ixinity [coagulation factor IX (recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The most common adverse reaction (> 2%) reported in clinical trials was headache.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 14 adverse reactions were reported following IXINITY administration among 6 of the 77 subjects who received at least one dose of IXINITY in trials of previously treated patients (PTPs), which included 11 subjects < 18 years of age. A total of 9641 infusions of IXINITY were administered to the 77 subjects. The adverse reactions that were assessed as probably or possibly related to study drug are provided in the table below.
Table 3 Summary of Adverse Reactions
|MedDRA Standard System Organ Class||Adverse Reaction||Number of Events||Number of Subjects
(n = 77)
Congenital, familial and genetic disorders
General disorders and administration site conditions
Infections and infestations
|Hemophilia (i.e. lack of efficacy)||1||1 (1.3%)|
|Injection site discomfort||1||1 (1.3%)|
|Nervous system disorders||Headache||5||2 (2.6%)|
|Psychiatric disorders||Apathy||1||1 (1.3%)|
|Skin and subcutaneous tissue disorders||Rash pruritic||1||1 (1.3%)|
All subjects participating in the clinical trial were monitored for inhibitory and non-inhibitory antibodies to factor IX and antibodies for CHO proteins at the following time points; pre-infusion, after the first 5 exposure days, and then every 3 months thereafter.
No subjects in IXINITY clinical trials developed inhibitors to factor IX, including 55 subjects with more than 50 exposure days and 45 of those subjects with more than 100 exposure days. Non-inhibitory factor IX binding antibodies were detected in 30% (23/77) of subjects, including 5 subjects positive at baseline. In three of the subjects, the non-inhibitory factor IX antibodies were persistent, while in the remainder the antibodies were sporadic and non-persistent. No clinical adverse findings related to non-inhibitory factor IX antibody formation were identified. Detection of non-inhibitory antibodies against factor IX has been reported following administration of other factor IX products. The clinical significance of this finding is unknown.
In IXINITY clinical trials, 29% (20/68) of subjects tested positive for antibodies against CHO cell proteins. No clinical adverse findings were associated with these antibodies. Reports have been published of sporadic detection of antibodies against CHO cell proteins in subjects treated with other recombinant coagulation factor products produced in CHO cells, as well as in non-hemophilic subjects (2). The clinical significance of this is unknown. The manufacturing process for IXINITY was modified to include an additional step to ensure increased clearance of CHO proteins to address the anti-CHO protein response seen in clinical trials. The anti-CHO protein response status of the clinical trial subjects who transitioned to the modified product (n = 17) remained negative (n = 10), stable/nonspecific assay binding (n = 5), or declined (n = 2) after the transition to modified IXINITY for at least 3 months.
The detection of antibody formation is dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection and concomitant medications. For these reasons, comparisons of the incidence of antibodies to IXINITY with the incidence of antibodies to other products may be misleading.
Read the entire FDA prescribing information for Ixinity ([Coagulation Factor IX (Recombinant)] for Injection)