REBINYN SIDE EFFECTS
- Generic Name: coagulation factor ix (recombinant)
- Brand Name: Rebinyn
- Drug Class: Hemostatics, Clotting Factors, Gene Therapy
Common adverse reactions (incidence ≥ 1%) reported in clinical trials for REBINYN were itching and injection site reactions.
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 clinical trials of another drug and may not reflect the rates observed in clinical practice.
During the clinical development program, 115 previously treated male patients received at least one dose of REBINYN.A previously treated patient was defined as a subject with a history of at least 150 exposure days to other Factor IX products (adolescent/adult subjects) or 50 exposure days to other Factor IX products (pediatric subjects), and no history of inhibitors. There were a total of 8801 exposure days, equivalent to 170 patient-years. A total of 40 patients (35%) were treated for more than 2 years. Adverse reactions are shown in Table 1.
Table 1: Summary of Adverse Reactions in Previously Treated Patients
|System Organ Class||Adverse Reaction||Number of subjects (%)|
|General disorders and administration site conditions||Injection site reactions||4 (4)|
|Immune system disorders||Hypersensitivity||1 (1)|
|Skin and subcutaneous tissue disorders||Itching||3 (3)|
Subjects were monitored for inhibitory antibodies to factor IX prior to dosing, on a monthly basis for the first three months, every two months up to one year, every three months for an additional year, and then every 6 months until end of trial.
No inhibitors were reported in the clinical trials in previously treated patients.
In an ongoing trial in previously untreated patients, anaphylaxis has occurred with development of a factor IX inhibitor following treatment with REBINYN. Inhibitor development and anaphylactic reactions are more likely to occur during the early phases of factor IX replacement therapy.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
Animals administered repeat doses of REBINYN showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown. The physician should consider whether the patient may be vulnerable, such as infants and children who have developing brains and patients who are cognitively impaired. Physician’s discretion is advised with regard to neurocognitive assessments, taking into consideration factors such as duration of use, cumulative dose, age of the patient and related comorbidities that are likely to increase the risks to patients. Adverse neurologic reactions should be reported.
SRC: NLM .