As with the intravenous administration of any protein product, the following reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. During clinical studies with ReFacto® Antihemophilic Factor (Recombinant), 77 adverse reactions in 43 of 218 patients (20%) probably or possibly-related to therapy were reported for 64,363 infusions (0.12%). These were anaphylaxis (1), dyspnea (6), urticaria (1), nausea (11), headache (4), vasodilation (5), dizziness (4), permanent venous access catheter complications (3), asthenia (3), fever (3), taste perversion [altered taste] (3), bleeding/hematoma (3), infected hematoma (1), anorexia (2), diarrhea (2), injection site reaction (2), somnolence (2), rash (2), pruritus (2), angina pectoris (1), tachycardia (1), perspiration increased (1), chills (1), increased amino transferase (1), increased bilirubin (1), pain in finger (1), muscle weakness (1), CPK increase (1), cold sensation (1), eye disorder-vision abnormal (1), coughing (1), myalgia (1), gastroenteritis (1), abdominal pain (1), acne (1), and forehead bruises (1). If any adverse reaction takes place that is thought to be related to administration of ReFacto, the rate of infusion should be
decreased or stopped.
Inhibitor development is a known adverse event associated with the treatment of patients with hemophilia A. In addition to the one report of high titer inhibitors in the clinical study of PTPs (see CLINICAL PHARMACOLOGY), there have been reports of high titer inhibitors in PTPs in the post-marketing setting. High and low titer inhibitors have been reported in PUPs in both clinical trials and the post-marketing setting (see PRECAUTIONS, General).
A total of 182 adverse reactions in 54 of 218 patients (25%) who received 32,013 infusions (0.6%) were reported by the investigator to have an "unlikely" or "not assessable" relationship to ReFacto administration. The study sponsor considered that the events may be of possible or of unknown relationship to therapy because of the temporal relationship to the infusion and/or the frequency of the event for a given patient and/or because insufficient information was available to assign another causality. In this category, 25 patients experienced the following 38 events which are different from the events described above: pain (10), rhinitis (10), vomiting (4), insomnia (3), constipation (2), pharyngitis (2), flushing (1), palpitation (1), sinusitis (1), gastritis (1), dyspepsia (1), hypotension (1), and URI (1).
Other adverse experiences that were reported during the clinical trials, but which were assessed by both the investigator and the sponsor as "unlikely" to be related to ReFacto administration included: dyspnea (3), rash (2), pruritus (1), neuropathy (1), arm weakness (1), and thrombophlebitis of upper arm (1).
REPORTS OF SUSPECTED REFACTO SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Refacto. The information is not vetted and should not be considered as verified clinical evidence.
Possible Refacto side effects / adverse reactions in 31 year old male
Reported by a physician from France on 2011-10-04
Patient: 31 year old male weighing 78.0 kg (171.6 pounds)
Reactions: Factor Viii Inhibition
Dosage: 3000 iu every twelve hours for ten days
Dosage: 3000 iu, 1x/day
End date: 2010-12-29
Dosage: 400 iu, 2x/day, just before surgery
Indication: Factor Viii Deficiency
Start date: 2010-12-17
Dosage: 3000 iu every eight hours for 24 hours after surgery
Indication: Intervertebral Disc Protrusion
Possible Refacto side effects / adverse reactions in 20 year old male
Reported by a consumer/non-health professional from United Kingdom on 2011-11-14
Patient: 20 year old male
Reactions: Malaise, Haemorrhage
Possible Refacto side effects / adverse reactions in 14 month old male
Reported by a physician from United Kingdom on 2011-11-16
Patient: 14 month old male
Reactions: Factor Viii Inhibition