Safety and Tolerability

Safety profile

  • In clinical trials, a similar safety profile was observed between fibryga and an active control comparator product1,2
  • No seroconversions for HIV, HAV, HBV, HCV, or
    Parvo B191-3
  • Most common adverse reactions (> 5% of subjects) were vomiting, weakness and pyrexia (fever). Adverse events were generally mild, single events1-3

The most serious adverse reactions that may potentially be observed with fibryga are thromboembolic episodes and anaphylactic type reactions.3

Clinical trials experience1-3

In clinical trials, the most common adverse effects (>5% of subjects) were vomiting, weakness and pyrexia (fever). Adverse effects were generally mild, single events.  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 the rate in the clinical trials of another drug and may not reflect the rates observed in practice.1

In the FORMA-01 trial, a similar safety profile was observed between fibryga and the active control1

  • Adverse events (AEs) generally occurred as mostly mild, single events, with similar incidence
    and severity between treatment arms (see Table)
  • Separate occurrences of mild pyrexia and a mild allergic reaction occurred in two patients and were considered possibly related to fibryga
  • One severe AE (urinary tract infection) occurred 6 days after infusion and one patient experienced two serious AEs on the same day (abdominal pain and vaginal hemorrhage) 25 days after infusion, but these events were not considered treatment-related
  • There were no deaths, or severe allergic reactions in the study, nor were there seroconversions (for HIV, HAV, HBV, HCV or parvovirus B19) related to either treatment
Summary of AEs in the fibryga FORMA-01 Trial1,2
N (%) of patients, Number of events
Fibryga Active Control
AEs 11 (50.0), 25 11 (50.0), 30
Mild
Moderate
Severe
8 (36.4), 15
4 (22.7), 9
1 (4.5), 1
9 (40.9), 26
3 (13.6), 4
0
Probably or possibly related AE 2 (9), 2 0
AE leading to withdrawal 0 0
SAE 1 (4.5), 2 0
Death 0 0
Summary of AEs (safety population)* in the fibryga FORMA-02 Trial2,3
Number of AEs
AE 16
Patients with AE, N (%) 7 (53.8)
Mild
Moderate
Severe
13
1
2
Relatedness to treatment (probably or possibly related) 1§
AE leading to discontinuation 0
Death 0

*N=38 infusions in 13 patients. Unless otherwise indicated, numbers are the number of AEs.
AEs include TEAEs, occurring between the start of the first fibrinogen concentrate infusion and the end of each 30-day observation and follow-up period, and non-TEAEs, AEs occurring outside of the follow-up period.
Patella fracture and ligament rupture of the left knee in one patient due to a fall.
§Mild skin reaction (itchiness and redness).
AE=adverse event; SAE=serious adverse event; TEAE=treatment-emergent AE.

  • In total, 16 AEs in seven patients (53.8%) were reported. Of these, the majority (81.3%) were mild
  • One patient had a mild skin reaction (itchiness and redness) after fibryga administration for a bleeding episode and was treated with diphenhydramine and hydrocortisone. Thereafter, the patient received another infusion of fibryga for the treatment of the same bleeding episode and another fibryga infusion for surgical prophylaxis during the next week. For both of those fibryga infusions the patient was treated with diphenhydramine and hydrocortisone prophylactically and did not experience any drug reactions
  • Of the one moderate and two serious AEs reported, none were related to treatment. No deaths or severe allergic reactions were reported.
References:
  1. Ross C, Rangarajan S, Karimi M, et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb Haemost. 2018;16:253-261.
  2. Fibryga full Prescribing Information. Hoboken,  NJ: Octapharma USA, Inc.; rev 2017.
  3. Lissitchkov T, Madan B, Djambas Khayat C, et al. Efficacy and safety of a new human fibrinogen concentrate in patients with congenital fibrinogen deficiency: an interim analysis of a Phase III trial. Transfusion. 2018;58:413-422.