Gain Control
In the Treatment of Congenital Fibrinogen Deficiency (CFD)
Indications and Usage
Fibryga® is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Fibryga is not indicated for dysfibrinogenemia.
Please see Important Safety Information throughout.
Please see enclosed full Prescribing Information.
Gain Control When You Need It Most
n Fibryga® supplements missing coagulation factor or increases low plasma fibrinogen levels in patients with CFD1
n Effective in restoring clot strength (maximum clot firmness)1,2
n 99% successful efficacy outcome in treating bleeding episodes in adolescents and adults1,3
n Fibryga achieved 100% successful efficacy outcome in treating BEs in pediatric patients1,4
Efficacy of Fibrinogen Concentrate for On-demand Treatment of Bleeding Episodes in Adults and Adolescents in FORMA-02 (N = 89 BEs in 24 Patients)3
Fibryga® Significantly Increased Clot Strength, as Measured by MCF, Using Surrogate Markers for Hemostatic Efficacy1,2
n For every patient treated with fibryga, MCF values significantly increased after administration, with a mean change of 9.7 mm at 1-hour post-infusion
Efficacy of Fibrinogen Concentrate for On-demand Treatment of Bleeding Episodes in Children in FORMA-04 (N = 10 BEs in 8 Patients) 4
*Analyses that excluded 2 minor BEs showed no impact on overall hemostatic efficacy (86 of 87 [98.9%] evaluable bleeding episodes rated as treatment success by IDMEAC).
Success rate is a rating of excellent/good, with 90% confidence intervals calculated according to the Blyth–Still–Casella interval for the proportion of patients with successful hemostatic efficacy.
BE = bleeding episode; IDMEAC = Independent Data Monitoring and Endpoint Adjudication Committee; N = number of BEs.
n 93% of bleeding episodes required a single infusion only1,3
Important Safety Information
Contraindications
Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to Fibryga or its components.
Adverse Reactions
The most serious adverse reactions that may be observed with Fibryga are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with Fibryga (> 5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis.
For one patient, the hemostatic efficacy assessment was missing. As per the statistical analysis plan, the rating by the investigator was designated as “None”. The success rate was a rating of excellent/good, with 95% confidence intervals calculated by the Clopper Pearson Method.
n For 100% of minor bleeds, just a single infusion of fibryga was needed to achieve control
= maximum clot firmness.
FOR THE FIRST TIME IN THIS RARE
DISEASE
SETTING, robust analysis methodology using objective efficacy criteria was implemented, demonstrating the hemostatic efficacy of fibryga.5
Phase II/Phase III Clinical Trials: Pharmacokinetics and Safety
Pharmacokinetic (PK) Profile
n Fibryga® demonstrated a similar PK profile for fibrinogen concentration compared to an active control, achieving levels well within the recommended target range of 1 to 1.5 g/L 2
Safety Profile Observed in Fibryga and Active Control Phase II and Phase III Clinical Trials
n Most common adverse effects (AEs) (>5% of subjects) were nausea, vomiting, pyrexia (fever), and thrombocytosis1-3
n AEs were generally mild, single events1,3
n No deaths or severe allergic reactions were reported1-4
n No clinical evidence of neutralizing antifibrinogen antibodies1-4
FORMA-02 trial2,3
n In total, 91 AEs in 19 patients (76.0%) were reported
n Three AEs in three patients were considered possibly related to treatment: a moderate AE reported as exacerbation of a preexisting condition of peripheral ischemia due to digital microthrombi, a mild skin reaction, and a mild AE reported as peripheral phlebitis of the upper limbs, all of which resolved
Important Safety Information
Warnings and Precautions
FORMA-04 trial1,4
n In total, 10 AEs in 4 patients (28.6%) were reported
n Two AEs in one patient were considered possibly related to treatment: portal vein thrombosis (PVT) and fever (pyrexia). The PVT was rated as a serious AE (SAE) and occurred after a splenectomy for spontaneous spleen rupture. The SAE was assessed as possibly related to fibryga while taking into consideration that PVT is a regular complication of splenectomy. The SAE led to the discontinuation of the patient from the study
Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving Fibryga® Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. Fibryga is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Please
Dosing and Convenience
Dosing and Reconstitution
n Fibryga® is a sterile, lyophilized powder for reconstitution for intravenous injection, provided in single-use bottles containing approximately 1 g fibrinogen concentrate
n Dosing is individualized based on clinical condition of patient, location/extent of bleeding, and laboratory values
– Functional fibrinogen level should be determined to calculate dosage
n Dose (mg/kg body weight) when fibrinogen level is known:
Adults and adolescents ≥12 years of age:
[Target fibrinogen level (mg/dL) - measured level (mg/dL)]
1.8 (mg/dL per mg/kg body weight)
Children 0 to <12 years of age: [Target fibrinogen level (mg/dL) - measured level (mg/dL)]
1.4 (mg/dL per mg/kg body weight)
Recommended target fibrinogen plasma levels: 100 mg/dL (minor bleeds); 150 mg/dL (major bleeds)
n Dose when fibrinogen level is unknown: 70 mg/kg body weight
n The injection rate should not exceed 5 mL per minute
n Monitoring of patient’s fibrinogen level is recommended during treatment
n Each fibryga package contains:
− 1 single-use bottle of fibryga concentrate
− 1 transfer device (Octajet®)
− 1 17-micron particle filter
n Reconstitute fibryga with 50 mL of sterile water for injection
Convenience in Clinical Practice
n Rapid reconstitution in approximately 5-10 minutes1
n Convenient transfer device with protective vacuum seal (Octajet)
n Storage at +2 °C to +25 °C for up to 30 months1
Fibrinogen Concentrate Is the Preferred Choice for Fibrinogen Replacement in CFD1
n Fibrinogen concentrate offers a broad range of advantages versus cryoprecipitate and fresh frozen plasma, including viral safety, efficacy, and convenience6-10
Fibryga® Is a Human Plasma-Derived, Purified, Virus-Inactivated and Nanofiltered Fibrinogen Concentrate1
n Sterile, freeze-dried preparation of highly purified fibrinogen
n Prepared from large pools of human plasma screened via serologic and nucleic acid tests (NATs)
n Undergoes 2-step process for viral inactivation (solvent/detergent) and removal (nanofiltration)
Plasma Donors, Collection Centers, and Donated Plasma Are Held to High Standards to Assure Safety
n All units of human plasma are collected at FDA-licensed establishments
n All plasma undergoes serologic testing for Hepatitis B surface antigen, and antibodies to HCV and HIV-1/2
n Plasma is also tested with NATs for HAV, HBV, HCV, HIV-1, and B19V
– Only plasma that passed virus screening is used for production
Multistage Virus Inactivation Process Before Final Release and Use in Patients
n Fibryga manufacturing process includes a solvent/detergent step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal1
Important Safety Information Contraindications
Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to Fibryga or its components.
Adverse Reactions
The most serious adverse reactions that may be observed with Fibryga are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with Fibryga (> 5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis.
The Only HFC That Offers Eligible Patients Co-Pay Assistance Up to $10,000 Per Calendar Year
The Octapharma Co-Pay Assistance Program provides eligible patients with commercial insurance currently using fibryga, or who have a prescription to begin therapy, up to $2500 on out-of-pocket costs associated with fibryga—and up to $10,000 in a calendar year with 3 renewals. This can be applied to co-payments, deductibles, and co-insurance subject to plan requirements.
Octapharma also provides free assistance with reimbursement, including:
n Individual insurance claims processing reviews
n A ssistance in appeals
n Insurance benefits investigations into product coverage
n Gaining approvals for prior authorizations for fibryga
Call the Octapharma Support Center at 1-800-554-4440 for more information on co-pay assistance and reimbursement
