SELECTED IMPORTANT SAFETY INFORMATION: KOVALTRY®
is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins.
*Co-pay program support is available for up to 1 year. Can include any out-of-pocket prescription costs, such as co-pay and co-insurance. Up to $20,000 in co-pay assistance available per year. Eligible patients will be auto-enrolled every January.
†Patients who are enrolled in any type of government insurance are not eligible. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.
‡Participation in the KOVALTRY Free Trial Program is limited to 1 time only per product (patients currently using KOVALTRY are not eligible for a Free Trial of their current product). The Free Trial Program includes 1 month supply up to a maximum of 40,000 IU. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.
§The medication provided through this program is at no cost to the patient and is not contingent on future use of this medication. Reselling or billing any third party for free product provided by this program is prohibited by law.
¶Formulary status is believed to be accurate as of January 1, 2022 but cannot be guaranteed. Formulary status for national plans may not reflect plan variation at the local level. Lower co-pay costs do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative cost. Formulary status does not imply a comparison of efficacy, safety, or dosing.
#KOVALTRY coverage includes pharmacy and medical lives across commercial (99%), fee-for-service Medicaid (100%), Managed Medicaid (100%) & Medicare Advantage (100%). Percentage represents the plan coverage within the book of business: n=1,798; 51; 410; 1,112.
INDICATION FOR KOVALTRY®
KOVALTRY® Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes
KOVALTRY is not indicated for the treatment of von Willebrand disease.
IMPORTANT SAFETY INFORMATION
KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins.
Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY if symptoms occur and seek immediate emergency treatment.
KOVALTRY may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
Neutralizing antibody (inhibitor) formation has occurred following administration of KOVALTRY. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all Factor VIII products. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor.
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
Catheter-related infections may occur when KOVALTRY is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.
The most frequently reported adverse reactions in clinical trials (≥5%) were inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs), and pyrexia, headache, and rash.
For additional important risk and use information, please see.