Free Trial Program*: Talk to your patients about requesting a free trial of KOVALTRY® with Vial Adapter
Patient Access to Therapy: Patients may be able to receive KOVALTRY® at no cost if they experience challenges getting insurance coverage for KOVALTRY®†
$0 Co-pay Program‡: Eligible patients can receive up to $12,000 in assistance per year
Live Helpline Support: Patients can call for answers to any insurance coverage questions†Download the Bayer Access Solutions Enrollment Form
*The KOVALTRY® Free Trial Program is available to newly diagnosed patients and patients who are currently using other therapy. Patients currently using KOVALTRY® are not eligible for the Free Trial Program. Participation in the KOVALTRY® Free Trial Program is limited to 1 time only. The medication provided through this program is complimentary and is not an obligation to purchase or use KOVALTRY® in the future. Reselling or billing any third party for the free product is prohibited by law.
†The program does not guarantee that patients will be successful in obtaining reimbursement. Support medication provided through Bayer's assistance programs is complimentary and is not contingent on future KOVALTRY® purchases. Reselling or billing any third party for free product provided by Bayer's patient assistance programs is prohibited by law. Bayer reserves the right to determine eligibility, monitor participation, determine equitable distribution of product, and modify or discontinue the program at any time.
‡People with private, commercial health insurance may receive KOVALTRY® co-pay or co-insurance assistance based on eligibility requirements. The program is on a first-come, first-served basis. Financial support is available for up to 12 months. Eligible patients can re-enroll for additional 12-month courses. The program is not for patients receiving prescription reimbursement under any federal-, state-, or government-funded insurance programs, or where prohibited by law. All people who meet these criteria are encouraged to apply. Bayer reserves the right to discontinue the program at any time.
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 can occur 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 (≥3%) were headache, pyrexia, and pruritus.
For additional important risk and use information, please see full Prescribing Information.
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer. Bayer Access Solutions is a service mark of Bayer.
Site Last Modified 12/2016