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. CONTINUE READING BELOW >

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.

CONTINUE READING BELOW

Reimbursement support, coverage, financial and affordability solutions

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Patient Loyalty Program†§

Bayer is committed to helping your patients start and stay on therapy regardless of changes in their commercial health insurance coverage status.

Eligible patients can receive KOVALTRY® at no cost if they experience gaps or changes with insurance coverage.

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Free Trial Program‡§

  • Patients new to KOVALTRY can receive 1-month of free therapy.
  • Selected product is delivered to your patient's home.
  • Any patient new to KOVALTRY is able to participate, regardless of type of insurance or if they have insurance.
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$0 Co-Pay Program*†

  • Eligible commercially insured patients can pay as low as $0 per prescription, regardless of income (up to $20,000 in co-pay assistance per year).
  • Assistance is awarded per patient. Multiple members of the same household can apply.
  • Patients can enroll here or in one short phone call to 1-800-288-8374.

Click here to submit a $0 prescription claim under your patient's medical benefit.

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Reimbursement for Lab Testing*†

Eligible patients can receive up to $250 per year to offset out-of-pocket costs for laboratory testing of KOVALTRY.

Download the KOVALTRY reimbursement claim form for your patients.

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to prescribe KOVALTRY to your patient and enroll them in Access Services by Bayer.

the Access Services patient support request form.

Speak with a health insurance expert. 9:00 AM–6:00 PM (ET) Monday–Friday Multiple languages are available, including Spanish.

KOVALTRY is covered for 99% of patients nationally¶#

 

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 full Prescribing Information.