See the PK data  
 
KOVALTRY(R), Antihemophilic Factor (Recombinant) BAYER
 
  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

Dear {{accTitle}} {{accFname}} {{accLname}},

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1. Thank you for taking time to meet with me to discuss KOVALTRY. You requested some information about KOVALTRY, and I wanted to follow up with some relevant material.

2. I'm sorry we missed each other when I stopped by your office. I have some information about KOVALTRY that I would like to share with you.

3. It's been a while since our last meeting, so I wanted to share some information about KOVALTRY that you might find interesting.

4. Hello, I'm a Bayer Representative. I would like to share some information with you about KOVALTRY that may be useful for you and your patients with hemophilia A.

5. Although we have not yet had the opportunity to meet in person, I wanted to send you some relevant information about KOVALTRY for your patients with hemophilia A.

6. It was great to see you recently at the NHF meeting. I wanted to share some information about KOVALTRY that you might find interesting.

7. It was great to see you recently at the HFA meeting. I wanted to share some information about KOVALTRY that you might find interesting.

8. It was great to see you recently at the chapter meeting. I wanted to share some information about KOVALTRY that you might find interesting.

9. It was great to see you recently at the community event. I wanted to share some information about KOVALTRY that you might find interesting.

10. It was great to see you recently at the meeting. I wanted to share some information about KOVALTRY that you might find interesting. ]}}

KOVALTRY® is an unmodified, full length, recombinant FVIII with the potential for as few as 2 infusions per week.1* 		 
 
 
KOVALTRY® and Advate® were studied in a randomized, crossover PK trial2  
 
See the results >  
 
* KOVALTRY® Dosing: The recommended dose for routine prophylaxis in adolescents and adults is 20 to 40 IU of KOVALTRY® per kg of body weight 2x/week or 3x/week. The recommended dose for routine prophylaxis in children 12 years old and younger is 25 to 50 IU of KOVALTRY® per kg of body weight 2x/week, 3x/week, or every other day according to individual requirements.1

PK=pharmacokinetics. 		 
 
 
INDICATIONS
 
• 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 click here for 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.

{{customText[

1. I would be glad to provide further information to help you and your patients with hemophilia A with their KOVALTRY treatment. If you'd like to speak more, please feel free to contact me at the number below.

2. Since we haven't met in a while, I would welcome the opportunity to talk with you in person about this information. If you're interested, please feel free to contact me at the number below.

3. Thank you for reviewing this information about KOVALTRY. I hope it is helpful. Please don't hesitate to call me if you have any questions about the information provided or if you need additional materials.

4. Since you requested this information, I want to answer any questions you may have. Please don't hesitate to call me if there is anything else I can help with.

5. If you have any questions, I would be happy to speak further, or to set up a visit at your convenience. ]}}

Sincerely,

{{userName}}
{{user.Phone}}
Bayer Hematology 		 
 
  References: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 2. Shah A, Solms A, Garmann D, et al. Improved pharmacokinetics with BAY 81-8973 versus antihemophilic factor (recombinant) plasma/albumin-free method: a randomized pharmacokinetic study in patients with severe hemophilia A [published online D‍ecember 22, 2‍016]. Clin Pharmacokinet. doi:10.1007/s40262-016-0492-2.  
 
 
KOVALTRY(R), Antihemophilic Factor (Recombinant) BAYER
 
 
  Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer.
Advate is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
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