Clinical use

• Clinical studies with Kovaltry did not include patients aged 65 and over to be able to determine whether they respond differently from younger adults. As with any patient receiving recombinant FVIII (rFVIII), dose selection for an elderly patient should be individualized.

Contraindications

• Hypersensitivity to this drug or to any ingredient in the formulation or component of the container
• Known hypersensitivity to mouse or hamster protein

Most serious warnings and precautions

• Development of circulating neutralizing antibodies: The development of circulating neutralizing antibodies (inhibitors) to Factor VIII (FVIII) may occur during the treatment of patients with hemophilia A. Patients should be carefully monitored for development of inhibitors.

Other relevant warnings and precautions

• Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis
• Hypersensitivity reactions, including anaphylaxis
• Pregnant and nursing women: FVIII should be used during pregnancy and lactation only if clearly indicated
• Consider risk of central venous access device (CVAD)-related complications if a CVAD is required
• Monitoring and laboratory tests: dosage requirement for recombinant FVIII (rFVIII) is extremely variable when an inhibitor is present and the dosage can be determined only by the clinical response

For more information
Please consult the Product Monograph at https://www.bayer.com/sites/default/files/2020-11/kovaltry-pm-en.pdf for important information relating to adverse reactions, drug interactions and dosing information, which have not been discussed in this piece.

The Product Monograph is also available by calling 1-800-265-7382.¹