myPKFiT Software for Adynovate Now Available in the US

A web-based software to help personalize dosing regimens for hemophilia A patients being treated with Adynovate is now available in the U.S., according to Takeda.

The software, called myPKFiT, previously was available only for individuals being treated with Advate. For Adynovate, it is to be used by patients 12 and older who weigh at least 29 kg (63.9 pounds).

Hemophilia A is caused by a functional lack of the clotting protein factor VIII (FVIII). Advate is a lab-made form of this protein designed to be used in replacement therapy (which aims to “replace” missing clotting proteins). Adynovate is essentially a modified version of Advate that has been tailored to last longer in the body.

When treating hemophilia with any kind of replacement therapy, it is necessary for clinicians to understand the therapy’s pharmacokinetics (PK), which refers to how a medication moves into, through, and out of the body.

Plotting these changes over time allows clinicians to calculate a unique PK curve for a given patient, a critical feature for ensuring the patient receives a therapeutically effective amount of medication over time.

Typically, calculating a PK curve for Adynovate would require nine to 11 blood samples from different points in time. With the myPKFiT software, a PK curve can be calculated with only two blood samples.

The software was approved by the U.S. Food and Drug Administration (FDA) for Adynovate at the start of this year. myPKFiT was developed by Shire (now part of Takeda), which also developed both Advate and Adynovate.

“myPKFiT for ADYNOVATE underscores our commitment to delivering personalized approaches to help manage hemophilia A,” Michael Denne, vice president of U.S. medical, hematology and rare disease at Takeda, said in a press release.

In addition to software that can be used by healthcare providers, myPKFiT is accompanied by a smartphone app for patients, which enables users to log and monitor bleeds and infusions while also keeping track of their FVIII level. This could allow patients to adjust activities based on their level of coverage at any given moment.

“The ability to adjust activity and lifestyle decisions based on estimated FVIII coverage is a step toward educating patients so their treatment can be personalized to their needs. That, for us, is the goal for PK-focused dosing to allow people to get the most out of their treatment regimen,” Denne said.

Cindy Leissinger, MD, professor and director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, added: “More than ever, hemophilia management is driven by personalization, as we attempt to take a customized approach to care for each individual patient. It’s important for healthcare professionals and patients to have access to treatment options that help them manage care and prevent bleeding.

“With the FDA approval of myPKFiT for ADYNOVATE, patients will have another option available to them as they work closely with their healthcare professional to tailor their treatment regimen to their needs,” Leissinger said.