Patient Education Key in Flexible Dosing Schedule for Opdivo


After a recent FDA approval for an additional dosing schedule option for Opdivo, patients must be educated on the potential side effects that may occur between prolonged visits.

Patients being treated with Opdivo (nivolumab) now have a more flexible dosing option, but with this, also comes fewer physician visits. As a result, patient education regarding potential side effects associated with Opdivo treatment are now more key than ever.

The Food and Drug Administration (FDA) recently approved a supplemental biologics license application to add a four-week dosing schedule of 480 mg of Opdivo across several of the PD-1 inhibitor’s indications — the agent was previously approved for a two-week dosing schedule of 240 mg. In addition, the new regimen would decrease infusion time in half, from 60 minutes to 30, for all approved Opdivo indications.

The new dosing regimen is intended to offer more flexibility to cancer treatments, according to Awny Farajallah, M.D., Vice President, Head of U.S. Medical at Bristol-Myers Squibb (BMS).

“We believe in the patient as a whole and how to provide innovative solutions to the patient,” he said in an interview with CURE. “Part of that is offering dosing schedule flexibility that can meet individual needs because each patient is different. So, that’s really what prompted us to look in to this. How can we make dosing more flexible and ‘friendly’ for patients?”

However, Farajallah noted this new dosing regimen may not be for every patient, and therefore, patient-physician discussions are very important.

“For patients, (this regimen) allows them to contact their physicians to discuss what their needs are so they can go and determine (which schedule) fits with their treatment plan — which is critical – and then decide on what would be the next steps and how to move forward,” he added. “It really empowers the patient to have a discussion with their physician on the choices they need.”

In order to speak with their physicians about this new dosing regimen, patients must first be aware of the schedule and its effects. Julie Brahmer, M.D., chair of the expert panel that developed the recently issued American Society of Clinical Oncology (ASCO) guidelines on understanding and managing immunotherapy-related toxicities highlighted the importance of education initiatives for patients.

“Giving Opdivo using a four-week dosing regimen is certainly more convenient for some patients,” she said in an interview with CURE. “With more convenient visit schedules, patients will need to be educated on the typical signs and symptoms of the more common side effects of immunotherapy in order to alert their care teams.”

To help with this, BMS offers wallet cards meant for patients to be able to show physicians, this way they know what treatments the patient is on. For example, if a patient were admitted to an emergency room, they would have readily accessible information regarding their Opdivo treatment regimen. In addition, the company gives patients symptom identification cards so they can recognize side effects and symptoms, signaling the need to see their doctor or go to an emergency room.

“Patients need to be educated on what adverse events or side effects they need to be looking for, and, whether they are being seen every two weeks or every four, they should be alerting their physician to any symptoms that they may have while they are on therapy,” said Farajallah.

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