Finding the Right Dose: Sublingual Fentanyl Spray for Breakthrough Cancer Pain


West Cancer Center researchers developed a best nursing practice protocol for titration of fentanyl sublingual spray, which is the most recently approved transmucosal immediate-release fentanyl formulation.

Sheila E. Ayers, BSN, MSN, ACNP-BC

Sheila E. Ayers, BSN, MSN, ACNP-BC

Sheila E. Ayers, BSN, MSN,


Nurses play a key role in assessing and managing breakthrough cancer pain (BTCP), a debilitating symptom that studies show can impact the quality of life of as many as 60% of adult patients.

In an effort to ensure that patients get the pain relief they need, Sheila E. Ayers, BSN, MSN, ACNP-BC, and her colleagues at the West Cancer Center in Memphis, Tennessee, developed a best nursing practice protocol for titration of fentanyl sublingual spray (FSS; Subsys), which is the most recently approved transmucosal immediate-release fentanyl (TIRF) formulation. Ayers presented the findings during a panel on complex care management issues at the 41st Annual ONS Congress.

“Our patients will typically have anywhere from 4-6 episodes of breakthrough pain in a day,” said Ayers, but the data suggest poor correlation between around-the-clock pain medication doses and patient breakthrough pain needs. Often when patients call with pain, the response may be: “Let’s go ahead and increase that dose,” said Ayers, “but without adequate assessment, we may actually be overdosing our patient, making them more lethargic, which is not going to increase their quality of life.”

Previous phase III research has shown that FSS produces significantly reduced pain intensity when compared with placebo, providing relief as quickly as 5 minutes after administration. This rapid relief is important for patients, but it requires individualized dose titration to determine the most effective and tolerable dose of the opioid.

Sublingual administration is often a good option for patients with nausea, vomiting, or dysphagia, Ayers explained, as well as those who are unable to tolerate oral medication, and for patients who can’t have parenteral administration because of emaciation, reduced venous access, or coagulation-related issues.

“Think of how many of our patients fit this profile,” said Ayers.

Identifying Appropriate Patients for FSS

The first step in titrating FSS correctly, she said, is to assess the adequacy of the patient’s current pain medication and how quickly it provides relief. The patients may previously have been on a different TIRF product, which come in forms including lozenges, tablets and nasal sprays, so nurses need to probe that to determine what their outcomes were with that medication.

Comorbidities also must be assessed, in particular the presence of neuropathy or arthritis, because to use the Subsys spray devices, patients need to be able to manipulate their fingers, which can be a problem for many due to neuropathy from their cancer treatments, Ayers noted.

She added that nurses also want to be aware of whether patients are experiencing mucositis of grade 2 or higher. “They may not be the most appropriate candidates for sublingual therapy because right underneath the tongue there are blood vessels close to the surface, which means patients get that quick absorption. When patients have a sore there, that can increase their exposure to the fentanyl. You want to be careful with that.”

In assessing patient pain, Ayers reminded her audience that “Pain is the fifth vital sign, and it’s whatever our patient tells us it is—not what their caregiver tells us it is, or what we may even think it is. With all TIRF products, we want to provide a dose that provides adequate pain control and minimizes potential adverse effects.”

Titration of FSS to Find the Effective Dose

Healthcare providers should not immediately conclude that a lack of effect with a particular titration dose means that the treatment is ineffective for the patient, Ayers said. It may instead suggest that an appropriate dose of FSS has not been identified for that individual.

When a patient is experiencing an episode of breakthrough pain, Ayers starts at a 100-µg dose of FSS. Patients spray it once underneath their tongue and are advised to wait 30 minutes, and are then asked to reevaluate their pain level. If relief is achieved after that interval, that will be the patient’s appropriate dose, and a clinician will follow up with the patient by telephone 3-5 days later.

If relief is not achieved, Ayers prescribes a second dose and the patient is instructed to wait 3½ to 4 hours before taking it, because Subsys is such a short-acting pain medicine that it can only be used every 4 hours. Ayers said she tells patients that when they experience their next episode of pain, they are advised to take two sprays underneath their tongue, and again give it 30 minutes before reevaluating their pain level to see if relief is achieved. If not, the process is repeated using stepwise dose escalation. Ayers said that patients unable to achieve any relief for their breakthrough pain need to come back to the clinic for reevaluation, as this may be a sign of disease progression.

Along with individualized titration, patient education and ongoing communication with patients and their caregivers are essential to ensure safe and appropriate use of agents such as FSS to manage BTCP, Ayers stressed.

“Once you achieve that adequate dose of FSS, what a difference you can make in the patient’s quality of life.”

Ayers S, Parikh N, Smith CO, et al. Nursing considerations for titration of fentanyl sublingual spray to effective dose. Presented at: the 41st Annual Congress of the Oncology Nursing Society; San Antonio, Texas; April 27-May 1, 2016. Podium abstract.

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