Adult Dosing
Management of breakthrough cancer pain in opioid-tolerant patients
- Initial dose: 100 mcg (1 spray) in each nostril x 1; treat subsequent episodes of breakthrough pain with this dose if adequate analgesia is achieved within 30 min of administration of this dose
- If adequate analgesia is not achieved with the first 100 mcg dose, titrate dose in a step-wise manner to a maximum of 800 mcg (i.e., from 100 mcg to 200 mcg, to 400 mcg, and then to 800 mcg) over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved
- Max: 800 mcg/dose
- Patients should wait at least 2 hrs before treating another episode of breakthrough cancer pain
- If pain relief is not achieved within 30 minutes of therapy dosing, a rescue medicine may be used as directed by the physician
Notes:- Monitor patients closely during the titration process to minimize the risk of therapy-related adverse reactions and to identify the appropriate dose
- After establishing an appropriate dose, instruct patients to use that dose for each subsequent breakthrough cancer pain episode; limit therapy use to treat four or fewer episodes of breakthrough pain per day
- Re-evaluate the dose of the long-acting opioid used for persistent underlying cancer pain if more than four episodes of breakthrough pain are experienced per day
- Consider discontinuing therapy along with a gradual downward titration of other opioids to minimize potential withdrawal effects in patients who no longer require opioid therapy
- Discontinue therapy in patients who continue receiving chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain
Testicular Torsion [Non-FDA Approved]
- 1-1.5 mcg/kg/dose intranasally. Additional second dose of 0.75-1 mcg/kg may be given if analgesia is insufficient. Consider use of IV route after second dose
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
Testicular Torsion [Non-FDA Approved]
- 1-1.5 mcg/kg/dose intranasally. Additional second dose of 0.75-1 mcg/kg may be given if analgesia is insufficient. Consider use of IV route after second dose
[Outline]
See Supplemental Patient Information
- Fentanyl nasal spray is indicated only for the management of breakthrough pain in patients (
18 yrs of age) with cancer who are already receiving and are tolerant to opioids. Patients are considered opioid tolerant if taking at least 60 mg/day of oral morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day oral oxycodone, 8 mg/day oral hydromorphone, 25 mg/day oral oxymorphone, or an equianalgesic dose of another opioid for >1 wk - Fatal respiratory depression and death may occur in patients not taking chronic opioids. Due to the risk of respiratory depression, therapy is contraindicated in the management of acute or postoperative pain including headache/migraine, dental pain, and in opioid non-tolerant patients [US Black Box Warning]
- Fentanyl nasal spray should be prescribed only by oncologists and pain specialists well trained in the use of Schedule II opioids to treat cancer pain
- Avoid substituting this product for any other fentanyl products as substantial differences exist in the pharmacokinetic profile of this product compared to other fentanyl products which may result in clinically significant differences in the extent of absorption of fentanyl and could result in fatal overdose [US Black Box Warning]
- When prescribing this product, do not convert patients on a mcg per mcg basis from any other fentanyl products to this product [US Black Box Warning]
- Serious or fatal respiratory depression has been reported even at recommended doses in patients using fentanyl nasal spray. This risk occurs more frequently in patients with underlying respiratory disorders and elderly or debilitated patients, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration
- Instruct patients/caregivers that fentanyl nasal spray contains medicine in an amount that could be fatal to a child; hence, instruct them to keep both used and unused bottles in child-resistant container and out of reach of children and discard open units appropriately
- Concomitant use of therapy with other CNS depressants (sedatives/hypnotics, general anesthetics, other opioids, tranquilizers, phenothiazines, skeletal muscle relaxants, and alcoholic beverages) may produce increased depressant effects such as hypoventilation, hypotension, and profound sedation. Use with potent inhibitors of cytochrome P450 3A4 isoform may elevate fentanyl levels, leading to increased depressant effects
- Monitor patients on concomitant CNS depressants for a change in opioid effects as they may require dose adjustment of fentanyl nasal spray
- Opioid analgesics may impair the mental and/or physical ability required for the performance of hazardous tasks such as driving a car or operating machinery
- Cautiously adjust the dose of fentanyl nasal spray in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression
- Use therapy cautiously in patients who may be susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Use opioids only if clinically warranted as they may obscure the clinical course of a patient with a head injury
- Use fentanyl nasal spray cautiously in patients with bradyarrhythmias
- Therapy is not recommended for use in patients who have received MAO inhibitors within 14 days, as severe and unpredictable potentiation by MAOIs has been reported with opioid analgesics
- Therapy is available only through a restricted program under a REMS called the TIRF REMS Access program, because of the risk for misuse, abuse, addiction, and overdose
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Pulmonary impairment
- Alcohol use
- CNS depression
- Labor and delivery
- Elderly patients
Supplemental Patient Information
- Warn patients not to take fentanyl nasal spray if they are not taking an opioid medication on a regular around-the-clock basis
- Inform patients that they must wait at least 2 hrs before treating another episode of breakthrough pain with the product
- Instruct patients and their caregivers to keep both used and unused bottles in child-resistant container and out of the reach of children at all times. Instruct them to wash their hands with soap and water immediately after handling the pouch
- Instruct patients not to perform activities that require a high level of attention such as driving a car or operating heavy machinery while on medication
- Instruct patients and their caregivers to read the Medication Guide each time fentanyl nasal spray is dispensed as new information may be available
- Caution patients not to combine fentanyl nasal spray with alcohol, sleep aids, or tranquilizers as dangerous additive effects may occur resulting in serous injury/death
- Inform patients to dispose fentanyl bottle and start a new one if it has been >5 days since they last used it or it has been 14 days or more after priming the bottle
Pregnancy Category:C
Breastfeeding: Fentanyl is excreted in human milk. Avoid use in women who are nursing because of risk of sedation and/or respiratory depression in their infants. Opioid withdrawal symptoms may occur in infants upon cessation of nursing by women using fentanyl.
