Fentanyl Sublingual Spray
Fentanyl sublingual spray is a highly potent synthetic opioid analgesic designed for rapid absorption through the oral mucosa under the tongue. It is indicated exclusively for breakthrough cancer pain in patients who are already opioid-tolerant. Because of the risk of severe respiratory depression, abuse, misuse, and addiction, it is classified as a Schedule II controlled substance and is only available through a restricted distribution program called the TIRF REMS (Transmucosal Immediate-Release Fentanyl Risk Evaluation and Mitigation Strategy).
Dosage by Body Weight
Dosage must be individually titrated to an effective dose that provides adequate analgesia and minimizes side effects. The initial dose is always 100 mcg, regardless of the dose of the concomitant around-the-clock opioid. Only one dose should be used per breakthrough pain episode. Patients must wait at least 4 hours before treating another episode of breakthrough pain with this medication.
- Body Weight
- Below 5 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression.
- Body Weight
- 5-7 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression.
- Body Weight
- 8-10 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression.
- Body Weight
- 11-15 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression.
- Body Weight
- 16-20 kg
- Dose
- Contraindicated
- Frequency
- Do not use
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Contraindicated | Do not use | Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression. |
| 5-7 kg | Contraindicated | Do not use | Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression. |
| 8-10 kg | Contraindicated | Do not use | Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression. |
| 11-15 kg | Contraindicated | Do not use | Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression. |
| 16-20 kg | Contraindicated | Do not use | Safety and efficacy have not been established in pediatric patients. Extremely high risk of fatal respiratory depression. |
Formulation
Purpose
Management of breakthrough cancer pain in adult patients who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Generic Name
FentanylBranded Drug Names
Fentanyl Sublingual Spray is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.