Subsys
Subsys is an opioid agonist indicated for the management of breakthrough pain in cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy. It is a sublingual spray containing fentanyl, a potent synthetic opioid. Due to the risk of misuse, abuse, addiction, and overdose, it is available only through a restricted program called the TIRF REMS Access Program.
Dosage by Body Weight
The initial dose of Subsys is always 100 mcg, regardless of the dose of other transmucosal immediate-release fentanyl (TIRF) products. Individually titrate to a tolerable dose that provides adequate analgesia. No more than two doses can be used to treat an episode of breakthrough pain, and patients must wait at least 4 hours before treating another episode.
- Body Weight
- Below 5 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established.
- Body Weight
- 5-7 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established.
- Body Weight
- 8-10 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established.
- Body Weight
- 11-15 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established.
- Body Weight
- 16-20 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Contraindicated | Not applicable | Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established. |
| 5-7 kg | Contraindicated | Not applicable | Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established. |
| 8-10 kg | Contraindicated | Not applicable | Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established. |
| 11-15 kg | Contraindicated | Not applicable | Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established. |
| 16-20 kg | Contraindicated | Not applicable | Safety and effectiveness of Subsys in pediatric patients under 18 years of age have not been established. |
Formulation
Purpose
Management of breakthrough cancer pain in adult patients (18 years of age and older) who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Generic Name
Fentanyl sublingual sprayScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.