A bstral is a sublingual (SL) dosage form of the pure opioid agonist fentanyl. It’s approved by the United States Food and Drug Administration (FDA) for managing breakthrough cancer pain in patients 18 years and older who are already receiving opioids and are opioid-tolerant to treat underlying persistent cancer pain. It is a schedule II controlled substance.¹

Boxed Warnings

1. Serious, life-threatening, and/or fatal respiratory depression has occurred.
2. Closely monitor patients, especially when starting therapy or after a dose increase.
3. Accidental ingestion, especially by children, can lead to a fatal fentanyl overdose. Ensure proper storage/disposal and keep out of children’s reach.
4. Concomitant use with CYP3A4 inhibitors (eg, macrolide antibiotics, azole antifungals, protease inhibitors, grapefruit juice) or discontinuation of CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin) can result in a fatal overdose.
5. Concomitant use with other central nervous system depressants, including benzodiazepines or alcohol, may lead to profound sedation, respiratory depression, coma, and death. Concomitant prescribing should be reserved for patients where alternative treatment options are inadequate, and limit dosages/durations to the minimum required. Closely follow patients and observe for respiratory depression/sedation.
6. When prescribing, do not convert patients on a mcg per mcg basis from other oral transmucosal fentanyl product to Abstral; follow the dosing guide in the label.
7. Abstral exposes users to risks of abuse, addiction, and misuse, which can lead to overdose and death. Assess the patient’s risk before prescribing and monitor patients closely for these behaviors/conditions.
8. Prolonged Abstral use during pregnancy can lead to neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

Drug Safety and Dosing

The transmucosal immediate-release fentanyl (TIRF) risk mitigation and management strategy (REMS) is an FDA-required program designed to ensure informed risk-benefit decisions prior to beginning treatment and during treatment for appropriate TIRF medication use. This product’s REMS is to decrease the following risks: abuse, addiction, misuse, overdose, and serious medication error complications.
TIRF medicines are contraindicated in opioid-nontolerant patients. Serious adverse events, including deaths, in patients treated with some oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection and/or improper dosing. The substitution of a TIRF medicine for any other fentanyl medicine, including another TIRF medicine, may result in fatal overdose.
The initial Abstral dose is 100 mcg. Doses should be titrated to a tolerable dose that provides adequate analgesia. No more than two doses can be taken per breakthrough pain episode. Patients should wait at least two hours before treating another breakthrough pain episode. No more than four episodes of breakthrough pain per day should be treated with Abstral.

Other Transmucosal Fentanyl Products²

1. Abstral (fentanyl SL) tablets, strengths: 100, 200, 300, 400, 600, and 800 mcg
2. Actiq (fentanyl solid oral transmucosal) lozenges (brand and generic), strengths: 200, 400, 600, 800, 1,200, and 1,600 mcg
3. Fentora (fentanyl buccal) tablet, strengths: 100, 200, 400, 600, and 800 mcg
4. Lazanda (fentanyl) nasal spray, strengths: 100 and 400 mcg/mcL
5. Onsolis (fentanyl buccal soluble film), strengths: 200, 400, 600, 800, and 1,200 mcg
6. Subsys (fentanyl SL) spray, strengths: 100, 200, 400, 600, and 800 mcg

Price³

The cost of 32 Abstral SL tablets is approximately $1,678 (100 mcg), $2,108 (200 mcg), $2,578 (300 mcg), $3,041 (400 mcg), $3,916 (600 mcg), and $4,790 (800 mcg). Discount cards are available.⁴ Drugs.com offers a discount card whereby 32 Abstral 100 mcg cost about $1,469.

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