Abstral (Fentanyl Sublingual Tablets)

Abstral fentanyl sublingual treats severe, ongoing pain that cannot be controlled with other medicines. This medicine is a narcotic pain reliever.

Abstral (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking Abstral.

Abstral is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, Abstral is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.

Abstral is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Active Ingredient:

Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4.

All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 400 mcg strength tablet contains 400 mcg of fentanyl free base.

Inactive Ingredients:

Croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.

DOSAGE AND ADMINISTRATION

Healthcare professionals who prescribe Abstral on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of Abstral.

As with all opioids, the safety of patients using such products is dependent on health care professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

Dose Titration

The objective of dose titration is to identify an effective and tolerable maintenance dose for ongoing management of breakthrough cancer pain episodes. The effective and tolerable dose of Abstral will be determined by dose titration in individual patients.

Carefully supervise patients until a dose that provides adequate analgesia with tolerable side effects is reached for breakthrough pain control.

Starting Dose:

Individually titrate Abstral to a dose that provides adequate analgesia with tolerable side effects. Begin titration of all patients with an initial dose of Abstral of 100 mcg. Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to Abstral must start with the 100 mcg dose. However, for patients converting from Actiq, see Table 1: Initial Dosing Recommendations for Patients on ACTIQ. Abstral is not equivalent on a mcg per mcg basis with all other fentanyl products, therefore, do not switch patients on a mcg per mcg basis from any other fentanyl product. Abstral is NOT a generic version of any other fentanyl product.

Start all patients with a single 100 mcg tablet.

– If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose.
– If adequate analgesia is not obtained after Abstral, the patient may use a second Abstral dose (after 30 minutes) as directed by their health care provider. No more than two doses of Abstral may be used to treat an episode of breakthrough pain.
– Patients must wait at least 2 hours before treating another episode of breakthrough pain with Abstral.