Data from FDA - Curated by EPG Health - Last updated 21 December 2016
Indication(s)
Related Content
Advisory information
4 CONTRAINDICATIONS ABSTRAL is contraindicated in the management of
Patients considered
ABSTRAL is contraindicated in
ABSTRAL is contraindicated in
Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.
Opioid non-tolerant patients.
(4)
6
3 %):
(6.1) To report SUSPECTED
6.1 Clinical Studies Experience Because clinical trials are conducted under widely
The
Two hundred and seventy (270) of these patients were treated in multiple-dose studies.
The duration of therapy for patients in multiple-dose studies ranged from
The most commonly observed
Expect opioid side effects and manage them accordingly.
The clinical trials of ABSTRAL were designed to evaluate
The
There has been
Table 2 lists
The
Table2:
5 % System Organ Class
5 % within the total population that occurred after a
Table3:
5 % System Organ Class
thoracic and mediastinal
1 % of patients from two clinical trials who experienced that reaction while receiving ABSTRAL. Reactions are classified by system organ class.
1 %) Cardiac
Eye
Gastrointestinal
General
Immune system
Metabolism and nutrition
Psychiatric
Reproductive system and breast
Respiratory, thoracic and mediastinal
Skin and subcutaneous
Vascular
Usage information
2 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
As with all opioids, the
(2.1)
(2.1) Wait at least 2 hours before treating another episode of
(2.4) Administer on the floor of the mouth directly under the tongue and allow to completely dissolve.
(2.5) 2.1 Dose Titration The objective of dose titration is to identify an
The
Starting Dose: Individually titrate ABSTRAL to a dose that provides
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
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
If
Patients must wait at least 2 hours before treating another episode of
If
If
Instruct patients not to use more than 4 tablets at one time.
If
In order to minimize the risk of
ABSTRAL-related
Figure 2.2 Conversion from Actiq The initial dose of Abstral is always 100 mcg with the only exception being patients already using Actiq.
For patients being converted from Actiq, prescribers must use the Initial Dosing
See Table 1 for initial dosing
Patients must be instructed to stop the use of Actiq and dispose of any remaining units.
Table 1: Initial Dosing
For patients converting from Actiq doses of 600 and 800 mcg, initiate titration with 200 mcg and 200 mcg Abstral, respectively and proceed using multiples of this strength.
For patients converting from Actiq doses of 1200 and 1600 mcg, initiate titration with 200 mcg and 400 mcg Abstral, respectively and proceed using multiples of this strength.
2.3 Maintenance Therapy Once an
Maintain patients on this dose.
If
Patients must wait at least 2 hours before treating another episode of
If more than four episodes of
If the long-acting opioid or dose of long-acting opioid is changed, re-evaluate and re-titrate the ABSTRAL dose as necessary to ensure
Limit the use of ABSTRAL to treat four or fewer episodes of
2.5 Administration of ABSTRAL Place ABSTRAL tablets on the floor of the mouth directly under the tongue immediately after
Do not
Allow ABSTRAL tablets to completely dissolve in the sublingual cavity.
Advise patients not to eat or drink anything until the tablet is completely dissolved.
In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking
In patients who continue to take their
8 USE IN SPECIFIC POPULATIONS Administer
(8.6) 8.1 Pregnancy - Category C There are
Use ABSTRAL during pregnancy only if the potential
In women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological
Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl.
Fentanyl is embryocidal in
Conversion to human equivalent doses indicates this is within the range of the human
Published studies demonstrated that administration of fentanyl (10, 100, or 500 mcg/ kg/day) to pregnant
Intravenous administration of fentanyl (10 mcg/ kg or 30 mcg/ kg) to pregnant female
8.2 Labor and Delivery Fentanyl readily crosses the placenta. Therefore do not
8.3 Nursing Mothers Fentanyl is excreted in human milk; therefore,
Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using ABSTRAL. 8.4 Pediatric Use The
8.5 Geriatric Use Of the 270 opioid
There was
ABSTRAL clinical trials.
Therefore, exercise
8.6 Patients with Renal and Hepatic
Fentanyl is metabolized primarily via human cytochrome P450 3A4 isoenzyme system and the
If the drug is used in these patients, use
8.7 Gender Both male and female opioid-tolerant
Interactions
More information
Category | Value |
---|---|
Authorisation number | NDA022510 |
Orphan designation | No |
Product NDC | 57881-338,57881-331,57881-333,57881-332,57881-334,57881-336 |
Date Last Revised | 30-11-2014 |
Type | HUMAN PRESCRIPTION DRUG |
RXCUI | 1053652 |
Storage and handling | 16.1 Storage and Handling ABSTRAL is supplied in individually sealed child-resistant blister packages contained in a cardboard outer carton, in pack sizes of 12 (100 mcg, 200 mcg, 300 mcg and 400 mcg strengths) or 32 (all strengths) tablets. The packaging is color-coded for each ABSTRAL tablet strength. Patients and their caregivers must be instructed to keep ABSTRAL out of the reach of children [see Boxed Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. |
Marketing authorisation holder | Galena Biopharma, Inc. |
Warnings | WARNING: RISK OF RESPIRATORY RISK OF RESPIRATORY Due to the risk of (4) Keep out of reach of children. (5.3) Use with CYP3A4 inhibitors may cause (7) When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL. (2.1, 5.2) When dispensing, do not substitute with any other fentanyl products. (5.2) Contains fentanyl, (9.1) Outpatients, healthcare professionals who prescribe to outpatients, (5.10) RESPIRATORY The substitution of ABSTRAL for any other fentanyl product may result in Due to the risk of respiratory [see Contraindications (4)] ABSTRAL must be kept out of reach of children. [see Patient Counseling Information (17.1) and How Supplied/Storage and Handling (16.1)] The concomitant use of ABSTRAL with CYP3A4 inhibitors may result in an [see Drug Interactions (7)] MEDICATION - When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to ABSTRAL. (2.1) - When dispensing, do not substitute an ABSTRAL prescription for other fentanyl products. This should be considered when prescribing or dispensing ABSTRAL in situations where the physician or Because of the risk for Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, TIRFREMSAccess.com or by calling1-866-822-1483. |