TRANSMUCOSAL FENTANYL CITRATE- fentanyl citrate lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

FENTANYL CITRATE

Composition:

FENTANYL 400 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain . Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain. OTFC is intended to be used only in the care of cancer

Product summary:

OTFC (oral transmucosal fentanyl citrate) is supplied in individually sealed child-resistant blister packages. The amount of fentanyl contained in OTFC can be fatal to a child. Patients and their caregivers must be instructed to keep OTFC out of the reach of children [see Boxed Warning - Warning: Importance Of Proper Patient Selection, Dosing, and Potential For Abuse, Warnings And Precautions (5), and Patient Counseling Information (17.1)] . Store at 20-25ºC (68-77ºF) with excursions permitted between 15° and 30°C (59° to 86°F) until ready to use. (See USP Controlled Room Temperature.) Protect OTFC from freezing and moisture. Do not use if the blister package has been opened. Patients must be advised to dispose of any units remaining from a prescription as soon as they are no longer needed. While all units should be disposed of immediately after use, partially consumed units represent a special risk because they are no longer protected by the child resistant blister package, yet may contain enough medicine to be fatal to a child [see Patient Counseling Information (17.5)] . A temporary storage bottle is provided as part of the OTFC Child Safety Kit [see Patient Counseling Information (17.4)] . This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. Instructions for usage of this container are included in the Medication Guide. Patients and members of their household must be advised to dispose of any units remaining from a prescription as soon as they are no longer needed. Instructions are included in Patient Counseling Information (17.6) and in the Medication Guide. If additional assistance is required, call Cephalon, Inc., at 1-800-896-5855. OTFC is supplied in six dosage strengths. Each unit is individually wrapped in a child-resistant, protective blister package. These blister packages are packed 30 per shelf carton for use when patients have been titrated to the appropriate dose. Each dosage unit has a white to off-white color. Each individual solid drug matrix is marked with "FENTANYL" and the strength of the unit ("200" ,"400", "600", "800" ,"1200", or "1600"). The dosage strength is also marked on the handle tag, the blister package and the carton. See blister package and carton for product information. Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

Authorization status:

New Drug Application

Patient Information leaflet

TRANSMUCOSAL FENTANYL CITRATE - FENTANYL CITRATE LOZENGE
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
Oral Transmucosal Fentanyl Citrate CII (OTFC) 200 mcg, 400 mcg, 600
mcg, 800 mcg, 1200 mcg, 1600
mcg
WARNING:
1.
Do not use Oral Transmucosal Fentanyl Citrate (OTFC) unless you are
regularly using other
opioid pain medicines around-the-clock for your constant cancer pain
and your body is used to
these medicines.
2.
You MUST keep OTFC in a safe place out of the reach of children.
Accidental ingestion by a
child is a medical emergency and can result in death. Death has been
reported in children who
have accidentally taken OTFC. If a child accidentally takes OTFC, get
emergency help right away.
Read the Medication Guide that comes with Oral Transmucosal Fentanyl
Citrate (OTFC) before you start
taking it and each time you get a new prescription. There may be new
information. This Medication
Guide does not take the place of talking to your doctor about your
medical condition or your treatment.
Share this important information with members of your household.
What is the most important information I should know about Oral
Transmucosal Fentanyl Citrate
(OTFC)?
1.
OTFC can cause life threatening breathing problems which can lead to
death:
•
if you are not regularly using other opioid pain medicines
around-the-clock for your
constant cancer pain and your body is not used to these medicines.
This means that you are
not opioid tolerant.
•
if you do not use it exactly as prescribed by your doctor.
2.
Your doctor will prescribe a starting dose of OTFC that is different
than other fentanyl containing
medicines you may have been taking. Do not substitute OTFC for other
fentanyl medicines
without talking with your doctor.
3.
Use no more than 2 units of OTFC per episode of breakthrough cancer
pain. You must wait at
least 4 hours before using OTFC again for another episode of
breakthrough cancer pain.
What is Oral Transmucosal Fentanyl Citrate (OTFC)?
•
OTFC is a prescription medicine that contains the medicine fent

Summary of Product characteristics

TRANSMUCOSAL FENTANYL CITRATE - FENTANYL CITRATE LOZENGE
H.J. HARKINS COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ORAL
TRANSMUCOSAL FENTANYL CITRATE
(OTFC) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OTFC.
ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) (FENTANYL CITRATE) ORAL
TRANSMUCOSAL LOZENGE, CII
INITIAL U.S. APPROVAL: 1968
WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Must not be used in opioid non-tolerant patients. (1)
Life-threatening hypoventilation could occur at any dose in patients
not taking chronic opiates. (5.2)
Contraindicated in management of acute or postoperative pain including
headache/migraines. (4)
Contains fentanyl, a Schedule II controlled substance with abuse
liability similar to other opioid analgesics. (9.1)
Contains medicine in an amount that can be fatal to a child. Keep out
of reach of children and discard opened units
properly. (5.3)
Use with strong and moderate CYP450 3A4 inhibitors may result in
potentially fatal respiratory depression. (7)
RECENT MAJOR CHANGES
Boxed Warning 09/2009
INDICATIONS AND USAGE
OTFC is an opioid analgesic indicated only for the management of
breakthrough cancer pain in patients 16 and older with
malignancies who are already receiving and who are tolerant to
around-the-clock opioid therapy for their underlying
persistent cancer pain. Patients must remain on around-the-clock
opioids when taking OTFC. (1)
DOSAGE AND ADMINISTRATION
Initial dose of OTFC: 200 mcg. Prescribe an initial supply of six 200
mcg OTFC units. (2.1)
Individually titrate to a tolerable dose that provides adequate
analgesia using single OTFC dosage unit per
breakthrough cancer pain episode. (2)
No more than two doses can be taken per breakthrough pain episode.
(2.2)
Wait at least 4 hours before treating another episode of breakthrough
pain with OTFC. (2.3)
Limit consumption to four or fewer units per da