New changes made to the Dose Conversion Guidelines on Fentanyl Transdermal Systems

Mar 11 2010

SUBJECT: New Changes to the Dosage Guidelines for Fentanyl Transdermal Systems (Patches)

The manufacturers of Fentanyl Transdermal Systems, in collaboration with Health Canada, would like to inform Canadians of important new changes made to the Dose Conversion Guidelines in the Product Monograph. These guidelines are used to help determine what dosage of Fentanyl Transdermal Systems is appropriate for each individual patient.

Fentanyl Transdermal Systems are skin patches that contain a high concentration of fentanyl. Fentanyl is a very strong opioid narcotic used to help control chronic (long-lasting) pain.

Fentanyl Transdermal Systems (patches) are only intended for use in patients who require continuous around-the-clock pain relief with strong narcotic pain relievers for an extended period of time and who already are taking narcotic pain relievers at a total daily dose of at least 60 mg/day oral Morphine Equivalents.

- Health Care Professionals and hospitals have been informed of the new changes made to the Dose Conversion Guidelines. These new Guidelines will allow them to adjust doses appropriately. - The dosage of Fentanyl Transdermal Systems must be calculated using the new conversion table, and must not be higher than the dose recommended. - Patients using Fentanyl Transdermal Systems should not stop or change their dosage without first consulting with their doctor. This medicine should always be used exactly as prescribed.

Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems if the dosage used is too high. Fentanyl Transdermal Systems should not be used in patients who are not already receiving opioid narcotic drugs.

Patients using a Fentanyl Transdermal Systems should seek emergency medical help immediately if they:

- have trouble breathing, or have slow or shallow breathing - have a slow heartbeat - have severe sleepiness - have cold, clammy skin - feel faint, dizzy, confused, or cannot think, walk, or talk normally - have a seizure - have hallucinations

The letters to health care professionals and the notice to hospitals have been posted on the Health Canada website and can be accessed by means of the link below:

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php

Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosing and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems:

DURAGESIC(R) (fentanyl DURAGESIC(R) MAT (fentanyl transdermal system) transdermal system) TEVA-fentanyl ratio-FENTANYL Transdermal System RAN-FENTANYL TRANSDERMAL SYSTEM RAN-FENTANYL MATRIX PATCH CO Fentanyl PMS-FENTANYL MTX Sandoz Fentanyl MTX Patch

Source: JANSSEN-ORTHO INC.

Source: TEVA CANADA LIMITED

Source: RATIOPHARM INC.

Source: PHARMASCIENCE INC.

Source: COBALT PHARMACEUTICALS INC.

Source: RANBAXY PHARMACEUTICALS CANADA INC.

Source: SANDOZ CANADA INC.