DURAGESIC Coupon

GREEN PRINT

Important Safety Information




Before using DURAGESIC®, you and your household members need to be aware of some important information about using this drug. You should discuss with your doctor the most important side effects of this drug prior to your using it. Contact your doctor with any questions or concerns you may have about DURAGESIC® and any suspected side effects.



Here are some of the important things you need to know about using DURAGESIC®:
  • DURAGESIC® is used to manage constant moderate to severe chronic pain that needs to be treated around the clock which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products.
  • DURAGESIC® should only be used by people who are receiving or have developed a tolerance to pain therapy with products known as opioids. DURAGESIC® should not be used if you have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions.
  • One serious important side effect is slow, shallow, and/or difficulty in breathing, if the dose is too high. This is more likely to happen the first time someone uses the product or after the dose is adjusted, so they should be watched more closely during the first 72 hours of treatment (or "3 days of treatment") after beginning treatment or after the dose is adjusted. You and your household members should discuss with your doctor what signs and symptoms to look for and what to do if they develop. If you are uncertain what to do, call your doctor and get other emergency medical help.
  • Safety of DURAGESIC® in children less than 2 years of age is unknown. DURAGESIC® should be administered to children only if they are opioid-tolerant and age 2 years or older.
  • DURAGESIC® can be abused in ways similar to other legal or illegal pain products. Care should be taken in storing this medication.
  • DURAGESIC® is a thin, adhesive, rectangular patch that is worn on your skin and delivers a strong pain-relieving medicine called fentanyl through the skin and into the bloodstream. Do not cut or change the DURAGESIC® patch in any way. Do not use a DURAGESIC® patch if it is cut, damaged, or changed in any way. Using cut or damaged patches can change the amount that is absorbed through the skin and can cause serious problems.
  • In clinical trials, the 5 most common side effects >10% associated with DURAGESIC® were nausea, vomiting, sleepiness, constipation, and excessive sweating. There is a potential for severe constipation.
  • DURAGESIC® may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients who have been given DURAGESIC® should not drive or operate dangerous machinery unless they are tolerant to the side effects of the drug.
  • Do not combine with alcohol or other CNS depressants (e.g., sleep medications, tranquilizers) because dangerous additive effects may occur, resulting in serious injury or death.
  • Tell your physician or pharmacist if you are taking any other medications.
  • If you are planning to become pregnant, consult a physician prior to starting or continuing therapy.
  • All patients and their caregivers should be advised to avoid exposing the DURAGESIC® application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.
  • Patients, family members, and caregivers should be instructed to keep patches (new and used) out of the reach of children and others for whom DURAGESIC® was not prescribed. A considerable amount of active fentanyl remains in DURAGESIC® even after used as directed. Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression that could result in death.
  • Used patches should be folded so that the adhesive side of the patch adheres to itself, then the patch should be flushed down the toilet immediately upon removal. Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed. Unused patches should be removed from their pouches, folded so that the adhesive side of the patch adheres to itself, and flushed down the toilet.
  • For more information about DURAGESIC®, talk to your doctor or call 1-800-526-7736, 9:00 AM - 5:00 PM (EST), Monday through Friday.

    Please see enclosed Important Safety Information, including Boxed Warning.

Boxed Warning

DURAGESIC® (fentanyl transdermal system) CII contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC®) may be a particular target for abuse and diversion.

DURAGESIC® is indicated for management of persistent, moderate to severe chronic pain that:
  • Requires continuous, around-the-clock opioid administration for an extended period of time, and
  • Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids
DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/hr. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.

Because serious or life-threatening hypoventilation could occur, DURAGESIC® is contraindicated:
  • In patients who are not opioid-tolerant
  • In the management of acute pain or in patients who require opioid analgesia for a short period of time
  • In the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
  • In the management of mild pain
  • In the management of intermittent pain (e.g., use on an as needed basis [prn])
(See CONTRAINDICATIONS section of the full Prescribing Information for further information.)

Since the peak fentanyl concentrations generally occur between 20 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.

The concomitant use of DURAGESIC® with all cytochrome P450 3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving DURAGESIC® and any CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted. (See CLINICAL PHARMACOLOGY-Drug Interactions, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the full Prescribing Information for further information.)

The safety of DURAGESIC® has not been established in children under 2 years of age. DURAGESIC® should be administered to children only if they are opioid-tolerant and 2 years of age or older. (See PRECAUTIONS - Pediatric Use section of the full Prescribing Information.)

DURAGESIC® is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESIC® dose when converting patients from another opioid medication can result in fatal overdose with the first dose (see DOSAGE and ADMINISTRATION – Initial DURAGESIC® Dose Selection - section of full Prescribing Information for further information). Due to the mean elimination half-life of approximately 20-27 hours, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.

DURAGESIC® can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing DURAGESIC® in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

DURAGESIC® patches are intended for transdermal use (on intact skin) only. Do not use a DURAGESIC® patch if the seal is broken or the patch is cut, damaged, or changed in any way.

Avoid exposing the DURAGESIC® application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependant increases in fentanyl released from the system resulting in possible overdose and death. Patients wearing DURAGESIC® systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the DURAGESIC® dose should be adjusted if necessary.

Please see the Full Prescribing Information and Important Safety Information.