Duragesic 12: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed DURAGESIC to help control the moderate to severe chronic (long-lasting) pain you are experiencing.

What it does:

What is DURAGESIC?

DURAGESIC is a thin, adhesive, rectangular patch that is placed on your skin. DURAGESIC delivers an opioid medicine called fentanyl continuously through the skin and into the bloodstream to control your pain around the clock.

What to expect from DURAGESIC

Because the medicine in DURAGESIC is gradually released from the patch and slowly absorbed through the skin, do not expect immediate pain relief after you apply your first patch. During this initial period, your doctor may ask you to take additional pain medication until you experience the full benefits of DURAGESIC.

While most patients obtain adequate pain relief with DURAGESIC, your pain may vary and occasionally break through. This is not unusual. If this occurs, your doctor may prescribe additional pain medication.

It is important to let your doctor know whether or not your pain is under control. If you frequently need additional short-acting pain medication, or if pain is waking you at night, you may need a change in your DURAGESIC dose. If you continue to have pain, call your doctor.

Always follow your doctor's instructions carefully and do not change or stop your DURAGESIC medication without first consulting with your doctor.

When it should not be used:

Because life-threatening decreases in breathing rate could occur, DURAGESIC should not be used:

• for the relief of pain following surgery.
• for the relief of pain which is only mild, or expected to last less than several weeks.
• if you have acute or severe bronchial asthma.
• if you have severe difficulty in breathing.

For the same reason, do not start on DURAGESIC unless you have already been taking a strong opioid medication.

Because constipation is a side-effect of opioids, DURAGESIC should not be used if you have a type of intestinal blockage known as “paralytic ileus”.

DURAGESIC is not for children under 18 years of age unless your doctor has decided otherwise.

Do not use DURAGESIC if you know you are allergic to fentanyl, other opioid-type pain medications, or any of the non-medicinal ingredients (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

fentanyl

What the nonmedicinal ingredients are:

Backing Layer: polyester film

Drug Reservoir: alcohol, hydroxyethyl cellulose, water Release Membrane: ethylene-vinyl acetate

Contact Adhesive: silicone adhesive

What dosage forms it comes in:

DURAGESIC transdermal patch is supplied in cartons containing 5 individually packaged systems. DURAGESIC comes in five strengths: 1.25 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg fentanyl per patch, delivering 12, 25, 50, 75, and 100 mcg fentanyl per hour respectively for 72 hours.

WARNINGS AND PRECAUTIONS

DURAGESIC patch is not safe for everyone. Tell your doctor about all your medical conditions. Before using DURAGESIC be sure to tell your doctor if:

• you have any other medical conditions (such as diseases

  of the heart, lung, brain, liver and kidney),

• you have pancreatitis, or other biliary tract diseases,

• you are pregnant or plan to become pregnant, or are

  breastfeeding,

• you are taking any other medications (see

  INTERACTIONS WITH THIS MEDICATION),

• you have ever had an allergic reaction to any other

  medication,

• you have a head injury or brain tumour,
• you have a history of drug abuse,
• you have chronic and severe constipation,
• you suffer from alcoholism.

This will help your doctor decide whether you should use DURAGESIC and what extra care should be taken during its use.

Do not drive a car or operate machinery until you are sure that using the patch does not make you drowsy.

Fever/exposure to heat sources

At high temperatures, greater than usual quantities of fentanyl can be released into your body. If you have a

fever, you should contact your doctor, who may adjust your dose if necessary. Increased release of fentanyl can also result from direct exposure to heat sources. You should avoid, for example, heating pads, electric blankets, heated

water beds, heat lamps, intensive sunbathing, hot water bottles, saunas, hot whirlpool spa baths, and long hot baths.

Tolerance

DURAGESIC may lead to tolerance in the long run. It is therefore possible that your doctor will prescribe a higher dose of DURAGESIC after some time to produce the same result.

Dependence

There is a possibility that you may become dependent on DURAGESIC (fentanyl) with longer term use. Discuss with your doctor.

INTERACTIONS WITH THIS MEDICATION

Tell you doctor about all the medicines you take. Some medicines may cause serious or life-threatening side effects when used with DURAGESIC. Your doctor will tell you if it is safe to take other medicines while you are using DURAGESIC.

Know the medicines you take. Keep a list of your medicines to show to your doctor and pharmacist.

It is extremely important to avoid alcohol and such medications as tranquilizers and sleeping pills when you are using DURAGESIC since their combined effect may cause drowsiness, depressed breathing, low blood pressure and possibly coma.

To avoid any potential drug interactions, be sure to inform your doctor when taking any other medications while you are using DURAGESIC, including

• certain antifungal drugs (e.g. ketoconazole),
• certain antiviral drugs (e.g. ritonavir),
• some antibiotics (e.g. clarithromycin),
• monoamine (MAO) inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline),
• over-the-counter medications that may cause drowsiness (e.g. antihistamines),
• muscle relaxants,
• anaesthetics,
• sedatives or hypnotics,
• phenothiazines,
• other opioid pain medication.

Drugs that cause a decrease in the ability of the liver to break down drugs including opioids can result in high levels of opioid in the bloodstream when taken at the same time as the patch is used. These drugs include some antifungals, some antibiotics, and some antivirals. Talk to your doctor before starting DURAGESIC if you are on one of these drugs.

PROPER USE OF THIS MEDICATION

You should already be taking another strong opioid medication before begin using DURAGESIC patches.

Your doctor will determine the strength of DURAGESIC you need based on your own particular needs. Do not change your dose without consulting your doctor. Do not wear more than one DURAGESIC patch at a time, unless your doctor tells you to do so. Each patch can be used for up to 72 hours (3 days).

Do not stop using DURAGESIC suddenly (see Discontinuation of DURAGESIC).

Do not use DURAGESIC if the pouch is torn upon purchasing, or if the patch is cut, damaged, or changed in any way as you may be exposed to a potentially fatal dose of medicine.

Where to apply DURAGESIC

Select a dry, non-hairy area on your chest, back, flank or upper arm. If the area you choose has body hair, clip (do not shave) the hair close to the skin with scissors.

Do not put the patch on skin that is excessively oily, burned, broken out, cut, irritated or damaged in any way. If you need to clean the skin where the patch will be applied, use only clear water. Soaps, oils, lotions, alcohol or other products may irritate the skin under the patch.

How to apply DURAGESIC

Step 1.

Each patch is sealed in its own protective pouch. Do not remove the patch from the pouch until you are ready to use it. When you are ready, tear open the pouch at the notched corner.

Step 2.

A stiff protective liner covers the sticky side of the patch - the side that will be put on your skin. Hold the liner at the edge and pull the patch from the liner. Try not to touch the sticky side of the patch. Throw away the liner.

Step 3.

Immediately after you have removed the liner, apply the sticky side of the patch to a dry area of your chest, back, flank or upper arm. Press the patch firmly on your skin with the palm of your hand for about 30 seconds.

Not all adhesive products stick to all patients. If the patch does not stick well, or loosens after application, tape the edges down with first aid tape. If problems with the patch not sticking persist, cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC patch with any other bandage or tape.

In the event that the patch falls off before 3 days or 72 hours, discard it (See Disposing of DURAGESIC.) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

Step 4.

Wash your hands, with water only, when you have finished applying the patch.

Step 5.

Special labels are provided to help you remember when you last put on your patch. After putting on the patch, write the date and time on a label, then stick the label on the patch.

Step 6.

After wearing the patch for 3 days, or as directed by your doctor, remove it (see Disposing of DURAGESIC). Then choose a different place on your skin to apply a new patch and repeat steps 1 to 5 in order.

Do not apply the new patch to the same place as the last one.

Water and DURAGESIC

You can bathe, swim, or take a warm shower while you are wearing DURAGESIC. If the patch falls off, discard the patch properly (see Disposing of DURAGESIC Patch) and apply a new one at a different skin site, making sure the new skin area you choose is dry. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

Disposing of DURAGESIC Patch

Before putting on a new DURAGESIC patch, remove the patch you have been wearing. Fold the used patch in half so the sticky side sticks to itself, and flush down the toilet immediately. A used DURAGESIC patch can be very dangerous for, or even lead to death in babies, children, pets and adults who have not been prescribed DURAGESIC as considerable amount of drug remains in the patch after use. Do not put used DURAGESIC patches in a trash can.

Wash your hands, with water only, after disposing the patch.

Dispose of any patches that are left over from your prescription as soon as they are no longer needed. Remove the left-over patches from their protective pouches and

remove the protective liners. Fold the patches in half and flush down the toilet. Do not flush the pouch or protective liner.

DURAGESIC contains fentanyl, a drug with a high potential for abuse. Your discarded patches contain a considerable amount of drug, and flushing is an effective way to prevent theft or misuse by others.

Safety and handling

DURAGESIC is sealed to keep the gel from getting on your hands or body. If the gel from the drug reservoir accidentally touches the skin, wash the area with large amounts of water. Do not use soap, alcohol, or other solvents to remove the gel because they may increase the drug’s ability to go through the skin.

Do not cut, damage or chew DURAGESIC.

DURAGESIC will not work properly, or may not be safe, if it is damaged in any way, as it may lead to uncontrolled release of DURAGESIC (fentanyl) and life-threatening consequences.

Do not let anyone else use your DURAGESIC. A DURAGESIC patch must be used only on the skin of the person for whom it was prescribed. DURAGESIC contains fentanyl, a drug with a high potential for abuse. Your patches must be protected from theft or misuse in the home or work environment.

Serious medical consequences, including death, have occurred when patches were accidentally transferred to other people, for example while hugging, sharing a bed or moving a patient. If your patch dislodges and accidentally sticks to the skin of another person, take the patch off of that person immediately, wash the area with water, and get medical care for them right away. This is true for both fresh and used patches, as a considerable amount of drug remains in the patch after use.

Do not exceed the dose recommended by your doctor.

Overdose:

The most important sign of overdose is suppressed breathing. If a person is breathing abnormally slowly or weakly, remove the patch and seek emergency medical care immediately. Meanwhile, keep the person awake by talking or by shaking him/her every now and then.

Other signs of fentanyl overdose may include tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, seizure and hallucination.

Missed Dose:

If a patch is left on for more than three days (72 hours), remove patch and apply a new patch following instructions given (see PROPER USE OF THIS MEDICATION).

Discontinuation of DURAGESIC:

Please do not suddenly stop taking DURAGESIC as it may cause unwanted side effects, such as nausea, vomiting, diarrhea, anxiety, and shivering. Your doctor can discuss the best way for you to stop taking DURAGESIC.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, DURAGESIC may cause unwanted effects. Most unwanted effects appear during the first month of treatment. These effects may be more pronounced if you have a fever. If you develop a fever while using the patch, contact your doctor right away.

The most frequently reported unwanted effects are nausea, vomiting, tiredness, constipation, sweating, dizziness, headache, dry mouth, confusion, depression, and skin irritation at the application site.

Slowed breathing has been reported by a small number of patients using DURAGESIC. If this occurs, seek emergency medical care immediately.

Be aware that removing the patch does not completely remove the source of drug, as drug is deposited under the skin and will continue to be released into the bloodstream over the next hours after the patch is removed.

Opioid Withdrawal Symptoms

Opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety and shivering are possible after converting from your previous opioid analgesic to DURAGESIC, or converting from DURAGESIC to another opioid. Contact your doctor if you experience these symptoms when switching to or from DURAGESIC.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Serious and life-threatening breathing problems can happen because of an overdose or if the dose you are using is too high for you (see Overdose). If breathing problems develop, seek emergency medical care immediately.

There have been very rare reports of serious allergic reactions, such as Stevens-Johnson syndrome (rash and fever or sore eyes/mouth), airway constriction, swelling, and anaphylactic shock. In one case, it was the patient caretaker who experienced the allergic reaction, from applying the patch to the patient. If these symptoms develop, seek emergency medical care immediately.

There have been rare reports of seizures (convulsions) in people using DURAGESIC. If you notice anything unusual, please contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking DURAGESIC, contact your doctor or pharmacist.

HOW TO STORE IT

Keep DURAGESIC out of the reach of children.

Keep DURAGESIC in its protective pouch until you are ready to use it. Store DURAGESIC between 15° and 25°C. Do not refrigerate or freeze. Remember, the inside of your car can reach temperatures much higher than 25°C (77°F) on a sunny day. Do not carry pouch in your pocket as it may reach body temperature (36°C).

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

Online: www.healthcanada.gc.ca/medeffect Email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Health Canada

Address Locator: 0701C

Ottawa, ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.janssen-ortho.com

or by contacting the sponsor, Janssen-Ortho Inc., at: 1-800-567-3331

Janssen-Ortho Inc.

Markham, Ontario L3R 0T5

Last revised: April 30, 2009

* All listed brand names are trademarks of their respective manufacturers.