Directory of Drugs - Actiq - fentanyl citrate facts and information

Directory of Drugs: Actiq - fentanyl citrate


Medication Guide Actiq® (AK-tik) CII (oral transmucosal fentanyl citrate) 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg WARNING: You MUST keep Actiq in a safe place out of the reach of children. Accidental ingestion by a child is a medical emergency and can result in death. If a child accidentally takes Actiq, get emergency help right away. Read the Medication Guide that comes with Actiq 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 Actiq? 1. Actiq can cause life threatening breathing problems which can lead to death: • if it is used by anyone who is not already taking other opioid pain medicines and their body is not used to these medicines (not opioid tolerant) • if it is not used exactly as prescribed. 2. Your doctor will prescribe a starting dose of Actiq that is different than other fentanyl containing medicines you may have been taking. Do not substitute Actiq for other fentanyl medicines without talking with your doctor. What is Actiq? • Actiq is a prescription medicine that contains the medicine fentanyl. Actiq is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. Actiq is to be used only to treat breakthrough pain in adult patients with cancer (16 years of age and older) who are already taking other opioid pain medicines for their constant (around-theclock) cancer pain. Actiq is started only after you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). Do not use Actiq if you are not opioid tolerant. • You must stay under your doctor’s care while taking Actiq. • Actiq must not be used for short-term pain from injuries and surgery. • Prevent theft and misuse. Keep Actiq in a safe place to protect it from being stolen since it can be a target for people who abuse narcotic medicines or street drugs. Never give Actiq to anyone else, even if they have the same symptoms you have. It may harm them and even cause death. Selling or giving away this medicine is against the law. Who should not take Actiq? Do Not Take Actiq if you: • are not already taking other opioid pain medicines for your constant (around-the-clock) cancer pain. Never use Actiq for short-term pain from injuries or surgery or pain that will go away in a few days, such as pain from doctor or dentist visits, or any short-lasting pain. • are allergic to anything in Actiq. The active ingredient in Actiq is fentanyl. See the end of this Medication Guide for a complete list of ingredients in Actiq. What should I tell my doctor before I start taking Actiq? Tell your doctor about all of your medical and mental problems, especially the ones listed below: • Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath • A head injury or brain problem • Liver or kidney problems • Seizures (convulsions or fits) • Slow heart rate or other heart problems • Low blood pressure • Mental problems including major depression or hallucinations (seeing or hearing things that are not there) • A past or present drinking problem or alcoholism, or a family history of this problem • A past or present drug abuse or addiction problem, or a family history of this problem • If you are diabetic. Each Actiq unit contains about ½ teaspoon (2 grams) of sugar. Tell your doctor if you are: • pregnant or planning to become pregnant. Actiq may harm your unborn baby • breast feeding. Fentanyl passes through your breast milk and it can cause serious harm to your baby. You should not use Actiq while breast feeding. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with Actiq. Sometimes, the doses of certain medicines and Actiq need to be changed if used together. Do not take any medicine while using Actiq until you have talked to your doctor. Your doctor will tell you if it is safe to take other medicines while you are using Actiq. Be especially careful about other medicines that make you sleepy such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers. Know the medicines you take. Keep a list of them to show your doctor and pharmacist. How should I use Actiq? • Use Actiq exactly as prescribed. Do not take Actiq more often than prescribed. Talk to your doctor about your pain. Your doctor can decide if your dose of Actiq needs to be changed. • Each unit of Actiq is sealed in its own blister package. • Do not open the blister package until you are ready to use Actiq. • When you are ready to use Actiq, cut open the package using scissors and remove the Actiq unit. • Place Actiq in your mouth between your cheeks and gums and actively suck on the medicine. • Move Actiq around in your mouth, especially along your cheeks. • Twirl the handle often. • Finish the Actiq unit completely in 15 minutes to get the most relief. If you finish Actiq too quickly, you will swallow more of the medicine and get less relief. • Do not bite or chew Actiq. You will get less relief for your breakthrough pain. • You may drink some water before using Actiq but you should not drink or eat anything while using Actiq. • If you begin to feel dizzy, sick to your stomach, or very sleepy before Actiq is completely dissolved, remove Actiq from your mouth. Dispose of Actiq right away or put it in the temporary storage bottle in the Welcome Kit for later disposal. If you have more than 4 episodes of breakthrough cancer pain per day, talk to your doctor. The dose of Actiq may need to be adjusted. • If you take too much Actiq or overdose, call 911 or your local emergency number for help. How should I dispose of Actiq after use? Partially used Actiq units may contain enough medicine to be harmful or fatal to a child or other adults who have not been prescribed Actiq. You must properly dispose of the Actiq handle right away after use even if there is little or no medicine left on it. Please follow these directions to dispose of the handle: 1. Once you have finished the Actiq unit and the medicine is totally gone, throw the handle away in a place that is out of the reach of children. 2. If any medicine remains on the handle after you have finished, place the handle under hot running water until the medicine is gone, and then throw the handle away out of the reach of children and pets. 3. If you did not finish the entire Actiq unit and you cannot dissolve the medicine under hot running water right away, put the Actiq in the temporary storage bottle that you received in the Actiq Welcome Kit for safe keeping. Push the Actiq unit into the opening on the top until it falls completely into the bottle. Never leave unused or partially used Actiq units where children or pets can get to them. 4. Dispose of the handles in the temporary storage bottle as soon as you can by following the directions in steps 1 and 2. You must dispose of all handles in the temporary storage bottle at least once a day. Do not flush entire unused Actiq units, Actiq handles, or blister packages down the toilet. What should I avoid while taking Actiq? • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Actiq affects how alert you are. Actiq can make you sleepy. Ask your doctor when it is okay to do these activities. • Do not drink alcohol while using Actiq. It can increase your chance of getting dangerous side effects. • Do not take any medicine while using Actiq until you have talked to your doctor. Your doctor will tell you if it is safe to take other medicines while you are using Actiq. Be especially careful about medicines that make you sleepy such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers. What are the possible or reasonably likely side effects of Actiq? • Actiq can cause serious breathing problems that can become life-threatening, especially if used the wrong way. See “What is the most important information I should know about Actiq?” • Call your doctor or get emergency medical help right away if you: o have trouble breathing o have extreme drowsiness with slowed breathing o have slow shallow breathing (little chest movement with breathing) o feel faint, very dizzy, confused, or have unusual symptoms These can be symptoms that you have taken too much (overdose) Actiq or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. • Actiq can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down. • Actiq can cause physical dependence. Do not stop taking Actiq or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction. • There is a chance of abuse or addiction with Actiq. The chance is higher if you are or have been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental problems. The most common side effects of Actiq are nausea, vomiting, dizziness and sleepiness. Other side effects include headache, low energy and constipation. Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Actiq and is unlikely to go away without treatment. Talk to your doctor about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Actiq. Actiq contains sugar. Cavities and tooth decay have occurred in patients taking Actiq. When taking Actiq, you should talk to your dentist about proper care of your teeth. Talk to your doctor about any side effects that bother you or that do not go away. These are not all the possible side effects of Actiq. For a complete list, ask your doctor. How should I store Actiq? • Keep Actiq in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes Actiq, get emergency help right away. • Actiq is supplied in single sealed child-resistant blister packages. Store Actiq at room temperature, 59° to 86°F (15° to 30°C) until ready to use. • Always keep Actiq in a secure place to protect from theft. How should I dispose of unopened Actiq units when they are no longer needed? • Dispose of any unopened Actiq units remaining from a prescription as soon as they are no longer needed. • If you are no longer using Actiq or if you have unused Actiq in your home, please follow these steps to dispose of the Actiq as soon as possible. 1. Remove all Actiq from the locked storage space. 2. Remove one Actiq unit from its blister package using scissors, and hold the Actiq by its handle over the toilet bowl. 3. Using wire-cutting pliers, cut the medicine end off so that it falls into the toilet. 4. Throw the handle away in a place that is out of the reach of children. 5. Repeat steps 2, 3, and 4 for each Actiq. 6. Flush the toilet twice after 5 Actiq units have been cut. Do not flush more than 5 Actiq units at a time. • Do not flush entire unused Actiq units, Actiq handles, or blister packages down the toilet. If you need help with disposal of Actiq, call Cephalon Professional Services at 1-800-896-5855. General Information About the Safe and Effective Use of Actiq Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use Actiq only for the purpose for which it was prescribed. Do not give Actiq to other people, even if they have the same symptoms you have. Actiq can harm other people and even cause death. Sharing Actiq is against the law. This Medication Guide summarizes the most important information about Actiq. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Actiq that is written for healthcare professionals. You can also call Cephalon, Inc. at 1-800-896- 5855. What are the ingredients of Actiq? Active Ingredient: fentanyl citrate Inactive Ingredients: Sugar, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, modified food starch, and confectioner’s sugar. How do I use the Actiq Welcome Kit? • You can use the Actiq Welcome Kit to help you store Actiq and your other medicines out of the reach of children. It is very important that you use the items in the Actiq Welcome Kit to protect the children in your home. • If you were not offered a Welcome Kit when you received your medicine, call Cephalon Professional Services at 1-800-896-5855 to request one. The Actiq Welcome Kit contains: • A child-resistant lock for you to secure the storage space where you keep Actiq and any other medicines at home. • A portable locking pouch for you to keep a small supply of Actiq nearby for your immediate use. The rest of your Actiq must be kept in the locked storage space. o Keep this pouch secured with its lock and keep it out of the reach and sight of children. • A child-resistant temporary storage bottle. • If for some reason you cannot finish the entire Actiq unit and cannot immediately dissolve the medicine under hot tap water, immediately put the Actiq unit in the temporary storage bottle for safe keeping. o Push the Actiq unit into the opening on the top until it falls completely into the bottle. You must properly dispose of the Actiq unit as soon as you can. • See “How should I dispose of unopened Actiq units when they are no longer needed?” for proper disposal of Actiq. This Medication Guide has been approved by the U.S. Food and Drug Administration. Rx Only. Cephalon, Inc. FRAZER, PA 19355, USA Reference Number XXX August, 2006