Actiq (generic: fentanyl) is a prescription medication used to treat breakthrough cancer pain. Actiq belongs to a group of drugs called opioids that work by binding to opioid receptors within the central nervous system to relieve pain.
The medication comes in the form of a lozenge.
Some of the common side effects of Actiq include nausea (upset stomach), vomiting, dizziness, and sleepiness. Actiq can reduce physical or mental abilities; patients must be careful when performing task which require mental alertness.
Actiq is a prescription medication used to treat breakthrough pain in adult patients with cancer (16 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Actiq can cause serious breathing problems that can become life-threatening. Call your doctor or get emergency medical help right away if you:
- have trouble breathing
- have extreme drowsiness with slowed breathing
- have slow shallow breathing (little chest movement with breathing)
- feel faint, very dizzy, confused
The most common side effects of Actiq are:
- nausea (upset stomach)
Other side effects include:
- low energy
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 ways to prevent or treat constipation.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- medicines that make you sleepy such as other pain medicines, cold medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, muscle relaxers, seizure medicines, or tranquilizers
- diltiazem (Cardizem, Dilacor, Taztia, Tiazac)
- aprepitant (Emend)
- antibiotic medicines such as clarithromycin (Biaxin) or erythromycin (E-Mycin, Ery-Tab, E.E.S.)
- antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox)
- verapamil (Calan, Covera, Isoptin, Verelan)
- HIV medicines such as indinavir (Crixivan), fosamprenavir (Lexiva), nelfinavir (Viracept), or ritonavir (Norvir)
- seizure medicines: carbamazepine (Carbatrol, Tegretol), oxcarbazine (Trileptal), phenytoin (Dilantin)
This is not a complete list of Actiq drug interactions. Ask your doctor or pharmacist for more information.
Do not drive, operate heavy machinery, or do other dangerous activities because you will not be alert while taking this medication. 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.
- Actiq can cause life threatening breathing problems, such as slow breathing or shallow breathing which can lead to death.
- This medication should be used only if you have been taking other opioid pain medicines and your body has gotten used to them (you are opioid tolerant).
- Actiq should only be used when you have breakthrough pain while you are taking regular pain medications.
- Use no more than 2 units of Actiq per episode of breakthrough cancer pain. You must wait at least 4 hours before using Actiq again for another episode of breakthrough cancer pain.
- 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.
- Selling or giving away this medicine is against the law.
- Never give Actiq to anyone else, even if they have the same symptoms you have.
Grapefruit and grapefruit juice may interact with Actiq and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Tell your doctor about all of your medical conditions, especially the ones listed below:
- shortness of breath
- head injury
- brain problem
- liver, kidney, or heart problems
- seizures (convulsions)
- slow heart rate
- low blood pressure
- hallucinations (seeing or hearing things that are not there)
- alcoholism, or a family history of this problem
- drug abuse or addiction or a family history of this problem
- diabetes. Each Actiq unit contains about ½ teaspoon (2 grams) of sugar.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal and dietary supplements.
Tell your doctor if you are pregnant or planning to become pregnant. Actiq may harm your unborn baby. It could cause addiction or withdrawal symptoms in a newborn if the mother uses Actiq during pregnancy.
Tell your doctor if you are breastfeeding. Actiq is excreted in human breast milk. It can cause serious harm to your baby and may cause sleepiness or breathing problems in a nursing baby. Actiq may also cause addiction and withdrawal symptoms in a nursing infant. You should not use Actiq while breastfeeding.
- Use Actiq exactly as prescribed by your doctor. Do not use 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. The end of the unit marked with “ACTIQ” and the strength of the unit (“200”, “400”, “600”, “800”, “1200”, or “1600”) is the end that is to be placed in your mouth as described below.
- 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. The medicine works by getting into your bloodstream through the cheeks and under your tongue.
- 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 Child Safety Kit for later disposal.
Take Actiq exactly as prescribed by your doctor and follow the instructions for using the medicine very carefully. Never take Actiq in larger amounts, or for longer than your doctor recommends.
- If your breakthrough cancer pain is not relieved 15 minutes after you finished the Actiq unit, use ONLY 1 more dose of Actiq at this time.
- Wait at least 4 more hours before using Actiq again for another episode of breakthrough cancer pain.
- Remember, you must continue taking your regularly-used around-the-clock opioid medicine while taking Actiq.
- Limit the use of Actiq to four or fewer units per day.
- Talk to your doctor if your dose of Actiq does not relieve your breakthrough cancer pain. Your doctor will decide if your dose of Actiq needs to be changed.
- Talk to your doctor if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
If you take too much Actiq seek emergency medical help or go to the nearest emergency room right away. Too much Actiq can be fatal.
Actiq oral transmucosal (across mucous membrane) lozenges are available in the following strengths: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, or 1600 mcg.
Active Ingredient: fentanyl citrate
Inactive Ingredients: Sugar, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, modified food starch, and confectioner’s sugar.
- 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.
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with Actiq, including following use in opioid non-tolerant patients and improper dosing. The substitution of Actiq for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Actiq is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Death has been reported in children who have accidentally ingested Actiq. Actiq must be kept out of reach of children.
The concomitant use of Actiq with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
- Substantial differences exist in the pharmacokinetic profile of Actiq compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Actiq.
- When dispensing, do not substitute an Actiq prescription for other fentanyl products.
Actiq contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Actiq can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Actiq in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Actiq is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.