Actiq

Actiq is a prescription medication used to treat breakthrough cancer pain. Actiq belongs to a group of drugs called opioid agonists or narcotic pain medications. These work by changing the way the brain and nervous system respond to pain.

This medication comes in a lozenge form. 

Common side effects of Actiq include nausea, vomiting, and headache.

Actiq can also cause changes in vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Actiq affects you.

Actiq is a prescription medication used to treat breakthrough cancer pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cephalon, Inc.

Serious side effects have been reported with Actiq. See the “Actiq Precautions” section.

Common side effects of Actiq include the following:

• nausea
• vomiting
• dizziness
• sleepiness 
• weakness
• headache
• anxiety
• confusion
• depression
• rash
• constipation

This is not a complete list of Actiq side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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:

• Antihistamines
• Barbiturates such as phenobarbital (Luminal)
• Buprenorphine (Buprenex, Subutex, in Suboxone)
• Butorphanol (Stadol)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Efavirenz (in Atripla, Sustiva)
• Modafinil (Provigil)
• Nalbuphine (Nubain)
• Nalmefene (Revex)
• Naloxone (Narcan)
• Nevirapine (Viramune)
• Oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
• Oxcarbazepine (Trileptal)
• Other pain medications
• Pentazocine (Talwin)
• Phenytoin (Dilantin, Phenytek)
• Pioglitazone (Actos, in Actoplus Met, in Duetact)
• Rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• Sedatives, sleeping pills, or tranquilizers

Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

This is not a complete list of Actiq drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Actiq including the following:

Breathing problems that can become life-threatening. Call your healthcare provider or get emergency medical help right away if you:

These symptoms can be a sign that you have used too much Actiq or the dose is too high for you.These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more Actiq until you have talked to your healthcare provider.

• have trouble breathing
• have drowsiness with slowed breathing
• have slow shallow breathing (little chest movement with breathing)
• feel faint, very dizzy, confused, or have other unusual symptoms

Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.

Physical dependence. Do not stop taking Actiq or any other opioid, without talking to your healthcare provider. 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.

A chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.

Actiq can cause drowsiness and vision changes. Do not drive or operate heavy machinery until you know how Actiq affects you.

Avoid drinking alcohol with Actiq. It can increase your chance of getting dangerous side effects.

Do not take Actiq

• if you are allergic to fentanyl or to any of its ingredients
• if you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for your cancer pain, and your body is used to these medicines.
• for short-term pain  that you would expect to go away in a few days, such as headache/migraines and dental pain

Grapefruit and grapefruit juice may interact with Actiq and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Actiq, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
• have or had a head injury or brain problem
• have liver or kidney problems
• have seizures
• have a slow heart rate or other heart problems
• have low blood pressure
• have mental problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
• have a past or present drinking problem (alcoholism), or a family history of drinking problems
• have a past or present drug abuse or addiction problem, or a family history of a drug abuse problem or addiction problem
• have diabetes. Each Actiq lozenge contains about ½ teaspoon (2 grams) of sugar.
• have any other medical conditions
• are pregnant or plan to become pregnant. Actiq may cause serious harm to your unborn baby.
• are breastfeeding or plan to breastfeed. Actiq passes into your breast milk. It can cause serious harm to your baby. You should not use Actiq while breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Actiq falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Actiq has been detected in human breast milk. Therefore, do not use Actiq if you are nursing because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using Actiq.

Take Actiq exactly as prescribed.

This medication comes in a lozenge form. 

Instructions for use of lozenges:

Place Actiq in your mouth between your cheeks and gums and actively suck on the medicine. Move the lozenge around in your mouth, especially along the inside of 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 cancer pain.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight
• your age

The recommended dose/dose range of Actiq (fentanyl) lozenge for the treatment of breakthrough cancer pain is 200 mcg to 1600 mcg. The lozenge should be consumed over 15 minutes. Actiq is only indicated for patients who are already taking around-the-clock opioid medications. The dose of Actiq is titrated based on your response to the medication and the dose may be repeated once in 30 minutes if additional pain relief is needed. Wait at least 4 hours before treating another episode of pain.

If you take too much Actiq, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Actiq is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Actiq at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION

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.

MEDICATION ERRORS

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.

ABUSE POTENTIAL

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.