Generic Name: fentanyl citrate (FEN-ta-nil SIT-rayt)

Brand Names: Actiq®

Classification: Narcotic Pain Medicine

Issue Date: 2006

Actiq treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief. Actiq may also be used for purposes other than those listed here.

Do not use Actiq if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan)
• phenelzine (Nardil)
• rasagiline (Azilect)
• selegiline (Eldepryl, Emsam)
• tranylcypromine (Parnate)

within the past 14 days. SERIOUS, life-threatening side effects could occur.

You should not use Actiq unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Seek emergency medical attention if you think you have used too much Actiq or if anyone else has accidentally swallowed it. An overdose of this medication can be fatal.

Overdose symptoms may include:

• weak pulse
• fainting
• shallow breathing
• or breathing that stops

Actiq may be habit-forming and should be used only by the person it was prescribed for. Actiq should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use more than four Actiq units per day.

Actiq (fentanyl citrate oral transmucosal) comes with a kit and instructions for storing and disposing of the Actiq units. It is very important to keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

You will also receive instructions for using the medicine. Follow these instructions carefully. Do not use the medication in larger amounts or for longer than prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.

Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.

Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit.

Do not use more than four Actiq units per day.

If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.

Do not stop using any other pain medicines your doctor has prescribed for you. Call your doctor if this medication does not relieve your pain. Actiq may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not stop using Actiq suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using this medication.

Store this medicine at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.

Pay special attention to your dental hygiene while you are using this medication. This medication can cause dry mouth leading to tooth decay.

You should not use Actiq unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Numorphan, Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not use Actiq if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan)
• phenelzine (Nardil)
• rasagiline (Azilect)
• selegiline (Eldepryl, Emsam)
• tranylcypromine (Parnate)

within the past 14 days. SERIOUS, life-threatening side effects can occur if you use fentanyl before the MAO inhibitor has cleared from your body.

You should not use this medication if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.

Before using Actiq, tell your doctor if you are allergic to any drugs, or if you have:

• a breathing disorder such as asthma or chronic obstructive pulmonary disease (COPD)
• a seizure disorder
• a history of head injury or brain tumor
• liver or kidney disease
• low blood pressure, heart disease
• a history of depression or other mental illness
• a history of drug or alcohol addiction

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. It is not known whether Actiq is harmful to an unborn baby. It could cause addiction or withdrawal symptoms in newborn if the mother uses fentanyl citrate during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Actiq may also cause addiction and withdrawal symptoms in a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.

If you are diabetic, you should know that each Actiq lozenge contains 2 grams (one-half teaspoon) of sugar.

Since Actiq is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose. Do not use more than four Actiq units per day.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Stop using Actiq and call your doctor AT ONCE if you have any of these SERIOUS side effects:

• shallow breathing, slow heart rate
• extreme sleepiness
• feeling light-headed, fainting

Less serious Actiq side effects may include:

• dry mouth
• headache, dizziness, weakness, anxiety
• nausea, vomiting, or constipation

Side effects other than those listed here may also occur. Call your doctor for medical advice about side effects.You may report side effects to FDA at 1-800-FDA-1088.

Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Actiq. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicine.

There are many other medicines that can cause serious medical problems if you take them together with Actiq, especially:

• aprepitant (Emend)
• diltiazem (Cardizem, Cartia, Dilacor, Tiazac)
• verapamil (Calan, Covera, Isoptin, Verelan)
• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin, Ery-Tab, E.E.S.)
• an antifungal medication such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox)
• HIV medicines such as indinavir (Crixivan), fosamprenavir (Lexiva), nelfinavir (Viracept), or ritonavir (Norvir)

If you are using any of these drugs, you may not be able to use Actiq or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Actiq. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.