Generic Name: fentanyl (sublingual) (FEN tan il sub LIN gwal)
Brand Names: Subsys
What is Subsys?
Subsys (fentanyl sublingual [under the tongue]) is an opioid pain medication. An opioid is sometimes called a narcotic.
Subsys spray is used to treat "breakthrough" cancer pain. Subsys is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.
Subsys may also be used for purposes not listed in this medication guide.
Important information about Subsys
Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).
Before using Subsys, tell your doctor if you have a breathing disorder (asthma, wheezing, COPD), slow heartbeats, seizures, mental illness, low blood pressure, liver or kidney disease, a debilitating condition, or a history of head injury, brain tumor, or addiction to drugs or alcohol.
Tell your doctor if there are children living in the home where you will store this medicine. Keep Subsys out of the reach of children. The amount of fentanyl in a Subsys spray unit can be fatal to a child. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
Before taking Subsys
Do not use Subsys 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. Do not use Subsys if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.
Tell your doctor if there are children living in the home where you will store this medicine. Keep Subsys out of the reach of children. The amount of fentanyl in a Subsys spray unit can be fatal to a child.
To make sure you can safely use Subsys, tell your doctor if you have any of these other conditions:
a breathing disorder such as wheezing, asthma, or chronic obstructive pulmonary disease (COPD);
seizures, epilepsy, or a history of head injury or brain tumor;
low blood pressure, slow heartbeats or other heart rhythm disorder;
mental illness such as depression, schizophrenia, or hallucinations;
liver or kidney disease; or
a personal or family history of drug or alcohol addiction.
Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share Subsys with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Subsys will harm an unborn baby. Fentanyl may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using Subsys. Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while you are using Subsys.
See also: Subsys pregnancy and breastfeeding warnings (in more detail)
How should I use Subsys?
Use Subsys spray exactly as prescribed. Never use Subsys in larger amounts, or for longer than recommended by your doctor. Keep using your around-the-clock narcotic pain medicine but never take Subsys together with a second form of fentanyl. Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device). If you switch to Subsys from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms). Your doctor may change your dose to make sure you get the best results.
Point the Subsys spray nozzle into your mouth, lift your tongue, and spray the medicine under your tongue. Hold the liquid under the tongue for 30 to 60 seconds. Do not spit, swallow, or rinse your mouth during this time.
You may use a second Subsys spray unit 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after using the second spray. Do not use more than 2 sprays for each episode of breakthrough cancer pain. You must wait at least 4 hours after your last dose of Subsys before you can treat a new pain episode.
Do not treat more than 4 pain episodes per day with Subsys. Call your doctor if you have breakthrough pain more than 4 times in one day.
Do not stop using Subsys or your other narcotic pain medicine without your doctor's advice. Ask your doctor how to avoid withdrawal symptoms when you stop using pain medication. Store in the original carton at room temperature, away from heat and moisture. Keep track of the amount of medicine used from each carton. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Keep out of the reach of children. The amount of fentanyl in each Subsys spray unit can be fatal to a child. Carefully follow the instructions for disposing of this medicine when it is no longer needed. Dispose of used spray units in the disposal bags provided with this medication. Empty any unused spray units into the disposal bottle provided.
What happens if I miss a dose?
Since Subsys is used as needed, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal. Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).
What should I avoid while taking Subsys?
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you. Do not drink alcohol. It can increase your risk of a dangerous side effect while taking Subsys.
Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
See also: Subsys and alcohol (in more detail)
Subsys side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Subsys: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Subsys and call your doctor at once if you have a serious side effect such as:
slow heart rate, weak or shallow breathing, sighing, severe drowsiness;
confusion, extreme fear, unusual thoughts or behavior; or
feeling like you might pass out.
Less serious Subsys side effects may include:
dry mouth, nausea, vomiting, constipation;
headache, drowsiness, tired feeling; or
white patches or sores inside your mouth or on your lips.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Subsys side effects (in more detail)
What other drugs will affect Subsys?
Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by fentanyl. Tell your doctor if you regularly use any of these medicines.
Many drugs can interact with fentanyl. Below is just a partial list. Tell your doctor if you are using:
phenobarbital (Solfoton) or other barbiturates;
pioglitazone (Actos, Actoplus Met, Duetact);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), telithromycin (Ketek), and others;
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV/AIDS medicine such as delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), nevirapine (Viramune), ritonavir (Norvir, Kaletra), and others;
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and others; or
steroids such as prednisone and others.
This list is not complete and there are many other drugs that can interact with Subsys. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
More Subsys resources
- Subsys Advanced Consumer (Micromedex) - Includes Dosage Information
- Subsys spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Subsys Prescribing Information (FDA)
- Abstral MedFacts Consumer Leaflet (Wolters Kluwer)
- Actiq lozenge MedFacts Consumer Leaflet (Wolters Kluwer)
- Actiq Prescribing Information (FDA)
- Duragesic Advanced Consumer (Micromedex) - Includes Dosage Information
- Duragesic patch MedFacts Consumer Leaflet (Wolters Kluwer)
- Duragesic Prescribing Information (FDA)
- Fentanyl Professional Patient Advice (Wolters Kluwer)
- Fentanyl Citrate Monograph (AHFS DI)
- Fentora Prescribing Information (FDA)
- Fentora MedFacts Consumer Leaflet (Wolters Kluwer)
- Ionsys Prescribing Information (FDA)
- Lazanda Advanced Consumer (Micromedex) - Includes Dosage Information
- Lazanda spray MedFacts Consumer Leaflet (Wolters Kluwer)
- Onsolis Prescribing Information (FDA)
- Onsolis soluble film MedFacts Consumer Leaflet (Wolters Kluwer)
- Sublimaze Prescribing Information (FDA)
- Sublimaze Advanced Consumer (Micromedex) - Includes Dosage Information
- fentanyl MedFacts Consumer Leaflet (Wolters Kluwer)
Where can I get more information?
- Your pharmacist can provide more information about Subsys.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Subsys only for the indication prescribed.
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Copyright 1996-2012 Cerner Multum, Inc. Version: 3.04. Revision Date: 2012-03-30, 4:06:32 PM.